Effectiveness of Sodium Fluoride Varnish to Control Dental Caries in School Children: A Randomised Controlled Trial

Abstract

Fluoride varnish application is an effective intervention in controlling dental caries. Objective of this study was to evaluate the effectiveness of six monthly application of sodium fluoride varnish in prevention of dental caries in deciduous teeth, permanent incisors and molars in children between six and seven years in a low resource setting, Sri Lanka. This was an open-label, randomized controlled trial (NCT02877888) in school children aged six to seven years, living in a district of Sri Lanka. Recruited children were randomly assigned to either a treatment (n=161) or to control group (n=162). Children in the treatment group received fluoride varnish professionally applied every 6 months combined with counselling on maintenance of oral hygiene and diet for a period of 2 years. Caries examinations were conducted using the International Caries Detection and Assessment System (ICDAS). The primary outcome studied was the number of new caries in the two study groups. At each time interval, the mean number of new dental caries was significantly lower in the intervention group. When independent effect of the intervention on development of new dental caries was assessed, application of fluoride varnish every 6 months for a period of 2 years was significantly associated with less number of new dental caries compared to controls. Fluoride varnish application in a low resource setting is an effective method of preventing dental caries among children. A national level programme would contribute to the reduction of dental caries in this age group. Keywords: Clinical trial, Fluoride varnish, Dental caries, Caries prevention, Effectiveness