drugset / Trial / NCT06602466
A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
RandomizedParallel-groupSingle-blindTreatment
Summary
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.
Timeline
- Start
- 2024-09-23
- Primary completion
- 2024-12-13
- Completion
- 2024-12-13
Outcome
Missed primary endpoint
registry analysis (superiority test); Test Toothpaste vs Reference Toothpaste (Negative Control); p = 0.2992; Adjusted Mean Difference -0.02 (95% CI -0.05 to 0.02); ANCOVA NCT06602466 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Colgate Cavity Protection Toothpaste | Unknown | 1450 ppm | Topical |
| Subject | Zinc Sulfate | Unknown | 0.3 % | Topical |
| Subject | stannous fluoride | Small molecule | 0.454 % | Topical |