Clinical of Hypersensitivity Reduction Efficacy on Two Toothpastes

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Hypersensitivity

Treatments

Drug: Test toothpaste

Drug: Control toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT06937697

CRO-2024-09-SEN-ZN-YPZ

Details and patient eligibility

About

To evaluate the clinical efficacy of a Dual Zinc Toothpast containing 5% small particle size silica (AC43) as compared to Colgate MaxFresh Tea Toothpaste on dentin hypersensitivity reduction after brushing two times daily (morning and evening) for a period of 8 weeks

Enrollment

87 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female subjects, ages 18-70, inclusive.
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 gms. 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 the parameters assessed (tactile or air) on 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 three months 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.
Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
Current participation in any other clinical study.
Pregnant or lactating subjects.
Allergies to oral care products, personal care consumer products, or their ingredients.
Medical condition which prohibits not eating/drinking for 4 hours.