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The objective of this study is to assess clinical efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an eight-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 toothpaste | Experimental | subjects will brush with assigned toothpaste morning & night |
|
| Control toothpaste | Active Comparator | subjects will brush with assigned toothpaste morning & night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste containing 8% Arginine | Drug | Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tactile stimulation with a Yeaple Probe. treatment Tactile and Air Blast Hypersensitivity scores. The mean Tactile and Air Blast Hypersensitivity will be computed and summarized | Sensitivity will be defined by a score in the range of 10-50 gms. of force | Baseline 4 week & 8 week |
| Schiff Cold Air Sensitivity Scale | Sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale | Baseline 4 week & 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yiming LI, DDS, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Colgate Cavity Protection Toothpaste | Drug | Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste |
|
| D000601 | Amino Acids, Essential |