drugset / Trial / NCT04947527
Efficacy and Safety Evaluation of Anti-Caries Varnish
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of the study is to determine the efficacy \& safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are: 1\) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.
Timeline
- Start
- 2022-06-04
- Primary completion
- 2024-06-19
- Completion
- 2024-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | 10 % | Topical |
| Comparator | sodium fluoride | Unknown | 5 % | Topical |