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Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 toothpaste | Active Comparator | fluoride toothpaste |
|
| Test 2 toothpaste | Experimental | non fluoride toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Cavity Protection | Drug | 1000ppm fluoride |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque collection | Fasting plaque will be collected before and after a sucrose rinse for lactic acid analysis and ammonia production.The plaque pH of collected samples will also be measured to provide trend data. | baseline, week 3, week 4, week 6, week 7, week 8, week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva collection | Differences in the arginine concentration in saliva pre- and post-brushing with treatment. Differences in microbiome composition and activity | week 5 and week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Volpe Clinical Center | Piscataway | New Jersey | 08854 | United States |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| TOM's Superior Sensitivity Relief Toothpaste |
| Drug |
fluoride free |
|