Clinical trial NCT01831817: Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Official title: A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentinal Hypersensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Mean Change From Baseline in Schiff Sensitivity Score at Week 4
timeFrame: Baseline and 4 weeks post administration of study treatment
measure: Mean Change From Baseline in Schiff Sensitivity Score at Week 8
timeFrame: Baseline and 8 weeks post administration of study treatment
measure: Median Change From Baseline in Tactile Sensitivity at Week 4
timeFrame: Baseline and 4 weeks post administration of study treatment
measure: Median Change From Baseline in Tactile Sensitivity at Week 8
timeFrame: Baseline and 8 weeks post administration of study treatment
measure: Mean Change From Baseline in Visual Rating Scale Score at Week 4
timeFrame: Baseline and 4 weeks post administration of study treatment
measure: Mean Change From Baseline in Visual Rating Scale Score at Week 8
timeFrame: Baseline and 8 weeks post administration of study treatment
Secondary outcomes:
measure: Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
timeFrame: Baseline and 4 weeks post administration of study treatment
measure: Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
timeFrame: Baseline and 8 weeks post administration of study treatment
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: