AntibaCterial presCribing & OraL Health Practice: The Leeds Dental Extraction Study
Conditions: Dental Anxiety, Tooth Loss
Sponsor: University of Leeds

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ACCOLaDE  Protocol version 1.0 dated 09 July  2018 
 
Dental Translational Clinical Research Unit (DenTCRU) 
 
 
Research Protocol 
 
Version Number 1.0 and Date 09 July 2018 
 
 
Study Short Title: 
ACCOLaDE 
Study Full Title: 
AntibaCterial presCribing & OraL Health practice: The 
Leeds Dental Extraction Study 
Sponsor Name:  
UNIVERSITY OF LEEDS 
 
Sponsor Number: 
DT17/103574 
 
ISRCTN:   
 
(to apply) 
 
 
Details of previous amendments 
 
 
 
 
 
Study Investigators 
 
 
 
Ashna Chavda 
Dental Research Nurse 
School of Dentistry  
University of Leeds  
Email:  a.chavda@leeds.ac.uk 
 
 
 
Gillian Dukanovic 
Dental Research Nurse 
School of Dentistry  
University of Leeds  
Email:  g.dukanovic@leeds.ac.uk 
 
 

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ACCOLaDE  Protocol version 1.0 dated 09 July  2018 
 
Key contacts 
 
Main Study Investigators: Ashna Chavda & Gillian Dukanovic 
School of Dentistry  
Faculty of Medicine & Health 
University of Leeds  
Level 6 Worsley Building  
Clarendon Way, Leeds, LS2 9LU 
 
Email:  a.chavda@leeds.ac.uk - Tel: 0113 34 39400  
 
  g.dukanovic@leeds.ac.uk - Tel: 0113 34 36127 
 
Jenny Boards  
DenTCRU Operations Manager  
Email:  J.A.Boards@leeds.ac.uk 
 
Professor Sue Pavitt  - Chief Investigator for REC submission 
Director of DenTCRU  
Email:  S.Pavitt@leeds.ac.uk 
 
Study Co-Advisors at the School of Dentistry 
University of Leeds, Clarendon Way, Leeds,  LS2 9LU  
are: 
 
Dr Jianhua Wu 
DenTCRU Statistician  
 
Wendy Thompson  
General Dental Practitioner (GDP) and PhD Student 
 
Peter Day 
Associate Professor in Paediatric Dentistry  
 
Jinous Tahmassebi 
Associate Professor in Paediatric Dentistry  
 
 
 
 
 
 

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ACCOLaDE  Protocol version 1.0 dated 09 July  2018 
 
SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agree and accepted and that 
the Main Study Investigators agree to conduct the study in compliance with the approved 
protocol and will adhere to the principles outlines in the Declaration of Helsinki, the 
Sponsor’s Standard Operation Procedures (SOPs) and other regulatory requirements. 
The Main Study Investigators agree to ensure that the confidential information contained in 
this document will not be used for any other purpose other than the evaluation or conduct 
of the investigation without the prior written consent of the Sponsor. 
The Main Study Investigators also confirm that they will make the findings of the study 
publically available through publication or other dissemination tools without any 
unnecessary delay and that an honest accurate and transparent account of the study will 
be given; and that any discrepancies from the study as planned in this protocol will be 
explained. 
For and on behalf of the Study Sponsor: 
 
Signature 
………………………………………………. 
Date:  ……/……/…… 
 
Name (please print)  ……………………………………………………………  
 
Position:……{Faculty Head of Research & Innovation Support}…. 
 
 Main Study Investigators: 
 
Signature 
………………………………………………. 
Date:  ……/……/…… 
 
Name (please print)  ……………………………………………………………  
 
Signature 
………………………………………………. 
Date:  ……/……/…… 
 
Name (please print)  ……………………………………………………………  
 
 

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1.0  
Study Summary 
 
GENERAL  INFORMATION 
Short Title 
ACCOLaDE 
Full Title 
AntibaCterial presCribing & OraL Health practice: The 
Leeds Dental Extraction Study 
Sponsor 
University of Leeds 
Sponsor ID 
DT17/103574 
REC No. 
To add  
Main Investigators 
Ashna Chavda and Gillian Dukanovic 
Co-ordinating Centre 
DenTCRU, Leeds School of Dentistry 
TRIAL INFORMATION 
Indication 
To explore the experience of patients undergoing tooth 
extraction at Leeds Dental Institute (LDI)  in relation to 
antibiotic medication, dental anxiety and oral health 
practices  
Design 
 Research questionnaire survey 
Objectives 
To better understand the increasing numbers of patients 
attending the Leeds Dental Institute (LDI) for extractions  
and: 
 Whether patients were managed by antibiotic only 
treatment plans. 
 Their level of dental anxiety 
 
Their underlying tooth brushing behaviours and oral  
health practices 
TRIAL  TIMELINES 
Expected start date 
June 2018 
End of Trial Definition 
Last Patient Last Visit  
Expected completion date June 2019 
TRIAL  SUBJECT  INFORMATION 
Number of trial subjects 
50   
Age group of trial subjects Parents/Guardians of children from 5yrs to 12 years, 
children aged 13-15 and adults (no upper age limit) 
Inclusion criteria 
a) Adult patients undergoing extraction of one or more 
teeth 
b) Parents/Guardians of children aged 5-12 years old 
undergoing extraction of one or more teeth  
c) Patients aged 13-15 undergoing extraction of one or 
more teeth  
d) Patients and Parents/Guardians  who are willing to give 
informed consent or assent to complete questionnaires   
Exclusion criteria 
(a) Patients, parents/guardians  unable or unwilling to 
provide informed consent 
(b) Parents/Guardians of patients aged less than 5 years 
old 
(c) Patients or parents who are unable to communicate 
directly with the health person carrying out the treatment 

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2.0 
Introduction 
 
2.1 
Background and Rational for the Study 
Professor Dame Sally Davies, the UK Chief Medical Officer has issued stark warnings about 
the global catastrophe faced if the threat of antimicrobial resistance (AMR) is not addressed. 
AMR 
has 
risen 
alarmingly 
over 
the 
last 
40 
years 
and 
inappropriate 
use 
of 
antibacterials/antimicrobials is a key driver. Dentists in England prescribe antibacterial drugs 
than more any other medication. Some 3.7 million dental prescriptions for antibacterial 
medicines were dispensed in England during 2014. Of all NHS antibacterial drug prescriptions, 
5% are attributed to general dental practice and overprescribing by dentists has been widely 
reported. Clear, evidence based guidance for appropriate antibacterial prescribing in general 
dental practice is available. Antibacterial prescriptions are only indicated in the presence of 
systematic spread of bacterial infection which is easily identified by dentists during 
appointments given sufficient time and patient compliance. Antibacterial-only treatment plans 
are generally inappropriate although may be indicated if a patient requires referral for sedation 
or to an oral surgeon. Reducing antibacterial prescribing by dentists has an important part to 
play in the UK AMR Strategy to slow the development and spread of resistance.  
University of Leeds (UoL) has a portfolio of projects exploring antibacterial drugs and 
dentistry. The APTiTUDE project1 is developing a complex intervention to address 
professional and patient behaviours to lower the prescribing rates of antibacterial medication 
by dentists. By identifying key behaviours of dentists, other members of the dental team (e.g. 
dental nurses and receptionists) and patients, this project will establish a logic model to 
underpin the development of the complex intervention. This ACCOLADE project will provide 
valuable information for the NIHR awarded APTiTUDE project in relation to patient experience 
of antibacterial medication in dentistry. It will include exploration of the observation that 
increasing numbers of patients are being referred into secondary care (Leeds Dental Institute, 
LDI) for extractions following antibacterial-only treatment plans in general dental practice.  
Teeth are extracted for various reasons including planned extractions of healthy teeth (e.g. as 
part of orthodontic treatment or impacted wisdom teeth) and urgent extraction of diseased 
teeth (for example due to an abscess) during unscheduled treatment. The UoL School of 
Dentistry’s HTA-compliant Skeletal Tissues Research Tissue Bank (the “Bank”) collects 
extracted teeth from consented participants; donated teeth are anonymised, stored and used 
for a variety of research purposes. By comparing the questionnaire responses of all 
consenting participants undergoing dental extraction (irrespective of reason) or involved with 
a child undergoing this procedure, this project aims to explore attitudes, knowledge and 
experience of participants about antibacterial medication and their use to treat dental disease, 
the amount of dental anxiety in those referred  and their general oral health practice. The 
collected 
data 
will 
underpin 
several 
clinical 
translational 
projects 
such 
as 
Dr Wendy Thompson’s APTiTUDE project, Dr Peter Day’s work on behavioural interventions 
for tooth brushing and Dr Jinous Tahmassebi’s work on child dental anxiety and extraction 
methods.  
 
 
3.0 
Aims and Objectives 
To explore the experience of patients undergoing tooth extraction at the Leeds Dental 
Institute in relation to antibiotic medication, dental anxiety and oral health practice.   
                                                 
1 Wendy Thompsons’s Registered PhD, NIHR Doctoral Fellowship [Short Title: APTiTUDE – Antimicrobial Prescribing: Towards a 
reduction during Urgent Dental care in England.] Enabling antimicrobial prescribing reduction during urgent primary dental care in 
England: Developing a complex intervention for behaviour change of professionals and patients.  
 

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This study will quantify and better understand the increasing numbers of patients attending 
the Leeds Dental Institute (LDI) for extractions and: 
           
1) Whether patients were managed by antibiotic only treatment plans. 
2) Their level of dental anxiety  
3) Their underlying tooth brushing behaviours and oral health practices.  
 
 
4.0 
Trial Design 
Patients who have attended pre assessment appointments at Leeds Dental Institute will be 
identified by the care team when booking appointments for day case admission for their 
extraction procedure.  The care team will send a separate invitation letter explaining this 
research and enclosing a copy of the relevant ACCOLaDE Participant Information Sheet to 
the patient for consideration. This information is sent to the patient up to two weeks prior to 
the treatment date. 
 
On the morning of the treatment visit, patients and parents/guardians will be approached by 
a member of the clinical care team and asked if they wish a member of the ACCOLaDE 
research team to discuss the study.  If they wish to consider the ACCOLaDE study a 
member of the research team will be introduced to them. Patients and relatives will have the 
opportunity to ask any questions they want to and if they are willing to take part in this 
research, they will be consented (or assented where applicable) to this study.  Patients 
willing to donate teeth for the Skeletal Tissue Bank may also be approached for the 
ACCOLaDE study.  
 
Consented participants will be given the 3 paper questionnaires to complete prior to their 
dental treatment taking place.  The questionnaires will take about 15 minutes to complete. 
The research staff and care team will be on hand to offer any reading support to any 
participant who may need assistance whilst completing these questionnaires.   
 
4.1 
Endpoints 
 
4.1.1: Primary Endpoint 
To have a better understanding of previous antibiotic management, the anxiety levels and 
basic oral health demographics and drivers of those requiring tooth extractions. 
 
4.1.2: Secondary Endpoint(s) 
1) 
To produce evidence by collating information on previous antibiotic use. 
2) 
To produce evidence of dental anxiety levels from collating the anxiety scores from 
completed questionnaires. 
3)  
To produce evidence to elucidate on the underlying tooth brushing behaviours and oral 
health practice in those patients requiring tooth extraction. 
 
 
5.0 
Trial Subject Selection 
 
5.1 
Eligibility Criteria 
 
5.1.1: Inclusion Criteria  
a) Adult patients undergoing extraction of one or more teeth 

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b) Parents/Guardians of children aged 5-12 years old undergoing extraction of one 
or more teeth  
c) Patients aged 13-15 undergoing extraction of one or more teeth  
d) Patients and Parents/Guardians  who are willing to give informed consent or 
assent to complete questionnaires   
5.1.2: Exclusion Criteria 
a) Patients, parents/guardians  unable or unwilling to provide informed consent 
b) Parents/Guardians of patients aged less than 5 years old 
c) Patients or parents who are unable to communicate directly with the health 
person carrying out the treatment 
5.2 
Recruitment Processes 
 
 
5.2.1: Recruitment  
Patients will have received a copy of the relevant ACCOLaDE Participant information sheet 
in the post prior to their day case admission for treatment.   This will include detailed 
information about the rationale, design of the study.  Following information provision, 
patients will be given the opportunity to discuss the trial with their family and on the day of 
treatment can discuss this with a member of the clinical care team and the researchers 
before they are asked whether they would be willing to take part or not. This process will 
be clearly documented in their electronic patient record by the clinical care team.  All 
participants will have had at least 24 hours to consider their participation. 
 
5.2.2: Consent 
Patients and parents/guardians will be formally assessed for eligibility and invited to 
provide informed, written consent. The right of the patient or parent/guardian to refuse 
consent without giving reasons will be respected. Further, the patient or parent/guardian 
will remain free to withdraw from the study at any time without giving reasons and without 
prejudicing any further treatment for them or their child. A copy of the consent will be given 
to the participant, one filed in the Trial Master File, and one filed in the electronic patient 
records. The written consent will be taken by a member of the research team designated 
on the study staff authorisation / delegation log.   
 
 
5.2.3: Participants who Withdraw Consent 
All participants will remain free to withdraw from the study at any time without giving 
reasons and without prejudicing any further treatment.  However participants must notify 
the researchers up to the 2 weeks following their tooth extraction appointment that they 
want to withdraw their study data    After this time the anonymised questionnaires will be 
used as part of the study results and may no longer be individually identifiable.    
 
5.2.4: Definition for the End of Trial 
Last patient last visit 
 
 
 6.0 
Data Collection, Source Data and Confidentiality 
 
6.1:  General 
All information collected during the course of the trial will be kept strictly confidential.   
Information will be held securely on paper and electronically at the Dental Translational 
Clinical Research Unit (DenTCRU), at the University of Leeds. 
 

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Dental Translational Clinical Research Team will comply with all aspects of the Data 
Protection Act 2018 and operationally this will include: 
 consent from patients/participants to record personal details including name, 
date of birth.  
 appropriate storage, restricted access and disposal arrangements for patient 
personal and clinical details 
 consent from participants for access to their study records by responsible 
individuals from the research staff, the sponsor or from regulatory authorities, 
where it is relevant to trial participation 
 consent from participants for the data collected for the trial to be used to develop 
new research. 
 
6.2 
End of Trial Report 
Upon completing the trial, an end of trial notification will be submitted to the Ethical 
Committee and a trial report will be given to the funder of this research.  A copy of this end 
of trial notification and trial report will be submitted to the Sponsor’s office.  
 
6.3 
Archiving 
At the end of the trial, data will be securely archived at Leeds Dental School for a minimum 
of 5 years.  Arrangements for confidential destruction will then be made. Anonymised 
study data collected from the questionnaires may be kept and shared with other 
researchers to help future research projects.  No study data may be destroyed without first 
obtaining written permission from the Sponsor. 
 
7.0 
Statistical Analysis 
A brief descriptive and summary analysis regarding patient demographics and 
questionnaires will be carried out for consented patients. 
 
 
8.0 
 Ethical Considerations 
The trial will be performed in accordance with the recommendations guiding ethical 
research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, 
Finland, 1964, amended at the 48th General Assembly, Somerset West Republic of South 
Africa, October 1996. Informed written consent will be obtained from the patients prior to 
registration into the study.  The right of a patient to refuse participation without giving 
reasons must be respected.  The patient must remain free to withdraw at any time from the 
study without giving reasons and without prejudicing his/her further treatment. The study 
will be submitted to and approved by a main Research Ethics Committee (REC) prior to 
entering patients into the study.  
 
9.0 
Statement of Indemnity 
This study is sponsored by The University of Leeds and The University of Leeds will be 
liable for negligent harm caused by the design of the study.  The NHS has a duty of care to 
patients treated, whether or not the patient is taking part in a clinical study, and the NHS 
remains liable for clinical negligence and other negligent harm to patients under this duty 
of care. 
 
10. 
Publication Policy 
Dissemination of the results through publication in academic literature and the oral health 
SMILE AIDER (patient and public involvement group) forum.    A summation with anonymised 
data of the main findings of the research will be disseminated via audio-visual screens in 

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Leeds Dental Institute so attending patients can see the results.  Study participants may 
contact the researchers to receive a copy of the summation as participant address details will 
not be kept. 
 
 
12. 
References 
Children’s Dental Health Survey 2013. Technical Report: England, Wales and Northern 
Ireland 
 
The English antibiotic awareness campaigns: did they change the public’s knowledge of 
and attitudes to antibiotic use? Cliodna A. M. McNulty, Tom Nichols, Paul J. Boyle, 
MarkWoodhead and Peter Davey   
J Antimicrob Chemother 2010; 65: 1526–1533 
 
Modified Dental Anxiety Scale  (MDAS): associated  references: 
 
Psychological Reporis, 1998,83, 1179-1186.  
PRELIMINARY VALIDATION AND RELIABILITY OF THE MODIFIED CHILD DENTAL 
ANXIETY SCALE '  H-M. WONG G. M. HUMPHRIS 
 
HUMPHRIS GM, MORRISON T and LINDSAY SJE (1995) 'The Modified Dental Anxiety Scale: 
Validation and United Kingdom Norms' Community Dental Health, 12, 143-150. 
 The original paper with UK norms, reliability and validity information, and justification for the 19 
‘cut off’ score  
 
GREEN RM, HUMPHRIS GM, LINDSAY SJE, MELLOR AC, MILLAR K, SIDEBOTHAM B (1997) 
 
'Minor psychiatric morbidity, pain and fear in patients in general dental practice' Community 
Dentistry and Oral Epidemiology, 25, 187-188. 
 Further paper with details of use of the MDAS in a dozen practices around the UK. 
 
HUMPHRIS GM, FREEMAN RE, TUTTI H, DESOUZA V (2000) ‘Further evidence for the reliability 
and validity of the Modified Dental Anxiety Scale’ International Dental Journal 50,367-370. 
 Details of MDAS scores in a number of countries following translation into native language of 
country concerned.  Further reliability and validity information. 
 
DAILEY Y-M, HUMPHRIS GM, LENNON MA (2001) ‘The use of dental anxiety questionnaires: a 
survey of a group of UK dental practitioners’ British Dental Journal 190(8) 450-453. 
 Survey of specialists in dental anxiety management and their use of formal psychometric 
instruments in their daily practice.   
 
DAILEY YM, HUMPHRIS GM, LENNON MA (2002) ‘Reducing patient’s state anxiety in 
general dental practice. A randomised controlled trial’ Journal of Dental Research 81(5): 
319-322.  (Abstract chosen for reprinting in the British Dental Journal under ‘Behavioural 
Science’ banner, vol 193(4):215). 
 
Study which shows the benefit to dental visitors of completing the MDAS and giving 
this to the dentist 
 
HUMPHRIS GM, CLARKE HMM, FREEMAN R. (2006) Does completing a dental anxiety 
questionnaire increase anxiety? A randomised controlled trial with adults in general dental practice. 
British Dental Journal,  

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ACCOLaDE  Protocol version 1.0 dated 09 July  2018 
 
 
Study shows that giving the MDAS to patients attending their general practitioner does not 
increase state anxiety in patients immediately prior to seeing their dentist 
FREEMAN R, CLARKE HMM, HUMPHRIS GM. (2007) Conversion Tables for the Corah and 
Modified Dental Anxiety Scales. Community Dental Health Mar;24(1):49-54 
 
Conversion tables and regression equations presented so that investigators can 
compare their results to other published sources regardless of whether they adopt 
Corah’s DAS or the MDAS  
HUMPHRIS G, HULL P. (2007) Do dental anxiety questionnaires raise anxiety in dentally anxious 
adult patients? A two wave panel study.  Primary Dental Care Jan;14(1):7-11 
 
Using the MDAS with Dental Access Patients.  No significant increase in anxiety following 
MDAS completion. 
 
YUAN S, FREEMAN R, LAHTI S, LLOYD-WILLIAMS F, HUMPHRIS G. (2008) Some 
psychometric properties of the Chinese version of the Modified Dental Anxiety Scale with 
cross validation. Health and Quality of Life Outcomes Mar 25;6(1):22  (free copy: 
http://www.hqlo.com/content/6/1/22 ) 
 
Use of confirmatory factor analysis and structural equation modelling to show 
validation of a new Chinese language version (sample within Beijing) with 
comparisons to an English sample from the North-west of England 
 
NEWTON JT, EDWARDS JC. (2005) Psychometric properties of the modified dental 
anxiety scale: an independent replication. Community Dent Health. Mar;22(1):40-2. 
● 
Study with 135 dental patients confirming reliability and some aspects of validity  
of the MDAS in England 
 
ILGUY D, ILGUY M, DINCER S, BAYIRLI G.  (2005) Reliability and validity of the Modified 
Dental Anxiety Scale in Turkish patients. J Int Med Res. Mar-Apr;33(2):252-9. 
 
Psychometrics of the Turkish version of the MDAS (294 dental patients) 
See Hyperlink: http://medicine.st-and.ac.uk/supplemental/humphris/dentalAnxiety.htm 
 
COOLIDGE T, CHAMBERS M, GARCIA LJ, HEATON LJ, COLDWELL SE Psychometric 
properties of Spanish-language adult dental fear measures. BMC Oral Health 2008, 8:15 
● 
Psychometrics of the Spanish version of the MDAS (various convenience samples) 
See Hyperlink: http://www.biomedcentral.com/1472-6831/8/15 
 
COOLIDGE T, ARAPOSTATHIS KN, EMMANOUIL D, DABARAKIS N, PATRIKIOU A, 
ECONOMIDES N, KOTSANOS N.  Psychometric properties of Greek versions of the 
Modified Corah Dental Anxiety Scale (MDAS) and the Dental Fear Survey (DFS). BMC 
Oral Health. 2008 Sep 30;8:29. 
● 
Psychometrics of the Greek version of the MDAS (two convenience samples, one 
from private practice and the other from a dental school) 
See Hyperlink: http://www.biomedcentral.com/1472-6831/8/29 
 
HUMPHRIS GM, DYER T, ROBINSON P. The Modified Dental Anxiety Scale: UK population 
norms in 2008 with further psychometrics and effects of age.  BMC Oral Health. 2009 
● 
New norms for UK derived from telephone survey representative sample (n=963) 
questioned in 2008, including respondents from all countries within UK.  Includes a table of 
percentiles for practitioners to estimate the percentage of people who would score the 

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level of dental anxiety that a particular patient may present with.  This table gives greater 
precision as estimates are provided by sex and three age bands. 
See Hyperlink: http://www.biomedcentral.com/1472-6831/9/20 
 M T Hosey, L M D Macpherson, P Adair, C Tochel, G Burnside and C Pine.  Dental 
anxiety, distress at induction and postoperative morbidity in children undergoing tooth 
extraction using general anaesthesia.  British Dental Journal 2006: 200:39-43 
See Hyperlink: 
https://www.researchgate.net/publication/7356249_Dental_anxiety_distress_at_inducti
on_and_postoperative_morbidity_in_children_undergoing_tooth_extraction_using_gen
eral_anaesthesia  
 M T Hosey, A J Asbury, A W Bowman, K Millar, K Martin, T Musiello and R Welbury.  
The effect of transmucosal 0.2 mg/kg midazolam premedication on dental anxiety, 
anaesthetic induction and psychological morbidity in children undergoing general 
anaesthesia for tooth extraction:  British Dental Journal 2009 
See Hyperlink:  https://www.ncbi.nlm.nih.gov/pubmed/1957499  
 
 
 
13.  
Appendices 
 
Appendix A – Participant Information Sheets and Consent Forms 
 
i) 
ACCOLaDE Participant Information Sheet and Consent Form – Adult 
 
ii) 
Parent/Guardian Information Sheet and Consent Form 
 
iii) 
ACCOLaDE Participant Information Sheet and Consent Form – Young Persons aged 
13-15 years 
 
 
 
Appendix B – Questionnaires 
 
i) 
MCDAS (Wong et al., 1998) Version 1  dated 17/10/2016 
 
ii) 
Antimicrobial Survey 
 
iii) 
WHO Oral Health Questionnaire for Adults 
 
iv) 
WHO Oral Health Questionnaire for Children