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Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Hygiene Regimen | Experimental | toothpaste, electric toothbrush, and mouth rinse |
|
| Negative Control | Active Comparator | toothpaste and manual toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous Fluoride Dentifrice | Drug | brush 2x a day in using a power brush (2 minutes of brushing) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding (GBI) | Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2 | Week 1, Week 3, and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation (MGI) | Modified Gingival Index- evaluation of the level of gingival tissue inflammation, scores from 0-4 | Week 1, Week 3, and Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Sci Research (Out of Business) | Las Vegas | Nevada | 89121 | 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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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sodium Fluoride Dentifrice | Drug | brush in their customary manner |
|
| electric toothbrush | Device | brush using a electric brush (2 minutes of brushing) |
|
| Cetylpyridinium Chloride (CPC) | Drug | use 20 ml of mouth rinse for 30 seconds |
|
| manual toothbrush | Device | brush in their customary manner |
|
| D009057 |
| Stomatognathic Diseases |