{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T21:05:21Z","timestamp":1791925521125,"version":"4.3.4"},"reference-count":142,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["15\/166\/08"],"award-info":[{"award-number":["15\/166\/08"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>\nThe presence of dental caries impacts on children\u2019s 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.<\/jats:p>\n<\/jats:sec>\nObjectives<\/jats:title>\nTo determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils.<\/jats:p>\n<\/jats:sec>\nDesign<\/jats:title>\nA multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations.<\/jats:p>\n<\/jats:sec>\nSetting<\/jats:title>\nSecondary 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.<\/jats:p>\n<\/jats:sec>\nParticipants<\/jats:title>\nPupils aged 11\u201313 years at recruitment, who have their own mobile telephone.<\/jats:p>\n<\/jats:sec>\nInterventions<\/jats:title>\nTwo-component intervention based on behaviour change theory: (1) 50-minute lesson delivered by teachers, and (2) twice-daily text messages to pupils\u2019 mobile phones about toothbrushing, compared with routine education.<\/jats:p>\n<\/jats:sec>\nMain outcome measures<\/jats:title>\nPrimary outcome: presence of at least one treated or untreated carious lesion using DICDAS4\u20136<\/jats:sub>MFT (Decayed, Missing and Filled Teeth) in any permanent tooth, measured at pupil level at 2.5 years. Secondary outcomes included: number of DICDAS4\u20136<\/jats:sub>MFT; presence and number of DICDAS1\u20136<\/jats:sub>MFT; 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).<\/jats:p>\n<\/jats:sec>\nResults<\/jats:title>\nFour thousand six hundred and eighty pupils (intervention, n<\/jats:italic>\u2005=\u20052262; control, n<\/jats:italic>\u2005=\u20052418) 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<\/jats:italic>\u2005=\u20050.72) 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<\/jats:italic>\u2005=\u20050.03) and gingival bleeding score (borderline) at 2.5 years (geometric mean difference 0.92, 95% confidence interval 0.85 to 1.00, p<\/jats:italic>\u2005=\u20050.05).<\/jats:p>\nThe intervention had higher incremental mean costs (\u00a31.02, 95% confidence interval \u22121.29 to 3.23) and lower incremental mean quality-adjusted life-years (\u22120.003, 95% confidence interval \u22120.009 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.<\/jats:p>\nThe COVID-19 pandemic hampered data collection. High rates of missing economic data mean findings should be interpreted with caution.<\/jats:p>\n<\/jats:sec>\nConclusions<\/jats:title>\nEngagement 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.<\/jats:p>\n<\/jats:sec>\nTrial registration<\/jats:title>\nThis trial is registered as ISRCTN12139369.<\/jats:p>\n<\/jats:sec>\nFunding<\/jats:title>\nThis award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15\/166\/08) and is published in full in Health Technology Assessment<\/jats:italic>; Vol. 28, No. 52. See the NIHR Funding and Awards website for further award information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/jqta2103","type":"journal-article","created":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T13:11:29Z","timestamp":1726060289000},"page":"1-142","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Behaviour change intervention (education and text) to prevent dental caries in secondary school pupils: BRIGHT RCT, process and economic evaluation"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0943-9637","authenticated-orcid":true,"given":"Zoe","family":"Marshman","sequence":"first","affiliation":[{"name":"School of Clinical Dentistry, University of Sheffield, Sheffield, 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