A school-based randomized clinical trial of silver diamine fluoride for dental caries incidence

Abstract

Background: Dental caries is a global health crisis. School-based sealant programs are effective strategies to increase access to care and reduce the risk of caries, but are limited by financial restraints and/or dental workforce barriers. The CariedAway trial was a study of alternative minimally-invasive treatments that can be used in a school-based caries prevention program. Methods: CariedAway was a longitudinal, cluster-randomized, single-blind, pragmatic non-inferiority trial comparing silver diamine fluoride (SDF) to glass ionomer sealants and atraumatic restorations (ART) for dental caries. All subjects also received fluoride varnish. Our subject population included children enrolled in New York City primary schools with a student population of at least 50% Hispanic/Latino or black and 80% from low-income families. Subjects were treated by dental hygienists or registered nurses under the supervision of a licensed pediatric dentist. We report on the four-year cumulative incidence and prevalence of caries. Results: We show that repeated application of a combinative therapy for dental caries consisting of SDF and fluoride varnish had similar effects compared to the standard of care sealants and atraumatic restorations over an approximate four year period. The crude incidence of caries in children treated with SDF was 9.2 per 1,000 tooth-years, versus 8.9 per 1,000 tooth-years in children treated with sealants and ART. The odds of decay prevalence decreased longitudinally (OR = 0.79, 95% CI = 0.753, 0.828) and SDF was non-inferior compared to sealants with ART (OR = 0.94, 90% CI = 0.795, 1.11). Conclusion: For high-risk, underserved populations, a minimally-invasive treatment of SDF with fluoride varnish resulted in similar caries prevalence and incidence compared to the standard of care over four years. Integration of silver diamine fluoride into school-based caries prevention may offer an attractive alternative to traditional school sealant programs.