Efficacy and Safety Evaluation of Anti-Caries Varnish
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
Outcome
Mixed primary results
registry analysis (superiority test); Test Varnish vs Control Varnish; p = 0.279; Mean Difference (Final Values) -1.5 (95% CI -4.2 to 1.2); t-test, 2 sided NCT04947527 ↗
registry analysis (superiority test); Test Varnish vs Control Varnish; p = 0.023; Difference in percentages/proportions -14.4 (95% CI -26.7 to -2.1); Chi-squared NCT04947527 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | 10 % | Topical |
| Comparator | sodium fluoride | Unknown | 5 % | Topical |