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The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Sham Comparator |
| |
| 1.15% Sodium Monofluorophosphate Dentifrice | Sham Comparator |
| |
| Marketed 0.454% Stannous Fluoride Dentifrice | Active Comparator |
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| 0.454% Stannous Fluoride Dentifrice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.76% Sodium Monofluorophosphate Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
| 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). | 3 Months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHRG | Whittier | California | 90602 | 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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| 1.15% Sodium Monofluorophosphate Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
| 0.454% Stannous Fluoride Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
| 0.454% Stannous Fluoride Dentifrice | Drug | Whole mouth brushing with a toothpaste, twice daily for the duration of the study. |
|
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 |
| D009057 |
| Stomatognathic Diseases |