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/NCT01831817
NCT01831817Phase 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 Apr 15, 2013·Updated Mar 26, 2015

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 Dentinal 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--
ConditionsDentinal Hypersensitivity
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2013
Enrollment StartJan 1, 2013
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.2 years ago

Interventions

5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifricedrug

Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate

0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifricedrug

No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate

Sodium monofluorophosphate dentifricedrug

Sodium monofluorophospate dentifrice (1000 ppm F)

Sodium Fluoride dentifricedrug

Dentifrice containing 1100ppm F as sodium fluoride