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Qualified subjects will be enrolled and randomized to either one of the two study groups described above 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 three months of product use. All subjects will be followed for adverse events throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colgate Dual Zinc Toothpaste | Experimental | toothpaste |
|
| Colgate Cavity Protection Toothpaste | Active Comparator | toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc containing toothpaste | Drug | Toothpaste |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Loe-Silness Gingival Index score | A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored. | baseline, 2 week, 6 week, 3 month |
| Quigley-Hein Plaque Index score | A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored. | baseline, 2 week, 6 week, 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deyu Hu, DDS, MS | West China Dental Institute of Chengdu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Dental Institute of Chengdu | Chengdu | Sichuan | 610041 | China |
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| MFP Fluoride toothpaste |
| Drug |
toothpaste |
|
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C432564 | green tea bioflavonoid, zinc ascorbate-containing toothpaste |
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