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

NCT01691560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-05-29

Study results available
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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.

Conditions

  • Dentine Hypersensitivity

Interventions

DRUG

5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

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

DRUG

0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice

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

DRUG

Sodium monofluorophosphate dentifrice

Dentifrice containing 1000 ppmF as sodium monofluorophosphate

DRUG

Sodium fluoride dentifrice

Dentifrice containing 1100 ppmF as sodium fluoride

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691560 on ClinicalTrials.gov