Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions

Phase 3 Terminated 830 enrolled University of Michigan NYU Langone Health · collab National Institute of Dental and Craniofacial Research (NIDCR) · collab University of Iowa · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial is a Phase III, multisite, randomized, placebo-controlled trial, with two parallel groups. The groups are SDF or placebo and they are applied every 6 months. The primary hypothesis of the trial is that SDF is better than placebo for stopping cavities with dentin exposed in baby teeth when assessed at 6 months after initial application.

Timeline

Start: 2018-10-08
Primary completion: 2023-04-11
Completion: 2023-04-27

Outcome

Met primary endpoint

Stopped (Enrollment): “The trial stopped early due to meeting interim analysis early stopping rules. Active participants at the time of the interim analyses results did complete their remaining study visits. No new participants were enrolled.”

registry analysis (superiority test); Silver Diamine Fluoride (SDF) vs Placebo; p <0.0001; Odds Ratio (OR) 4.06 (99.9% CI 2.54 to 6.48); Regression, Logistic NCT03649659 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	silver diammine fluoride	Small molecule	—	Topical

Indications

No indication recorded.