Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01494649
First received: September 1, 2011
Last updated: March 21, 2013
Last verified: August 2012
  Purpose

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.


Condition Intervention
Dentinal Sensitivity
Hypersensitivity
Drug: Test Toothpaste
Drug: Negative Control Toothpaste

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Study Investigating the Efficacy of a Toothpaste 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:
  • Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment [ Time Frame: Baseline and immediately after treatment administration ] [ Designated as safety issue: No ]
    Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 [ Time Frame: Baseline and Day 3 ] [ Designated as safety issue: No ]
    Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.

  • Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.

  • Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment [ Time Frame: Baseline and immediately after treatment administration ] [ Designated as safety issue: No ]
    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.

  • Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 [ Time Frame: Baseline and Day 3 ] [ Designated as safety issue: No ]
    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.

  • Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.


Enrollment: 118
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Toothpaste containing 0.454% stannous fluoride
USA marketed toothpaste [test]
Drug: Test Toothpaste
0.454% stannous fluoride toothpaste
Toothpaste containing 0.76% sodium monofluorophosphate
USA marketed toothpaste [negative control]
Drug: Negative Control Toothpaste
0.76% sodium monofluorophosphate toothpaste

  Eligibility

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

Inclusion:

  • Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
  • Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  • Teeth having a gingival index score of less than or equal to 1
  • Teeth with a clinical mobility less than or equal to 1
  • sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

Exclusion:

  • Presence of chronic debilitating disease which could affect study outcomes.
  • Any condition which 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, or not expected to respond to treatment with an over-the counter dentifrice.
  • Daily doses of a medication which could interfere with the perception of pain.
  • Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
  • Individuals who require antibiotic prophylaxis for dental procedures.
  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: NCT01494649

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: NCT01494649     History of Changes
Other Study ID Numbers: Z7871335
Study First Received: September 1, 2011
Results First Received: March 21, 2013
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
dentinal
hypersensitivity

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

ClinicalTrials.gov processed this record on October 01, 2014