Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01831817
First received: April 11, 2013
Last updated: March 23, 2015
Last verified: February 2015
  Purpose

The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.


Condition Intervention Phase
Dentinal Hypersensitivity
Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
Drug: Sodium monofluorophosphate dentifrice
Drug: Sodium Fluoride dentifrice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in Schiff Sensitivity Score at Week 4 [ Time Frame: Baseline and 4 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.

  • Mean Change From Baseline in Schiff Sensitivity Score at Week 8 [ Time Frame: Baseline and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.

  • Median Change From Baseline in Tactile Sensitivity at Week 4 [ Time Frame: Baseline and 4 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.

  • Median Change From Baseline in Tactile Sensitivity at Week 8 [ Time Frame: Baseline and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.

  • Mean Change From Baseline in Visual Rating Scale Score at Week 4 [ Time Frame: Baseline and 4 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".

  • Mean Change From Baseline in Visual Rating Scale Score at Week 8 [ Time Frame: Baseline and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".


Secondary Outcome Measures:
  • Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 [ Time Frame: Baseline and 4 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.

  • Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 [ Time Frame: Baseline and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
    DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.


Enrollment: 140
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate
Active Comparator: 0% calcium sodium phosphosilicate/sodium monofluorophosphate
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate
Active Comparator: Sodium monofluorophosphate
Dentifrice containing 1000 ppmF as sodium monofluorophosphate
Drug: Sodium monofluorophosphate dentifrice
Sodium monofluorophospate dentifrice (1000 ppm F)
Active Comparator: Sodium fluoride
Dentifrice containing 1100 ppmF as sodium fluoride
Drug: Sodium Fluoride dentifrice
Dentifrice containing 1100ppm F as sodium fluoride

Detailed Description:

This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
  • Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.

Exclusion Criteria:

  • Specific Dentition Exclusions for Test teeth

    1. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
    2. Tooth with exposed dentin 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 etiologies other than erosion, abrasion or recession of exposed dentin.
    3. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
  • Use of a sensitivity dentifrice within 8 weeks of screening
  • 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: NCT01831817

Locations
United States, Indiana
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01831817     History of Changes
Other Study ID Numbers: RH01591
Study First Received: April 11, 2013
Results First Received: March 6, 2014
Last Updated: March 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Calcium, Dietary
Fluorides
Fluorophosphate
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Bone Density Conservation Agents
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015