ArticleJournal of oral biology and craniofacial research
Clinical effectiveness and cost-effectiveness of two sodium fluoride varnish systems in preventing dental caries in children: a randomized clinical trial.
Article in Journal of oral biology and craniofacial research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Dental caries frequently affects first permanent molars soon after eruption due to their anatomical susceptibility. Fluoride varnish is a widely accepted preventive measure; however, different formulations vary in fluoride retention and cost. Evidence comparing both clinical outcomes and economic value of available varnishes in children remains limited. Aim: To compare the clinical effectiveness and cost-effectiveness of resin-based and alcohol-based 5 % sodium fluoride varnishes in preventing dental caries in permanent first molars of high-risk schoolchildren. Design: A double-blind, parallel-arm randomized controlled trial was conducted among 84 children (330 M) aged 6-8 years from a private school in Varanasi, India. Participants received either resin-based varnish (163 teeth) or alcohol-based varnish (167 teeth) at six-month intervals. Caries incidence was assessed at baseline, 6, 12, 18, and 24 months using ICDAS-II. A financial cost-benefit perspective was adopted, considering direct material and application costs borne by the provider and estimated restorative treatment savings for patients. Appropriate statistical tests were used for analysis (α = 0.05). Results: Caries incidence remained low in both groups after 24 months (resin-based: 7.4 %; alcohol-based: 7.8 %; p = 0.961). No significant differences were found in early or advanced lesions at any interval (p > 0.05). ITT and Per-protocol analyses revealed negligible effect sizes (Cliff's Delta ≤0.05). Cost-effectiveness analysis demonstrated that the alcohol-based varnish produced ₹62.22 savings per ₹1 spent, compared to ₹8.47 in resin-based group. The cost to save ₹100 in future restorative expenses was ₹1.61 (alcohol-based) and ₹11.80 (resin-based). Conclusion: Both varnishes were equally effective, but alcohol-based varnish was substantially more cost-effective, making it a suitable choice for large-scale preventive programs in resource-constrained settings.
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