Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: Does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial

Background: Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone based interventions such as Short Messaging Service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention; classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS for young people from deprived areas, on the incidence of dental caries. The objective of this study is to investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. Methods/design: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5,040 11-13 year olds in 42 schools with a three year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at three years. Secondary outcomes are: frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted. Discussion: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies including departments for education, dental public health and guideline development organisations. Trial registration: ISRCTN12139369, date of initial registration 10/5/2017, https://doi.org/10.1186/ISRCTN12139369. Keywords: Dental caries, caries prevention, prevention, behaviour change, randomised controlled trial, child dental health, m-health, short messaging service