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The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Control | Active Comparator | 2 brushings per day (AM and PM) |
|
| Negative Control | Sham Comparator | 2 brushings per day (AM and PM) |
|
| Experimental Control | Experimental | Brush with Positive control in the morning and negative control in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.454% stannous fluoride | Drug | Brush two times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Baseline |
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silverstone Research Group | Las Vegas | Nevada | 89146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39118360 | Derived | He T, Zou Y, Grender J, Amini P, Kaminski M, Biesbrock AR. Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis. JDR Clin Trans Res. 2025 Apr;10(2):124-134. doi: 10.1177/23800844241263031. Epub 2024 Aug 8. |
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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 |
| C012980 | fluorophosphate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.76% sodium monofluorophosphate |
| Drug |
Brush two times daily |
|
| 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM | Drug | Brush two times daily |
|
| D009057 |
| Stomatognathic Diseases |
| D017971 |
| Tin Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |