Last updated: 11/04/2018 10:26:50
Exploratory study to evaluate the efficacy of an occlusion based dentifrice in relief of dentinal hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in Schiff sensitivity score at Week 4
Timeframe: Baseline and 4 weeks post administration of study treatment
Mean Change from baseline in Schiff Sensitivity Score at Week 8
Timeframe: Baseline and 8 weeks post administration of study treatment
Median change from baseline in Tactile sensitivity at Week 4
Timeframe: Baseline and 4 weeks post administration of study treatment
Median change from baseline in Tactile sensitivity at Week 8
Timeframe: Baseline and 8 weeks post administration of study treatment
Mean change from baseline in Visual rating scale score at Week 4
Timeframe: Baseline and 4 weeks post administration of study treatment
Mean change from baseline in Visual rating scale score at Week 8
Timeframe: Baseline and 8 weeks post administration of study treatment
Secondary outcomes:
Mean change from baseline in Dentine Hypersensitivity Experience Questionnaire total score at Week 4
Timeframe: Baseline and 4 weeks post administration of study treatment
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
Interventions:
Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
Drug: Sodium monofluorophosphate dentifrice
Drug: Sodium Fluoride dentifrice
Enrollment:
140
Observational study model:
Not applicable
Primary completion date:
2013-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentinal Hypersensitivity
Product
Calcium sodium phosphosilicate/ sodium monofluorophosphate
Collaborators
Not applicable
Study date(s)
January 2013 to May 2013
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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.
- Specific Dentition Exclusions for Test teeth
- a) Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
Inclusion and exclusion 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 a) Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening. b) 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. c) 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-31-05
Actual study completion date
2013-31-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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