drugset / Trial / NCT01657903
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
RandomizedCrossoverSingle-blindTreatment
Summary
The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-02
- Completion
- 2012-02
Outcome
Met primary endpoint
registry NaF/KNO3 Toothpaste 1 vs No Fluoride/KNO3 Toothpaste; p <0.0001; Adjusted Mean Difference 41.15 (95% CI 34.42 to 47.89); ANOVA NCT01657903 ↗
registry NaF/KNO3 Toothpaste 1 vs No Fluoride/KNO3 Toothpaste; p <0.0001; Adjusted Mean Difference 9.36 (95% CI 6.01 to 12.72); ANOVA NCT01657903 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium fluoride | Unknown | 1450 ppm | Topical |
| Background | Potassium Nitrate | Other / unclassified | 5 % | Topical |