Status:
COMPLETED
To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.
Lead Sponsor:
Colgate Palmolive
Conditions:
Sensitivity, Tooth
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07149376
Start Date
August 18 2025
End Date
October 14 2025
Last Update
November 5 2025
Active Locations (1)
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1
FAR Oral and Systemic Health Consulting, Inc
Costa Mesa, California, United States, 92627