Silver Diamine Fluoride vs Atraumatic Restoration for Managing Dental Caries in Schools: A Cluster Randomized Clinical Trial.

Importance: Dental caries is a pervasive and inequitable chronic disease stemming from a lack of access to preventive and therapeutic care. Minimally invasive interventions may be provided in schools to treat caries in children. Objective: To compare the effectiveness of silver diamine fluoride (SDF) with atraumatic restorative treatment (ART) in the control of dental caries among US schoolchildren. Design, Setting, and Participants: The CariedAway study was a cluster randomized clinical trial conducted from February 1, 2019, to June 1, 2023, in 48 primary schools in New York City. Participants were followed up for up to 4 years. Schools with a student population of at least 50% Black and/or Hispanic or Latino students and 80% receiving free or reduced-cost lunch were eligible. Within enrolled schools, any child with parental informed consent was eligible. Treatment was provided biannually. Analysis was restricted to children aged 5 to 13 years who completed at least 1 follow-up observation and had at least 1 tooth surface with dental caries. Interventions: Participants were randomized at the school level to receive SDF or ART. Main Outcomes and Measures: Any surface lesion with an International Caries Detection and Assessment System score of 5 or 6 was recorded as caries. The primary outcome was the number of carious surfaces that had a recurrence of caries. Analysis was performed on an intent-to-treat basis. Results: Of the 17 741 children eligible, 7418 were randomized (mean [SD] age at baseline, 7.6 [1.9] years; 4006 girls [54.0%]), and 1668 were analyzed (mean [SD] age at baseline, 6.8 [1.5] years; 881 girls [52.8%]; 861 in the SDF group and 807 in the ART group). The total surface-level failure in the SDF group was 38.3% (2167 of 5651 carious surfaces) compared with 45.5% (2116 of 4647) in the ART group. There were 2167 surface failures observed among SDF participants over 1372 person-years compared with 2116 ART surface failures over 1291 person-years (incidence rate ratio, 0.96 [95% CI, 0.91-1.02]). At the person level, 45.5% of SDF recipients (392 of 861) experienced at least 1 surface failure compared with 53.3% of ART recipients (430 of 807; odds ratio, 0.51 [95% CI, 0.39-0.66]). There were no significant differences in the risk of recurrent surface failure between treatments (hazard ratio, 0.92 [95% CI, 0.82-1.04]). Conclusions and Relevance: In this study of treatments for caries, similar failures in surface control were observed among children receiving SDF or ART. These results support the use of secondary preventive therapies for caries in schools. Trial Registration: ClinicalTrials.gov Identifier: NCT03442309.