Background: Evidence-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. Methods: In 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. 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. Results: A total of 7418 children were enrolled in the trial, of which 2338 (1193 in the SDF group, 1145 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 32.5%, compared to 32% in the ART group. There were 461 failures observed in SDF participants over 1105 person-years, compared to 431 ART failures over 1039 person-years, yielding an incidence rate ratio of 1.01 (95% CI = 0.88, 1.15). Within the SDF group, children treated by nurses were at lower risk of failure than those treated by other clinicians (IRR = 0.75, 95% CI = 0.59, 0.96). Additionally, children with more affected surfaces had higher chances of failure (OR = 1.11, 95% CI = 1.09, 1.13), though this did not differ across treatment groups. Conclusions: In 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.

The authors have declared no competing interest.

NCT03442309

Research presented in this report was funded by the Patient-Centered Outcomes Research Institute (#PCS-160936724).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study received IRB approval from the New York University School of Medicine (i17-00578)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data will be available upon request and completion of a data use agreement by 12/1/2025