BRIGHT Trial: Brushing RemInder 4 Good oral HealTh: the clinical and cost-effectiveness of a Short Messaging Service behaviour change programme to improve the oral health of young people living in deprived areas

BACKGROUND: Dental caries affects 1 in 3 UK 12 year-olds and is closely linked to deprivation. Brushing with fluoridated toothpaste is a highly effective preventive measure. The Keep on Brushing SMS programme in New Zealand increased self-reported toothbrushing in unemployed young people (aged 18-24 years) over 10-weeks. AIM: The BRIGHT trial will evaluate the clinical and cost-effectiveness of a SMS behaviour change programme with a classroom-based session to improve the oral health of young people living in deprived areas. DESIGN: Multi-centre, school based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Internal Pilot Trial: Aimed to randomise 1,200 young people (aged 11-12 and 12-13 years) from 10 schools at the year-group level to intervention or control group. Key progression criteria: 1) An indication of a positive effect of the intervention on self-reported frequency of tooth brushing at approximately 3 months using an 80% one-sided confidence interval approach; 2) Engagement with 80% of the schools required for the main trial and obtain agreement to participate, in principle; 3) Recruiting an average of 48 young people per year group from the 10 schools included in the pilot trial; 4) Minimum 80% response rate to questionnaires completed by young people; A mixed-method process evaluation will complement the outcome evaluation and examine implementation, mechanisms of impact and context, as per Medical Research Council guidance. SETTING: 42 Secondary Schools (with an above average percentage of pupils eligible for free school meals) across England (South Yorkshire and West Yorkshire), Scotland and South Wales. TARGET POPULATION: 5040 young people (11-13 years at trial entry) attending school in UK deprived areas. HEALTH TECHNOLOGIES BEING ASSESSED: The BRIGHT intervention, based on the New Zealand Keep on Brushing programme, comprises a curriculum-embedded classroom-based session (CBS) and a series of follow-up text messages for young people living in deprived areas, and is compared to routine education and no text messaging. SAMPLE SIZE: Based on the pilot trial, it was estimated that approximately 5040 young people from 42 schools would be required in total across the main trial and internal pilot, using within-school cluster randomisation (year group level, where schools are randomised to deliver the intervention to either 11-12 year olds [Year 7/S1] or 12-13 year olds [Year 8/S2], with the other year group allocated to control). This sample size would give 90% power (5% two-sided a) to detect an 8% absolute reduction, from 34% to 26%, in the proportion of young people with ’obvious decay experience’ and is based on a conservative assumed intra-cluster correction coefficient of 0.02, an average of 60 young people per year group and 20% attrition at follow-up. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome • Caries prevalence for ‘obvious decay experience’ at approximately 2.5 years: Presence of at least one treated or untreated carious lesion in any permanent tooth, measured at the young person-level at the 2.5 year follow-up using the permanent tooth index ‘DMFT’ (Decayed, Missing, and Filled Teeth), where decay is measured as carious lesions extending into dentine - International Caries Detection and Assessment System (ICDAS) levels 4-6 (‘obvious decay experience’). Secondary outcomes • Self-reported frequency of twice-daily toothbrushing at time of CBS (pilot only), between CBS and 12 weeks (pilot only), 6 months, 1 year, 2 years (pilot only) and 2.5 years; plaque levels and gingivitis at 2 (pilot only) and 2.5 years). • Caries prevalence for all carious lesions at 2 (pilot only) and 2.5 years - Presence of at least one treated or untreated carious lesion of any severity (ICDAS levels 1-6) in any permanent tooth at 2 (pilot only) and 2.5 years clinical follow-up. • Number of treated or untreated carious teeth (using the DMFT) at 2 (pilot only) and 2.5 years (ICDAS 1-6), and caries into dentine (ICDAS 4-6) at 2 (pilot only) and 2.5 years follow-up. • Caries prevalence for obvious decay experience at 2 years (pilot only) - Presence of at least one treated or untreated carious lesion in any permanent tooth, measured at the young person-level using DMFT where decay is measured as caries into dentine (ICDAS levels 4-6), at 2 years follow-up (pilot only). • Child health-related quality of life and oral health-related quality of life (Child Health Utility-9D and CARIES-QC at 1, 2 [pilot only] and 2.5 years). • School Attendance at 1, 2 (pilot only) and 2.5 years. Cost-effectiveness • Resource use will be assessed via parent questionnaires at 1, 2 (pilot only) and 2.5 years and may be estimated from routine data sources. Quality adjusted life years will be calculated using CHU-9D data from young people via questionnaires. Cost-effectiveness will be calculated over 2.5 years and modelled to a child’s lifetime. PROJECT TIMETABLE: Start date: 01/01/17; pilot recruitment start: 01/08/2017; Main trial recruitment start: 01/07/18; follow up over 2.5 years; final report submission: 31/07/22. EXPERTISE IN TEAM Child oral health, secondary education, trial methods, trial statistics, health economics, digital technology, process evaluation, behaviour change, patient/ public involvement.