Clinical trial NCT01691560: Exploratory Study to Evaluate 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: Dentine Hypersensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: BioSci Research
First posted: 2012-09-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
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 arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory 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:

1. 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
2. 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:

1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
2. Breast-feeding: Women who are breast-feeding.
3. Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc.
4. Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs.
5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months.
6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
7. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit b) Previous participation in this study.
8. Other: Any subject who in the opinion of the investigator, should not participate in the study.

Primary outcomes:
measure: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
timeFrame: Baseline to 4 weeks post administration of study treatment
measure: Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
timeFrame: Baseline to 4 weeks post administration of study treatment
measure: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
timeFrame: Baseline to 8 weeks post administration of study treatment
measure: Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
timeFrame: Baseline to 8 weeks post administration of study treatment
measure: Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
timeFrame: Baseline to 4 weeks post administration of study treatment
measure: Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
timeFrame: Baseline to 8 weeks post administration of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: BioSci Research America
state: Nevada
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: