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The goal of this clinical trial is to learn if powered toothbrushing is more effective than manual toothbrushing in removing dental plaque. It will also learn about the safety of power toothbrushing. The main questions the study aims to answer are:
Does power toothbrushing remove more dental plaque than manual toothbrushing? Does power toothbrushing reduce symptoms of gingivitis better than manual toothbrushing?
Participants will:
Brush their teeth twice a day with either a manual or power toothbrush Visit the clinic twice during the study, after two and six weeks after the study starts.
Keep a diary of when they brushed their teeth
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Toothbrush | Active Comparator | Administered using Colgate Classic Adult Manual Toothbrush |
|
| Power Toothbrush | Experimental | Administered using Sonicare Power toothbrush with All-in-One brush head |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| power toothbrush | Device | Sonicare Powered Toothbrush and All-in-One Brush head |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks | Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque,
Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks | Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque,
Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups. |
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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 |
Data is available upon request
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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 |
Colgate Classic Adult manual toothbrush |
|
| 2 weeks |
| Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 2 weeks | Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation,
Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the manual and power toothbrush groups. | 2 weeks |
| Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 6 weeks | Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation,
Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the manual and power toothbrush groups. | 6 weeks |
| Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 2 weeks | Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding,
Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the manual and power toothbrush groups. | 2 weeks |
| Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 6 weeks | Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding,
Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the manual and power toothbrush groups. | 6 weeks |
| D009057 |
| Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |