To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.
Not Applicable
Active, not recruiting
- Conditions
- Sensitivity, Tooth
- Interventions
- Device: TOMs of Maine Sensitive SLS Free Xtra FreshDrug: Colgate Cavity protection toothpaste
- Registration Number
- NCT07149376
- Lead Sponsor
- Colgate Palmolive
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test 1 toothpaste TOMs of Maine Sensitive SLS Free Xtra Fresh 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. Test 2 toothpaste Colgate Cavity protection 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.
- Primary Outcome Measures
Name Time Method Tactile stimulation by the Yeaple Probe baseline, 3 day, 4 weeks, 8 weeks Hypersensitivity defined by a response score in the range of 10-50 grams of force.
Air blast stimulation baseline, 3 day, 4 weeks, 8 weeks Jet of air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F \[± 3°F\]) \[hypersensitivity defined by a response score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FAR Oral and Systemic Health Consulting, Inc
🇺🇸Costa Mesa, California, United States
FAR Oral and Systemic Health Consulting, Inc🇺🇸Costa Mesa, California, United States