Authors' objectives: The presence of dental caries impacts on children’s daily lives, particularly among those living in deprived areas. There are successful interventions across the United Kingdom for young children based on toothbrushing with fluoride toothpaste. However, evidence is lacking for oral health improvement programmes in secondary-school pupils to reduce dental caries and its sequelae. To determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils. Reducing the high prevalence and severity of dental caries in the UK is a public health priority. Dental caries is largely preventable with several evidence-based child oral health promotion interventions including toothbrushing with fluoride toothpaste. However, evidence is lacking for interventions targeting toothbrushing practices to reduce dental caries and its sequelae (pain, infection and tooth loss) in secondary-school pupils. The Brushing RemInder 4 Good oral HealTh (BRIGHT) trial investigated a two-component behaviour change intervention (lesson and text messages) to prevent dental caries in secondary-school pupils. Conduct an internal pilot phase with feasibility components to: Tailor the intervention to young people. Test trial processes. Assess feasibility of within-school cluster randomisation (by year group). Investigate the intervention’s effect on caries prevalence, twice-daily toothbrushing, oral health-related quality of life and oral health behaviours. Investigate the intervention’s cost effectiveness. Explore implementation, mechanisms of impact and context through process evaluation.

Authors' results and conclusions: Four thousand six hundred and eighty pupils (intervention, n = 2262; control, n = 2418) from 42 schools were randomised. The primary analysis on 2383 pupils (50.9%; intervention 1153, 51.0%; control 1230, 50.9%) with valid data at baseline and 2.5 years found 44.6% in the intervention group and 43.0% in control had obvious decay experience in at least one permanent tooth. There was no evidence of a difference (odds ratio 1.04, 95% confidence interval 0.85 to 1.26, p = 0.72) and no statistically significant differences in secondary outcomes except for twice-daily toothbrushing at 6 months (odds ratio 1.30, 95% confidence interval 1.03 to 1.63, p = 0.03) and gingival bleeding score (borderline) at 2.5 years (geometric mean difference 0.92, 95% confidence interval 0.85 to 1.00, p = 0.05). The intervention had higher incremental mean costs (£1.02, 95% confidence interval −1.29 to 3.23) and lower incremental mean quality-adjusted life-years (−0.003, 95% confidence interval −0.009 to 0.002). The probability of the intervention being cost-effective was 7% at 2.5 years. However, in two subgroups, pilot trial schools and schools with higher proportions of pupils eligible for free school meals, there was an 84% and 60% chance of cost effectiveness, respectively, although their incremental costs and quality-adjusted life-years remained small and not statistically significant. The process evaluation revealed that the intervention was generally acceptable, although the implementation of text messages proved challenging. The COVID-19 pandemic hampered data collection. High rates of missing economic data mean findings should be interpreted with caution. Engagement with the intervention and evidence of 6-month change in toothbrushing behaviour was positive but did not translate into a reduction of caries. Future work should include work with secondary-school pupils to develop an understanding of the determinants of oral health behaviours, including toothbrushing and sugar consumption, particularly according to free school meal eligibility. Clinical effectiveness results Of the 14,083 pupils approached in the 42 recruited schools, 4699 (33.4%) were eligible and consented and were asked to complete baseline data collection; however, 19 withdrew pre randomisation leaving 4680 pupils (92.9% of our target of 5040) included in the randomised sample (intervention, n = 2262; control, n = 2418). The average number of pupils recruited per school was 111.4 [standard deviation (SD) 35.9, median 107, range 46–189] and per year group was 55.7 (SD 21.6, median 53, range 13–119). The average age of pupils at recruitment was 12.7 years (SD 0.6), 54.2% were female and 21.9% were eligible for FSM. Over three-quarters (77.6%) reported brushing their teeth at least twice a day. There was a valid baseline dental assessment for 4625 pupils; 1603 (34.7%) had evidence of obvious decay experience (presence of DICDAS4–6MFT in at least one permanent tooth) and 2929 (63.3%) had at least one treated or untreated carious lesion in any permanent tooth (DICDAS1–6MFT). Baseline data were similar between the intervention and control groups. Confirmation of lesson delivery was received from 39 of the 42 schools, with an estimated 2016 (89.1%) of 2262 pupils randomised to the intervention group attending. Text messages were sent to 2258 (99.8%) intervention pupils. The other four withdrew shortly after receiving the lesson and so their messages were not commenced. Participants were sent text messages until they requested them to stop or until 12 July 2020 (when a technical error occurred with the text provider that meant texts stopped being sent). A total of 962 intervention participants (42.5%) withdrew from receiving the text messages, a median of 2.8 months after they commenced (range 1 day to 30 months). Participants were sent messages for between 0 and 127 weeks (approximately 30 months, mean 53.4 weeks, SD 35.4, median 62). This equated to between 1 and 1708 text messages (mean 694.5, SD 468.9, median 789). On average, 71.4% of the text messages sent to a participant were successfully delivered. At 2.5 years, 1043 out of 2383 pupils (43.8%; intervention 514, 44.6%; control 529, 43.0%) had obvious decay experience in at least one permanent tooth. There was no evidence of a difference between the intervention and control groups [odds ratio (OR) 1.04, 95% confidence interval (CI) 0.85 to 1.26, p = 0.72]. The sensitivity analyses produced similar results to the primary analysis. The CACE estimates of the treatment effect based on attending the CBS session and on attending the CBS session and receiving at least 50% of their messages per week for the first 12 weeks were similar to the intention to treat estimate (OR 1.05, 95% CI 0.85 to 1.31, p = 0.64, and 1.07, 95% CI 0.72 to 1.59, p = 0.74, respectively). The CACE estimate associated with the number of texts sent was OR 1.00 (95% CI 0.999 to 1.001, p = 0.93), which indicates that for every additional text message sent, there was no evidence of a decrease in likelihood of having a carious lesion. There was no significant interaction between treatment allocation and either number of carious teeth at baseline or pilot/main trial schools, but there was evidence of a qualitative interaction for FSM status, with a benefit of the intervention seen among FSM pupils (OR 0.69, 95% CI 0.44 to 1.08, p = 0.10) but not among non-FSM pupils (OR 1.17, 95% CI 0.93 to 1.46, p = 0.18). There was evidence of a statistically significant difference for twice-daily toothbrushing at 6 months (OR 1.30, 95% CI 1.03 to 1.63, p = 0.03) and borderline evidence of a difference in gingival index score between the two groups (geometric mean difference 0.92, 95% CI 0.85 to 1.00, p = 0.05) at 2.5 years. One non-serious adverse event was recorded during the trial, which was deemed possibly related and unexpected, for a pupil in the control group. No suspected serious pathologies were identified during dental assessments. Fifteen safeguarding issues arose during the course of the trial. All were dealt with according to the trial safeguarding procedure. At the 2.5-year follow-up, there was no evidence of a difference between the control and intervention groups in the prevalence of caries extending to dentine (primary outcome) or including enamel and dentine lesions. The proportion of participants with caries into dentine was high (intervention group 34.4% at baseline and 44.7% at the 2.5-year follow-up, and control group 34.9% at baseline and 43.1% at follow-up). There was an indication of a positive effect on short-term toothbrushing behaviour at 6 months. The subgroup analysis of participants eligible for FSM suggests a significant, qualitative interaction effect whereby the intervention appeared to be beneficial in terms of caries prevalence within pupils eligible for FSM but not for those not eligible for FSM. The process evaluation found the intervention to be broadly acceptable with some technical issues of text message delivery. The primary economic analysis shows that the intervention is not likely to be cost-effective. Further research is needed to understand how to prevent dental caries in secondary-school pupils.

Authors' methods: A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations. Secondary schools in Scotland, England and Wales with above-average proportion of pupils eligible for free school meals. Randomisation occurred within schools (year-group level), using block randomisation stratified by school. Pupils aged 11–13 years at recruitment, who have their own mobile telephone. Two-component intervention based on behaviour change theory: (1) 50-minute lesson delivered by teachers, and (2) twice-daily text messages to pupils’ mobile phones about toothbrushing, compared with routine education. Primary outcome: presence of at least one treated or untreated carious lesion using DICDAS4–6MFT (Decayed, Missing and Filled Teeth) in any permanent tooth, measured at pupil level at 2.5 years. Secondary outcomes included: number of DICDAS4–6MFT; presence and number of DICDAS1–6MFT; plaque; bleeding; twice-daily toothbrushing; health-related quality of life (Child Health Utility 9D); and oral health-related quality of life (Caries Impacts and Experiences Questionnaire for Children). Design A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot phase, and embedded health economic and process evaluations. Criteria determining progression to the main phase were pre-specified and reviewed within the internal pilot phase. Secondary schools in Scotland, England and Wales with above national average percentage of pupils eligible for free school meals (FSM) were recruited. Schools had to have pupils aged 11–16 years and at least 60 pupils per year group. Pupils aged 11–13 years (Years 7 and 8 in England and Wales; S1 and S2 in Scotland) in participating schools were eligible to take part and received an information session about BRIGHT. Parents/carers had 2 weeks to decline their child’s participation. Pupils who had not been opted out were invited to participate by completing a consent form and providing their mobile telephone number. If they did not own a mobile telephone or could not provide their number, they were ineligible.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/15/166/08

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/JQTA2103

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: United Kingdom

DOI: 10.3310/JQTA2103

Organisation Name: NIHR Health and Social Care Delivery Program

Contact Name: Rhiannon Miller

Contact Email: rhiannon.m@prepress-projects.co.uk