Using sequential applications of a novel silver diamine fluoride gel and sodium fluoride varnish to arrest severe early childhood caries lesions: A clinical trial with single group assignment.

BACKGROUND: Silver diamine fluoride (SDF) gel was developed to overcome the clinical limitations of liquids with children. The authors conducted a clinical trial to determine caries lesion arrest in primary teeth at 1-year follow-up when 38% SDF gel and 2.5% sodium fluoride varnish were applied sequentially at the same appointment. Parent satisfaction was assessed.

METHODS: The study design was an open-label prospective, clinical trial with single group assignment. Participants were 237 children aged 3 through 4 years at enrollment and from 5 centros educativos iniciales (preschools). Eligible children had 1 or more d3 (cavitation into dentin) active caries lesions. Teeth with active caries lesions (cavitation confined to enamel [d2] or d3) were treated by applying 1 or 2 drops of viscous 38% SDF gel (Advantage Silver Dental Arrest Gel, Elevate Oral Care, LLC) dabbing the excess with cotton. Treated teeth were covered with 2.5% sodium fluoride varnish (Fluorimax, Elevate Oral Care, LLC) to mask the taste. Treatment was repeated at 5 months postexamination. The primary outcome was caries lesion (d2-d3) arrest at 1 year.

RESULTS: Two hundred nineteen children were available at the 1-year follow-up. There was a median of 21 (interquartile range [IQR], 13-34) active carious surfaces (d2-d3) at baseline. Median arrested carious surfaces was 92.6% (IQR, 81.1%-100.0%; 95% CI, 86.8% to 95.2%). When parents were asked whether they were bothered by the color change of teeth, the median response on a 10-point scale in which 1 equaled not bothered at all and 10 equaled very bothered was 1.0 (IQR, 1.0-2.0).

CONCLUSIONS: Two applications of 38% SDF gel and 2.5% sodium fluoride varnish arrested greater than 90% of carious surfaces at 1 year and with high levels of parental satisfaction.

PRACTICAL IMPLICATIONS: Combined treatment was highly efficacious in a population with many caries lesions. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT05395065.