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To evaluate and compare the plaque removal efficacy of a battery-powered toothbrush and a 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 battery-operated toothbrush and a marketed manual toothbrush. This study will accept up to 64 subjects, 18-65 years of age, in anticipation that 60 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. Scale used is Rustogi Modification of the Navy Plaque Index (RMNPI). Up to 504 sites scored in the mouth, with each score a 0 or 1, and subject scores an average over all sites measured. Minimum score of 0 and maximum score of 1. For each timepoint, a larger score means more plaque. For reduction from baseline, a larger score means a greater reduction in plaque. | up to 2 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 C | Canada |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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single use, examiner blinded, randomized, two-period, cross-over
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Examiner blinded to toothbrush used.
| Manual toothbrush |
| Device |
Device on plaque removal efficacy |
|