Comparison of the caries-protective effect of fluoride varnish with treatment as usual in nursery school attendees receiving preventive oral health support through the Childsmile oral health improvement programme - the Protecting Teeth@3 Study: a randomised controlled trial

William Wright, Stephen Turner, Yulia Anopa, Emma McIntosh, Olivia Wu, David I Conway, Lorna M D Macpherson, Alex D McMahon, William Wright, Stephen Turner, Yulia Anopa, Emma McIntosh, Olivia Wu, David I Conway, Lorna M D Macpherson, Alex D McMahon

Abstract

Background: The Scottish Government set out its policy on addressing the poor oral health of Scottish children in 2005. This led to the establishment of Childsmile, a national programme designed to improve the oral health of children in Scotland. One element of the programme promotes daily tooth brushing in all nurseries in Scotland (Childsmile Core). A second targeted component (Childsmile Nursery) offers twice-yearly application of fluoride varnish to children attending nurseries in deprived areas. Studies suggest that fluoride varnish application can reduce caries in both adult and child populations. This trial aims to explore the effectiveness and cost-effectiveness of additional preventive value fluoride varnish application compared to Childsmile Core.

Methods/design: The Protecting Teeth@3 Study is an ongoing 2 year parallel group randomised treatment as usual controlled trial. Three-year-old children attending the ante pre-school year are randomised (1:1) to the intervention arm (fluoride varnish & treatment as usual) or the control arm (treatment as usual). Children in the intervention arm will have Duraphat® fluoride varnish painted on the primary tooth surfaces and will continue to receive treatment as usual: the core Childsmile Nursery intervention. Children in the treatment as usual arm will receive the same series of contacts, without the application of varnish and will also continue with the Childsmile Core intervention. Interventions are undertaken by Childsmile trained extended duty dental nurses at six-monthly intervals. Participants receive a baseline dental inspection in nursery and an endpoint inspection in Primary 1 at the age of 5 years old. We will use primary and secondary outcome measures to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual with treatment as usual only in preventing any further dental decay. We will also undertake a full economic evaluation of the trial.

Trial registration: This study is registered at ClinicalTrials.gov. Number: NCT01674933 (24 August 2012).

Figures

Fig. 1
Fig. 1
Flow diagram of the PT@3 Study

References

    1. Abanto J, Tsakos G, Ardenghi TM, Paiva SM, Raggio DP, Sheiham A, et al. Responsiveness to change for the Brazilian Scale of Oral Health Outcomes for 5-year-old children (SOHO-5) Health Qual Life Outcomes. 2013;11(1):137. doi: 10.1186/1477-7525-11-137.
    1. Blair Y, Macpherson LMD, McCall DR, McMahon AD, Stephen KW. Glasgow nursery-based caries experience, before and after a community development-based oral health programme's implementation. Community Dent Health. 2004;21:291–8.
    1. Blair YI, Macpherson LMD, McCall DR, McMahon AD. Dental health of 5-year-olds following community-based oral health promotion in Glasgow, Scotland. Int J Paediatr Dent. 2006;16:388–98. doi: 10.1111/j.1365-263X.2006.00767.x.
    1. Borutta A, Reuscher G, Hufnagl S, Möbius S. Caries prevention with fluoride varnishes among preschool children. Gesundheitwesen. 2006;68:731–4. doi: 10.1055/s-2006-927247.
    1. Chestnutt IG, Chadwick BL, Hutchings S, Playle R, Pickles T, Lisles C, et al. Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay. BMC Oral Health. 2012;12(1):51. doi: 10.1186/1472-6831-12-51.
    1. DOH . Research Governance Framework for Health and Community Care (second edition) 2005.
    1. Hardman MC, Davies GM, Duxbury JT, Davies RM. A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children. Caries Res. 2007;41:371–376. doi: 10.1159/000104795.
    1. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. Br Med J. 1999;319:670–674. doi: 10.1136/bmj.319.7211.670.
    1. Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2002;Issue 1:Art No: CD002279.
    1. Milsom KM, Blinkhorn AS, Walsh T, Worthington HV, Kearney-Mitchell P, Whitehead H, Tickle M. A cluster-randomized controlled trial: fluoride varnish in school children. J Dent Res. 2011;90:1306–11. doi: 10.1177/0022034511422063.
    1. McMahon AD. Study control, violators, inclusion criteria, and defining explanatory and pragmatic trials. Stat Med. 2002;21(10):1365–1376. doi: 10.1002/sim.1120.
    1. NHS Scotland. Childsmile. National Standards for Toothbrushing Programme – early years and childhood. NHS Scotland; 2008. . Accessed 12 December, 2008.
    1. NHS Scotland . Programme Manual for Childsmile Staff, Version 2. 2011.
    1. National Institute for Health and Care Excellence. Guide to the methods of technology appraisal. London: NICE; 2013. . Accessed 25 July 2014.
    1. Scottish Dental Clinical Effectiveness Programme. Prevention and Management of Dental Caries in Children; 2010. . Accessed 31 October 2011.
    1. Scottish Dental Epidemiology Co-ordinating Committee . National Dental Inspection Programme of Scotland. Report of the 2004 Survey of P1 Children. 2004.
    1. Scottish Dental Practice Board . Annual Report, 2003/04. 2004.
    1. Scottish Dental Practice Board. Enhanced Capitation Survey. Edinburgh: Practitioner Services Division, NHS Scotland; 2005. . Accessed July, 2008.
    1. Scottish Executive. Dental Action Plan for Improving Oral Health and Modernising Dental Services in Scotland. Edinburgh; Scottish Executive Health Department; 2005. . Accessed July 2008.
    1. Scottish Intercollegiate Guidelines Network . Prevention and management of Dental Decay in the Pre-school Child: SIGN Guideline 83. 2005.
    1. Skold UM, Petersson LG, Lith A, Birkhed D. Effect of school-based fluoride varnish programmes on approximal caries in adolescents from different carries risk areas. Caries Res. 2005;39:273–279. doi: 10.1159/000084833.
    1. Steele MM, Steele RG, Varni JW. Reliability and validity of the PedsQL™ oral health scale: measuring the relationship between child oral health and health-related quality of life. Child Health Care. 2009;38(3):228–244. doi: 10.1080/02739610903038818.
    1. Stevens K. The Child Health Utility 9D (CHU9D). A new, paediatric, preference-based measure of health related quality of life. PRO Newsletter. 2010;43:11–12.
    1. The Medicines for Human Use (Clinical Trials) Regulations (as amended); 2005. . Accessed 9 December 2015.
    1. Tsakos G. Oral health-related quality of life (OHRQoL) measurement in 5-year-olds in Glasgow: developing and evaluating a new OHRQoL measure: final report. London: University College London; 2010.
    1. Tsakos G, Blair YI, Yusuf H, Wright W, Watt RG, Macpherson LM. Developing a new self-reported scale of oral health outcomes for 5-year-old children (SOHO-5) Health Qual Life Outcomes. 2012;10:62. doi: 10.1186/1477-7525-10-62.
    1. University of Sheffield. A brief overview of the Child Health Utility 9D (CHU9D); 2014. . Accessed 28 July 2014.
    1. Van Hout BA, Al MJ, Gordon GS, Rutten FS. Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994;1994(3):309–319. doi: 10.1002/hec.4730030505.
    1. Varni J, Limbers C, Burwinkle T. Parent proxy-report of their children's health-related quality of life: an analysis of 13,878 parents' reliability and validity across age subgroups using the PedsQLTM 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007;5(1):2. doi: 10.1186/1477-7525-5-2.
    1. World Health Organisation [WHO] The Ottawa Charter for Health Promotion. Ottawa: World Health Organization and Canadian Public Health Association; 1986.

Source: PubMed

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