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This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Control | Active Comparator | 0.76% sodium monofluorophosphate |
|
| Test | Active Comparator | 0.454% stannous fluoride |
|
| Positive Control | Active Comparator | 0.454% stannous fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Drug | Brush two times a day for 1 minute with manual toothbrush |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Bleeding Sites | Total number of bleeding sites | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salus Research | Salus Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | 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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| 0.454% Stannous Fluoride Dentifrice | Drug | Brush two times a day for 1 minute with manual toothbrush |
|
| 0.454% Stannous Fluoride Dentifrice | Drug | Brush two times a day for 2 minutes with electric toothbrush |
|
| D009057 |
| Stomatognathic Diseases |