New Study: Silver Diamine Fluoride May Halt Progression in 54% of Dental Caries|Tooth Decay in Young Children, but Causes Permanent Tooth Blackening

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

DentalGoodNews｜Recently, a Phase III randomized controlled trial published in JAMA Pediatrics evaluated the effect of 38% silver diamine fluoride (SDF) on arresting caries lesion progression in primary teeth among children under 6 years of age with Severe Early Childhood Caries (S-ECC). The study results indicate that 38% SDF is an effective intervention for controlling the progression of dentin caries lesions in primary teeth of children with S-ECC: after application at baseline and at 6 months, the lesion arrest rate (LAR) at the 6-month follow-up was 54.0%, significantly higher than the 22.5% in the placebo group.

DGN previously reported that early studies had preliminarily shown that silver diamine fluoride can halt the progression of tooth decay in young children without the need for drilling. This study was led by Professor Margherita Fontana of the University of Michigan School of Dentistry, with participants recruited from dental clinics, medical facilities, and Head Start programs across Michigan, New York, and Iowa, enrolling a total of 830 children under 6 years of age. According to Fontana, the therapy is a "very effective and safe treatment," and she noted that the minimum enrollment age in the trial was 1 year.

In clinical practice, dentists need only clean and dry the cavity, apply SDF liquid with a micro-sponge tip for approximately 10 seconds, and then blot it dry, without the need for drilling, local anesthesia, or sedation; existing materials have not quantified the specific impact of this procedure on young children's fear or discomfort. Study data show that the lesion arrest rate (LAR) in the SDF group was 57.5% at 3 months; at 6 months, after receiving a second application, the SDF group had a rate of 50.2% at the 8-month follow-up, compared with 17.4% in the placebo group; the incidence of adverse events was similar between the two groups (SDF 22.9%, placebo 22.2%), with no significant difference in pain.

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

The main limitation of this therapy is that treated caries tissue permanently turns dark brown or black, significantly affecting the aesthetics of anterior teeth, and parents need to be informed in advance. Additionally, it should be noted that approximately 46% of SDF-treated lesions had not arrested progression at 6 months, the trial lasted 8 months, and about 30% of participants did not complete follow-up (partly due to the COVID-19 pandemic). The study authors recommend that SDF should be used in combination with daily oral hygiene, sugar intake restriction, and regular fluoride prevention measures, rather than as a replacement for conventional restorative treatment.

Currently, SDF has been FDA-cleared in the United States since 2014 for the treatment of dentin hypersensitivity (DH), and its use for arresting dental caries progression remains an off-label use; this trial aims to provide pediatric clinical evidence for applying for a formal indication. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR) under the National Institutes of Health (NIH), and the SDF and placebo used in the trial were provided by Elevate Oral Care. The researchers believe that if the relevant indication is approved in the future, it may improve clinical accessibility, dentist acceptance, and insurance coverage, but the actual impact still requires subsequent policy and reimbursement evidence for verification.