Plain English Summary
Background and study aims
A series of eight storybooks has been developed by a health psychologist, public health dentist, science educator, children's author and illustrators with guidance from the Department for Education (England). The storybooks are designed to encourage twice daily toothbrushing with fluoride toothpaste and discourage eating sugary snacks, especially at bedtime. The aim of this study is to find out whether children’s dental health can be improved using these storybooks.
Who can participate?
Children aged 5-7 at 60 primary schools in England and Scotland whose headteachers have agreed to participate in the study.
What does the study involve?
Participating schools are randomly allocated to one of three groups. Children in group 1 schools receive the storybooks containing the dental health messages. Children in group 2 schools receive storybooks with exactly the same illustrations, characters and story but without the dental health messages. Children in group 3 schools receive the storybooks containing the dental health messages, undertake supervised toothbrushing at school, and receive a supply of toothbrushes and toothpaste to use at home. All children in the study will have a dental examination annually and parents will be asked to complete questionnaires at the start of the study and after 1 and 2 years. A subset of children and families are invited to join a study of the child’s diet and saliva composition at the start of the study and at the final assessment 2 years later.
What are the possible benefits and risks of participating?
All children whose parents give permission for them to take part will be given 8 bright and colourful story books to take home and keep. Risks to all participants could include inconvenience due to time taken to complete the questionnaire (up to 30 minutes on three occasions).
Where is the study run from?
60 primary schools across England and Scotland (UK).
When is the study starting and how long is it expected to run for?
June 2013 to December 2017.
Who is funding the study?
Queen Mary University of London (UK).
Who is the main contact?
Louise Robinson
louise.robinson@srft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Cynthia Pine
ORCID ID
Contact details
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
Turner Street
London
E1 2AD
United Kingdom
Type
Public
Additional contact
Ms Louise Robinson
ORCID ID
Contact details
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
Turner Street
London
E1 2AD
United Kingdom
+44 (0)207 882 8636
l.robinson@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
QMREC2013/43
Study information
Scientific title
A cluster randomised controlled trial to prevent dental caries in primary school children: The BBaRTS Healthy Teeth Behaviour Change Programme
Acronym
BBaRTS
Study hypothesis
The primary aim of this research is to determine whether children’s dental health can be improved by increasing parental self-efficacy using a storybook approach for two child behaviours: toothbrushing and sugars snacking. Specifically, with the following objective:
Objective:
To determine whether an intervention (Test 1) designed to increase parental self-efficacy using a storybook approach with embedded Behaviour Change Techniques (BCTs) for two child behaviours: toothbrushing with fluoride toothpaste and reducing consumption of free sugars, especially at bedtime, can improve child oral health compared to:
1. An exactly similar intervention without embedded health messages and BCTs (Control)
2. The intervention (Test 1) supplemented with home supply of fluoride toothpaste and supervised toothbrushing on schooldays (Test 2).
Ethics approval
Queen Mary University Ethics Committee, 21/08/2013, ref: QMREC2013/43
Study design
Three-arm multicentre cluster randomised controlled trial with blinded outcome assessment
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dental caries
Intervention
A series of 8 story books have been developed by a health psychologist, public health dentist, science educator, children's author and illustrators with guidance from the Department for Education (England). The books are given out each school term over two years.
Participants are children (estimated 2000 – 2600) aged 5-7 years and their families from 60 Primary Schools in England and Scotland. Schools are randomized into three groups:
Group 1 (test 1) will receive 8 story books (the test books) containing the intervention messages
Group 2 (control) will receive 8 story books with exactly the same illustrations, characters and story but without the intervention messages
Group 3 (test 2) will receive the 8 test books and supervised toothbrushing at school and a supply of toothbrushes and toothpaste to use at home
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Dental caries experience in permanent teeth at age 7 years, measured by a simple visual dental examinations conducted in the child’s school at baseline, after one year and after two years. The examinations will be conducted by independent dental examiners, trained in standardised dental epidemiological survey techniques and blinded to the group allocation of the school. Dental caries experience on any surface in either dentition will be recorded. All children will be examined using sterilised or single use mouth mirrors, CPITN probes, a standardized halogen lamp (2,000 lux) and cotton wool rolls as needed.
Secondary outcome measures
1. Oral cleanliness, measured by plaque assessment on the buccal surfaces of upper anterior teeth at the dental examinations
2. Oral health behaviours
3. Family satisfaction
4. Early Child Oral Health Impact
5. Reading Intensity
Parents/guardians of children will be asked to complete a questionnaire pack at baseline, one year and two years post enrollment.
Overall trial start date
01/06/2013
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 5-7 at primary schools in England and Scotland whose headteachers have agreed to participate in the study
3. Parent/legal guardian completed informed consent
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
60 schools, estimated 2000 – 2600 children
Participant exclusion criteria
1. No parent/guardian consent obtained
2. Schools that have existing toothbrushing programmes or fluoride varnish schemes
Recruitment start date
07/09/2013
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
60 primary schools across England and Scotland
-
United Kingdom
Funders
Funder type
University/education
Funder name
Queen Mary University of London, supported by an unrestricted grant from GSK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26897029