Randomized Clinical Trial Finds Silver Diamine Fluoride Effective and Safe in Arresting Caries Preschool Children
Alexandria, VA, USA – At the 95th General Session & Exhibition of the International Association for Dental Research (IADR), researcher Jeremy Horst, University of California, San Francisco, USA presented an abstract titled “RCT of Silver Diamine Fluoride for Caries Arrest in Children.” The IADR General Session was held in conjunction with the 46th Annual Meeting of the American Association for Dental Research and the 41st Annual Meeting of the Canadian Association for Dental Research.
Horst reported topical silver diamine fluoride was effective and safe in arresting dental caries in the teeth of preschool children. (clinical trial #NCT02536040). The Stopping Cavities Trial was a Phase III multi-site double-blinded randomized placebo-controlled trial with two parallel groups and primary endpoint of caries inactivity 14 days after the intervention.
The study was conducted in community settings in Oregon. 66 subjects were randomized. Thirty-six subjects were assigned to Group 1, treated with liquid A or D, and 30 subjects were assigned to Group 2, treated with liquid B or C. Follow-up was completed on 64 (97%) of the subjects. The statistician was blind to treatment condition.Results: Mean fraction of arrested caries in Group 2 (silver diamine fluoride) was 0.72 (95% CI; 0.55 to 0.84) and 0.05 in Group 1 (placebo, 95% CI; 0.00 to 0.16). The mean fraction of arrested caries was significantly higher in Group 2 than Group 1 (mean difference was 0.67; 95% CI: 0.49 to 0.80; exact P < 0.0001). Confirmatory analysis, using GEE log-linear regression, which accounted for the number of treated surfaces and length of follow-up, indicated the rate of arrested caries was significantly higher in Group 2 than Group 1 (relative risk 17.3; 95% CI: 4.3 to 69.4; P < 0.0001). Parents, 4 in each treatment condition, reported eight adverse events. Based on enrolled subjects, the adverse event rate was 11.1% in Group 1 (exact 95% CI: 3.2 to 26.7%) and 13.3% in Group 2 (exact 95% CI: 3.7 to 30.7%). Adverse event rates were not significantly different between the two treatment conditions. None were attributed to the test drug. The authors concluded topical silver diamine fluoride was effective and safe in arresting dental caries in the teeth of preschool children.
This is a summary of abstract #2988 titled “RCT of Silver Diamine Fluoride for Caries Arrest in Children”, presented by Jeremy Horst on Saturday, March 25, 2017, 8 a.m. – 9:30 a.m. at Moscone West, San Francisco, Calif., USA.
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