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This study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stannous fluoride toothpaste | Experimental | brush twice a day for 8 weeks |
|
| cavity protection toothpaste | Sham Comparator | brush twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stannous fluoride toothpaste | Drug | 0.454% stannous fluoride toothpaste |
| |
| Measure | Description | Time Frame |
|---|---|---|
| plaque scores | baseline | |
| plaque scores | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| gingivitis score | baseline | |
| gingivitis score | 8 weeks |
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Inclusion Criteria:
In order to be included in the study, each subject must:
Exclusion Criteria:
Subjects are excluded from study participation where there is evidence of:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |
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| ID | Term |
|---|---|
| C546060 | hydrated silica gel-based toothpaste |
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| cavity protection toothpaste |
| Drug |
0.243% sodium fluoride toothpaste |
|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |