Condition category
Digestive System
Date applied
16/09/2015
Date assigned
23/09/2015
Last edited
22/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Joint Research Management Office (JRMO)
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26897029

Publication citations

Additional files

Editorial Notes

22/02/2016: Publication reference added.