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| Name | Class |
|---|---|
| All Sum Research Center Ltd. | OTHER |
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The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks.
Data will be analyzed and reported as mean. The target population is approximately 70 healthy adult volunteers. There will be two groups with a total of 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, patients will be randomly assigned in a 1:1 ratio to receive either:
With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.
The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.
Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre & post, 2 weeks and 4 weeks (=/- 2 days)
Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed up.
Subjects will complete a questionnaire at the completion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric toothbrush and power interdental device | Experimental | Electric toothbrush and power interdental device |
|
| Electric toothbrush | Active Comparator | Electric toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric toothbrush | Device | Electric toothbrush and power interdental device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks. | Bleeding on Probing | 4 weeks |
| Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks | Modified Gingival Index | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks. | Rustogi Modification of the Navy Plaque Index | pre & post, 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy Qaqish | All Sum Research Center Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum Research Center Ltd. | Mississauga | Ontario | L5N 6J2 | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 4, 2021 | Nov 1, 2021 | 2 | ||
| Jun 25, 2024 |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Control | Device | Oscillating-rotating |
|
| Jul 15, 2024 |
| 3 |
| D009057 |
| Stomatognathic Diseases |