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

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ClinicalTrials.gov Identifier: NCT01494649
Recruitment Status : Completed
First Posted : December 19, 2011
Results First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Dentinal Sensitivity Hypersensitivity Drug: Test Toothpaste Drug: Negative Control Toothpaste

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment [ Time Frame: Baseline and immediately after treatment administration ]
    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 :
  1. Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 [ Time Frame: Baseline and Day 3 ]
    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.

  2. Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 [ Time Frame: Baseline and Day 14 ]
    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.

  3. Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment [ Time Frame: Baseline and immediately after treatment administration ]
    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.

  4. Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 [ Time Frame: Baseline and Day 3 ]
    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.

  5. Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 [ Time Frame: Baseline and Day 14 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01494649     History of Changes
Other Study ID Numbers: Z7871335
First Posted: December 19, 2011    Key Record Dates
Results First Posted: May 8, 2013
Last Update Posted: May 8, 2013
Last Verified: August 2012

Keywords provided by GlaxoSmithKline:
dentinal
hypersensitivity

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