Phase 2
N=140
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Dentinal Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01831817 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Mean Change From Baseline in Schiff Sensitivity Score at Week 4 — 2.39; 2.41; 2.40; 2.38 Score on a scale — p=0.4321
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
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Schiff Sensitivity Score at Week 4 |
2.39; 2.41; 2.40; 2.38; 1.83; 1.94 | 0.4321 |
| PRIMARY Mean Change From Baseline in Schiff Sensitivity Score at Week 8 |
2.40; 2.41; 2.40; 2.38; 1.60; 1.56 | 0.8030 |
| PRIMARY Median Change From Baseline in Tactile Sensitivity at Week 4 |
10.00; 10.00; 10.00; 10.00; 10.00; 10.00 | 0.9642 |
| PRIMARY Median Change From Baseline in Tactile Sensitivity at Week 8 |
10.00; 10.00; 10.00; 10.00; 15.00; 15.00 | 0.9834 |
| PRIMARY Mean Change From Baseline in Visual Rating Scale Score at Week 4 |
6.66; 6.69; 6.41; 6.92; 5.45; 5.72 | 0.5555 |
| PRIMARY Mean Change From Baseline in Visual Rating Scale Score at Week 8 |
6.71; 6.69; 6.41; 6.92; 4.65; 4.46 | 0.6727 |
| SECONDARY Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 |
136.53; 132.55; 121.09; 133.89; -3.91; -4.39 | — |
| SECONDARY Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 |
134.33; 132.55; 120.09; 133.89; -6.43; -7.97 | — |
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
- Specific Dentition Exclusions for Test teeth
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT01831817). 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.