38 Percent Silver Diamine Fluoride Effectively Arrests Severe Early Childhood Caries: JAMA
Researchers have found in a new blinded randomized clinical trial involving 830 children with severe early childhood caries (S-ECC) that 38% silver diamine fluoride (SDF) was significantly more effective than placebo in arresting cavitated dentin caries lesions at 6 months. The findings support the use of 38% SDF as an effective, non-invasive treatment for managing dental caries in primary teeth and may help inform future FDA regulatory approval.
The study was published in JAMA Pediatrics by Margherita F. and colleagues. To determine the therapeutic effectiveness and safety of topical silver diamine fluoride, researchers have undertaken a multi-center, double blind, randomized controlled phase III study with a design of two parallel groups in medical, dental, and community settings of pre-schools including Head Start programs. The enrolled patients involved a total of 830 generally healthy children of age group ranging from 12 to 71 months with active cavitated dentin lesions and high caries experience.
The treatment was provided to the children where they were randomly allocated to either topical 38% SDF or placebo solution to be applied on the cavitated lesion both at the time of baseline and after 6 months. The clinical assessment of dental lesion was conducted at the time of baseline, 3 months, 6 months, and 8 months.
Key findings:
- Of 830 children aged 1 to 6 years enrolled in the study (428 females [52%] and 402 males [48%]), 584 (70%) completed all follow-up visits and protocols, with 81 participants (9.8%) lost due to study interruption resulting from the COVID-19 pandemic.
- The study group started with a relatively high caries index with a mean (SD) dmft of 11.36 (4.56), ranging from 1 to 23 teeth.
- At 3, 6, and 8 months of the intent-to-treat analysis, the SDF achieved both percentage of lesion arrest of 57.5, 54.0, and 50.2% and arrest that occurred in placebo group (18.8, 22.5, and 17.4%, respectively).
- The differences in net rate of arrests in the main analysis of 38% SDF were 38.7% (28.7%–48.6%) at 3 months, 31.5% (21.5%–41.6%) at 6 months, and 32.8% (22.3%–43.2%) at 8 months.
- The adverse events were registered in 196 (47.3%) participants of the SDF group and 180 (43.3%) participants of the placebo group, with the counts of the treatment-related adverse events being almost equal (SDF=22.9%, placebo=22.2%) and the AE discontinuation rate being the same (7.5% in both groups).
In summary, 38% SDF is significantly more effective than placebo in treating dentin carious lesions in primary teeth of young children suffering from S-ECC, and thus can be used as a pain-free intervention in young high-risk children and warrants further investigation as a candidate for FDA approval as a pharmaceutical product. Use of 38% SDF in pediatric dental care is safe, non-invasive, and extremely effective in treating severe tooth decay.
Reference:
Fontana M, Moursi A, Gonzalez-Cabezas C, et al. Efficacy of Silver Diamine Fluoride on Young Children With Severe Early Childhood Caries: A Randomized Clinical Trial. JAMA Pediatr. Published online July 27, 2026. doi:10.1001/jamapediatrics.2026.2567
