drugset / Trial / NCT01831817

Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

NCT01831817 ↗

Phase 2 Completed 140 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

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
2013-01
Primary completion
2013-05
Completion
2013-05

Outcome

Missed primary endpoint

registry 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate; p = 0.4321 NCT01831817 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject PHOSPHINE SILANE Other / unclassified 5 % —
Comparator sodium fluoride Unknown 1100 ppm —
Comparator sodium monofluorophosphate Unknown 1000 ppm —
Comparator sodium monofluorophosphate Unknown 1500 ppm —

Indications