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Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) Brush 2 x day / 2 mins Colgate Total Mouthwash (CPC+Zn) Swish 20 mL / 30 secs |
|
| Group II | Placebo Comparator | Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) | Drug | Toothpaste, toothbrush & mouthwash regime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quigley and Hein Plaque Index | reductions in dental plaque | Baseline, 1-, 3-, 6-, and 12-week |
| Loe and Silness Gingival Index | reductions in gingivitis | Baseline, 1-, 3-, 6-, and 12-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farid Ayad, B.D.S., D.D.S., MSC | FAR Oral and Systemic Health Consulting, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa Dental Centre | Costa Mesa | California | 92627 | United States |
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| manual toothbrush + Colgate dental cream | Drug | toothpaste + toothbrush |
|
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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