Plain English Summary
Background and study aims
This study is about how to look after children’s teeth which have decayed. Dentists often drill and then fill milk (baby) teeth that have decay in them. However, this is not the only way they can look after decayed teeth. This study will compare three different ways dentists can look after decayed teeth to find out which works best. These methods are already used by dentists, but no one has done a study to find out which one of them is best for children. The three treatments methods we are studying are:
1. Conventional management of decay, with prevention - this is commonly known as the ‘drill and fill’ method, where dental drills and injections are used to cut away the decay and fill the cavity
2. Biological management of decay, with prevention - the decay is sealed off from the mouth by a filling or a metal crown, generally without using dental drills or injections
3. No fillings, only prevention
It is possible to slow down the rate of tooth decay and to stop a decayed tooth from getting worse without having to use fillings. Ways we can stop tooth decay getting worse include regular tooth brushing and making changes to what and when we eat. Dentists can also paint a fluoride varnish or place a protective coating onto teeth and children older than 10 might be prescribed high fluoride toothpaste.
Who can participate?
Children who are 3-7 years old, with tooth decay.
What does the study involve?
At the first appointment parents and children are given a short questionnaire and a follow–up appointment. The treatment method (described above) is then chosen at random, and the dentist will then look the child's teeth in this way for about 3 years. Each time the child sees the dentist they complete a short questionnaire. At the start of the study and then every year, parents are asked to complete some questionnaires about their child and their teeth.
What are the possible benefits and risks of participating?
As this is a study comparing treatments that are all being used in standard practice there are no particular benefits for the participants. None of the treatments we are testing in this study are new. They are all safe and used already by many dentists. As with any dental treatment, if there is any pain or discomfort, you should talk to your dentist.
Where is the study run from?
Newcastle University (UK).
When is the study starting and how long is it expected to run for?
April 2010 to December 2017.
Who is funding the study?
NIHR Health Technology Assessment (HTA) programme (UK).
Who is the main contact?
Mark Palmer
Mark.palmer@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Palmer
ORCID ID
Contact details
Newcastle Clinical Trials Unit
1–2 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 208 2515 Mon/Fri or +44 (0)191 208 8393 Tues/Wed/Thurs
Mark.palmer@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/44/03; Protocol 3.0
Study information
Scientific title
FiCTION - Filling Children's Teeth: Indicated Or Not? A rehearsal pilot randomised controlled trial
Acronym
FiCTION
Study hypothesis
What is the relative clinical and cost effectiveness of conventional filling of caries in primary teeth vs. no treatment vs an intermediate treatment strategy based on the biological management of caries?
This pilot randomised controlled trial (RCT) will also examine patient recruitment and retention rates, and collection of data on clinical outcomes. The findings will inform the decision of whether to proceed to a large-scale RCT and whether any refinements to the design or conduct of that trial are warranted.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/074403
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0008/51848/PRO-07-44-03.pdf
On 04/09/2009 the overall trial end date was updated from 01/01/2011 to 31/12/2015.
On 13/05/2010 the overall trial start and end dates were updated from 01/10/2009 and 31/12/2015 to 01/04/2010 and 30/06/2016, respectively.
On 06/10/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2016 to 31/12/2017.
2. The target number of participants was changed from 200 to 1113.
Ethics approval
The Tayside Committee on Medical Research Ethics B, 12/02/2010, ref: 10/S1402/8
Study design
Three-arm parallel-group patient-randomised multi-centre rehearsal pilot trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Parent info sheet: http://research.ncl.ac.uk/fictiontrial/forparentschildren/informationforparents/Parent%20Information%20Sheet%20V3%200%2024072014.pdf; Child info sheet: http://research.ncl.ac.uk/fictiontrial/forparentschildren/informationforchildren/Child's%20Information%20sheet.pdf
Condition
Oral health
Intervention
Participants will be individually randomised to the following three arms:
1. Conventional filling (surgical management) of dental caries
2. Intermediate treatment strategy (biological management - Hall technique) of dental caries
3. No active treatment (best practice preventive measures only) of dental caries
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Current primary outcome measures as of 06/10/2015:
Either pain or sepsis related to dental caries. Episodes of dental pain (toothache) measured by patient/parent reporting and by dentist direct questioning, signs of infection detected through dentist clinical examination
Previous primary outcome measures:
1. Number of children experiencing dental pain, as assessed by the Dental Discomfort Questionnaire (DDQ-8)
2. Number of children experiencing dental sepsis, as assessed by clinical examination (child's own dentist) and radiographic signs (independent blinded assessor)
Secondary outcome measures
Current secondary outcome measures as of 06/10/2015:
1. Incidence of caries in primary and secondary teeth; caries experience recorded using International Caries Detection and Assessment System (ICDAS) via CRF
2. Patient quality of life; patient and parent completed questionnaires
3. Cost-effectiveness of arm (treatment strategy); parent questionnaire and data collection on clinical activity via CRF, study specific estimates of unit costs
4. Acceptability of treatment strategy to participants and parents and their experiences; patient and parent questionnaires; parental interviews/ focus groups/child participatory activities
5. Dentists’ management strategy preferences; dentist questionnaire via CRF
Previous secondary outcome measures:
1. Measurements of caries experience, as assessed by the validated International Caries Detection and Assessment System (ICDAS)
2. Child's quality of life, proxy assessed by Parental-Caregivers Perceptions Questionnaire (P-CPQ)
3. Child's global rating of oral health and impact on everyday life
4. Child's dental anxiety, as assessed by Modified Child Dental Anxiety Scale (MCDAS)
5. NHS costs of dental visits and treatment
6. Parental/family costs of dental visits and treatment
Overall trial start date
01/04/2010
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Child aged 3-7 years
2. At least one tooth with decay into dentine (assessed by the General Dental Practitioner [GDP] and defined as International Caries Detection and Assessment System [ICDAS] code 3,4,5 or 6)
3. At least one primary molar tooth
4. Willing to be examined and can have bitewing radiographs taken (i.e. have not had dental radiographs for at least 11 months and are cooperative with the procedure)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1113
Participant exclusion criteria
1. Patients at the recruitment appointment with either toothache or sepsis (as diagnosed by the GDP from patient history, examination, radiographs) will not be enrolled into the study but after treatment may be reassessed for eligibility
2. Patients who are accompanied by an adult who lacks the legal or mental capacity to give informed consent
3. Patients with a medical condition requiring special considerations with their dental management, e.g., cardiac defects, blood dyscrasias
Recruitment start date
06/09/2012
Recruitment end date
30/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
Trial participating centre
Dundee Dental Hospital and School
Park Place
Dundee
DD1 4HR
United Kingdom
Trial participating centre
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
Trial participating centre
Centre for Oral Health Research, School of Dental Sciences
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
Trial participating centre
Department of Oral Health and Development
School of Clinical Dentistry
Claremont Crescent
University of Sheffield
Sheffield
S10 2TA
United Kingdom
Trial participating centre
School of Dentistry
University of Cardiff
Cardiff
CF10 3XQ
United Kingdom
Trial participating centre
Institute of Dentistry
Queen Mary University of London
Mile End Road
London
E1 4NS
United Kingdom
Trial participating centre
Department of Child Dental Health
University Dental Hospital Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Nethergate
Dundee
DD1 4HN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
01/07/2018
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/22913464
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25415040
Publication citations
-
Results
Marshman Z, Innes N, Deery C, Hall M, Speed C, Douglas G, Clarkson J, Rodd H, The management of dental caries in primary teeth - involving service providers and users in the design of a trial., Trials, 2012, 13, 143, doi: 10.1186/1745-6215-13-143.
-
Results
Keightley A, Clarkson J, Maguire A, Speed C, Innes N, Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers, Br Dent J, 2014, 217, 10, E22, doi: 10.1038/sj.bdj.2014.1009.