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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, and 6, 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 |
|---|---|---|---|
| Test regimen | Experimental | Brush with full ribbon toothpaste, 2x day / 2mins with paste & toothbrush provided |
|
| Control regimen | Active Comparator | Brush with full ribbon toothpaste, 2x day / 2mins with paste & toothbrush provided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test regimen | Drug | toothpaste & manual toothbrush |
| |
| Control regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque assessment | The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas. | Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks |
| Gingivitis Assessment | 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. | Initial reading, 1-week, 3-weeks, and 6-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Gallob, DMD | Consumer Research Consulting, LLC. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consumer Research Consulting, LLC | Melbourne | Florida | 32940 | United States |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| Drug |
toothpaste & manual toothbrush |
|
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |