Abstract
BACKGROUND
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.
OBJECTIVES
To determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils.
DESIGN
A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations.
SETTING
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.
PARTICIPANTS
Pupils aged 11-13 years at recruitment, who have their own mobile telephone.
INTERVENTIONS
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.
MAIN OUTCOME MEASURES
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).
RESULTS
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.
CONCLUSIONS
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.
TRIAL REGISTRATION
This trial is registered as ISRCTN12139369.
FUNDING
This 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; Vol. 28, No. 52. See the NIHR Funding and Awards website for further award information.
Plain language summary
Tooth decay has an impact on children and young people’s daily lives, particularly those living in deprived areas. For young children, programmes to improve toothbrushing with fluoride toothpaste help prevent tooth decay. The Brushing RemInder 4 Good oral HealTh trial (BRIGHT) investigated whether a secondary-school-based toothbrushing programme would work. We developed a new programme which included a lesson and twice-daily text messages sent to pupils’ phones. In total, 4680 pupils, aged 11–13 years, from 42 secondary schools in the United Kingdom took part in the trial. At each school, one year group was randomly selected to receive the programme, while the other year group did not receive it. All pupils were followed up for 2.5 years to see whether there were any differences in levels of tooth decay, frequency of toothbrushing, plaque or quality of life. We also considered the programme’s value for money and the views of pupils and school staff. We followed up 2383 pupils and found no difference in tooth decay, plaque or quality of life. We found those who had the programme were more likely to brush their teeth twice daily after 6 months than those who did not. The programme was not good value for money overall. However, the programme appeared to be of more benefit at preventing tooth decay in pupils eligible for free school meals compared to those not eligible. In the schools with more pupils eligible for free school meals, the chance of the programme representing good value for money increased. The programme was generally liked by the pupils and school staff. Some pupils found the text messages useful, although others said they were annoying. The programme helped pupils brush their teeth more frequently in the short term, but this did not lead to less tooth decay. Further research is needed to understand how to prevent tooth decay in secondary-school pupils.
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References
- Public Health England. Health Matters: Child Dental Health. 2017. URL: www.gov.uk/government/publications/health-matters-child-dental-health/health-matters-child-dental-health (accessed 15 June 2021).
- Welsh Government. The Oral Health and Dental Services Response. 2018. URL: https://gov.wales/sites/default/files/publications/2019-03/the-oral-health-and-dental-services-response.pdf (accessed 11 September 2022).
- NHS England. Outcome of 2022/23 Dental Contract Negotiations. 2022. URL: www.england.nhs.uk/wp-content/uploads/2022/07/B1802_First-stage-of-dental-reform-letter_190722.pdf (accessed 11 September 2022).
- Macpherson LM, Rodgers J, Conway DI. Childsmile after 10 years part 2: programme development, implementation and evaluation. Dent Update 2019;46:238–46. https://doi.org/10.12968/denu.2019.46.3.238
- Walsh T, Worthington HV, Glenny AM, Marinho VCC, Jeroncic A. Fluoride toothpastes of different concentrations for preventing dental caries. Cochrane Database Syst Rev 2019;3:CD007868. https://doi.org/10.1002/14651858.CD007868.pub3 doi: 10.1002/14651858.CD007868.pub3. [DOI] [PMC free article] [PubMed]
- Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res 2015;94:650. https://doi.org/10.1177/0022034515573272 doi: 10.1177/0022034515573272. [DOI] [PubMed]
- Pitts NB, Chadwick B, Anderson T. Children’s Dental Health Survey 2013. Report 2: Dental Disease and Damage in Children. England, Wales and Northern Ireland. Health and Social Care Information Centre. 2015. URL: https://digital.nhs.uk/data-and-information/publications/statistical/children-s-dental-health-survey/child-dental-health-survey-2013-england-wales-and-northern-ireland (accessed 15 June 2021).
- Merrett MCW, Goold S, Jones CM, Levin KA, McCall DR, Macpherson LMD, et al. National Dental Inspection Programme of Scotland: Report of the 2005 Survey of P7 Children. Scottish Dental Epidemiological Co-ordinating Committee. 2005. URL: https://ndip.scottishdental.org/ndip-reports/ (accessed 8 February 2023).
- ISD Scotland. National Dental Inspection Programme (NDIP) 2015: Report of the 2015 Detailed National Dental Inspection Programme of Primary 7 Children and the Basic Inspection of Primary 1 and Primary 7 Children. NHS National Services Scotland. 2015. URL: https://ndip.scottishdental.org/ndip-reports/ (accessed 8 February 2023).
- ISD Scotland. National Dental Inspection Programme (NDIP) 2019: Report of the 2019 Detailed Inspection Programme of Primary 7 Children and the Basic Inspection of Primary 1 and Primary 7 Children. NHS National Services Scotland. 2019. URL: https://ndip.scottishdental.org/ndip-reports/ (accessed 8 February 2023).
- Jackson SL, Vann WF, Kotch JB, Pahel BT, Lee JY. Impact of poor oral health on children’s school attendance and performance. Am J Public Health 2011;101:1900–6. https://doi.org/10.2105/AJPH.2010.200915 doi: 10.2105/AJPH.2010.200915. [DOI] [PMC free article] [PubMed]
- Gilchrist F, Marshman Z, Deery C, Rodd HD. The impact of dental caries on children and young people: what they have to say? Int J Paediatr Dent 2015;25:327–38. https://doi.org/10.1111/ipd.12186 doi: 10.1111/ipd.12186. [DOI] [PubMed]
- Stennett M, Tsakos G. The impact of the COVID-19 pandemic on oral health inequalities and access to oral healthcare in England. Br Dent J 2022;232:109–14. https://doi.org/10.1038/s41415-021-3718-0 doi: 10.1038/s41415-021-3718-0. [DOI] [PMC free article] [PubMed]
- Adam M. Chart of the Week: How Has the Pandemic Affected Inequalities in Tooth Extractions for Children? Nuffield Trust. 2022. URL: www.nuffieldtrust.org.uk/resource/chart-of-the-week-how-has-the-pandemic-affected-inequalities-in-tooth-extractions-for-children (accessed 11 September 2022).
- Krisdapong S, Prasertsom P, Rattanarangsima K, Sheiham A. School absence due to toothache associated with sociodemographic factors, dental caries status, and oral health-related quality of life in 12- and 15-year-old Thai children. J Public Health Dent 2013;73:321–8. https://doi.org/10.1111/jphd.12030 doi: 10.1111/jphd.12030. [DOI] [PubMed]
- Knapp R, Gilchrist F, Rodd HD, Marshman Z. Change in children’s oral health-related quality of life following dental treatment under general anaesthesia for the management of dental caries: a systematic review. Int J Paediatr Dent 2017;27:302–12. https://doi.org/10.1111/ipd.12259 doi: 10.1111/ipd.12259. [DOI] [PubMed]
- Knapp R, Marshman Z, Gilchrist F, Rodd H. The impact of dental caries and its treatment under general anaesthetic on children and their families. Eur Arch Paediatr Dent 2021;22:567–74. https://doi.org/10.1007/s40368-020-00591-1 doi: 10.1007/s40368-020-00591-1. [DOI] [PMC free article] [PubMed]
- Gilchrist F, Rodd HD, Deery C, Marshman Z. Development and evaluation of CARIES-QC: a caries-specific measure of quality of life for children. BMC Oral Health 2018;18:202. https://doi.org/10.1186/s12903-018-0662-8 doi: 10.1186/s12903-018-0662-8. [DOI] [PMC free article] [PubMed]
- Paisi M, Plessas A, Pampaka D, Burns L, Witton R. Effect of treating carious teeth on children’s and adolescents’ anthropometric outcomes: a systematic review of randomised controlled trials. Community Dent Health 2020;37:32–8. https://doi.org/10.1922/CDH_4611Paisi07 doi: 10.1922/CDH_4611Paisi07. [DOI] [PubMed]
- Abed R, Bernabe E, Sabbah W. Family impacts of severe dental caries among children in the United Kingdom. Int J Environ Res Public Health 2020;17:109. https://doi.org/10.3390/ijerph17010109 doi: 10.3390/ijerph17010109. [DOI] [PMC free article] [PubMed]
- Public Health England. Hospital Tooth Extractions of 0 to 19 Year Olds. 2021. URL: www.gov.uk/government/publications/hospital-tooth-extractions-of-0-to-19-year-olds (accessed 5 August 2022).
- Lewis C, Stout J. Toothache in US children. Arch Pediatr Adolesc Med 2010;164:1059–63. https://doi.org/10.1001/archpediatrics.2010.206 doi: 10.1001/archpediatrics.2010.206. [DOI] [PubMed]
- NHS England. Improving Dental Care and Oral Health – A Call to Action. 2017. URL: www.england.nhs.uk/2014/02/improve-dental-cta/
- GOV.UK. Adult Oral Health: Applying All Our Health. 2022. URL: www.gov.uk/government/publications/adult-oral-health-applying-all-our-health/adult-oral-health-applying-all-our-health (accessed 11 September 2022).
- Righolt AJ, Jevdjevic M, Marcenes W, Listl S. Global-, regional-, and country-level economic impacts of dental diseases in 2015. J Dent Res 2018;97:501–7. https://doi.org/10.1177/0022034517750572 doi: 10.1177/0022034517750572. [DOI] [PubMed]
- Listl S, Galloway J, Mossey PA, Marcenes W. Global economic impact of dental diseases. J Dent Res 2015;94:1355–61. https://doi.org/10.1177/0022034515602879 doi: 10.1177/0022034515602879. [DOI] [PubMed]
- Pitts NB, Twetman S, Fisher J, Marsh PD. Understanding dental caries as a non-communicable disease. Br Dent J 2021;231:749–53. https://doi.org/10.1038/s41415-021-3775-4 doi: 10.1038/s41415-021-3775-4. [DOI] [PMC free article] [PubMed]
- Scottish Dental Clinical Effectiveness Programme. Prevention and Management of Dental Caries in Children: Dental Clinical Guidance. 2nd edn. 2018. URL: www.sdcep.org.uk/published-guidance/caries-in-children/ (accessed 8 February 2023).
- Innes NP, Chu CH, Fontana M, Lo EC, Thomson WM, Uribe S, et al. A century of change towards prevention and minimal intervention in cariology. J Dent Res 2019;98:611–7. https://doi.org/10.1177/0022034519837252 doi: 10.1177/0022034519837252. [DOI] [PubMed]
- Tsakos G, Hill K, Chadwick B, Anderson T. Children’s Dental Health Survey 2013. Report 1: Attitudes, Behaviours and Children’s Dental Health. England, Wales and Northern Ireland, 2013. Health and Social Care Information Centre. 2015. URL: https://digital.nhs.uk/data-and-information/publications/statistical/children-s-dental-health-survey/child-dental-health-survey-2013-england-wales-and-northern-ireland (accessed 15 June 2021).
- White D, Steele J, Fuller E. Children’s Dental Health Survey 2013. Report 3: Good Oral Health in Children. England, Wales and Northern Ireland. Health and Social Care Information Centre. 2015. URL: https://digital.nhs.uk/data-and-information/publications/statistical/children-s-dental-health-survey/child-dental-health-survey-2013-england-wales-and-northern-ireland (accessed 8 February 2023).
- Verrips GH, Kalsbeek H, Van Woerkum CM, Koelen M, Kok-Weimar TL. Correlates of toothbrushing in preschool children by their parents in four ethnic groups in The Netherlands. Community Dent Health 1994;11:233–9. [PubMed]
- Zeedyk MS, Longbottom C, Pitts NB. Tooth-brushing practices of parents and toddlers: a study of home-based videotaped sessions. Caries Res 2005;39:27–33. https://doi.org/10.1159/000081653 doi: 10.1159/000081653. [DOI] [PubMed]
- White DJ, Kozak KM, Gibb R, Dunavent J, Klukowska M, Sagel PA. A 24-hour dental plaque prevention study with a stannous fluoride dentifrice containing hexametaphosphate. J Contemp Dent Pract 2006;7:1–11. [PubMed]
- Pine CM, Adair PM, Nicoll AD, Burnside G, Petersen PE, Beighton D, et al. International comparisons of health inequalities in childhood dental caries. Community Dent Health 2004;21:121–30. [PubMed]
- American Academy of Pediatric Dentistry. Guideline on adolescent oral health care. Pediatr Dent 2015;37:151–8. [PubMed]
- Skinner J, Johnson G, Blinkhorn A, Byun R. Factors associated with dental caries experience and oral health status among New South Wales adolescents. Aust N Z J Public Health 2014;38:485–9. https://doi.org/10.1111/1753-6405.12245 doi: 10.1111/1753-6405.12245. [DOI] [PubMed]
- Tsai C, Raphael S, Agnew C, McDonald G, Irving M. Health promotion interventions to improve oral health of adolescents: a systematic review and meta-analysis. Community Dent Oral Epidemiol 2020;48:549–60. https://doi.org/10.1111/cdoe.12567 doi: 10.1111/cdoe.12567. [DOI] [PubMed]
- Webb T, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res 2010;12:e1376. https://doi.org/10.2196/jmir.1376 doi: 10.2196/jmir.1376. [DOI] [PMC free article] [PubMed]
- Calderon SJ, Mallory C. A systematic review of oral health behavior research in American adolescents. J Sch Nurs 2014;30:396–403. https://doi.org/10.1177/1059840514544034 doi: 10.1177/1059840514544034. [DOI] [PubMed]
- Albino J, Tiwari T. Preventing childhood caries: a review of recent behavioral research. J Dent Res 2016;95:35–42. https://doi.org/10.1177/0022034515609034 doi: 10.1177/0022034515609034. [DOI] [PMC free article] [PubMed]
- Kay E, Vascott D, Hocking A, Nield H, Dorr C, Barrett H. A review of approaches for dental practice teams for promoting oral health. Community Dent Oral Epidemiol 2016;44:313–30. https://doi.org/10.1111/cdoe.12220 doi: 10.1111/cdoe.12220. [DOI] [PubMed]
- Public Health England. Achieving Behaviour Change. A Guide for Local Government and Partners. 2019. URL: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/875385/PHEBI_Achieving_Behaviour_Change_Local_Government.pdf (accessed 11 August 2022).
- Mohr DC, Schueller SM, Montague E, Burns MN, Rashidi P. The behavioral intervention technology model: an integrated conceptual and technological framework for eHealth and mHealth interventions. J Med Internet Res 2014;16:e146. https://doi.org/10.2196/jmir.3077 doi: 10.2196/jmir.3077. [DOI] [PMC free article] [PubMed]
- WHO Global Observatory for eHealth. mHealth: New Horizons for Health through Mobile Technologies: Second Global Survey on eHealth. 2011. URL: https://apps.who.int/iris/handle/10665/44607 (accessed 13 February 2023).
- Nilsen W, Kumar S, Shar A, Varoquiers C, Wiley T, Riley WT, et al. Advancing the science of mHealth. J Health Commun 2012;17:5–10. https://doi.org/10.1080/10810730.2012.677394 doi: 10.1080/10810730.2012.677394. [DOI] [PubMed]
- Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med 2009;36:165–73. https://doi.org/10.1016/j.amepre.2008.09.040 doi: 10.1016/j.amepre.2008.09.040. [DOI] [PubMed]
- Armanasco AA, Miller YD, Fjeldsoe BS, Marshall AL. Preventive health behavior change text message interventions: a meta-analysis. Am J Prev Med 2017;52:391–402. https://doi.org/10.1016/j.amepre.2016.10.042 doi: 10.1016/j.amepre.2016.10.042. [DOI] [PubMed]
- Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev 2010;32:56–69. https://doi.org/10.1093/epirev/mxq004 doi: 10.1093/epirev/mxq004. [DOI] [PMC free article] [PubMed]
- Ofcom. Children and Parents: Media Use and Attitudes Report 2022. 2022. URL: www.ofcom.org.uk/research-and-data/media-literacy-research/childrens/children-and-parents-media-use-and-attitudes-report-2022 (accessed 13 February 2023).
- Ofcom. Children and Parents: Media Use and Attitudes Report 2017. 2017. URL: www.ofcom.org.uk/__data/assets/pdf_file/0020/108182/children-parents-media-use-attitudes-2017.pdf (accessed 15 June 2021).
- Fernández CE, Maturana CA, Coloma SI, Carrasco-Labra A, Giacaman RA. Teledentistry and mHealth for promotion and prevention of oral health: a systematic review and meta-analysis. J Dent Res 2021;100:914–27. https://doi.org/10.1177/00220345211003828 doi: 10.1177/00220345211003828. [DOI] [PubMed]
- Toniazzo MP, Nodari D, Muniz FWMG, Weidlich P. Effect of mHealth in improving oral hygiene: a systematic review with meta-analysis. J Clin Periodontol 2019;46:297–309. https://doi.org/10.1111/jcpe.13083 doi: 10.1111/jcpe.13083. [DOI] [PubMed]
- Lima IFP, de Andrade Vieira W, de Macedo Bernardino I, Costa PA, Lima APB, Pithon MM, Paranhos LR. Influence of reminder therapy for controlling bacterial plaque in patients undergoing orthodontic treatment: a systematic review and meta-analysis. Angle Orthod 2018;88:483–93. https://doi.org/10.2319/111117-770.1 doi: 10.2319/111117-770.1. [DOI] [PMC free article] [PubMed]
- Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The Behavior Change Technique Taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46:81–95. https://doi.org/10.1007/s12160-013-9486-6 doi: 10.1007/s12160-013-9486-6. [DOI] [PubMed]
- Schluter P, Lee M, Hamilton G, Coe G, Messer-Perkins H, Smith B. Keep on brushing: a longitudinal study of motivational text messaging in young adults aged 18–24 years receiving work and income support. J Public Health Dent 2015;75:118–25. https://doi.org/10.1111/jphd.12079 doi: 10.1111/jphd.12079. [DOI] [PubMed]
- Champion VL, Skinner CS. Chapter 3: The Health Belief Model. In Glanz K, Rimer B, Viswanath K, editors. Health Behavior and Health Education – Theory, Research and Practice. Hoboken, NJ: Jossey-Bass/Wiley; 2008.
- Marshman Z, Ainsworth H, Chestnutt IG, Day PF, Dey D, El Yousfi S, et al. 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. Trials 2019;20:452. https://doi.org/10.1186/s13063-019-3538-6 doi: 10.1186/s13063-019-3538-6. [DOI] [PMC free article] [PubMed]
- National Institute for Health and Care Research. 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. NIHR Funding and Awards. 2021. URL: www.fundingawards.nihr.ac.uk/award/15/166/08 (accessed 12 April 2021).
- Ainsworth H, Marshman Z, Whiteside K, Sykes D, Fairhurst C, Turner E, et al. Set up and assessment of progression criteria for internal pilots: the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial example. Pilot Feasibility Stud 2023;9:17. https://doi.org/10.1186/s40814-023-01243-z doi: 10.1186/s40814-023-01243-z. [DOI] [PMC free article] [PubMed]
- Department for Education. Schools, Pupils and Their Characteristics: January 2016. 2016. URL: www.gov.uk/government/statistics/schools-pupils-and-their-characteristics-january-2016 (accessed 18 June 2021).
- Welsh Government. School Census Results, 2016. 2016. URL: https://statswales.gov.wales/Catalogue/Education-and-Skills/Schools-and-Teachers/Schools-Census/Pupil-Level-Annual-School-Census/Provision-of-Meals-and-Milk/pupilseligibleforfreeschoolmeals-by-school-year (accessed 28 June 2017).
- Scottish Government. Summary Statistics for Attainment, Leaver Destinations and Healthy Living, No.6: 2016 Edition. 2016. URL: www.webarchive.org.uk/wayback/archive/20161003230310; http://www.gov.scot/Topics/Statistics/Browse/School-Education/SchoolMealsDatasets/schmeals2016 (accessed 31 March 2017).
- GOV.UK. Get Information about Schools. 2021. URL: www.get-information-schools.service.gov.uk/ (accessed 18 June 2021).
- StatsWales. Pupil Level Annual School Census (PLASC). 2021. URL: https://statswales.gov.wales/Catalogue/Education-and-Skills/Schools-and-Teachers/Schools-Census/Pupil-Level-Annual-School-Census (accessed 16 June 2021).
- Scottish Government. School Education Statistics. 2020. URL: www.gov.scot/collections/school-education-statistics/ (accessed 18 June 2021).
- Murray DM. Design and Analysis of Group-randomized Trials. Oxford: Oxford University Press; 1998.
- White DA, Chadwick BL, Nuttall NM, Chestnutt IG, Steele JG. Oral health habits amongst children in the United Kingdom in 2003. Br Dent J 2006;200:487–91. https://doi.org/10.1038/sj.bdj.4813523 doi: 10.1038/sj.bdj.4813523. [DOI] [PubMed]
- Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol 2013;66:197–201. https://doi.org/10.1016/j.jclinepi.2012.09.002 doi: 10.1016/j.jclinepi.2012.09.002. [DOI] [PubMed]
- Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health 2008;31:180–91. https://doi.org/10.1002/nur.20247 doi: 10.1002/nur.20247. [DOI] [PubMed]
- Twetman S, Axelsson S, Dahlgren H, Holm A-K, Källestål C, Lagerlöf F, et al. Caries-preventive effect of fluoride toothpaste: a systematic review. Acta Odontol Scand 2003;61:347–55. https://doi.org/10.1080/00016350310007590 doi: 10.1080/00016350310007590. [DOI] [PubMed]
- Pine C, Adair P, Robinson L, Burnside G, Moynihan P, Wade W, et al. The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial. Trials 2016;17:103. https://doi.org/10.1186/s13063-016-1226-3 doi: 10.1186/s13063-016-1226-3. [DOI] [PMC free article] [PubMed]
- Schwarzer R. Modeling health behavior change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol 2008;57:1–29. https://doi.org/10.1111/j.1464-0597.2007.00325.x
- Michie S, Atkins L, West R. The Behaviour Change Wheel: A Guide to Designing Interventions. London: Silverback Publishing; 2014.
- Marshman Z, El-Yousfi S, Kellar I, Dey D, Robertson M, Day P, et al. Development of a secondary school-based digital behaviour change intervention to improve tooth brushing. BMC Oral Health 2021;21:546. https://doi.org/10.1186/s12903-021-01907-3 doi: 10.1186/s12903-021-01907-3. [DOI] [PMC free article] [PubMed]
- Department for Education. Science Programmes of Study: Key Stage 3 National Curriculum in England. 2013. URL: www.gov.uk/government/publications/national-curriculum-in-england-science-programmes-of-study (accessed 12 April 2021).
- Department for Education. Science Programmes of Study: Key Stage 4 National Curriculum in England. 2014. URL: www.gov.uk/government/publications/national-curriculum-in-england-science-programmes-of-study (accessed 12 April 2021).
- PSHE Association. PSHE Education Programme of Study (Key Stage 3) (online). PSHE Association. 2014. URL: https://pshe-association.org.uk/key-stage-3-5
- Learning and Teaching Scotland. Curriculum for Excellence, Health and Wellbeing: Experiences and Outcomes (online). Education Scotland. 2009. URL: https://education.gov.scot/media/5p4dvqvm/health-and-wellbeing-eo.pdf (accessed 12 April 2021).
- Learning and Teaching Scotland. Curriculum for Excellence, Science: Experiences and Outcomes (online). Education Scotland. 2009. URL: https://education.gov.scot/curriculum-for-excellence/curriculum-for-excellence-documents/experiences-and-outcomes/ (accessed 12 April 2021).
- Welsh Assembly Government. Personal and Social Education Framework for 7–19 Year Olds in Wales (online). Education Wales. 2008. URL: https://hwb.gov.wales/curriculum-2008/key-stages-2-to-4/personal-and-social-education-framework-for-7-to-19-year-olds-in-wales (accessed 12 April 2021).
- Crombie IK, Irvine L, Williams B, Sniehotta FF, Petrie D, Jones C, et al. Texting to Reduce Alcohol Misuse (TRAM): main findings from a randomized controlled trial of a text message intervention to reduce binge drinking among disadvantaged men. Addiction 2018;113:1609–18. https://doi.org/10.1111/add.14229 doi: 10.1111/add.14229. [DOI] [PubMed]
- Dombrowski SU, McDonald M, Van Der Pol M, Grindle M, Avenell A, Carroll P, et al. Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss. BMJ Open 2020;10:e032653. https://doi.org/10.1136/bmjopen-2019-032653 doi: 10.1136/bmjopen-2019-032653. [DOI] [PMC free article] [PubMed]
- Pitts N. ‘ICDAS’ – an international system for caries detection and assessment being developed to facilitate caries epidemiology, research and appropriate clinical management. Community Dent Health 2004;21:193–8. [PubMed]
- Gil GS, Morikava FS, Santin GC, Pintarelli TP, Fraiz FC, Ferreira FM. Reliability of self-reported toothbrushing frequency as an indicator for the assessment of oral hygiene in epidemiological research on caries in adolescents: a cross-sectional study. BMC Med Res Methodol 2015;15:1–7. https://doi.org/10.1186/s12874-015-0002-5 doi: 10.1186/s12874-015-0002-5. [DOI] [PMC free article] [PubMed]
- Anderson T, Thomas C, Ryan R, Dennes M, Fuller E. Children’s Dental Health Survey 2013. Technical Report. England, Wales and Northern Island. Health and Social Care Information Centre. 2015. URL: https://digital.nhs.uk/data-and-information/publications/statistical/children-s-dental-health-survey/child-dental-health-survey-2013-england-wales-and-northern-ireland (accessed 25 January 2021).
- Gholami M, Knoll N, Schwarzer R. A brief self-regulatory intervention increases dental flossing in adolescent girls. Int J Behav Med 2015;22:645–51. https://doi.org/10.1007/s12529-014-9459-6 doi: 10.1007/s12529-014-9459-6. [DOI] [PubMed]
- Kamalikhah T, Mazllomi Mahmood abad S, Khalighinejad N, Rahmati-Najarkolaei F. Dental flossing behaviour and its determinants among students in a suburb area of Tehran–Iran: using transtheoretical model. Int J Dent Hyg 2017;15:106–12. https://doi.org/10.1111/idh.12154 doi: 10.1111/idh.12154. [DOI] [PubMed]
- Quigley GA, Hein JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc 1962;65:26–9. https://doi.org/10.14219/jada.archive.1962.0184 doi: 10.14219/jada.archive.1962.0184. [DOI] [PubMed]
- Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol 1970;41:41–3. https://doi.org/10.1902/jop.1970.41.1.41 doi: 10.1902/jop.1970.41.41.41. [DOI] [PubMed]
- Löe H, Silness J. Periodontal disease in pregnancy. I. Prevalence and severity. Acta Odontol Scand 1963;21:533–51. doi: 10.3109/00016356309011240. [DOI] [PubMed]
- Goldberg P, Matsson L, Anderson H. Partial recording of gingivitis and dental plaque in children of different ages and in young adults. Community Dent Oral Epidemiol 1985;13:44–6. https://doi.org/10.1111/j.1600-0528.1985.tb00419.x doi: 10.1111/j.1600-0528.1985.tb00419.x. [DOI] [PubMed]
- Stevens M, Hainsworth KR, Weisman SJ, Layde PM. PedsQL Performance in the Pediatric Emergency Department: Can We use HRQOL for Acute Care Outcomes?(FR). In Quality of Life Research. Vol 20. Netherlands: Springer van Godewijckstraat 30, 3311 Gz dordrecht; 2012. pp. 96–96.
- Stevens K. Valuation of the child health utility 9D index. PharmacoEcon 2012;30:729–47. https://doi.org/10.2165/11599120-000000000-00000 doi: 10.2165/11599120-000000000-00000. [DOI] [PubMed]
- Gilchrist F. Development of a Child-centred, Caries-specific Seasure of Oral Health-related Quality of Life. Sheffield: University of Sheffield; 2015; 2015.
- Rogers HJ, Sagabiel J, Marshman Z, Rodd HD, Rowen D. Adolescent valuation of CARIES-QC-U: a child-centred preference-based measure of dental caries. Health Qual Life Outcomes 2022;20:1–15. https://doi.org/10.1186/s12955-022-01918-w doi: 10.1186/s12955-022-01918-w. [DOI] [PMC free article] [PubMed]
- StatsWales. Pupils Eligible for Free School Meals by School. 2020. URL: https://statswales.gov.wales/Catalogue/Education-and-Skills/Schools-and-Teachers/Schools-Census/Pupil-Level-Annual-School-Census/Provision-of-Meals-and-Milk/pupilseligibleforfreeschoolmeals-by-school-year (accessed 18 June 2021).
- Scottish Government. School Meals Dataset Set 2016. 2016. URL: www.webarchive.org.uk/wayback/archive/20161003230310; http://www.gov.scot/Topics/Statistics/Browse/School-Education/SchoolMealsDatasets/schmeals2016 (accessed 28 June 2017).
- Scottish Government. School Meals Dataset Set 2017. 2017. URL: www.webarchive.org.uk/wayback/archive/20180515163544; www.gov.scot/Topics/Statistics/Browse/School-Education/SchoolMealsDatasets/schmeals2017 (accessed 18 August 2022).
- Estyn. Inspection. 2022. URL: www.estyn.gov.wales/inspection (accessed 19 September 2022).
- Education Scotland. Inspection Reports. 2022. URL: https://education.gov.scot/education-scotland/inspection-reports/?orderBy=dateDescending (accessed 10 October 2022).
- National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal 2022. London: NICE; 2022. [PubMed]
- Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, et al. Cost-effectiveness analysis alongside clinical trials II – an ISPOR Good Research Practices Task Force report. Value Health 2015;18:161–72. https://doi.org/10.1016/j.jval.2015.02.001 doi: 10.1016/j.jval.2015.02.001. [DOI] [PubMed]
- El Alili M, van Dongen JM, Goldfeld KS, Heymans MW, van Tulder MW, Bosmans JE. Taking the analysis of trial-based economic evaluations to the next level: the importance of accounting for clustering. PharmacoEcon 2020;38:1247–61. https://doi.org/10.1007/s40273-020-00946-y doi: 10.1007/s40273-020-00946-y. [DOI] [PMC free article] [PubMed]
- Faria R, Gome M, Epstein D, White IR. A guide to handling missing data in cost-effectiveness analysis conducted within randomised controlled trials. PharmacoEcon 2014;32:1157–70. https://doi.org/10.1007/s40273-014-0193-3 doi: 10.1007/s40273-014-0193-3. [DOI] [PMC free article] [PubMed]
- Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ 2015;350:h1258. https://doi.org/10.1136/bmj.h1258 doi: 10.1136/bmj.h1258. [DOI] [PMC free article] [PubMed]
- Linnan L, Steckler A. Process evaluation for public health interventions and research: an overview. In Steckler A, Linnan L, editors. Process Evaluation for Public Health Interventions and Research. San Francisco: Jossey-Bass; 2002, vol. 28. pp. 1–23.
- Elyousfi S, Innes N, Leggett H, Ainsworth H, Chestnutt IG, Day P, et al. Acceptability of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial intervention: a qualitative study of perspectives of young people and school staff. BMC Oral Health 2022;22:1–12. https://doi.org/10.1186/s12903-022-02073-w doi: 10.1186/s12903-022-02073-w. [DOI] [PMC free article] [PubMed]
- Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res 2017;17:1–13. https://doi.org/10.1186/s12913-017-2031-8 doi: 10.1186/s12913-017-2031-8. [DOI] [PMC free article] [PubMed]
- Ritchie J, Lewis J, Nicholls CM, Ormston R. Qualitative Research Practice: A Guide for Social Science Students and Researchers. 2nd edn. London: SAGE Publications Ltd; 2013.
- INVOLVE. Payment for Involvement: A Guide for Making Payments to Members of the Public Actively Involved in NHS, Public Health and Social Care Research. 2010. URL: www.invo.org.uk/wp-content/uploads/documents/INVOLVEPayment%20Guiderev2012.pdf (accessed 4 August 2022).
- StatsWales. Schools by Local Authority, Region and Type of School. 2016. URL: https://statswales.gov.wales/Catalogue/Education-and-Skills/Schools-and-Teachers/Schools-Census/Pupil-Level-Annual-School-Census/Schools/schools-by-localauthorityregion-type (accessed 15 August 2022).
- McHugh ML. Interrater reliability: the kappa statistic. Biochem Medica 2012;22:276–82. [PMC free article] [PubMed]
- Department for Education. Changes to Personal, Social, Health and Economic (PSHE) and Relationships and Sex Education (RSE). GOV.UK. 2019. URL: www.gov.uk/government/publications/changes-to-personal-social-health-and-economic-pshe-and-relationships-and-sex-education-rse (accessed 23 November 2021).
- Foster Page LA, Thomson WM, Marshman Z, Stevens KJ. The potential of the Child Health Utility 9D Index as an outcome measure for child dental health. BMC Oral Health 2014;14:1–7. https://doi.org/10.1186/1472-6831-14-90 doi: 10.1186/1472-6831-14-90. [DOI] [PMC free article] [PubMed]
- Baherimoghadam T, Naseri N, Hamedani S, Nikmehr S, Mokhtar M. Influence of multimedia reminders on oral hygiene status during removable orthodontic treatment: a randomized controlled trial. J Orthod Sci 2022;11:27. https://doi.org/10.4103/jos.jos_193_21 doi: 10.4103/jos.jos_193_21. [DOI] [PMC free article] [PubMed]
- Santos JB, Pereira LC, Neves JG, Pithon MM, Santamaria M. Can text messages encourage flossing among orthodontic patients? Angle Orthod 2021;91:650–5. https://doi.org/10.2319/012121-61.1 doi: 10.2319/012121-61.1. [DOI] [PMC free article] [PubMed]
- World Health Organization. Promoting Health through Schools: Report of a WHO Expert Committee on Comprehensive School Health Education and Promotion. Geneva: World Health Organization; 1997. [PubMed]
- Badawy SM, Kuhns LM. Texting and mobile phone app interventions for improving adherence to preventive behavior in adolescents: a systematic review. JMIR MHealth UHealth 2017;5:e50. https://doi.org/10.2196/mhealth.6837 doi: 10.2196/mhealth.6837. [DOI] [PMC free article] [PubMed]
- MacDougall S, Jerrott S, Clark S, Campbell LA, Murphy A, Wozney L. Text message interventions in adolescent mental health and addiction services: scoping review. JMIR Ment Health 2021;8:e16508. https://doi.org/10.2196/16508 doi: 10.2196/16508. [DOI] [PMC free article] [PubMed]
- Kocielnik R, Hsieh G. Send me a different message: utilizing cognitive space to create engaging message triggers. In Proceedings of the 2017 ACM Conference on Computer Supported Cooperative Work and Social Computing. 2017: 2193–2207.
- Muench F, Baumel A. More than a text message: dismantling digital triggers to curate behavior change in patient-centered health interventions. J Med Internet Res 2017;19:e147. https://doi.org/10.2196/jmir.7463 doi: 10.2196/jmir.7463. [DOI] [PMC free article] [PubMed]
- Loescher LJ, Rains SA, Kramer SS, Akers C, Moussa R. A systematic review of interventions to enhance healthy lifestyle behaviors in adolescents delivered via mobile phone text messaging. Am J Health Promot AJHP 2018;32:865–79. https://doi.org/10.1177/0890117116675785 doi: 10.1177/0890117116675785. [DOI] [PMC free article] [PubMed]
- Peng W, Kanthawala S, Yuan S, Hussain SA. A qualitative study of user perceptions of mobile health apps. BMC Public Health 2016;16:1–11. https://doi.org/10.1186/s12889-016-3808-0 doi: 10.1186/s12889-016-3808-0. [DOI] [PMC free article] [PubMed]
- Ramsey A, Lord S, Torrey J, Marsch L, Lardiere M. Paving the way to successful implementation: identifying key barriers to use of technology-based therapeutic tools for behavioral health care. J Behav Health Serv Res 2016;43:54–70. https://doi.org/10.1007/s11414-014-9436-5 doi: 10.1007/s11414-014-9436-5. [DOI] [PMC free article] [PubMed]
- Nishida C, Uauy R, Kumanyika S, Shetty P. The joint WHO/FAO expert consultation on diet, nutrition and the prevention of chronic diseases: process, product and policy implications. Public Health Nutr 2004;7:245–50. https://doi.org/10.1079/phn2003592 doi: 10.1079/phn2003592. [DOI] [PubMed]
- Masood M, Masood Y, Newton T. Impact of national income and inequality on sugar and caries relationship. Caries Res 2012;46:581–8. https://doi.org/10.1159/000342170 doi: 10.1159/000342170. [DOI] [PubMed]
- Moores CJ, Kelly SM, Moynihan PJ. Systematic review of the effect on caries of sugars intake: ten-year update. J Dent Res 2022;101:1034–45. https://doi.org/10.1177/00220345221082918 doi: 10.1177/00220345221082918. [DOI] [PubMed]
- Ha DH, Spencer AJ, Moynihan P, Thomson WM, Do LG. Excess risk of dental caries from higher free sugars intake combined with low exposure to water fluoridation. J Dent Res 2021;100:1243–50. https://doi.org/10.1177/00220345211007747 doi: 10.1177/00220345211007747. [DOI] [PubMed]
- Rowen D, Rivero-Arias O, Devlin N, Ratcliffe J. Review of valuation methods of preference-based measures of health for economic evaluation in child and adolescent populations: where are we now and where are we going? PharmacoEcon 2020;38:325–40. https://doi.org/10.1007/s40273-019-00873-7 doi: 10.1007/s40273-019-00873-7. [DOI] [PubMed]
- National Institute for Health and Care Excellence. NICE Health Technology Evaluations: The Manual. Process and Methods [PMG36]. 2022. URL: www.nice.org.uk/process/pmg36 (accessed 8 February 2023).
- Stevens K. Assessing the performance of a new generic measure of health-related quality of life for children and refining it for use in health state valuation. Appl Health Econ Health Policy 2011;9:157–69. https://doi.org/10.2165/11587350-000000000-00000 doi: 10.2165/11587350-000000000-00000. [DOI] [PubMed]
- Pitts NB, Stamm JW. International Consensus Workshop on Caries Clinical Trials (ICW-CCT)—final consensus statements: agreeing where the evidence leads. J Dent Res 2004;83:125–8. https://doi.org/10.1177/154405910408301s27 doi: 10.1177/154405910408301s27. [DOI] [PubMed]
- Chesters RK, Pitts NB, Matuliene G, Kvedariene A, Huntington E, Bendinskaite R, et al. An abbreviated caries clinical trial design validated over 24 months. J Dent Res 2002;81:637–40. https://doi.org/10.1177/154405910208100912 doi: 10.1177/154405910208100912. [DOI] [PubMed]
- Ellwood RP, Goma J, Pretty IA. Caries clinical trial methods for the assessment of oral care products in the 21st century. Adv Dent Res 2012;24:32–5. https://doi.org/10.1177/0022034512449464 doi: 10.1177/0022034512449464. [DOI] [PubMed]
- da Costa Rosa T, de Almeida Neves A, Azcarate-Peril MA, Divaris K, Wu D, Cho H, et al. The bacterial microbiome and metabolome in caries progression and arrest. J Oral Microbiol 2021;13:1886748. https://doi.org/10.1080/20002297.2021.1886748 doi: 10.1080/20002297.2021.1886748. [DOI] [PMC free article] [PubMed]
- National Institute for Health and Care Research (NIHR). Elucidating the mechaNism of action of behavioural changes on Child tOoth decay in the Randomised controlled CHOICE trial a role for salivary lactic Acid? (ENCOURAGE). NIHR Funding and Awards. 2023. URL: https://fundingawards.nihr.ac.uk/award/NIHR151317 (accessed 8 February 2023).
- Sutherland R, Ying Ooi J, Finch M, Yoong SL, Nathan N, Wrigley J, et al. A cluster randomised controlled trial of a secondary school intervention to reduce intake of sugar-sweetened beverages: mid-intervention impact of switchURsip environmental strategies. Health Promot J Aust Off J Aust Assoc Health Promot Prof 2022;33:176–86. https://doi.org/10.1002/hpja.469 doi: 10.1002/hpja.469. [DOI] [PubMed]
- Perry Y, Werner-Seidler A, Calear A, Mackinnon A, King C, Scott J, et al. Preventing depression in final year secondary students: school-based randomized controlled trial. J Med Internet Res 2017;19:e369. https://doi.org/10.2196/jmir.8241 doi: 10.2196/jmir.8241. [DOI] [PMC free article] [PubMed]
- Glazebrook C, Mullen N, McWilliams L, Batty M, Hogarth L, Macdonald I, et al. Factors influencing recruitment to a school-based trial of a targeted intervention to promote exercise self-efficacy in children with risk factors for obesity. Pediatr Res 2011;70:375–375. https://doi.org/10.1038/pr.2011.600
- Lohan M, Aventin A, Maguire L, Curran R, McDowell C, Agus A, et al. Increasing boys’ and girls’ intention to avoid teenage pregnancy: a cluster randomised control feasibility trial of an interactive video drama based intervention in post-primary schools in Northern Ireland. Public Health Res 2017;5:1–344. https://doi.org/10.3310/phr05010 [PubMed]
- National Health and Medical Research Council. 2007 National Statement on Ethical Conduct in Human Research. 2007. URL: www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018 (accessed 13 February 2023).
- Staniszewska S, Brett J, Simera I, Seers K, Mockford C, Goodlad S, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ 2017;358:j3453. https://doi.org/10.1136/bmj.j3453 doi: 10.1136/bmj.j3453. [DOI] [PMC free article] [PubMed]
- Conner M, Grogan S, Simms-Ellis R, Flett K, Sykes-Muskett B, Cowap L, et al. Evidence that an intervention weakens the relationship between adolescent electronic cigarette use and tobacco smoking: a 24-month prospective study. Tob Control 2020;29:425–31. https://doi.org/10.1136/tobaccocontrol-2018-054905 doi: 10.1136/tobaccocontrol-2018-054905. [DOI] [PMC free article] [PubMed]