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A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.

NCT02753075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-08-27

Study results available
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Summary

This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Conditions

  • Dentin Sensitivity

Interventions

DEVICE

Experimental Oral Rinse 1

Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5

DEVICE

Experimental Oral Rinse 2

Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5

OTHER

Placebo Oral Rinse

Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5

DRUG

Fluoride toothpaste

Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

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
Yes

Timeline & Regulatory

Start
2015-09-08
Primary Completion
2015-12-01
Completion
2015-12-18

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 NCT02753075 on ClinicalTrials.gov