CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01691560
NCT01691560Phase 2Completed
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A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity

GlaxoSmithKline·interventional·Posted Sep 24, 2012·Updated May 29, 2014

In Brief

A Phase 2 clinical trial evaluating 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice, and 2 other interventions for Dentine Hypersensitivity. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDentine Hypersensitivity
CountriesUnited States
CollaboratorsBioSci Research

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2012
Enrollment StartAug 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.8 years ago

Interventions

5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifricedrug

Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifricedrug

Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Sodium monofluorophosphate dentifricedrug

Dentifrice containing 1000 ppmF as sodium monofluorophosphate

Sodium fluoride dentifricedrug

Dentifrice containing 1100 ppmF as sodium fluoride