Efficacy Of A PVP-I Fluoride Varnish
Summary
The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.
Timeline
- Start
- 2017-03-30
- Primary completion
- 2019-05-07
- Completion
- 2019-05-07
Outcome
Mixed primary results
registry analysis (superiority test); Test Varnish vs Standard Varnish; p = 0.037; Mean Difference (Final Values) -1.0 (95% CI -1.9 to -0.1); t-test, 2 sided NCT03082196 ↗
registry analysis (superiority test); Test Varnish vs Standard Varnish; p = 0.062; Mean Difference (Final Values) -0.7 (95% CI -1.5 to 0.1); t-test, 2 sided NCT03082196 ↗
Publications
- Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial. JDR Clin Trans Res. 2021 Apr;6(2):195-204. doi: 10.1177/2380084420922968. Epub 2020 May 21.
- Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial. BMJ Open. 2017 Jun 30;7(6):e017866. doi: 10.1136/bmjopen-2017-017866.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | 10 % | — |
| Comparator | sodium fluoride | Unknown | 5 % | — |