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: July 27, 2015
Last verified: July 2015
  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: 14 days ] [ 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: 14 days ] [ 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: 14 days ] [ 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

Inclusion

  • Demonstrates understanding of the study and willingness to participate
  • Aged at least 18 to 65 years
  • Understands and is willing, able and likely to comply with all study procedures and restrictions
  • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
  • Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
  • Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
  • At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline

Exclusion

  • Pregnant or breast-feeding women
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
  • Recent history (within the last year) of alcohol or other substance abuse
  • An employee of the sponsor or the study site or members of their immediate family
  • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
  • Any condition which, in the opinion of the investigator, causes xerostomia
  • Dental prophylaxis within 4 weeks of screening
  • Tongue or lip piercing or presence of dental implants
  • Professional desensitising treatment within 12 weeks of screening
  • Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
  • Teeth bleaching within 12 weeks of screening
  • Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening
  • Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine
  • Sensitive tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator.
  • Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
  • Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
  • Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
  • Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
  • Individuals who require antibiotic prophylaxis for dental procedures
  • Any participant who, in the judgment of the investigator, should not participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 27, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 02, 2015