This phase III, multisite RCT evaluated 38% silver diamine fluoride (SDF) vs placebo for arresting active cavitated dentin caries lesions in 830 US children aged 12–71 months with severe early childhood caries (S-ECC), with applications at baseline and 6 months and follow-up through 8 months.
SDF arrested significantly more lesions than placebo at all time points: 57.5% vs 18.8% at 3 months, 54.0% vs 22.5% at 6 months, and 50.2% vs 17.4% at 8 months (arrest rate differences of ~39%, ~32%, and ~33%, respectively). Adverse events, pain, and discontinuation rates were similar between groups.
- High attrition (~30% lost to follow-up, including 9.8% due to COVID-19), which may affect generalizability. - Follow-up was limited to 8 months, leaving long-term efficacy and durability of arrest unknown. - Only 70% of enrolled children completed the study, though intent-to-treat analyses were used.
38% SDF is a highly effective, noninvasive option for arresting cavitated dentin caries in young high-risk children with S-ECC — clinicians should consider it especially when conventional restorative care is not feasible. This trial directly supports FDA regulatory consideration of SDF as an approved drug for this indication.
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