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

Abstract

AbstractImportanceDental caries is the world’s most prevalent noncommunicable disease and a source of severe health inequity. To prevent and reduce this burden, the Centers for Disease Control and Prevention recommends school dental sealant programs.ObjectiveTo determine whether silver diamine fluoride (SDF) is non-inferior to dental sealants and atraumatic restorative treatment (ART) for dental caries when used in a school-based program.DesignThe CariedAway study was a cluster-randomized, single-blind, pragmatic non-inferiority trial conducted from 2018-2023. Four years of follow-up were included.SettingPrimary schools in New York City with at least 55% of the student population reporting as Black or Hispanic/Latino and at least 80% receiving free or reduced lunch.ParticipantsAny child between the ages of 5 and 13 was eligible. There were 17741 eligible children across 48 schools.InterventionsParticipants were cluster-randomized at the school level to receive either a 38% concentration SDF solution or glass ionomer sealants and ART. Each participant also received fluoride varnish.Main OutcomesPrimary study outcomes were the prevalence and incidence of dental caries. Our a priori hypothesis was that SDF was non-inferior to sealants and ART in reducing caries prevalence.ResultsA total of 7418 children were enrolled and treated, of which 4100 completed at least one follow-up observation (55%). The overall baseline prevalence of dental caries was approximately 27% (95% CI = 25.7, 28.6). Following treatment, the odds of decay prevalence decreased longitudinally (OR = 0.79, 95% CI = 0.75, 0.83) and SDF was non-inferior compared to sealants and ART (OR = 0.94, 95% CI = 0.80, 1.11). The crude incidence of dental caries in children treated with SDF was 10.2 per 1,000 tooth-years, versus 9.8 per 1,000 tooth-years in children treated with sealants and ART, for a rate ratio of 1.046 (95% CI = 0.97, 1.12).Conclusions and RelevanceIn a pragmatic trial, application of silver diamine fluoride resulted in nearly identical caries incidence compared to dental sealants and ART and was non-inferior in the longitudinal prevalence of caries. SDF is an effective alternative for use in school caries prevention, increasing access and reducing costs for oral healthcare.Trial RegistrationClinicalTrials.gov, #NCT03442309