drugset / Trial / NCT04750902
A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.
Timeline
- Start
- 2021-01-21
- Primary completion
- 2024-02-29
- Completion
- 2024-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-arginine | Small molecule | 1.5 % | Topical |
| Subject | L-arginine | Small molecule | 4 % | Topical |
| Subject | L-arginine | Small molecule | 8 % | Topical |
| Comparator | sodium fluoride | Unknown | 0.24 % | Topical |