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To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.
This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. This study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.
After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Battery operated toothbrush | Active Comparator | battery operated toothbrush |
|
| Manual toothbrush | Active Comparator | Manual toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Battery operated toothbrush | Device | Device on plaque removal efficacy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal | Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured. | up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum Research Center Ltd. | Mississauga | Ontario | L5N 6J2 C | Canada |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2021 | |
| Reset | May 11, 2021 | |
| Release | Jul 27, 2021 | |
| Reset | Aug 20, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2021 | May 11, 2021 | |||
| Jul 27, 2021 |
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Manual toothbrush |
| Device |
Device on plaque removal efficacy |
|
| Aug 20, 2021 |