Original Investigation

Efficacy of Silver Diamine Fluoride on Young Children With Severe Early Childhood Caries

JAMA Pediatrics 10.1001/jamapediatrics.2026.2567

July 27, 2026 at 11:00 AM EDT

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To inform US Food and Drug Administration regulatory approval, what is the clinical effectiveness of 38% silver diamine fluoride (SDF) when used in medical, dental, and school settings in arresting cavitated dentin caries lesions in the primary dentition of children with severe early childhood caries (S-ECC) at a 6-month follow-up? In this blinded, randomized clinical trial of 830 children with S-ECC, 38% SDF demonstrated significantly greater efficacy than placebo in arresting cavitated dentin caries lesions. These results demonstrate that application of 38% SDF was an effective intervention for arresting dentin caries lesions in the primary teeth of young children with S-ECC at a 6-month interval.

Corresponding Author: Margherita Fontana, DDS, PhD, University of Michigan, 1011 North University, Room 2500, Ann Arbor, MI 48109 (mfontan@umich.edu).

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