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The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADA (American Dental Association) approved Manual Toothbrush | Active Comparator |
| |
| Marketed Power Toothbrush | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADA approved Manual Toothbrush | Device | ADA approved Manual Toothbrush |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in supragingival plaque, as measured by Modified Plaque Index | 6 months | |
| Change in clinical attachment level | 6 months | |
| Change in periodontitis, as measured by probing pocket depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38289823 | Derived | Jenkins W, Starke EM, Nelson M, Milleman K, Milleman J, Ward M. The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24-week randomized clinical trial. Int J Dent Hyg. 2024 Aug;22(3):727-735. doi: 10.1111/idh.12783. Epub 2024 Jan 30. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
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| Marketed Power Toothbrush | Device | Marketed Power Toothbrush |
|
| 6 months |
| D014076 |
| Tooth Diseases |