A school-based cluster-randomized pragmatic trial to control dental caries using minimally invasive interventions

BackgroundEvidence-based non-surgical interventions to halt the progression of dental caries, the most prevalent noncommunicable disease in the world, include atraumatic restorative treatment (ART) and silver diamine fluoride (SDF). Data are needed on their effectiveness when used in school caries prevention programs. MethodsIn this school-based, cluster-randomized pragmatic trial conducted from February 1, 2018 to June 1, 2023, 48 primary schools in New York City were randomly assigned to receive either silver diamine fluoride or atraumatic restorations for untreated caries on any mesial, occlusal, distal, buccal, and lingual surface of permanent molars, premolars, and primary molars. All children then received fluoride varnish. Children were treated by either dental hygienists, pediatric dentists, or medical nurses (SDF group only). Dental caries was diagnosed as any lesion scoring either 5 or 6 on the ICDAS scale. The primary outcome was the caries control rate. ResultsA total of 7418 children were enrolled in the trial, of which 1668 (861 in the SDF group, 807 in the ART group) presented with treatable dental caries and completed at least one follow-up observation. The total surface-level failure in the SDF group was 38.3%, compared to 45.5% in the ART group. There were 2167 failures observed in SDF participants over 1372 person-years, compared to 2116 ART failures over 1291 person-years, yielding an incidence rate ratio of 0.96 (95% CI = 0.86, 1.03). At the subject level, 45.5% of SDF recipients experienced at least one surface failure, compared to 53.3% of ART recipients. There were no significant differences in the risk of recurrent surface failure between treatments (HR = 0.92, 95% CI = 0.82, 1.04). ConclusionsIn this four-year pragmatic trial of school-based utilization of minimally invasive interventions for dental caries, similar control rates were observed in children receiving either SDF or ART. These results support the use of secondary preventive therapies for school dental programs. Author rolesRRR conceptualization, formal analysis, methodology, funding acquisition, supervision, writing-original draft; AG: formal analysis; QX: formal analysis; TJBG: data curation, investigation.