Clinical of Hypersensitivity Reduction Efficacy on Two Toothpastes

NCT ID: NCT06937697

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2024-12-13

Brief Summary

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

Conditions

Hypersensitivity

Study Design

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

Study Groups

Test 1 toothpaste

Subjects will be instructed to brush their teeth with their assigned test dentifrice and toothbrush twice daily

Group Type: EXPERIMENTAL

Test toothpaste

Intervention Type: DRUG

A commercially available fluoride toothpaste

Control toothpaste

Subjects will be instructed to brush their teeth with their assigned test dentifrice and toothbrush twice daily

Group Type: ACTIVE_COMPARATOR

Control toothpaste

Intervention Type: DRUG

A commercially available fluoride toothpaste

Interventions

Test toothpaste

A commercially available fluoride toothpaste

Intervention Type: DRUG

Control toothpaste

A commercially available fluoride toothpaste

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deyu Hu, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

West China Dental Institute of Chengdu

Locations

West China Dental Institute of Chengdu

Chengdu, Sichuan, China

Countries

China

Other Identifiers

CRO-2024-09-SEN-ZN-YPZ

Identifier Type: -

Identifier Source: org_study_id