Effectiveness of Fluoride Varnish in Prevention of Early Childhood Caries in 3-4 Years Old Children – A 36 Month Prospective Community Based Randomized Controlled Trial

Background: Evidence for the benefit of applying Fluoride Varnish FV to permanent teeth is generally very positive. However, the caries-inhibiting effect of FVs on primary teeth is still debatable. Aim: To assess the effectiveness of fluoride varnish in prevention of early childhood caries in children over the period of 3 years in high fluoride areas. Study design: A double-blind cluster-randomized controlled trial was undertaken amongst 3-4 years old children. The varnish application was done at three points in the intervention group. Results: Experimental group showed significantly lesser increment in mean ICDAS score than control group at both 12 month and 36 months. Preventive fraction was 72.4% at 12 months and 18.2% at 36 months. Multiple linear regression showed that at 12 months, intervention was the significant predictor with varnish group having 0.140 (95% CI 0.175–0.230) lower net caries increment. At 36 months, baseline ICDAS score and intervention were the significant predictors. Conclusion: This study suggests that fluoride varnish is an effective and a safe mode of prevention of early childhood caries in children residing in high fluoride zone. However, the overall effect is influenced by the baseline caries status.

Fluoride varnish; Early childhood caries; Randomized controlled trial

1. Wyne AH. Early childhood caries: nomenclature and case definition. Community Dent Oral Epidemiol. 1999 Oct;27(5):313-5.

2. Vadiakas G. Case definition, aetiology and risk assessment of early childhood caries (ECC): a revisited review. Eur Arch Paediatr Dent 2008; 9:114-25.

3. Mani SA, John J, Ping WY, Ismail NM. Early childhood caries: parent’s knowledge, attitude and practice towards its prevention in Malaysia. Oral Health Care-Pediatric, Research, Epidemiology and Clinical Practices. 2012 Feb 29.

4. Harris R, Nicoll AD, Adair PM, Pine CM. Risk factors for dental caries in young children: a systematic review of the literature. Community Dent Health. 2004 Mar;21(1):71-85.

5. Çolak H, Dülgergil ÇT, Dalli M, Hamidi MM. Early childhood caries update: A review of causes, diagnoses, and treatments. J Nat Sci Biol Med. 2013 Jan; 4(1):29.

6. Ganesh A, Muthu MS, Mohan A, Kirubakaran R. Prevalence of early childhood caries in india–a systematic review. Indian J Pediatr. 2019 Mar 11;86(3):276-86.

7. Poobalan A, Brazzelli M, Aucott L, Smith WCS, Helms P. Prevention of early childhood caries : a systematic review. (Accessed from www.scottishdental.org/index.aspx?o=2415 on 29 November 2014)

8. Lawrence HP, Binguis D, Douglas J, McKeown L, Switzer B, Figueiredo R et al. A 2-year community-randomized controlled trial of fluoride varnish to prevent early childhood caries in Aboriginal children. Community Dent Oral Epidemiol. 2008;36:503–16.

9. Borutta A, Wagner M, Shakovets N, Tserekhova T. Caries Prevention by Use of Fluoride Varnish in Primary School Children in Minsk. 2009.

10. Arruda AO, Senthamarai KR, Inglehart MR, Rezende CT, Sohn W. Effect of 5% fluoride varnish application on caries among school children in rural Brazil: a randomized controlled trial. Community Dent Oral Epidemiol. 2012 Jun; 40(3):267-76.

11. Petersson LG, Westerberg I. Intensive fluoride varnish program in Swedish adolescents: economic assessment of a 7-year follow-up study on proximal caries incidence. Caries Res. 1994;28(1):59-63. doi: 10.1159/000261622. PMID: 8124699.

12. Carvalho DM, Salazar M, Oliveira BH, Coutinho ES. Fluoride varnishes and decrease in caries incidence in preschool children: a systematic review. Revista Brasileira de Epidemiologia. 2010;13:139-49.

13. Marinho VC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2013 Jul 11;(7):CD002279. doi: 10.1002/14651858.CD002279. pub2. PMID: 23846772.

14. Marinho VC, Higgins JP, Sheiham A, Logan S. Combinations of topical fluoride (toothpastes, mouthrinses, gels, varnishes) versus single topical fluoride for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews. 2004(1).

15. Twetman S, Dhar V. Evidence of effectiveness of current therapies to prevent and treat early childhood caries. Pediatric dentistry. 2015 May 15;37(3):246-53.

16. de Sousa FS, Dos Santos AP, Nadanovsky P, Hujoel P, Cunha-Cruz J, de Oliveira BH. Fluoride Varnish and dental caries in preschoolers: a systematic review and meta-analysis. Caries research. 2019;53(5):502-13.

17. Astdd. Page 4, 2017. Association of State & Territorial Dental Directors (astdd). School based Fluoride Varnish Program Report [Accessed 6th November 2020]. Available from: https://www.astdd.org/docs/fluoride-varnish-program-report.pdf

18. Ismail AI, Sohn W, Tellez M, et al. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007; 35 (3):170‐8.

19. Singh T, Sharma S, Nagesh S. Socio-economic status scales updated for 2017. Int J Res Med Sci. 2017 Jul;5(7):3264-7.

20. Autio-Gold JT, Courts F. Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition. J Am Dent Assoc. 2001 Sep 1;132(9):1247-53.

21. Divaris K, Preisser JS, Slade GD. Surface-specific efficacy of fluoride varnish in caries prevention in the primary dentition: results of a community randomized clinical trial. Caries Res. 2013;47(1):78-87.

22. McMahon AD, Wright W, Anopa Y, McIntosh E, Turner S, Conway DI et al.. Fluoride Varnish in Nursery Schools: A Randomised Controlled Trial– Protecting Teeth. Caries Res. 2020;54(3):274-82.

23. Muñoz‐Millán P, Zaror C, Espinoza‐Espinoza G, Vergara‐Gonzalez C, Muñoz S, Atala‐Acevedo C et al. Effectiveness of fluoride varnish in preventing early childhood caries in rural areas without access to fluoridated drinking water: A randomized control trial. Community Dent Oral Epidemiol 2018 Feb;46(1):63-9.

24. CGWB. Figure 35, Page 74, 2015. Central Ground Water Board (CGWB). Report on Aquifer Mapping and Management Plan National Capital Region (NCR), Haryana Volume-I [Assessed 6th October 2020]. Available from: http://cgwb.gov.in/AQM/NAQUIM_REPORT/Haryan_NCR/NCR_I.pdf

25. Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD et al.. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6.

26. Oliveira BH, Salazar M, Carvalho DM, Falcão A, Campos K, Nadanovsky P. Biannual fluoride varnish applications and caries incidence in preschoolers: a 24-month follow-up randomized placebo-controlled clinical trial. Caries Res. 2014;48 (3):228-36.

27. Holve S. An observational study of the association of fluoride varnish applied during well child visits and the prevention of early childhood caries in American Indian children. Maternal and child health journal. 2008 Jul 1;12(1):64-7.