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The objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Power toothbrush | Experimental |
| |
| Manual toothbrush | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power toothbrush | Device | Experimental power toothbrush |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Gingival Index | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). | Baseline |
| Modified Gingival Index | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). | Week 1 |
| Modified Gingival Index | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). | Week 8 |
| Rustogi Modification of the Navy Plaque Index | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | Baseline |
| Rustogi Modification of the Navy Plaque Index | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | Week 1 |
| Rustogi Modification of the Navy Plaque Index | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum Research Ltd. | Mississauga | Ontario | L4W0C2 | Canada |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Manual toothbrush |
| Device |
Marketed manual toothbrush |
|
| D009057 |
| Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |