CompletedInterventionalNot ApplicableUpdated May 20, 2026
The Efficacy of a Toothpaste to Reduce Sensitivity | NCT00763269 | Trialant
CompletedInterventionalPhase 3Updated Mar 7, 2012
The Efficacy of a Toothpaste to Reduce Sensitivity
The Efficacy of a Toothpaste to Reduce Sensitivity
ClinicalTrials.gov ID
NCT00763269
Lead Sponsor
Colgate PalmoliveINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
626Actual
Last Update Posted
Mar 7, 2012Estimated
Start Date
Sep 2008
Primary Completion Date
Dec 2008Actual
Completion Date
Dec 2008Actual
Official Title
The Efficacy of a Toothpaste to Reduce Sensitivity
Brief Summary
Hypersensitivity
Dentin Hypersensitivity
Triclosan, Silicon dioxide, fluoride
Triclosan, fluoride
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.