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The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592864
First received: May 3, 2012
Last updated: August 2, 2012
Last verified: July 2012
History of Changes
  Purpose

A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Schiff Sensitivity Score [ Time Frame: after eight weeks twice daily brushing ] [ Designated as safety issue: No ]
    Reduction of dentinal hypersensitivity as measured by Schiff Sensitivity Score


Secondary Outcome Measures:
  • Tactile Threshold Score [ Time Frame: after eight weeks twice daily brushing ] [ Designated as safety issue: No ]
    Reduction of dentinal hypersensitivity as measured by tactile threshold score.


Enrollment: 120
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Dentifrice containing stannous fluoride
 Drug: Stannous Fluoride
dentifice
Active Comparator: Arm 2
Marketed dentifrice containing Sodium Monofluorophosphate
 Drug: Sodium Monofluorophosphate
dentifrice

  Eligibility

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

Inclusion Criteria:

  • Subjects who suffer from tooth sensitivity

Inclusion Criteria:

- none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592864

Locations
United States, Nevada
BioSci Research America, Inc.
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592864     History of Changes
Other Study ID Numbers: RH01325
Study First Received: May 3, 2012
Last Updated: August 2, 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 May 19, 2013