Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Summary
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
Timeline
- Start
- 2012-08
- Primary completion
- 2012-11
- Completion
- 2012-11
Outcome
Mixed primary results
registry analysis (superiority or other test); 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate; p = 0.4553 NCT01691560 ↗
registry MEAN 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate: 7.31 (Standard Deviation 11.227) grams NCT01691560 ↗
registry MEAN 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate: 3.64 (Standard Deviation 6.030) grams NCT01691560 ↗
registry analysis (superiority or other test); 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate; p = 0.0467; Median Difference (Final Values) 0 (95% CI 0 to 5); Wilcoxon (Mann-Whitney) NCT01691560 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PHOSPHINE SILANE | Other / unclassified | 5 % | — |
| Comparator | sodium fluoride | Unknown | 1100 ppm | — |
| Comparator | sodium monofluorophosphate | Unknown | 1000 ppm | — |
| Comparator | sodium monofluorophosphate | Unknown | 1500 ppm | — |