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Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

NCT02226562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2018-08-27

Study results available
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Summary

The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.

Conditions

  • Dentin Sensitivity

Interventions

DRUG

Potassium nitrate and sodium fluoride

3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride

DRUG

Standard fluoride dentifrice

Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-02
Primary Completion
2014-12-01
Completion
2014-12-05

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 NCT02226562 on ClinicalTrials.gov