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8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Group | Active Comparator | Subjects without gingivitis (\ |
|
| Unhealthy Group | Active Comparator | Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride | Drug | brush twice daily with stannous fluoride toothpaste for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| MGI | Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation). | 8 weeks |
| GBI | Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding) | 8 weeks |
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Inclusion Criteria:
For Unhealthy Group:
For Healthy Group:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39215289 | Derived | Ramji N, Xie S, Bunger A, Trenner R, Ye H, Farmer T, Reichling T, Ashe J, Milleman K, Milleman J, Klukowska M. Effects of stannous fluoride dentifrice on gingival health and oxidative stress markers: a prospective clinical trial. BMC Oral Health. 2024 Aug 30;24(1):1019. doi: 10.1186/s12903-024-04785-7. |
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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 |
|---|---|
| D014002 | Tin Fluorides |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| D009057 |
| Stomatognathic Diseases |
| D017971 |
| Tin Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |