Title: 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
Funder: Chief Scientist Office, Scotland

Abstract: 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 found increased self-reported toothbrushing in unemployed young people over 10-weeks. AIM: BRIGHT will evaluate clinical and cost-effectiveness of SMS behaviour change programme 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: 1,200 young people (10 schools) randomised 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 3 months using an 80% one-sided confidence interval approach; 2) engage with 48 schools for main trial and obtain agreement to participate, in principle 3) consent rate of 50% or more of eligible children; 4) minimum 80% response to questionnaires at 3 months A mixed-method process evaluation will complement the outcome evaluation and examine implementation, mechanisms of impact and context as per MRC guidance . SETTING: 48 Secondary Schools (based on percentage of pupils eligible for FSM) across England, Scotland and Wales. TARGET POPULATION: 5760 young people (11-16 years) attending school in UK deprived areas. HEALTH TECHNOLOGIES BEING ASSESSED: The BRIGHT intervention, based on New Zealand KOB study[13] comprises a classroom-based, curriculum-embedded session and a series of follow-up text messages, for young people living in deprived areas and compared to routine education and no text messaging. SAMPLE SIZE: Main trial design depends upon pilot results; a school based (not year group) cluster randomised trial, with schools randomised to deliver the intervention to either 11-12 year olds and 12-13 year olds with control schools to assess effectiveness. This would require 5760 pupils in 48 schools, powered at 90% to detect an absolute reduction in caries of 8% from 32% to 24%, based on a conservative assumed intra-cluster correction coefficient of 0.02, average cluster size of 120 and 20% attrition. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome • Incidence of carious lesions in permanent teeth, measured using DMFT where decay is measured as caries into dentine - International Caries Detection and Assessment System [ICDAS] levels 4-6), over 3 years. Recorded at baseline,2,3 yrs Secondary outcomes • Caries incidence; 2 years • Number of carious permanent teeth at 3 years • Self report measures of frequency of daily tooth brushing; 3, 6 months, 1, 2 & 3 years and clinical assessment of plaque[16] & gingivitis[17] ; 2 & 3 years • Cost effectiveness (cost utility analysis and modelling for longer term cost-effectiveness) • Health-related quality of life, oral health-related quality of life and oral health behaviours (Child Health Utility-9D[18] and CARIES-QC[19]) PROJECT TIMETABLE:Start 01/01/17, recruitment pilot 2 months; (follow up over 3 years) Main trial start: 01/06/18 recruitment Main: 4 months; follow up over 3 years; final report submission 01/04/21 EXPERTISE IN TEAM Child oral health, secondary education, trial methods, trial statistics, health economics, digital technology, process evaluation, behaviour change, patient/ public involvement

Lay abstract: BACKGROUND: Tooth decay is very common affecting one-third of young people aged 12-15 years, increasing to nearly one-half in young people living in deprived areas. Young people with tooth decay often have toothache, loss of sleep, problems eating and need to take off school. However, tooth decay can be prevented and one of the most effective ways is regular tooth brushing with fluoride toothpaste. In New Zealand a study found that sending unemployed young adults a short message service (SMS, also known as text message) on their mobile phone every week increased how often they brushed their teeth. However, the researchers recommended further testing over a longer period and with some modifications. AIM: This project called BRIGHT will test whether a classroom-based lesson about dental health followed by a series of text messages delivered through schools to young people, aged 11-16, years reduces tooth decay, increases how often (and how well) they brush their teeth and would be of enough benefit to ensure it was worth the cost of running it. DESIGN AND METHODS: The project will be run in schools where there are a high proportion of young people eligible for free school meals (as an indicator of areas of deprivation) in England, Scotland and Wales. We plan to carry out a pilot trial first to check whether it is possible to run the main study. The pilot will run in 10 schools with 1200 young people. In each school we will have one class of young people receiving a classroom-based talk about looking after teeth and they will then get a series of text messages to their phones. We will also have another class who do not have a talk or text messages. The pilot will also let us check that the classroom based lesson works with the schools’ curriculum and ensure we have the best way to work with the schools to collect the information we need from young people. If the pilot trial shows the main trial is possible we will involve a maximum total of 48 schools and 5760 young people. We will collect information from the young people for 3 years about tooth decay, how often they brush their teeth and how much tooth decay affects their lives. This will see whether there is a difference between those who have the programme and those who do not. We will encourage the young people taking part to provide the information we need by making it as fun as possible and by using a variety of methods including prize draws and thank-you vouchers. Throughout the main study we will be also find out how well the programme is working from school staff, young people themselves and parents. PATIENT AND PUBLIC INVOLVEMENT We have already worked with teachers and school staff to help ensure the trial will work in schools. We have asked young people about their mobile phone use and preferences for text messages. In the trial we will involve pupils as school research champions and youth workers to help make sure it engages all young people. DISSEMINATION We will develop a BRIGHT website with blog and social media accounts to describe the trial progress. The results will be published in a report and dental and education journals, newsletters and presented at conferences. If the intervention is effective we will encourage its uptake into the school curriculum, guidance produced about digital health programmes and the National Institute for Health and Care Excellence guidance on oral health promotion programmes.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: ORAL AND GASTROINTESTINAL