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The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis
This study is a single-arm clinical trial. Up to one hundred (100) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in order to complete the study with eighty (80) subjects. Subjects will undergo oral examinations, gingival crevicular fluid collection, saliva collection, plaque collection, and will complete questionnaires. All subjects will all be supplied with a study toothbrush and toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brushing with sodium fluoride toothpaste | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium monofluorophosphate toothpaste | Drug | All subjects will receive the same treatment for standardization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative abundance of Streptococcus and Porphyromonas | Comparative relative abundance of Streptococcus and Porphyromonas in sites with high plaque/low gingivitis and high plaque/high gingivitis at Visit 3 | 23-26 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Milleman, DDS, MPA | Contact | 260-755-1099 | milleman@salusresearch.us |
| Name | Affiliation | Role |
|---|---|---|
| Gabriella John, MS | Colgate Palmolive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Recruiting | Fort Wayne | Indiana | 46825 | United States |
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| 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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