Cost-effectiveness and efficacy of fluoride varnish for caries prevention in South African children: A cluster-randomized controlled community trial
Abstract
Objectives
This cluster-randomized controlled community trial aimed to assess the efficacy and costs of fluoride varnish (FV) application for caries prevention in a high-risk population in South Africa.
Methods
513 children aged 4–8 years from two schools in a township in South Africa were randomly allocated by class to the FV or Control (CO) groups. In addition to supervised toothbrushing with fluoridated toothpaste in both groups, FV was applied in 3-month intervals by trained local non-professional assistants. Intraoral examinations were conducted at baseline, 12, 21 and 24 months. Primary outcome was the increment of teeth with cavitated lesions (i.e. newly developed or progressed, formerly non-cavitated lesions), requiring restoration or extraction over the study period. Additionally, treatment and re-treatment costs were analyzed.
Results
513 children (d1-4mft 5.9 ± 4.3 (mean ± SD)) were randomly allocated to FV (n = 287) or CO (n = 226). 10.2% FV and CO teeth received or required a restoration; 3.9% FV and 4.1% CO teeth were extracted, without significant differences between groups. While FV generated high initial costs, follow-up costs were comparable in both groups, resulting in FV being significantly more expensive than CO (1667 ± 1055 ZAR vs. 950 ± 943 ZAR, p < .001).
Conclusions
Regular FV application, in addition to daily supervised toothbrushing, had no significant caries-preventive effect and was not cost-effective in a primary school setting within a peri-urban, high-risk community in South Africa. Alternative interventions on community or public health level should be considered to reduce the caries burden in high-risk communities.
CONFLICT OF INTEREST
NM, KS and DS declare that they have no conflict of interest. LG is heading the Dental Wellness Trust Charity. LG, MW and FS are consultants for DMG Dental-Material Gesellschaft mbH, but did not receive any payment or personal benefits for this study. SE and MC are employees of DMG Dental-Material Gesellschaft mbH, but do not receive any personal benefit from the sales of the product used in this study.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
