A Randomized Trial of a School-Based Silver Diamine Fluoride Program for Reducing Untreated Dental Caries in High-Risk Children

Abstract

Background: Untreated dental caries remains a major public health problem among school-aged children, particularly in underserved communities where access to preventive and restorative dental care is limited. Silver diamine fluoride is a minimally invasive, low-resource intervention that may be suitable for school-based caries control. Objective: To determine whether a single school-based application of 38% silver diamine fluoride is more effective than standardized oral health education alone in reducing active untreated dental caries among high-risk children aged 5–12 years. Methods: A parallel-group randomized controlled trial was conducted among high-risk children attending government schools in Central Punjab, Pakistan. Eighty-four children with at least one active untreated cavitated carious lesion were randomized equally to receive either single-dose topical 38% silver diamine fluoride or standardized oral health education. Outcomes were assessed at baseline and follow-up. The primary outcome was mean number of active untreated carious lesions; secondary outcomes included new lesion development, Simplified Oral Hygiene Index scores, and dental pain-related absenteeism. Results: Final complete-case analysis included 77 participants. At final follow-up, the silver diamine fluoride group had fewer active untreated lesions than controls (2.1 ± 1.0 vs 4.3 ± 1.4; mean difference −2.2, 95% CI −2.75 to −1.65; p<0.001). New lesion development, oral hygiene scores, and pain-related absenteeism were also significantly lower in the intervention group. Conclusion: A single school-based application of 38% silver diamine fluoride significantly reduced active untreated carious lesions and improved clinically relevant secondary outcomes compared with oral health education alone