The Efficacy of a Dentifrice in Providing Relief From Dentinal Hypersensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01724008
First received: March 1, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity


Condition Intervention Phase
Dentine Hypersensitivity
Drug: Stannous Fluoride
Drug: Sodium Monofluorophosphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Schiff Sensitivity Score. [ Time Frame: twice daily brushing at Day 14 ] [ Designated as safety issue: No ]
    compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity


Secondary Outcome Measures:
  • Tactile (Yeaple) Pain Threshold [ Time Frame: twice daily brushing Day 14, Day 3 and Day 0 ] [ Designated as safety issue: No ]
    compare the efficacy of a test dentifrice against that of a control dentifrice in reducing tactile stimulated (grams of force, Yeaple Probe) dentinal hypersensitivity following twice daily brushing

  • Schiff Sensitivity Score [ Time Frame: twice daily brushing Day 14, Day 3 and Day 0 ] [ Designated as safety issue: No ]
    compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity following twice daily brushing


Enrollment: 120
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dentifrice containing stannous fluoride
Toothpaste
Drug: Stannous Fluoride
Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
Active Comparator: Dentifrice containing Sodium Monofluorophosphate
Toothpaste
Drug: Sodium Monofluorophosphate
Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Participants who suffer from tooth sensitivity.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724008

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01724008     History of Changes
Other Study ID Numbers: RH01327
Study First Received: March 1, 2012
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dentin Sensitivity
Hypersensitivity
Tooth Diseases
Stomatognathic Diseases
Immune System Diseases
Fluorides
Tin Fluorides
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014