A large US clinical trial has found that a quick, noninvasive dental treatment using silver diamine fluoride can help manage aggressive tooth decay in young children, according to findings released on Aug. 3.
The study, published in JAMA Pediatrics, investigated the efficacy of 38% silver diamine fluoride (SDF) in arresting active cavitated dentin caries lesions among children aged 12 to 71 months with severe early childhood caries. The randomized, placebo-controlled phase 3 trial included 830 generally healthy children who were assigned to receive either SDF or a placebo at baseline and again after six months. The primary objective was to determine the ability of SDF to halt progression of cavitated dentin lesions at six and eight months after application.
Results showed that SDF arrested an estimated 57.5%, 54.0%, and 50.2% of lesions at three, six, and eight months respectively, compared with arrest rates of between approximately 17% and 22% in the control group over the same periods. Differences between groups ranged from about 31 to nearly 39 percentage points depending on timing. Analyses accounted for multiple lesions per child and missing data.
No significant difference in pain was observed between groups during follow-up assessments at six or eight months. Adverse events occurred in similar proportions: about 47% in the SDF group versus about 43% among controls; most events were mild or moderate, and rates of treatment-related adverse events were nearly identical between groups.
Researchers noted that while one application showed clinically meaningful effectiveness in arresting caries lesions, there was no clear additional benefit from a second application at six months based on this study's design. They also observed higher arrest rates for front teeth than molars and suggested dental anatomy may influence outcomes.
The researchers concluded that these findings support further regulatory evaluation by the US Food and Drug Administration regarding SDF’s use as a drug for caries arrest among young children with severe early childhood caries.
