The Efficacy of a Toothpaste to Reduce Sensitivity

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypersensitivity

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides; Silicon; Triclosan

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.