Phase 2
N=134
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Dentine Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01691560 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 — -0.36; -0.43; -0.40; -0.45 Score on a scale — p=0.4553
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice (Drug); 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice (Drug); Sodium monofluorophosphate dentifrice (Drug); Sodium fluoride dentifrice (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 |
-0.36; -0.43; -0.40; -0.45 | 0.4553 |
| PRIMARY Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 |
7.31; 6.32; 4.09; 3.64 | 0.0467 sig |
| PRIMARY Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 |
-0.55; -0.43; -0.43; -0.92 | 0.0292 sig |
| PRIMARY Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 |
10.15; 5.88; 4.39; 11.97 | 0.8861 |
| PRIMARY Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 |
-1.22; -1.07; -1.35; -1.25 | 0.9421 |
| PRIMARY Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 |
-1.76; -1.22; -1.31; -2.06 | 0.4797 |
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.
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
- Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding: Women who are breast-feeding.
- 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.
- 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.
- 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.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- 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.
- Other: Any subject who in the opinion of the investigator, should not participate in the study.
Data sourced from ClinicalTrials.gov (NCT01691560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.