Last updated: 11/04/2018 10:26:25
Exploratory study to evaluate 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:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Change from baseline in tactile sensitivity pain response (g) at Week 4
Timeframe: Baseline to 4 weeks post administration of study treatment
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
Change from baseline in tactile sensitivity pain response (g) at Week 8
Timeframe: Baseline to 8 weeks post administration of study treatment
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
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:
Not applicable
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:
2012-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentine Hypersensitivity
Product
Calcium sodium phosphosilicate/ sodium monofluorophosphate
Collaborators
BioSci Research
Study date(s)
August 2012 to November 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
BioSci Research America
Las Vegas, NV, United States, 89121-5466
Status
Study Complete
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
2012-30-11
Actual study completion date
2012-30-11
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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