Status:
COMPLETED
The Efficacy of a Toothpaste to Reduce Sensitivity
Lead Sponsor:
Colgate Palmolive
Conditions:
Dentin Hypersensitivity
Eligibility:
All Genders
12-80 years
Phase:
PHASE3
Brief Summary
Hypersensitivity
Eligibility Criteria
Inclusion
- Male and female subjects, ages: 12 years or older.
- Availability for the eight-week duration of the study.
- Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
- Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for one month prior to entry into the study.
- Signed Informed Consent Form.
Exclusion
- Gross oral pathology, chronic disease, or history of allergy to test products.
- Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- Sensitive teeth with a mobility greater than one.
- Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
- Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
- Current participation in any other clinical study.
- Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
- Medical condition which prohibits not eating/drinking for 4 hours.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT00763269
Start Date
September 1 2008
End Date
December 1 2008
Last Update
March 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Concordia Clinical Research
Cedar Knolls, New Jersey, United States, 08225