Using sequential applications of a novel silver diamine fluoride gel and sodium fluoride varnish to arrest severe early childhood caries lesions

AbstractBackground 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.