The Efficacy of a Toothpaste to Reduce Sensitivity

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dentin Hypersensitivity

Treatments: Drug: Triclosan, fluoride; Drug: Triclosan, Silicon dioxide, fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763269

CRO-0208-TOT-SEN-PR

Details and patient eligibility

About

Hypersensitivity

Enrollment: 626 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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626 participants in 2 patient groups

A

Experimental group

Description:

sensitive toothpaste

Treatment:

Drug: Triclosan, Silicon dioxide, fluoride

B

Active Comparator group

Description:

Triclosan control toothpaste

Treatment:

Drug: Triclosan, fluoride