University of Manchester Oral Health Education Dissertation

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Thesis and Dissertation
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This dissertation, submitted to the University of Manchester by Yasser Khan, explores the effectiveness of verbal and nonverbal oral health clinical education in improving oral health in male and female Type 1 diabetic patients. The study, supervised by Azad Aziz, investigates whether a combined approach of verbal and nonverbal training enhances oral health compared to standard instructions. The research includes a literature review, methodology detailing study design, participant selection, randomization, and assessment tools (BOAS, MPS, and an oral health assessment tool). The dissertation outlines data management, statistical analysis, and ethical considerations. It aims to determine the impact of different training methods on oral health conditions, measured by dental caries, periodontal diseases, and other relevant metrics. The research utilizes a randomized control trial with pre- and post-test analysis to compare the outcomes of experimental and control groups, providing insights into the efficacy of comprehensive oral health education for diabetic patients.
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The effectiveness of Verbal and Nonverbal Oral Health Clinical Education in improving Oral
Health in Male and Female Type 1 Diabetic Patients.
A dissertation submitted to the University of Manchester for the degree of Masters of
Restorative and Aesthetic Dentistry in the Faculty of Biology, Medicine and Health
2018-2020
Yasser khan
10328243
Supervised by
Azad Aziz
DIVISION OF DENTISTRY
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Table of Contents
Abbreviation...............................................................................................................................6
Abstract......................................................................................................................................7
Declaration.................................................................................................................................8
Author information...................................................................................................................10
Background and Introduction...............................................................................................11
Definitions................................................................................................................................11
Hypotheses...............................................................................................................................15
Aims and objectives.................................................................................................................16
Research Question................................................................................................................16
Hypotheses...........................................................................................................................16
Research Aim.......................................................................................................................16
Objectives.............................................................................................................................16
Literature review......................................................................................................................17
Introduction/ Rationale.........................................................................................................17
Search strategy.....................................................................................................................19
Collection of the data...........................................................................................................20
Critique of the methodology used........................................................................................28
Assess for risk of bias..........................................................................................................34
Conclusion............................................................................................................................35
Study Design and methodology...............................................................................................37
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Executive summary..................................................................................................................37
Table for abbreviations............................................................................................................38
Introduction..............................................................................................................................39
Literature review......................................................................................................................39
Research question.....................................................................................................................43
Research aim........................................................................................................................43
Research objectives..............................................................................................................43
Methodology............................................................................................................................43
Study design.........................................................................................................................43
Study population and sampling............................................................................................44
Randomisation......................................................................................................................45
Consent process....................................................................................................................45
Oral health training sessions................................................................................................46
Schedule of training.............................................................................................................47
Schedule of assessment........................................................................................................48
Data management.....................................................................................................................48
Data collection.................................................................................................................48
Data analysis....................................................................................................................51
Expected outcomes...................................................................................................................51
Ethical issues............................................................................................................................52
Roles and responsibilities of each team member.....................................................................52
Protocol ready..........................................................................................................................53
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Timeline of the study...............................................................................................................53
Data management, quality assurance and statistical analysis..................................................57
1. Data Collection and Management........................................................................................57
2. Quality Assurance................................................................................................................60
3. Sample size calculation........................................................................................................60
4. Hypotheses...........................................................................................................................62
5. Qualitative Analysis.............................................................................................................62
6. Statistical Analysis...............................................................................................................65
6. Critical Implication..............................................................................................................68
Ethics........................................................................................................................................69
Participant Information Sheet..................................................................................................69
Consent Form...........................................................................................................................73
Final Sections and Appendices................................................................................................74
Budget......................................................................................................................................74
Collaborations..........................................................................................................................75
References................................................................................................................................77
Appendix-A..............................................................................................................................85
Search results.......................................................................................................................85
Appendix-B..............................................................................................................................87
Interview questions..............................................................................................................87
Mucosal-Plaque Score (MPS)..............................................................................................88
Beck Oral Assessment Score (BOAS), modified.................................................................89
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Oral Health Assessment Tool...............................................................................................90
Mucosal-Plaque Score (MPS)..............................................................................................92
Beck Oral Assessment Score (BOAS), modified.................................................................93
Oral Health Assessment Tool...............................................................................................94
Introductory Letter...............................................................................................................95
Interview questions..............................................................................................................96
Abbreviation
T1D Type 1 diabetes
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HLA human leukocyte antigen
AIHW Australian Institute of Health and Welfare
DMFT Decay-missing- filled teeth
CPITN index Community Periodontal Index of Treatment
Needs index
CRP level C-Reactive Protein level
FPG Fasting Plasma Glucose
HbA1c glycosylated hemoglobin
PI Plaque Index
GI Gingival index
PD Pocket Depth
CAL Clinical Attachment Level
NSPT Non-Surgical Periodontal Treatment
OHI Oral Hygiene Instructions
RCT Randomized Control Trial
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Abstract
Type 1 diabetes (T1D) is prevalent among children and adolescents and creates an impact on
their health and wellbeing. People suffering from T1D are at an increased risk of developing
dry mouth, periodontitis, gingivitis, burning mouth syndrome and poor healing of the
damaged oral tissues. This research proposal aims to evaluate whether verbal and nonverbal
training helps in improving oral health of T1D patients, when compared to standard
instructions.
This study includes 30 participants in this study while dividing the participants into two
groups, 15 participants in experimental and 15 participants with control. Initially, an
interview will be done to identify their current awareness and Oral hygiene practices to
maintain good oral health. Experimental group has been provided with verbal and nonverbal
training programs and control group has been provided with only standard oral hygiene
instructions. Finally, multiple oral assessment tools are used to compare the resulting
improvement in oral health. Pre-test, post-test with comparative T-test analysis (both one tail
and two tail) will be done to compare the results of experiment and control group of
participants.
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Figure 1
This figure shows two tailed t test with the significance (p value in x axis) and degree of
freedom (in y axis).
From this research it has been found that there is a significant difference in oral health
condition between the participants provided with extensive verbal and nonverbal training and
participants provided with only standard instruction. Therefore, it has been recommended that
through collaborative partnership of private and public organizations, verbal and non-verbal
training in Oral hygiene instruction for the patients with T1D helps in improving the Oral
health.
Declaration
No portion of the work referred to in the dissertation has been submitted in support of an
application for another degree or qualification of this or any other university or other institute
of learning.
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Intellectual property statement
i. The author of this dissertation (including any appendices and/or schedules to this
dissertation) owns certain copyright or related rights in it (the “Copyright”) and s/he
has given The University of Manchester certain rights to use such Copyright,
including for administrative purposes.
ii. Copies of this dissertation, either in full or in extracts and whether in hard or
electronic copy, may be made only in accordance with the Copyright, Designs and
Patents Act 1988 (as amended) and regulations issued under it or, where appropriate,
in accordance with licensing agreements which the University has entered into. This
page must form part of any such copies made.
iii. The ownership of certain Copyright, patents, designs, trademarks and other
intellectual property (the “Intellectual Property”) and any reproductions of copyright
works in the dissertation, for example graphs and tables (“Reproductions”), which
may be described in this dissertation, may not be owned by the author and may be
owned by third parties. Such Intellectual Property and Reproductions cannot and must
not be made available for use without the prior written permission of the owner(s) of
the relevant Intellectual Property and/or Reproductions.
Further information on the conditions under which disclosure, publication and
commercialization of this dissertation, the Copyright and any Intellectual Property and/or
Reproductions described in it may take place is available in the University IP Policy (see
http://documents.manchester.ac.uk/display.aspx?DocID=487), in any relevant Dissertation
restriction declarations deposited in the University Library, The University Library’s
regulations (see http://www.manchester.ac.uk/library/aboutus/regulations) and in The
University’s Guidance for the Presentation of Dissertations
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Author information
The principal investigator of the research is Dr Yasser Khan. Dr Khan completed his Bachelor of dental surgery
from the If you are making a statement on the outcome of the results you also need to provide a figure for the
statistical significance and confidence interval. This is a hypothetical scenario but need to look like real data.
in TN, India in 2004. After working 3 years in India, he went on to practice dentistry in
Melbourne Australia from 2008 till present. He is presently a student of the Msc programme
of Aesthetic and Restorative dentistry offered by the University of Manchester
His address is 65 high street, Kyneton, Victoria.
The contact details of the principal investigator is +61404211374.
Email ID of the principal investigator is Yasserkhan20@gmail.com.
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Title of the study
The effectiveness of verbal and nonverbal oral health clinical education in improving oral
health in male and female Type 1 Diabetic patients.
Background and Introduction
Diabetic patients are often at risk of developing oral health challenges. The most common of
these problems include dry mouth, dental caries, tooth loss and periodontal diseases, among
others (Nazir et al., 2018). The proposed study seeks to assess the efficacy of verbal and
nonverbal oral health training on Type 1diabetic patients in comparison to standard verbal
oral health instructions without any verbal or non-verbal training. The aim of the study is to
discover the effectiveness of dental health knowledge among Type 1 diabetic patients, over a
period of 2 years. The primary objective of this study to examine determine efficacy of verbal
and non-verbal training. The secondary objective is to compare the efficacy of both of the
training with the references of different scores.
Definitions
Dental Health Clinical Training
Dental Health Clinical Training helps patients with dental problems to prevent the
consequences caused by the poor oral health. In these types of training the dental health
workers support the patient clinically or non-clinically to prevent oral disease and poor oral
health practices (Dwiel et al., 2019). The clinical interventions are related to different
medications whereas the non-clinical interventions are related to several health educational
programs and presentation or graphical representation of different training programs. Public
Health Dentistry is one of the better ways of dental heath training which helps general public
to get better oral health.
Type 1 diabetes
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Type 1 diabetes is a health condition where the pancreas do not produce sufficient
insulin and as a result the level of glucose is increased in blood(Katsarou et al., 2017).
This type of diabetes is also known as juvenile diabetes. Thirst, frequent urination, blurred
vision and hunger fatigue are some symptoms of type 1 diabetes.
Standard oral hygiene instructions
The standard oral hygiene instructions are aimed to improve the oral health practices and
to prevent different oral diseases. There are a few good practices which will help a person to
maintain good oral hygiene. The standard oral instructions are
One should brush his or her teeth twice a day
One should practice flossing to clean in between the teeth once daily.
An individual should avoid sweets or sugar rich foods in his or her diet.
An individual should visit the dentist on regular basis to evaluate his or her oral
health.
One should not smoke for better oral health.
Nonverbal Training
Nonverbal training consists of graphical representation of objectives of oral health
maintenance in diabetes type 1 patient. The training consists of power point presentation,
graphical presentations, Picture Exchange Communication System, motivational toys,
cartoons and slides, colour posters and written instructions or the diagrams of definite oral
health practices. It can also include techniques such as Tell show do and role play.Moreover,
usage of artefacts and touching behaviour will also be incorporated in the nonverbal training
sessions that will focus on the steps that need to be maintained for enhancing oral health.
Dental Caries
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Dental caries is demineralization of the calcified tissues of teeth by acids produced by
bacteria in the mouth. The condition leads to destruction of the organic and inorganic
structure of the tooth leading to cavitation.
Periodontitis
Periodontitis is a condition involving an inflammation of supporting tissues of teeth
caused by microorganisms or groups of microorganisms, resulting in progressive destruction
of the periodontal ligament and alveolar bone, which can then result in tooth loss.
Bleeding on probing
Bleeding on probing is a term used by dentists when referring to bleeding that is
induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface
between the gingiva and a tooth. Bleeding on probing often is indicative of gum
inflammation or gingivitis.
CPITN index
Community Periodontal Index of Treatment Needs (CPITN) is used for measuring the
periodontal treatment needs of the population. WHO created the index in 1978 for recording
and promoting better oral health practices and oral health awareness among the populations
(Saribas et al., 2017).The CPITN index is the score of the screening procedure of the clinical
assessment for presence and absence of the gingival bleeding, calculus and periodontal
pockets.
Plaque scores
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The score signifies the total amount of plaque/bacteria present in the oral cavity. The
score measures the location, number and percentage of bio-film surfaces in the oral cavity.
Teeth are measured as having four surfaces. These sites are being checked while giving the
Plaque score.
PICO Question
What is the impact of verbal and nonverbal oral health training on improving the Type 1
diabetic patient’s oral health, as opposed to standard verbal oral health instructions?
What population group do
you intend to study (P)?*
Male and Female Type 1 Diabetic Patients within 18-
25 years of age and having carbohydrate rich diet.
What intervention do you
intend to examine (I)?*
Dental Health Clinical Training using Verbal and
Non Verbal oral hygiene instructions (audio-visual
presentation, power-point presentation, training
sessions with practical explanations of oral hygiene
practices).
What comparator do you
intend to use (C)?*
Verbal oral hygiene instructions.
What is/are your outcome
measure/s (O)?*/**
Oral Health Condition, measured by the incidence of
dental disease such as dental caries and periodontal
diseases (measured by Bleeding on probing, CPITN
index and plaque scores) every 6 months for a period
of 24 month.
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Scores or assessment
tool
Duration
BOAS (Beck Oral
Assessment Scale)
1 hour 5minutes
MPS(mucosal-plaque
score)
50 minutes
Oral health assessment
tool
1 hour 10 minutes
Hypotheses
The proposed study will aim to test the following hypotheses:
H0: Oral health training among Type 1 diabetic patients does not have any impact on the risk
of patients developing dental health problems such as dental caries and periodontal diseases.
H1: Oral health training among Type 1 diabetic patients reduces the risk of the patients
developing dental health problems such as dental caries and periodontal diseases.
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Aims and objectives
Research Question
Do verbal and nonverbal oral health training help to improve Type 1 diabetic patient’s oral
health (during the 2-year period as opposed to standard verbal oral health instructions)?
Hypotheses
The proposed study will aim to test the following hypotheses:
H01: No statistical difference between the dental and periodontal parameters is present
among T-1-Daibetes patients following the interventions (Verbal and Non-Verbal) of Oral
hygiene instructions and standard verbal Oral hygiene instructions over a 24-month period.
H2: Statistical difference between the dental and periodontal parameters is present among T-
1-Daibetes patients following the interventions (Verbal and Non-Verbal) Oral hygiene
instructions and standard verbal Oral hygiene instructions over a 24-month period.
Research Aim
To investigate the effectiveness of Verbal and Nonverbal Oral Health Clinical Education in
improving Oral Health Type 1 Diabetic Patients (Male and Female) over a period of 2 years
Objectives
The objective of the research is to find the effectiveness of both verbal and non-verbal
training in the improvement of oral health of the patients with type 1 Diabetes and to compare
the methods to intervene for best outcomes.
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Literature review
Introduction/ Rationale
Type 1 Diabetes is a metabolic disorder that can cause acute and chronic complications due
to insulin resistance developed by a relative lack of insulin. Chronic inflammatory disease
can destroy dental health (Verhulst et al., 2019). Type 1 diabetes is an autoimmune disease.
The body's immune response destroys insulin-producing cells (beta cells) in the pancreas.
When the insulin producing cells are destroyed, it leads to a deficiency in Insulin, which
results in a decrease uptake of glucose by the cells and increase of glucose/sugar levels in the
blood. This leads to a situation often referred to as Hyperglycaemia. Type 1 diabetes is a
disease in which the body does not produce enough insulin. It is also called insulin dependent
diabetes or juvenile diabetes. Following digestion, to provide energy to the cells, glucose
needs to enter the various cells of the body.
In Diabetes , there is a change in the micro and macro vascular integrity which is the cause
of end organ damage e.g. Retinopathy. In people with poor control of glucose, there is a high
level of advanced glycation end products (AGE) in the periodontal tissues. These AGEs
induce changes in the cells structure and function. Accumulation of AGEs increase the
immune response of periodontal pathogens resulting in increase of inflammatory proteins
such Cytokines and Tissue necrosis factor and interleukins.
In the oral cavity, periodontitis, dry mouth, caries, oral mucosal lesions, oral cancers and taste
disturbances are some of the dysfunctions which are caused by diabetes. Common
complications of Diabetes include retinopathy, nephropathy, neuropathy, macrovascular
diseases and altered wound healing.
In Diabetes, the function of cells involved in the immune response (neutrophils, monocytes,
macrophages), is altered. Also, the chemotaxis and phagocytosis of neutrophils is impaired.
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Neutrophils are the first line of defense, and any dysfunction in them results in periodontal
destruction. Another immune response that is often seen, if the increased level of
proinflammatory cytokines and mediators such as Tissue Necrosis Factor in response to
periodontal bacteria which results in increased periodontal tissue destructionThere is
defective wound healing in Diabetics. Fibroblasts is the primary reparative cell in the
periodontium and the count and function of fibroblasts is altered in Hyperglycemia. The
resulting collagen produced is susceptible to rapid degradation.
Diabetes is condition that can affect the whole body including the mouth. It has been
found that people with diabetes have a higher risk of dental conditions such as dry mouth,
gingivitis, periodontal disease, Mouth ulcers, Oral thrush and fungal infection etc. It has been
stated that uncontrolled diabetes can decrease the saliva resulting in dry mouth. Medications
for diabetes may also cause dry mouth and taste disturbance, such as a metallic taste. Poor
blood glucose control leads to increase in bacterial growth which results in gingivitis and
periodontitis and increases the risk of infections. Oral fungus thrives on high levels of
glucose in the saliva. Overall, it has been found that people with diabetes have very limited
knowledge of the direct and indirect relationship between oral condition and glucose levels
and hence it is necessary to educate patients about their increased risk of oral health problems
(Poudel et al., 2018). This provides the rationale behind the fact, why is it necessary to
educate patients about diabetes. Kaur et al. (2015) have stated that clinicians should be
empowered to explain the need for oral hygiene and its background to their enquiries related
to the gum disease.
This research will provide a literature review to evaluate the effectiveness of verbal
and the non-verbal education to promote oral hygiene in type 1 diabetic patient.
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A literature review was conducted to assess the impact of both verbal and non-verbal
oral health training in improving the Type 1 diabetic patient’s oral health.
Search strategy
Only EMBASE search engine was used to search the articles for the research
methodology. Different keywords are used for searching proper articles. Some examples for
the suitable keywords are given below:
“Use of oral health education in type 1 diabetes.”
“ Instructions promoting oral hygiene in type 1 diabetes”,
“ relation between diabetes and oral problems”,
“effectiveness of verbal and non –verbal training in oral health”,
“Diabetics and oral hygiene.”
“Verbal and non-verbal instructions for maintaining oral hygiene in diabetic patients.”
“periodontitis”
“Type 1 Diabetes and dental problem”
“plaque score ”
“CIPTN and bleeding probe”
“gum disease”
All the studies were selected by adhering to the following inclusion criteria: -
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The articles chosen were in English between the years 2013 to 2020, scientific
journals with human participants.
The participants of the articles should be Diabetic.
The interventions in the papers should include verbal and non-verbal training
with the screening methods consisting plaque score, CIPTN and bleeding
probe.
The exclusion criteria were studies before the year 2013, studies with animal studies
and published in language other than English. Only those papers having full text pdf version
is selected for the literature review. The paper which are not relevant to the topic or out of the
context of this research.
Collection of the data
A tab-based collection of data was designed for the item included in the review. Risk
analysis was done to evaluate the quality of the systematic review and the meta-analysis. The
research incorporates qualitative risk analysis as the objective of this research and to review
the probability and impact according to the scale (Liu et al., 2018). All the data obtained has
been cross checked. The search conducted in EMBASE identified about 43,824 articles in the
initial search. After rigorous research, out of which 146 articles were selected based on the
title of the papers. The search conducted in EMBASE identified about the 43,824 articles in
the initial search. After rigorous research, out of which 146 articles were selected based on
the title of the papers. Out of those, 7 papers have been taken for constructing this short
systematic review. The inclusion criteria of the paper are:
The papers should be peer-reviewed
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The paper should be written in English
The article should include the keywords
The articles should be included with the issues of Type 1 Diabetes and oral health
problems.
The articles should be published within the 5-10 years of the research
The articles should emphasise on the effectiveness of the oral hygiene instructions
among the diabetic patients.
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A PRISMA table has been given below to show the selection of the articles.
Records identified through the use of
limiters (n=3500)
Studies included
(n=7)
Records after Duplicates removed
(n=453)
Records screened
N=146
Full-text articles on assessment
(n=20)
Records excluded based on the title
only
(n=90)
Records excluded based on abstract
(n=20)
Identification
Screenin
g
Eligibility
Include
d
EMBASE
(n=43824)
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The 20 articles were chosen for the similarity of inclusion and exclusion criteria of the
research analysis. The 20 articles contained the appropriate keywords with the proper
intervening strategies. The included seven articles were taken as these papers have specific
topics related to the research questions.
From 20 articles, we exclude 2 articles as those were discussed about the type
2 diabetes among children who are below 18.
5 articles did not mention about BOAS and MPS scores for assessing oral
health condition among the participants.
3 article discussed about the gestational diabetes.
3 articles were eliminated as these described effectiveness of different surgical
methods and clinical apparatus on dental problems.
The papers also have mentioned the population with issues related to diabetes which
leads to different oral problems. The intervention strategies related to verbal and non-verbal
training and the effectiveness or drawbacks of the intervening strategies.
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Critical appraisal of Key publications.
Assessment of the risk of bias requires a degree of the methodological expertise and
can be conducted by the development of the guidelines. Once it has been completed, the risk
of the based assessment can be used for informing the synthesis of the studies, findings and
integrated into the overall assessment of the certain body of evidence. CASP (Critical
Appraisal Skills Program) tool has been used for evaluating the studies. The articles are
evaluated by the help of critical appraisal and then incorporated in the research analysis.
Critical appraisal is one of the explicit and transparent methods to evaluate the data in the
published researches. The validity, adherence standard, conclusions and generalizability can
be assessed in the critical appraisal of the research paper. The evaluation process helps in the
assessment of the trustworthiness, value and relevance in a particular context ("CASP
Checklist: 10 questions to help you make sense of a Systematic Review", 2020). After
conducting the critical appraisal, understanding of core concepts related to the papers and
effectiveness of interventions can be assessed easily. The assessment will focuses on
periodontal diseases and the oral abnormalities scores for the selected participants. After
performing critical appraisal, statistical significance and comparison of effective
interventions can be observed among the selected articles. After performing critical appraisal,
unnecessary literatures can be eliminated and valid studies can be selected. Validity of the
articles and importance of results of systematic review can be addressed. The valued
important articles are evaluated as an evidence of caring for the patient. Examples for
questions regarding critical appraisal are;
“Are the result of this paper valid?”
“Are the valid results of article important?”
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The paper by Saengtipbovorn and Taneepanichskul (2014) have stated that one of the
disadvantages of a quasi-experimental study is that, it can cause selection bias, due to the
willingness to participate. The participants were chosen from very less number of clinics
which can be a cause of selection bias. The paper had also rightfully pointed out that the
single blinded technique can cause the measurement bias so that the participants did not
know whether they were part of intervention or control group .
Raman et al. (2017) does not employ a double blinded trial, hence the risk of bias has
not been assessed. A proper inclusion and exclusion criteria has been used for avoiding any
kind of bias. The risk of bias in the study by Doger et al. (2017) can be due to the short
duration of the study as significant differences has been detected in shorter duration
It has been well established by several literary sources which proves that
communication between the patients and a health care worker is necessary to make patients
adhere to the guidelines of maintain a sound oral health and glycemic control. It has been
stated information can be imparted to the patients by verbal mode or non-verbal mode.
Verbal mode of education can be facilitated by non-verbal teaching or consultation with the
doctors. Non –verbal mode of communication involves using internet-based practice such as
tele-health to educate the patients (Macdonald et al. 2013). The clinical implication of the
study is that it indicates towards the fact that internet-based teaching can be initiated in the
hospitals.
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According to Dickinson et al. (2017) stigma has historically been associated with the
diagnosis of the diabetes that contributes to stress and feelings of judgment and fear. It has
been stated that non-handicapping language helps to maintain the integrity of an individual
by the avoidance of language implying that a person as a whole is disabled. The paper has
recommended that while providing verbal instructions to patients with diabetes should be
normal, non-judgmental and should be based on actions, facts or the physiology. It has been
found that judgmental words can promote stigma. The paper has discussed about the
techniques and importance of the verbal communication in controlling a physical condition
(diabetes). This selected paper helps to suggest the different ways of effective communication
with proper intervention methods. The article will help the study by promoting
communication
In a study by Raman et al., (2014), it has been found that oral health information in
addition to periodontal therapy has been found to be effective in patients suffering from type
1 diabetes. The difference between the plaque indexes of the two groups were found to be
significant, with the P values. The result are highly significant as the p-value is less than
0.001.The difference between two subject groups has significant outcomes for the periodontal
parameter, Serum HbA1c and CRP(C-reactive Protein) levels and responses of the patients
with the references of serum HbA1c and CRP levels for the respective subjects. The
periodontal parameters are improved significantly with the depth of the probing pockets
(which is less than 4mm). The difference in plaque index (PI) between NSPT (nonsurgical
periodontal treatment) and OHI (oral hygiene instructions) groups were significant at 2
months recall (p = 0.013). The indexes are significant also as it is higher than the 0.001 but
0.05. The p-value for the index is significant in both the responses of the groups.
No significant difference has been found between the other clinical parameters.
Information about patterns of bushing and washing of teeth after meals are necessary.
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Similarly, this fact is supported by stating that diabetic patients should also refrain from the
consumption of sweetened food as that will keep them healthy and glycemic control will be
achieved.
According to Nakre and Harikiran (2013), oral health education in patients suffering
from diabetes have shown a reduction in plaque, bleeding and treatment of the dental caries.
The review has rightfully proved that oral health education of patients by the dental
professional is important to reduce dental problems and helps in glycemic control in
individuals with high blood glucose level.
Apart from verbal education, nonverbal education modalities should also be used for
educating patients with type 1 diabetes.
Doger et al. (2019) have stated that information technology and online education can
be recommended to teach the patients, families as well as the health care programs in their
graduate and the undergraduate program of nursing. It has been clearly stated that
communication programs that are internet based are mainly are useful for providing
education to the patients residing in the rural areas. Another positive feature of the program is
that patients can receive suggestions in line with the requirements rapidly. In does not require
any face to face direct communication, expenses are saved that could have used in the
transportation. Educating healthcare professionals is helpful for implementation of better
educational interventions. Higher rate of education will help the health professionals to assess
condition of patients within less interval of time and reduce the associated risks.
In the paper by Chrvala, Sherr and Lipman (2016) it was stated that 86 % of the
interventions have achieved significant improvements in the blood glucose level. Most of the
studies have shown a statistically significant reduction of the blood glucose level (P=0.13).
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The alpha value of the probability test is 0.05 and the p-value of the study is 0.13, which
cannot be considered as a significant value. The clinical implication of the impact of DSME
on the decrease in glycemic control is essential. The reason behind the clinical significance is
to predict glycemic control among the major factors of disease progression and the
development of microvascular and macrovascular problems in the participants with T2DM.
All the studies have shown that the overall mean reduction to be 0.7 and 0.17 for the
intervention group and the control group. The clinical implication for this study is that
Diabetes self-management education and support tool kit (DSME) is a feasible educational
tool that can be applied, although the heterogeneity of the intervention, still needs to be
researched.
In the paper by Saengtipbovorn and Taneepanichskul (2015) the analysis had used 95
% confidence interval with a P value < 0.05, thus increasing the rigor and the validity of the
results. The results show that the P-value is less than 0.05. Therefore it can be said that the
result is statistically significant with each test (Tal, 2011). The baseline characteristics,
glycemic status, periodontal status showed that p values are less than in most of the cases. In
this article P value for FPG (fasting plasma glucose) and HbA1C are less than 0.05.
However, the baseline results do not show a significant p-value as most of the data were less
than the 0.05. On the other side, the confidence interval is 95%, so it can be showed that the
results are significant The strengths of this study are 98.5% of response rate and use of
biomarkers, including FPG, HbA1c, PI, GI, PD, and CAL for examination of the expected
outcomes.
The implication of the paper is that lifestyle intervention programs and interventions
need to be introduced to spread awareness among elderly people for maintaining the oral
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health. Though the paper is focused on the elderly population, the results and information
related to the outcomes need to be considered as general aspect of education.
Critique of the methodology used
The paper by and Harikiran (2013) is a systematic review evaluating the
effectiveness of educational program to maintain oral hygiene and diabetes control in
patients. The paper belongs to level 1 of the hierarchy of evidence. As they provide the
strongest data. This study has used about 40 articles necessary that fulfilled the inclusion and
exclusion criteria. 40 papers increase the validity and reliability of the study. The validity of
the study is high because it used the best available evidence that supported the quality aspect
of the review. The use of empirical intervention was used for summarizing the evidence. The
research has combined the findings of different studies that were carried out in the
investigation. The review has rightfully proved that oral health education of patients by the
dental professional is important to reduce dental problems and helps in glycemic control in
individuals with high blood glucose level. Although the quantitative values of effectiveness
have not been explained in the paper and difficulties are not listed clearly due to lack of
identification of the factors.
Along with the effectiveness of oral health education, it was found that it is important
to improve the awareness, approach and training of oral health for reducing tooth loss, plaque
scores, gingival and periodontal inflammation. This paper is useful, as it has drawn relating
information that assessed the effectiveness of oral health programs and assessing its
importance. They have used systematic review, which was similar to the study that was
chosen in order to offer a high level of evidence-based study. The study was based on 40
articles that were chosen based on appropriate keywords for selecting appropriate papers for
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the literature review. The article has cited correct inclusion and the exclusion criteria. All the
studies have been selected based on some mentioned coding variables such has Oral hygiene
indices and blood sugar levels. The dependent variable is the blood glucose level and the
independent variable is oral hygiene. However, it was difficult to collate the idea into a single
theme as different research have used different approaches.
The randomized clinical study by Raman et al. (2014), have proved that both dental
health education and periodontal therapy is necessary to treat the clinical manifestations in
chronic periodontitis in patients with the high glycemic level. The methodology adopted by
this paper is relevant to the clinical question due to this fact. Randomized control is the most
rigorous way of determining a cause and effect relation. A randomized control increases the
reliability of the study as they involve random allocation of the intervention groups. This
primary quantitative study used statistical analysis for understanding the effect of nonsurgical
periodontal therapy in comparison to oral hygiene instruction specifically in Type 2 diabetes
patients. The evidence from RCT was used that helped in critically assessing the issue from
the perspective of diabetic patients. Due to the different allocated groups, plaque index in the
NSPT group and gingival bleeding index in the OHI group can be analyzed in an effective
way. Moreover, RCTs demonstrate the effect of periodontal therapies with 0.4% reduction in
HbA1C in the interval of 3 months.
Dickinson et al. (2017) have conducted a systematic review to find out the use of
languages in diabetes care and education. This paper belongs to level one of the hierarchies of
evidence due to its high impact factor. The paper had provided information about the
different types of verbal communication that were used for educating a target population,
such as a person’s ability to understand a language and his mastery over it. Different types of
verbal communication can be used in treating oral hygiene among diabetic patients. It was
found that the use of verbal communication was useful in spreading awareness among the
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population; thus, the impact of language is stated to be critical in this context. The strength
includes that the study addressed a clearly focused question like how effective language can
be used in diabetic care and education. This paper has chosen certain relevant papers.
The quasi-experimental study by Saengtipbovorn and Taneepanichskul, (2014) have
proved that together with some lifestyle changes and dental care in one program has been
found to be helpful in managing the oral complication in elderly patients having diabetes.
This paper has employed a quasi-experimental study as it brings about realistic features from
both the experimental data and non –experimental designs. This was done by improving the
metabolic condition of an individual which in turn helped in management of diabetes in an
effective manner. The blood glucose was variable due to oral health complications.
Therefore, it can be stated that the management of oral hygiene is useful in controlling
diabetes, which is in alignment with the hypothesis of the study. In can be used for
maximizing the internal and the external validity of the study. 66 diabetic patients have been
chosen for the study; hence the sample size of the participant is low. The total number of
patients took appointment to the doctors’ clinic is 500. However, only 132 people were
involved and as a result each group is consist of 66 participants. The low number of
participants can be associated with confidentiality interval and errors (type 1and type 2). It is
low because a large number of people on a worldwide basis are suffering from diabetes and
are in need of strategies for controlling and managing it. There was no sample size
calculation, the reason is unknown. This increases the generalizability of the study. Faber and
Fonseca (2014) have stated that inappropriate sample sizes reduce the power of the study and
can compromise the conclusions that are drawn from the study. Another methodological
constraint of the study is that it was a single-blinded study, which increases the risk of bias.
The single-blinded study is stated to be a type of clinical trial that is used by the investigator
for either understanding the treatment or intervention that was received by the participants.
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The study has shown that the program (Lifestyle Change plus Dental Care (LCDC) program)
mentioned in the article is negatively correlated with the periodontal and glycemic status and
these were maintained for three months. Implementation of the specific program is able to
reduce the dental problem that is why the program is negatively correlated with the dental
problems of the patients. The program was continued with the 3 months of follow-up and
multiple linear regression was done.
In summary, the study conducted on assessing the effectiveness of verbal and non-
verbal education to promote oral hygiene in type 1 diabetic patients, it was found that verbal
communication was extensively investigated by various researchers in conducting the study.
However measuring the effectiveness was not focused by any of the studies. The findings
state that it is important to reduce mortality and morbidity rate related to diabetes, which is
considered as a public health issue. Therefore, the complication of poor oral hygiene needs to
be understood and strategies need to be developed for addressing it on priority basis.
Nakre and Harikiran (2013) is a systematic review, where recommendations for using
appropriate language can be used for providing health education to the patients suffering
from diabetes. The reliability of the methodology used in the paper was supported by several
cross references supporting facts like use of proper phrases free from stigma, using simple
languages that can be used to provide education to common people.
In relation to this (Macdonald et al. (2017) have stated that simple languages can be
used while providing education to patients. The paper discusses the different interventions as
relevant, in the papers used in the systematic review. During the evaluation of the papers, it
has been observed that the target population of most of the selected articles are children and
adolescents. This research emphasizes on oral health education and training and the
effectiveness of these procedures among children and adolescents. The authors of the paper
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preferred articles which discussed the oral health of migrants. Some papers were chosen for
discussing innovative intervention designs. The training involved videos, pictures, graphics
and other digital media. These innovative techniques can help to educate oral health
practices.
Non-verbal education modalities such as application of tele-health for educating
patient have been discussed in the paper by Döğer et al. (2014). The paper has used a
randomized control trial for establishing a relationship between diabetic control and
education by using telehealth. Telehealth helps in provision of health services with the help
of telecommunication and electronic media among the patient population. Information
technology can help patients who live far away, by connecting them with the clinician who
can help with giving advice, education ,interventions and providing some facilities like
monitoring, remote admission(Estai et al., 2016).
Blood glucose level and the oral health are related. Hyperglycemia is often related
with poor oral or dental health. This article has discussed the effectiveness of telehealth in
managing glucose levels in adolescents and children. This article is relevant as it has discuses
easy intervening techniques for management of glucose levels. The paper is helpful as it only
focuses on the telehealth, as a means of managing blood sugar levels.
As per the evidence-based hierarchy level, this paper belongs to the first level. The
ample use of the randomized control trials has increased the generalizability of the study. 82
patients have been recruited for the study, indicating towards an ample sample size.
Chrvala, Sherr and Lipman (2016) have assessed the effect of diabetes self-
management education, the support methods, duration, providers and contact time on the
glycemic control in adults. This a systemic search in databases like MEDLINE, CINAHL,
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EMBASE, ERIC, and PsycINFO. This systematic review can be placed at the level 1 of the
evidence-based pyramid. HbA1C or glycosylated hemoglobin reflects blood glucose level of
past six or eight weeks. However, this hemoglobin does not represent daily fluctuation of
blood glucose level. The A1C level is affected by the implementation of controlling factors
on the intervention groups. The result of the research paper shows that contact hours of less
than 10 hours can give a positive result in reduction of A1C or glycated hemoglobin. If
effective glycemic control can be observed in the participants of this research, dental diseases
will also decrease in a rapid way. The relevance of the article underlies the evaluation and
assessment of controlling factors on the intervention group. Additionally, the research also
shows how A1C controlling factors can be developed with the help of different clinical
management techniques.
The review mainly contained randomized control trial papers with unique
interventions. All the studies have been assessed for the presence of the statistically
significant difference.
Saengtipbovorn and Taneepanichskul (2015) have assessed the effectiveness of
education on lifestyle changes and dental care in improving the periodontal and the glycemic
status in elderly patients. The study employs a randomized control trial including 66 patients.
Oral health education was given the in the form of booster education apart from life style
counselling. RCT is the highest level of evidence. The variables used for the study were sex,
age, education levels, presence of health insurance, duration of the study and smoking.
Descriptive statistic has been used for the test. Randomization had been done reducing the
risk of bias.
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Assess for risk of bias
One of the limitations of the paper Nakre and Harikiran (2013) is that the search
strategy for this paper is limited to Medline and hence the articles that were found were not
much specialized. Many of the good articles that were found in the Medline were only
available by payment. The study indicated towards the fact that there is an increasing need of
systematic review on studies evaluating the effectiveness of the educational programs. No
such tools have been used for assessing the risk of the bias.
.
In the paper by Chrvala, Sherr and Lipman (2016), retention rates were considered
acceptable to reduce the risk of attrition bias, that is consistent with the Cochrane
Collaboration Criteria. The study has also examined performance bias for determining the
risk of possible contamination. Thus, this study was valuable. Saengtipbovorn and
Taneepanichskul (2015) have employed a single mask technique, which has increased the
chance of selection bias.
Conclusion
In conclusion, it can be stated that dental health education is an important and integral
part of education that can be provided to patients suffering from diabetes. Both verbal
interactions like consultations and group discussions and non-verbal mode of
communications like mass media campaigns, telehealth education can be effective in
promoting good dental health among patients. Both verbal and non-verbal communication
have been suggested alongside medications for ensuring good oral health. The papers chosen
for the studies have been tested for reliability and validity making them suitable for this
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dissertation. The outcome measures have been appropriate in relation to the clinical question
of this paper and have provided a baseline data in order to compare the intervention in
patients.
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Study Design and methodology
Executive summary
Type 1 diabetes (T1D) is prevalent among children and adolescents and creates an impact on
their health and wellbeing. Not only does the metabolic syndrome create an impact on blood
glucose level, but also results in the onset and progress of oral health problems. People
suffering from T1D are at an increased risk of developing dry mouth, periodontitis, gingivitis,
burning mouth syndrome, plaque, calculus, and poor healing of the damaged oral tissues.
This research proposal aims to evaluate whether verbal and nonverbal training helps in
improving oral health of T1D patients, when compared to standard instructions.
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Table for abbreviations
T1D Type 1 diabetes
HLA human leukocyte antigen
AIHW Australian Institute of Health and Welfare
DMFT Decay-missing- filled teeth
TNF-α Tumor necrosis factors
IL-6 Interleukin 6
IL-1 Interleukin 1
OHI-S Simplified Oral Hygiene Index
GI Gingival Index
PPD Periodontal Pocket Depth
aHR adjusted hazard ratio
NDSS National Diabetes Services Scheme
HbA1c Hemoglobin A1c
BOAS Beck Oral Assessment Scale
MPS Mucosal-plaque score
PI Principal investigator
Co-I Co-investigator
Table 1- List of abbreviations used in the proposal
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Introduction
Type 1 diabetes (T1D) is typically considered to be a direct consequence of immune-
related dysfunction and occurs due to impairment of the pancreatic β cells to produce insulin
hormone. Historically, T1D was predominantly considered as an ailment in adolescents and
children, however, this view has altered over the past years. Some of the classic symptoms of
this metabolic syndrome are increased thirst and hunger, frequent urination, sudden loss in
weight, blurry vision, poor wound healing, and tiredness (Mayer-Davis et al. 2017).
Moreover, people suffering from T1D report signs of dry mouth. Majority of patients who
have been diagnosed with T1D show an increase in human leukocyte antigen (HLA) genes
(Pociot and Lernmark 2016). There were an estimated 2742 individuals diagnosed with T1D
in 2017 that accounted for 1 in every 8,000 Australians or 12 cases per 100,000 population
(AIHW 2019). Owing to the high risk of dry mouth that the T1D patients are susceptible to,
they are at an increased risk of suffering from ulcers, soreness, tooth decay and infection. In
addition, gum inflammation and periodontitis are quite common amid these patients. The
onset of such tooth problems can be accredited to the fact that uncontrolled blood glucose
level results in abnormal function of the white blood cells, which act as primary form of
defence in the body against bacterial infections occurring in the mouth (Aritaet al. 2016).
This assignment will contain a research proposal focused on oral health of patients, diagnosed
with T1D.
Literature review
Novotnaet al. (2015) elaborated on the well-accepted fact that bacterial existence in
dental plaque has been identified as the major contributing factor for the onset and progress
of periodontal diseases. These diseases manifest in the form of infections occurring in the
structures surrounding the gums, the periodontal ligament, the cementum, and the alveolar
bone. The researchers highlighted on the relatively higher incidence of chronic gingivitis
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amid T1D patients, when compared to the healthy population and elucidated that children
suffering from T1D, with a mean age of 5-9 years demonstrated a1.54 ± 0.5 gingival
inflammation index. Moreover, it was also found that hyperglycaemia results in an increase
in the concentration of glucose in saliva, besides causing an upsurge in its concentration in
gingival crevicular fluid. Hence, augmented availability of glucose in the oral cavity upsurges
proliferation of cariogenic and periodontopathic bacteria, thus causing an increase in oral
inflammation. These findings were confirmed by Rafatjouet al. (2016) who stated that there
existed statistically significant differences in gingival inflammation index between T1D
affected group and healthy population (P=0.001). Remarkably, a greater Decay-missing-
filled teeth (DMFT) index was perceived in the control group (P=0.008). Moreover, the GI
and DMFT index amplified considerably in T1D patients, with duration of diabetes. Hence, it
could be deduced from the findings that proper oral health instruction must be provided to
diabetic adolescents and children.
Duda-Sobczak, Zozulinska-Ziolkiewicz and Wyganowska-Swiatkowska (2018)
mentioned that an increase in the concentrations of different inflammatory markers such as,
prostaglandin E2, TNF-α, IL-6, IL-1, and C-reactive protein is typically observed in T1D
patients, and these markers are anticipated to exert an influence on the onset of periodontal
damage. In addition, the researchers also stated that there occurs microangiopathic alterations
in the oral mucosa of patients suffering from both T1D and T2D. These alterations commonly
comprise of a reduction in the density, modification in the diameter and length of loops, and
an increase in the periodontal capillary density.
According to Madjovaet al. (2016) oral hygiene index encompasses two essential
components namely, the calculus index and the debris index. The researchers found that
children suffering from T1D manifested a calculus and debris index of 1.0 and 1.9,
respectively. Moreover, upon evaluating the OHI-S, they found that there was poor oral
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hygiene amid children diagnosed with diabetes. Bleeding gums were also noted amid 65.5%
of children with T1D, in comparison to 31.3% of their healthy counterparts. Presence of soft
tissue inflammation in 11 girls and 8 boys with T1D also highlighted the impact that the
metabolic syndrome creates on oral health, thus calling for the need of proper patient
education and training. The impacts of diabetes on dental and periodontal status have also
been elaborated by Sadeghiet al. (2017) who found that T1D patients are more likely to suffer
from tooth loss and periodontal diseases. On conducting a cross-sectional study, the
researchers found an increase in values of PPD (Periodontal Pocket Depth), GI (Gingival
Index), and DMFT (Decayed, Missing, Filled Permanent Teeth) with aging, and there were
no significant differences between diabetic individuals and healthy controls. However, GI
was greater in diabetic patients aged 13-18 years (p<0.01). Nonetheless, they failed to record
any association between periodontal indices and HbA1c. However, Coelho et al. (2018)
argued the aforementioned findings and stated that T1D children are related with particular
risk factors for dental caries and periodontal diseases. In relation to bleeding from the gums,
calculus index, and plaque index, greater values were recorded in diabetic children, and their
differences with healthy counterparts was statistically substantial for the parameters.
Moreover, there existed a statistically noteworthy relationship between poor metabolic
glucose control and salivary parameters.
These findings were echoed by Sun et al. (2019) who conducted a population-based
nationwide study in Taiwan and found that T1D affected patients demonstrated an increased
likelihood of suffering from periodontal disease, in comparison to non-diabetes affected
persons [adjusted hazard ratio (aHR) = 1.45]. Moreover, T1D patients who paid visits to the
emergency room, not less than twice each year demonstrated an increased HR for 13.0 for the
onset and progress of periodontal diseases. In addition, the periodontal disease HR was
around 13.2 in T1D patients, who had to be admitted to hospitals more than twice a year.
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Đuričković and Ivanović (2019) also stated that children diagnosed with T1D suffer from
more dental calculus, dental plaque, and decreased saliva, when compared to children who
are healthy. The researchers found that there was significant variation in the plaque index in
T1D group (1.29 ± 0.56) and control group (1.01 ± 0.50) (p =0.001). Moreover, there also
existed substantial difference in calculus index between the diabetes affected individuals
(0.09 ± 0.23) and their healthy counterparts.
According to Jivanescuet al. (2018) the degree of periodontal impairment is directly
under the influence of glycaemic control and the immune system capacity of the individual
suffering from diabetes. The researchers described a case study involving a T1D affected
female who reported signs and symptoms of tooth loss, periodontal disease and poor decay
control. In addition loss of teeth, particularly in T1D affected children and young people, is
an incapacitating condition that results in functional and psychological difficulties. Matos et
al. (2018) under circumstances when there exists a correlation between two or more ailments,
it is particularly difficult for bringing about improvements in the health and quality of life,
particularly in case of periodontal disease and T1D, both of which have bidirectional
association. The researchers also took into consideration the complicating potential of
patients with inappropriate metabolic control and highlighted the importance of dental
assessment. Some of the frequently reported dental complications were namely, xerostomia,
periodontal disease, frequent abscesses, enamel hypocalcification, and opportunistic gum
infections among others. Moreover, it was also stated that diabetes affected patients may also
have oral manifestations like halitosis, burning mouth syndrome, glossodynia, palate changes,
fungal infections, cheilitis, fissured tongue, and lichen planus. Despite the vast evidence on
occurrence of dental problems and their correlation with T1D in children, not much work has
been done to identify the impacts that verbal and nonverbal oral health training on the oral
health of T1D affected patients, in comparison to standard training.
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Research question
Do verbal and nonverbal oral health training improve oral health of type 1 diabetes
patients, as opposed to standard instructions?
This research question has been formulated following the PICO format and the table given
below highlights the different components of PICO:
P (population) Type 1 diabetes patients
I (intervention) Verbal and nonverbal oral health training
C (comparison) Standard instructions
O (outcome) Improved oral health
Table 2- PICO format of research question
Research aim
To assess whether verbal and nonverbal oral health training helps in improving oral
health in the T1D patients.
Research objectives
To evaluate the impacts of verbal oral health training on oral health status of T1D
patients
To assess the impacts of nonverbal oral health training on oral health status of T1D
patients
Methodology
Study design
The research will be based on an observational cohort design. The reason for selecting
observational design can be accredited to the fact that these researchers draw inference from a
particular sample, where the researchers are not able to exert control over the independent
variable (Creswell and Creswell 2017). A cohort study will be conducted in order to establish
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the association between the cause (verbal and nonverbal training) and the effect (improved
oral health). The cohort will comprise of children and adolescents, who share common
characteristic that is suffer from type 1 diabetes. The comparison group will also encompass
similar population from which the cohort will be drawn, and both the groups will only differ
in terms of the exposure to the phenomenon under investigation (training). One major
advantage of selecting a cohort design is that they will provide a clear indication for the
temporal sequence between the outcome and the exposure. Moreover, the study will also
facilitate calculation of the incidence of improved oral health amid the selected participants
(Bryman 2017).
Study population and sampling
The prospective cohort study will be conducted amid children and adolescents,
diagnosed with type 1 diabetes, who will be selected from the National Diabetes Services
Scheme (NDSS) register. The NDDS is an initiative developed by the Australian government,
in collaboration with Diabetes Australia (NDDS 2019). Normally, all people residing in
Australia or visiting from a nation where reciprocal health agreements exist for Australia, get
registered in the NDSS, following their diagnosis by an endocrinologist, doctor, or
credentialed diabetes educator. The inclusion criteria will be namely, (i) children or
adolescents diagnosed with T1D, at least a year ago, (ii) HbA1c levels more than 6.5%, and
(iii) not subjected to any kind of training or instruction about oral hygiene. In addition, adults
diagnosed with T1D and those who have already been provided instructions or educated
about oral health maintenance will not be included in the study. Children and adolescents
diagnosed with the metabolic syndrome less than a year ago will not be considered
prospective for the study since development of oral symptoms might take considerable time.
An estimated 30 children and adolescents will be selected for the research.
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Randomisation
Probability sampling will be followed for this research that refers to the procedure of
selecting a sample from a wider population, based on the theory of probability. Hence,
conducting simple random sampling from the names obtained from the register will ensure
that all individuals who meet the eligibility criteria have an equal prospect and chance of
being nominated for the research (Aladag and Cingi 2015). The steps involved in
randomisation would be as follows:
defining the population of interest
selecting the sample size
listing the population
assigning numbers to each participant
exploring a list of random numbers prior to selection of the sample
selecting which of the prospective participants will be sent invitations to participate in
the investigation
Consent process
Consent from the participants will be collected by the principal investigator, along
with a team member. Agreement will be documented and will be used in the form of a
guideline for verbally explaining the intended research. First step will encompass explaining
the research to the potential participants by providing them important information about
objective, process, benefits, risks, and alternative to participation. The participants will be
allowed time to ask questions and clarify doubts. Following the verbal description, they will
be given a written consent form and adequate time for considering their decision (Wolf et al.
2015). The potential subjects will be contacted after a suitable time to know about their
decisions and resolve any additional queries. The form must contain signature, date and time
during participation. The investigator will also sign the document.
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Oral health training sessions
15 research participants will be assigned to each exposure group. The intervention
group will comprise of verbal and nonverbal training of the participants about oral health.
Sessions involving the training will be conducted in schools and community centres, based on
the convenience of the children and adolescents, and each session would last for an estimated
30 minutes. These sessions will be conducted bi-weekly, for a duration of 12 months.
Nonverbal training would comprise of PowerPoint presentation, graphics, cartoons, body
language, facial expressions, and gestures. Moreover, tell show do, role play and usage of
artefacts and touching behaviour will also be incorporated in the nonverbal training sessions
that will focus on the steps that need to be maintained for enhancing oral health (Neill 2017).
This will be conducted in addition to verbal training that would comprise of small group
communication and interpersonal communication. These sessions would last for 45 minutes
and 60 minutes, respectively, twice each month. During these conversations the T1D patients
will be educated on the steps related to brushing, flossing with the use of interdental brushes,
fixed appliance care, oral rinse, and dietary modifications (Harnackeet al. 2016). They will
also be explained about the need for eliminating sweet and sticky carbohydrates from their
diet. Both types of training will focus on the time that must be spent on each stage of oral
hygiene.
In contrast, the remaining 15 participants will just be asked to brush their teeth at least
twice each day and floss once daily. They will also be asked to visit their dentist every month
and check their gums on a regular basis, to ensure that they are pink. Standard instructions
will be given once a week. Both types of interventions will be administered for a duration of
24 months.
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Schedule of training
Verbal training Schedules Duration
Small group
communication
(45 minutes)
Twice each month 24 months
Interpersonal
communication
(60 minutes)
Non-verbal training Schedules Duration
PowerPoint presentation
(15 minutes)
First week of every month 24 months
Graphics
(5 minutes)
Third week of every month
Cartoons
(5 minutes)
After two months
Body language, facial
expression and gestures
(10 minutes)
Twice each month
Standard instructions Schedules Duration
Educating on teeth
brushing, dental visits and
gum check
(30 minutes)
Once a week 24 months
Table 3- Schedule of training
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Schedule of assessment
Phases BOAS MPS Oral health
assessment tool
Initial Lips, tongue, teeth
(15 minutes)
Mucosa
(10 minutes)
Lips, tongue, teeth
(15 minutes)
Final Tongue, teeth, saliva
(15 minutes)
Plaque
(15 minutes)
Gums and tissues,
saliva, dentures
(25 minutes)
Follow-up Gingiva, oral
mucosa, saliva, total
score
(35 minutes)
Inflammation,
plaque, mucosa
(25 minutes)
Dental pain, oral
cleanliness
(30 minutes)
Table 4- Schedule of assessments
Data management
Data collection
Semi-structured interview, Beck Oral Assessment Scale (BOAS), mucosal-plaque
score (MPS), and the Oral Health Assessment Tool formulated by the Australian Institute of
Health and Welfare will be used for data collection, at the end of twentyfour months. During
the interviews, the participants will not be asked questions from any formalised list. Rather,
they will be subjected to open-ended questions on their perceptions and views about oral
health knowledge, practices, and skills. This will provide comparable and reliable qualitative
data and will also provide the participants freedom of choice for expressing their opinion in
their own terms (McIntosh and Morse 2015). While, the BOAS will help in determining the
frequency of performing oral assessments each day, the MPS scores will facilitate evaluation
of the mucosa, presence of inflammation, redness, and plaques in the mouth (Haghighiet al.
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2017). The scores obtained from the Oral Health Assessment Tool will also help in assessing
the lips, saliva, dentures, natural teeth, dental pain, tongue, and gums (AIHW 2009).
Oral health will be assessed after 6 months from initiation of the project, at the end of
12 months, and after a follow-up period of 6 months. This will help in determining the long-
term impacts of the interventions. The flow chart given below demonstrates the assessments
that will be conducted during initial, final and follow-up visits. The data will be collected in
both interview and questionnaire format. The responses of each participant for both the
format will be printed, following which they will be categorised according to the pseudonym
given to each participant and stored in a secure cabinet. Not only that, the soft copy of the
data (both types) will be categorised according to the participants and stored in secure
folders, with each participant having different folder names, categorised into the discrete
intervention and control categories. No third party will be allowed to utilise the folders, since
the drive will be password protected. The hard copies will be stored till the research has been
published and disseminated. However, the soft copies will not be destroyed since they might
prove beneficial for future use.
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Figure 1- Flowchart demonstrating all stages of dental training
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Data analysis
The impacts of verbal and nonverbal training on the oral health of the children and
adolescents will be evaluated with that of the reference children and adolescents, subjected to
standard instructions using both thematic analysis and descriptive statistics. The interview
responses will audio recorded and transcribed verbatim. After assigning pseudonym to the
participants in both the groups, the responses will be segregated by question, followed by
inductive development of codes for all the responses (Vaismoradiet al. 2016). These codes
will be arranged in categories, following which thematic analysis will be performed for
identifying salient themes. Differences between the two groups, on the basis of scores
obtained from the three oral assessment tools will be analysed using chi-square statistics and
Student's t-test (Ho and Yu 2015).
Expected outcomes
It is anticipated that the children and adolescents who attended the nonverbal and
verbal training sessions will demonstrate improved oral health, in comparison to those who
had only been provided standard instructions. Those subjected to the training will be able to
manifest better knowledge about oral health and its maintenance and will also report less
incidents of periodontitis, gum bleeding, and plaque formation. In comparison, standard
instructions are not expected to bring about any significant improvement in knowledge,
perception and oral health status of the research participants. Amid the participants who
attended the nonverbal and verbal training sessions, scores for the Oral Health Assessment
Tool, BOAS, and MPS are expected to be from 0-1, 11–15 or 16–20, and 1-2, respectively.
Hence, it is estimated that there will be less change of mucosal plaque formation in those
participants, and that they would be capable of performing oral assessment during every shift
(8-12 hours).
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Ethical issues
Since this research will involve human participants, approval will be taken from the
Human Research Ethics Committee of the University. Taking into consideration the
diminished autonomy of children, who will be the research participants, respect for people
will be demonstrated, in order to ensure security of the vulnerable target population against
harm. The study will be designed in a manner that the inclusion and exclusion criteria are fair
for all, and none of the children or adolescents are discriminated during their selection and
enrolment, on grounds of age, sex, religion, or ethnicity. The risks of the study must be
sensible in the light of the predictable benefits (Yip, Han and Sng 2016).
Efforts will also be taken to resolve any kinds of conflict between the participants,
sponsors, ethics committee, and the co-investigators. Moreover, it is essential to ensure that
the study design minimises risk of any harm to the participants and encompasses community
representatives during the investigations. Prior to enrolment of the participants, informed
consent shall be taken from their parents since children are typically not in a position to
provide voluntary consensus to a research (Wolf et al. 2015). They shall be provided the
opportunity to refuse participation and withdraw from the study at any point of time. All
collected data will be de-identified, with the aim of ensuring confidentiality of the
participants and the collected data shall be stored in safe cabinet, which cannot be accessed
by any third parties.
Roles and responsibilities of each team member
The principal investigator (PI) will be accountable for integrity and management of
the research design, its conduction, and final reporting of the investigation. Moreover, the
person will also be responsible for effectively monitoring all stages of the research and will
ensure that no incorrect procedures have been adopted. In contrast, co-investigators will act
as the chief personnel who will have almost similar role as that of the PI. The co-I will also
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have an obligation to guarantee that the research has been conducted in complete adherence
to the relevant regulations, laws and institutional policies that govern the execution of the
funded research. Data collection specialists will be responsible for conducting the interview
and obtaining responses of the participants to the different questionnaires and health
assessment tools. They will also ensure that all responses have been audio recorded and
transcribed. In contrast, data analysis specialists will have the primary role of conducting the
statistical analysis and presenting the obtained results in a well-elaborated and graphical
form.
Protocol ready
Sponsorship will be obtained from the NDDS and Diabetes Australia for conduction
of this research. The table given below provides an estimate of the budget for the
observational study:
Training equipment A$ 800
Travel allowances A$ 3380
Principal investigator’s time A$ 37500
Data collection and analysis A$ 9390
Sampling A$ 1000
Indirect costs A$ 500
Total A$ 52570
Table 1- Budget estimation
Timeline of the study
The research will be conducted over a period of 23 months from January 2020 till
November 2021.
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Stages
Ja
n-
20
Fe
b-
20
Ma
r-
20
Ap
r-
20
Ma
y
20-
Apr
il
21
Ma
y-
21
Ju
n-
21
Ju
l-
21
Au
g-
21
Se
p-
21
Oc
t-
21
No
v-
21
Selection of a
research topic
and background
reading
Developing
research question
Literature review
Sampling
Training for oral
hygiene
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Data collection
Thematic
analysis
Statistical
analysis
Drawing
conclusions
Writing the
research findings
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Data management, quality assurance and statistical analysis
1. Data Collection and Management
The data collection process of this research is based on two types of data collection
tools namely the semi-structured interview and a set of oral health assessment tools. As oral
health assessment tools that have been used are Mucosal-Plaque Score (MPS), Beck Oral
Assessment Score (BOAS), and Oral Health Assessment Tool (OHAT) formulated by the
Australian Institute of Health and Welfare. The BOAS will help in determining the frequency
of performing oral assessments each day, the MPS scores will facilitate evaluation of the
mucosa, presence of inflammation, redness, and plaques in the mouth (Haghighiet al. 2017).
The scores obtained from the Oral Health Assessment Tool will also help in assessing the
lips, saliva, dentures, natural teeth, dental pain, tongue, and gums (AIHW 2009).
Through the interview session oral health knowledge, practices, and skills of the participants
have been collected qualitatively. After Taking the interview of all participants including
control group and experiment group, a verbal and audio-visual training has been provided to
experimental group. The Control Group were provided with only the instructions about oral
hygiene maintenance practice through giving them manual handout and leaflets about oral
hygiene and techniques for brushing teeth and gum (figure 2).
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Figure 1: Leaflet of Oral Health Awareness
After this intervention the data regarding their current oral health have been collected through
the oral health assessment tools. The data has been collected through electronic Case Report
Form. After the collecting the data from each data collection session it was stored in a
electronic database system which is secured and encrypted, where only the researcher of this
paper can access. The MS Excel based database management plan has been used where the
database manager is the author or administrator of this study.
The analysis process of this research is based on both the thematic coding based qualitative
analysis and the 2 independent sample t-test statistical analysis have been done. After
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collecting the data from interview the thematic coding-based analysis has been done by
MAXQDA software considering thematic map presented in figure 2.
Figure 2: Thematic Map
After collecting the data through oral health assessment tools, the data has been segregated
into 2 sets namely data of Control Group and data of experiment group. Both one tailed and
two tailed data has been considered with t-value to find the significant difference between
two groups. In this study 0.05 is taken as the probability test value of P-value, where if the
probability value is found lower than 0.05, the null hypothesis becomes rejected and
alternative one becomes accepted and otherwise alternate hypotheses becomes accepted and
null-hypothesis becomes rejected.
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2. Quality Assurance
The quality of this research is based on the ethical consideration of this research. The ethical
consideration of this research has three major aspects namely the consent of the participants,
the confidentiality of the participant and the health concern of the intervention procedure.
Before conducting the research, the participants will be provided with a consent form
mentioning the purpose, method and significance of the participation. After collecting the
acknowledgement, the participants were recruited. The research proposal along with the
research tools have been verified by the ethical committee by the university. As per the data
privacy and protection act the data will be stored in a secured database where only the
researcher can have the access. It has been also assured that the data will not be used in any
other research accept this research.
3. Sample size calculation
For sampling the GPower software has been used and presented in figure 1. According to the
result found in Amiri et al (2015), the training based dental health promotions can have the
effect size of 1.37 when it is analyzed in Two-tailed T test. Hence, for this study this effect
size has been considered as d=1.37. The standard estimation of error probability is 0.05 and
power of 1-beta error probability is 0.95. The aim of this paper is to take equal sample size
for both groups. Hence the ratio of two group N1/N2=1.
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Figure 2: GPower Based Sampling Calculation
From the above electronically calculated result the sample size should be 30. Therefore, the
total number of respondents is 30. Through Random Probability Sampling 15 participants
have been allocated as Control Group and other 15 participants have been allocated as
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experiment group. Therefore, the sample size of Control Group is 15 and the experiment
group is 15.
For sampling total 45 potential participants were proposed, who have diabetes type 1 as well
as some level of dental issues. Among them 36 potential participants were agreed to take a
part in this research. However, through random selection 30 participants were selected for
this study.
4. Hypotheses
As per the context and aim of this research, this research is a comparative analysis of two
groups where one group is to be provided with oral hygiene training and another group is to
be provided with only the instructions. Therefore, the null hypothesis and the alternative
hypothesis are:
Null Hypothesis H0: There is no significant difference of oral health scores between the group
provided with verbal and nonverbal oral health training and the group provided with only
standard instruction.
Alternative Hypothesis H1: There is significant difference of oral health scores between the
group provided with verbal and nonverbal oral health training and the group provided with
only standard instructions.
5. Qualitative Analysis
In the following section the qualitative analysis of the data collected from semi-structure
interview has been presented through thematic map and frequency analysis.
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`
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From the above thematic code frequency analysis, it has been found that many
participants do not have enough knowledge and understanding about the oral hygiene and
oral hygiene maintenance practice.
6. Statistical Analysis
Independent Sample t-test for Mucosal-Plaque Score
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Control
group
Experim
ental
Group
Mean 5.2
6.466666
667
Variance
1.457142
857
0.838095
238
Observations 15 15
Pooled Variance
1.147619
048
Hypothesized Mean Difference 0
Df 28
t Stat
-
3.238128
654
P(T<=t) one-tail
0.001545
675
t Critical one-tail
1.701130
934
P(T<=t) two-tail
0.003091
349
t Critical two-tail
2.048407
142
On the other hand, the t Stat data is 3.23, which is positive, and it indicates that the
Experimental Group Scored better than the Control Group. The variance of Control Group is
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higher than the Experimental Group that implies that the mean value found in experimental
group is more significantly accurate where the mean value of control group is not that much
significant or accurate. From the both p value of one tail and two tail for Mucosal-Plaque
Score it has been found that probability test values are very less than the value 0.05.
Therefore, it can be said that for the tool of MPS the null hypothesis is rejected, and
alternated hypothesis has been accepted.
Independent Sample t-test for Beck Oral Assessment Score
Control
group
Experim
ental
Group
Mean 12.8
14.46666
667
Variance
1.17142
8571
2.266666
667
Observations 15 15
Pooled Variance
1.71904
7619
Hypothesized Mean Difference 0
Df 28
t Stat
-
3.48125
1725
P(T<=t) one-tail
0.00082
7589
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t Critical one-tail
1.70113
0934
P(T<=t) two-tail
0.00165
5179
t Critical two-tail
2.04840
7142
In this study, the t Stat data is 3.48, which is positive, and it indicates that the
Experimental Group Scored better than the Control Group in this Beck Oral Assessment Score.
The variance of Experimental Group is higher than the Control Group that implies that the
mean value found in control group is more accurate than the mean value of experimental
group. From the both p value of one tail and two tail for Beck Oral Assessment Score it has
been found that probability test values are very less than the value 0.05. Therefore, it can be
said that for the tool of BOAS the null hypothesis is rejected, and alternated hypothesis has
been accepted.
Independent Sample t-test for Oral Health Assessment Tool
Control
Group
Experimenta
l Group
Mean 9.533333333 11.93333333
Variance 1.980952381 2.495238095
Observations 15 15
Pooled Variance 2.238095238
Hypothesized Mean Difference 0
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Df 28
t Stat
-
4.393418676
P(T<=t) one-tail 7.26005E-05
t Critical one-tail 1.701130934
P(T<=t) two-tail 0.000145201
t Critical two-tail 2.048407142
In this study, the t Stat data is 4.39 which is positive, and it indicates that the
Experimental Group Scored better than the Control Group in this Oral Health Assessment Tool.
The variance of Experimental Group is higher than the Control Group that implies that the
mean value found in control group is more accurate than the mean value of experimental
group. From the both p value of one tail and two tail for Oral Health Assessment Tool it has
been found that probability test values are very less than the value 0.05. Therefore, it can be
said that for the tool of HAT the null hypothesis is rejected, and alternated hypothesis has
been accepted.
6. Critical Implication
From the data analysis section presented above it has been found that for all the oral
health assessment tool the P value is less than 0.05 which mean the null hypothesis is rejected
and alternative hypothesis has been accepted. Therefore, there is significant difference of oral
health scores between the group that is provided with verbal and nonverbal oral health
training and the group provided with only standar instruction. From the T-Stat value it has
been also found that group that provided with verbal and nonverbal oral health training has
significantly higher oral health condition than the group provided with only standard
instruction. Currently most of the children and adults do not have enough knowledge and
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understanding of oral health and hygiene practice. Hence, it can be interpreted that verbal and
nonverbal training can significantly improve the oral Hygiene practice of Type 1 diabetes
(T1D) children and adolescents.
The alternative scenario can also occur that could even cause the high variance found
in the t tests. Here the medicines intake by the participants can reduce the glucose level in the
body while reducing the oral health related problems. A participant in experimental group can
experience positive effect due to changes in the glucose level and on the other hand a
participant in control group can experience negative effect due to increment of glucose level.
Therefore, medication intake and changes in glucose level can affect the result irrespective of
experimental group and control group. At the same, the intervention or training method used
in this study can have a major downside, such as any wrong/incorrect information provided in
training can have a negative impact on oral hygiene practices.
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Ethics
Participant Information Sheet
Version: 1.2
Impact of verbal and nonverbal oral health training on improving the Type 1 diabetic
patient’s oral health
Invitation
You are requested to take a part in this study which will include various awareness programs
and an oral health assessment program. Hope this study will bring benefits for you in terms of
health and benefits for us in terms of knowledge. Kindly go through the following
information details regarding this study.
Purpose of the study
The purpose of this study is to find if different awareness methods have different impact on
oral health within the people who are suffering from the diabetes type 1. The aim is to assess
the effectiveness of verbal and non-verbal oral health training in Type 1 Diabetic patients.
Why have I been chosen?
This study is aimed to find the effectiveness of verbal and non-verbal oral health training
program on people with type 1 diabetes. The participants have been selected through National
Diabetes Services Scheme (NDSS) register. Your medical details related to diabetic issues
have been found in the NDSS register and therefore, you have been selected.
Do I have to take part?
Your participation is voluntary not mandatory. You will not have any strict obligation to
continue with this study. You can leave the research procedures anytime you want.
What do I have to do?
You must go through an initial dental examination for all participants. After that the
participants will be included in different dental health wellness program. Finally, again the
dental health assessment process will be executed along with a face to face interview.
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What is the drug, device or procedure being tested?
This study will not include any drug or device-based intervention. You have been assessed
with some medical tools where medical professional will be asking you some questions about
your oral health and inspect your dental condition visually. The tools are Beck Oral
Assessment Scale (BOAS), mucosal-plaque score (MPS), and the Oral Health Assessment.
All these tools are medically approved and highly reliable.
What are the alternatives available?
There are two alternatives in this pregame. Either you will be provided with written
instruction about how to maintain a good oral health, or you will be provided with verbal and
non-verbal oral health training audio-visual presentation and interpersonal communication
What are the potential side effects or risks in taking part?
Since, this study entirely is based on non-medical intervention, it will not cause any side
effect or risk to the participants because of their participation. You just need to take part in
this project for duration.
What are the possible benefits of taking part?
Instead of having any risk, participants of this study will have a free oral health check-up
using various tools. Apart from that you will be randomly selected in any of the two
participant groups. If you are selected in, you will be also provided with oral health related
training which can have positive impact on your oral health in the long term.
Do our study team have the necessary skills/resources to conduct this research?
The study team includes Principal Investigator, Research Associate and Assistant Researcher.
All these team members have adequate resources and skills to conduct to study
What happens when the research stops?
When the research stops, you with other participants will be provided with a free copy of
training hand-out on oral health. After the study completes you will be communicated again
for you to know what the outcome of this study would be.
What do I do if there is a problem?
In case of any problem, like other participants you will be able to directly communicate with
our research associates and the principal investigator regarding any issues. You will be also
able to quit this study anytime you want.
Will the study team examine each stage of the process for ethical considerations?
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The ethical considerations have been checked in four major steps namely, before the
intervention, after the intervention, before the assessment and after the assessment.
Will my taking part in this research be kept confidential?
As per privacy and security concerns, participant's details will be strictly confidential,
guaranteed and will not be disclosed following the national code and data privacy and
security guidelines University of Manchester template on Confidentiality and ethical
consideration for accessing patient’s identifiable information as well as University code of
conduct.
How will data be recorded and stored?
Initially the data will be recorded in physical paper and pen. After that the data will be stored
in a secured digital database system for data storage and analysis. The data collected from the
participations will be stored in an encrypted digital database system which will be only
accessed by the research teams. It is assured that the raw data will not be used for any other
researches or any other purpose.
What happens if relevant new information becomes available?
In case, new information becomes available regarding the chosen topic of this study, the
study will still be continued as expected to testify the validity and reliability of the newly
available information.
What happens if I don’t want to continue the study?
Like other participants you will be able to directly communicate with our research associates
and the principal investigators regarding your concern. You can discontinue this program
anytime you want.
Will any genetic tests be done?
This study will not conduct any genetic test
What will happen to the results of the study?
The outcome of the study will be available in peered review journal of University of
Manchester. You will be provided with the soft copy link through mail where you can see the
entire study after publication. The raw data you will provide will be kept in a secured and
private digital database system.
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How will capacity to consent be assessed?
The capacity of consent will be assessed by ethical committee and the research coordination
board of the university
What will be done and have been done regarding consent?
The consent from will be provided to the potential participants with the participation request
letter, participants information sheet and through face to face communication. The consent
forms will be provided to the research assistant and he will be responsible to collect the
consent from the potential research participants.
Who is organizing and funding the research?
The major funding resources are Personal Grants and Grants from University of Manchester
What are the provisions for indemnity?
The obligation to pay for any loss or damage goes to the principal researcher or the research
coordinator.
Who has reviewed the research proposal?
This research proposal has been reviewed by the ethical committee and the research
coordination board of the University Of Manchester.
Contact details for further information?
Yasser khan +61404211374
Yasserkhan20@gmail.com
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Consent Form
Version: 1.1
Project Title Impact of verbal and nonverbal oral health training in
improving the Type 1 diabetic patient’s oral health
Name of the Investigator Dr Yasser khan
1. I confirm that I have read and understand the purpose and the significance of
the research and the contribution of my participation as well as all other details
in the participant information sheet (PIS: 1.2; date-11/11/19) to the project
C
h
2. I am ready to take a part in this research as a voluntary participation and I have
the privilege to withdraw my participation any-time I want C
h
3. I am also acknowledging procedures through which I must go that includes the
oral health assessment process C
h
4. I abide by the security and privacy of my data in this project according to the
standard data security regulation of ethical committee of University of
Manchester and the Data Protection Act 2008
Name of the Participant Signature Date
Person Taking Consent Signature Date
Final Sections and Appendices
Budget
Uni Cost/Unit Expense
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75
t
Staff’s Salaries $ 33,500
Researchers 1 $ 15,000 $ 15,000
Research assistants 2 $ 8,000 $ 16,000
Administrative support 1 $ 2,500 $ 2,500
Equipment $ 6,400
Cost of Clinic and premises 1 $ 2,500 $ 2,500
Education Material-Printed
papers
150 $ 10 $ 1,500
Education Material-Projector
and sound system
3 $ 750 $ 2,250
Blank papers and pens 1 $ 150 $ 150
Services $ 1,850
Telephone 1 $ 250 $ 250
Postage 1 $ 250 $ 250
Electricity bill 1 $ 300 $ 300
Internet 1 $ 300 $ 300
Computer system and database 1 $ 750 $ 750
Miscellaneous $ 250
Travel and Transportation for
patients
1 $ 300 $ 300
Others 1 $ 250 $ 250
Total $ 42,350
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Collaborations
Position Name Roles and responsibilities
Principal Investigator Yasser khan Communicate and coordinate the research
team, developing draft, decision making,
planning and execution
Research Associate Data Manager Managing Database, inserting the collected
data, analyze data, Cooperating with
research team member
Assistant Researcher Mark Kidman Assisting to collect data, assisting to
analyse data, Cooperating with research
team member
Intervention team
members
Nurses, Trainers Communicating with the participants,
providing training, Cooperating with
research team member
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Appendices
Appendix-A
Search results
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Appendix-B
Interview questions
1. What is tooth decay?
2. Do you have a dry mouth?
3. Do you suffer from bleeding gums?
4. Do you think regular brushing is essential?
5. Does regular brushing prevent tooth decay?
6. Does regular brushing and flossing prevent gum disease?
7. Is regular brushing essential for making teeth white?
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Mucosal-Plaque Score (MPS)
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Beck Oral Assessment Score (BOAS), modified
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Oral Health Assessment Tool
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Patient Selection
Standard
Instruction
Patient with Type 1
Diabetes No Intervention
Intervention
Verbal Training
Interview
Group Division
Once a Week
Verbal and Non-Verbal
Training
Non-Verbal Training
Small Group
Communication
Interpersonal
Communication
45 Minutes 60 Minutes
Twice A Month
PPT
Presentation
PPT Graphics
Cartoon
Body Language
Facial Expression
and Gesture
Start Assessment
BOAS
MPS
Oral Health
Assessment Tool
Initial
Final
Follow-up
Initial
Final
Follow-up
Initial
Final
Follow-up
Lips, Tongue, Teeth
Tongue, Teeth, Saliva
Gingiva, Oral Mucosa, Total Score
Mucosa
Plaque
Inflammation, Plaque, Mucosa
Lips, Tongue, Teeth
Gums, Tissues, Saliva, Dentures
Dental Pain, Oral Cleanliness
Methodological Concept Framework of Experiment
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Mucosal-Plaque Score (MPS)
Version: 1.13.2; Source: Ames et al., 2011
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Beck Oral Assessment Score (BOAS), modified
Version: 2.13; Source: Beck, 1979
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Oral Health Assessment Tool
Version: 1.10; Source: Chalmers, 2005
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Introductory Letter
Project Title Impact of verbal and nonverbal oral health training on
improving Type 1 diabetic patient’s oral health
To the Potential Participants of The Project
I am Yasser khan pursuing a master's degree in Aesthetic and Restorative dentistry at
University of Manchester.
The purpose of this study is to find if different communications method has an impact on
oral health of diabetic patients. For this research all the potential participants are requested
to take a part in this study which will include various awareness program and an oral health
assessment program.
The method of this study will include an initial dental examination for all participants.
After that the participants will be included in different oral health instructions programs.
Finally, again the dental health assessment process will be executed along with a face to
face interview.
The survey will be conducted in the intervention clinic of the university
Please try to complete the survey with honesty and transparency, as participant's details
will be strictly confidential, and will not be disclosed in accordance with the national code
and data privacy and security guidelines UK (Data Protection Act 2018.)
Principal Investigator Yasser khan
Date 1/1/20
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References:
Ames, N. J., Sulima, P., Yates, J. M., McCullagh, L., Gollins, S. L., Soeken, K., &Wallen, G.
R. (2011). Effects of systematic oral care in critically ill patients: a multicenter
study. American Journal of Critical Care, 20(5), e103-e114.
Beck, S. (1979). Impact of a systematic oral care protocol on stomatitis after
chemotherapy. Cancer nursing, 2(3), 185-200.
Chalmers, J. M., King, P. L., Spencer, A. J., Wright, F. A. C., & Carter, K. D. (2005). The
oral health assessment tool—validity and reliability. Australian Dental Journal, 50(3), 191-
199.
Interview questions
Version: 1.1
1. What is included in good oral hygiene routine?
2. Do you experience a dry mouth?
3. Do you suffer from bleeding gums?
4. Do you think regular brushing and flossing is essential?
5. Does regular brushing prevent tooth decay and other oral health issues?
6. Does regular brushing and flossing prevent gum disease?
7. Do you think Diabetes has an effect on your oral health and vice versa?
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