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A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity

NCT03361774 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-02-15

No results posted yet for this study

Summary

The aim of this study is to develop the clinical methodology to characterize the efficacy profiles of an experimental 5% potassium nitrate (KNO3) and 0.454% stannous fluoride (SnF2) combination dentifrice and a marketed desensitizing 0.454% SnF2 only dentifrice for the relief of dentin hypersensitivity (DH), at multiple time points, over an 8 week treatment period.

Conditions

  • Dentin Sensitivity

Interventions

DRUG

Dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride).

Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.

DRUG

Dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride).

Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.

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
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2018-12-03
Completion
2018-12-03
FDA Drug
Yes

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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 NCT03361774 on ClinicalTrials.gov