To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.

NCT ID: NCT07149376

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2025-10-14

Brief Summary

The objective of this clinical investigation is to assess the efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over an eight (8) week period.

Conditions

Sensitivity, Tooth

Study Design

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

Study Groups

Test 1 toothpaste

During this clinical study, you will be assigned to one of the two study groups. You will be provided with a toothpaste and toothbrush for at home use. You will be instructed to brush your teeth twice daily for one (1) minute each time. You are to repeat the same procedures for the duration of the study.

Group Type: ACTIVE_COMPARATOR

TOMs of Maine Sensitive SLS Free Xtra Fresh

Intervention Type: DEVICE

Cover the entire length of bristled head with toothpaste. Brush your teeth twice daily (morning and evening) for one (1) minute each time.

For investigational use only by the study participant. Not for Sale.

Test 2 toothpaste

During this clinical study, you will be assigned to one of the two study groups. You will be provided with a toothpaste and toothbrush for at home use. You will be instructed to brush your teeth twice daily for two (2) minute each time. You are to repeat the same procedures for the duration of the study.

Group Type: ACTIVE_COMPARATOR

Colgate Cavity protection toothpaste

Intervention Type: DRUG

Cover the entire length of bristled head with toothpaste. Brush your teeth twice daily (morning and evening) for (2) two minutes each time.

For investigational use only by the study participant.

Interventions

TOMs of Maine Sensitive SLS Free Xtra Fresh

Cover the entire length of bristled head with toothpaste. Brush your teeth twice daily (morning and evening) for one (1) minute each time.

For investigational use only by the study participant. Not for Sale.

Intervention Type: DEVICE

Colgate Cavity protection toothpaste

Cover the entire length of bristled head with toothpaste. Brush your teeth twice daily (morning and evening) for (2) two minutes each time.

For investigational use only by the study participant.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sign an Informed Consent Form;
• Male or female 18 to 70 years of age, inclusive;
• Be in good general health as determined by the study investigators;
• Available for the eight (8) weeks duration of the study;
• Must present two (2) sensitive teeth which must meet ALL of the following criteria:
• Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
• Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10-50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA);
• Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.

Exclusion Criteria

• Gross oral pathology, chronic disease, and/or history of allergies to any of the test products
• Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
• Advanced periodontal disease and/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 any other oral clinical study for the duration of this study
• Self-reported pregnancy and/or currently breastfeeding;
• Allergies to oral care products, personal care consumer products, and/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

Farid Ayad

Role: PRINCIPAL_INVESTIGATOR

FAR ORAL SYSTEMIC HEALTH CONSULTING INC.

Locations

FAR Oral and Systemic Health Consulting, Inc

Costa Mesa, California, United States

Countries

United States

Other Identifiers

CRO-2025-05-SEN-TOMS-CA-DR

Identifier Type: -

Identifier Source: org_study_id