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Assess the clinical efficacy of CSPR Toothpaste containing 8% arginine to provide dentinal hypersensitivity relief
The objective of this study is to assess the clinical efficacy of CSPR Toothpaste containing 8% arginine to provide dentinal hypersensitivity relief (tactile and air blast) at instant, 3 days, 4 weeks and 8 weeks in comparison to Colgate Cavity Protection Toothpaste over an eight-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Toothpaste | Experimental | Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily |
|
| Control toothpaste | Active Comparator | Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSPR Toothpaste | Drug | a commercially available 8% arginine toothpaste |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe | Tactile sensitivity will be assessed by use of Sensing Probe Yeaple Electronic Force Sensing Probe, Model 200A. Sensitivity will be defined by a score in the range of 10-50 gms. of force. | baseline, 3 day, 4 weeks, 8 weeks |
| Air Sensitivity using the Schiff Cold Air Sensitivity Scale | The air will be directed at the exposed buccal surface of the sensitive tooth air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F[± 3°F]. | baseline, 3 day, 4 weeks, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Dental Institute of Chengdu | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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This study will be monocentric, randomized, double-blind, two-treatment, parallel clinical study
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The tubes of test dentifrices will present the same shape/color to avoid that both investigators and subjects can identify the dentifrices.
| Colgate Dental Cream Toothpaste |
| Drug |
a commercially available fluoride toothpaste |
|