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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 toothpaste | Active Comparator | 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. |
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| Test 2 toothpaste | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOMs of Maine Sensitive SLS Free Xtra Fresh | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tactile stimulation by the Yeaple Probe | Hypersensitivity defined by a response score in the range of 10-50 grams of force. | baseline, 3 day, 4 weeks, 8 weeks |
| Air blast stimulation | 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](streamdown:incomplete-link) | baseline, 3 day, 4 weeks, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farid Ayad | FAR ORAL SYSTEMIC HEALTH CONSULTING INC. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FAR Oral and Systemic Health Consulting, Inc | Costa Mesa | California | 92627 | United States |
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| Colgate Cavity protection toothpaste | 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. |
|
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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