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The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed Stannous Fluoride Toothpaste | Experimental | Brush twice daily |
|
| Marketed Cavity Protection Toothpaste | Placebo Comparator | Brush twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Toothpaste | Drug | Marketed stannous fluoride (0.454%) toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Baseline |
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | 1 Month |
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Turesky Modified Quigley-Hein Index | The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth). | Baseline |
| Turesky Modified Quigley-Hein Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silverstone Research Group | Las Vegas | Nevada | 89146 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Marketed Cavity Protection Toothpaste | Drug | Marketed sodium monofluorophosphate (0.76 %) toothpaste |
|
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth). |
| 1 Month |
| Turesky Modified Quigley-Hein Index | The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth). | 3 Months |
| D009057 |
| Stomatognathic Diseases |