To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.
Completed · Phase 3
Conditions studied: Sensitivity, Tooth
In brief
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.
Key facts
- Study ID
- NCT07149376
- Run by
- Colgate Palmolive
- People needed
- 84
- Starts
- 2025-08-18
- Expected to finish
- 2025-10-14
- Last updated by the study team
- 2025-11-05
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- FAR Oral and Systemic Health Consulting, Inc — Costa Mesa, California, United States
Full record on ClinicalTrials.gov
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