BBaRTS Children's Healthy Teeth Programme
| ISRCTN | ISRCTN21461006 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21461006 |
| Secondary identifying numbers | QMREC2013/43 |
- Submission date
- 16/09/2015
- Registration date
- 23/09/2015
- Last edited
- 11/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
Turner Street
London
E1 2AD
United Kingdom
Public
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
Turner Street
London
E1 2AD
United Kingdom
| Phone | +44 (0)207 882 8636 |
|---|---|
| l.robinson@qmul.ac.uk |
Study information
| Study design | Three-arm multicentre cluster randomised controlled trial with blinded outcome assessment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A cluster randomised controlled trial to prevent dental caries in primary school children: The BBaRTS Healthy Teeth Behaviour Change Programme |
| Study acronym | BBaRTS |
| Study objectives | 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(s) | Queen Mary University Ethics Committee, 21/08/2013, ref: QMREC2013/43 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2013 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 7 Years |
| Sex | Both |
| Target number of participants | 60 schools, estimated 2000 – 2600 children |
| Key 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 |
| Key exclusion criteria | 1. No parent/guardian consent obtained 2. Schools that have existing toothbrushing programmes or fluoride varnish schemes |
| Date of first enrolment | 07/09/2013 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
Joint Research Management Office (JRMO)
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom
"ROR" |
https://ror.org/026zzn846 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/02/2016 | Yes | No |
Editorial Notes
11/12/2018: The overall trial end date has been updated from 31/12/2017 to 30/06/2019.
22/02/2016: Publication reference added.
