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The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.
Primary endpoint: difference in "full mouth plaque score" between before and after brushing.
Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.
Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic toothbrush with nylon bristles | Experimental |
| |
| Automatic toothbrush with silicone bristles | Active Comparator |
| |
| Manual toothbrush used for 2 minutes | Active Comparator |
| |
| Manual toothbrush used for 45 seconds | Active Comparator |
| |
| No brushing | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic toothbrush with nylon bristle | Other | The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in full mouth plaque score | Difference in full mouth plaque score between before and after brushing | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of "clean mouth" | Sensation of "clean mouth" assessed on a visual analogue scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, The University of Florence | Florence | 50127 | Italy |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Automatic toothbrush with silicone bristle | Other | The automatic toothbrush with silicone bristles will be used for 10 seconds |
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| Manual toothbrush used for 2 minutes | Other | A conventional manual toothbrush will be used for 2 minutes |
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| Manual toothbrush used for 45 seconds | Other | A conventional manual toothbrush will be used for 45 seconds |
|