The Efficacy of a Toothpaste to Reduce Sensitivity

NCT ID: NCT00763269

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 626 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2008-12-31

Brief Summary

Hypersensitivity

Conditions

Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

sensitive toothpaste

Group Type: EXPERIMENTAL

Triclosan, Silicon dioxide, fluoride

Intervention Type: DRUG

Brush twice daily

B

Triclosan control toothpaste

Group Type: ACTIVE_COMPARATOR

Triclosan, fluoride

Intervention Type: DRUG

Brush twice daily

Interventions

Triclosan, Silicon dioxide, fluoride

Brush twice daily

Intervention Type: DRUG

Triclosan, fluoride

Brush twice daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Augusto Elias, DDS

Role: PRINCIPAL_INVESTIGATOR

Univ of Puerto Rico

Locations

Concordia Clinical Research

Cedar Knolls, New Jersey, United States

Countries

United States

Other Identifiers

CRO-0208-TOT-SEN-PR

Identifier Type: -

Identifier Source: org_study_id