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The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush.
Up to 22 healthy children (5-8 years old) will be enrolled in a single-center, single-use, randomized, two-period, IRB approved cross-over study. Subjects will be randomly assigned to one of two treatment sequences: 1) brush two minutes with marketed children's manual toothbrush (MTB) or 2) brush 30 seconds with AutoBrush® 360° Sonic Toothbrush (AB) and fluoride toothpaste. Qualified subjects will have pre-brushing supragingival plaque levels ≥ 1.8 according to the Lobene-Soparkar Modified Turesky Modification of the Quigley-Hein Plaque Index (PI), following 12-16 hours plaque accumulation period. Under parent's supervision, subjects brushed at home with their assigned toothbrush, twice daily during a 2-day familiarization period. After refraining (12-16 hours) from oral hygiene, subjects returned for plaque assessment, supervised use of their assigned toothbrush and a post-brushing plaque evaluation. Subjects were given the second toothbrush to begin the next 2-day familiarization period and second period evaluation procedures. Analysis of covariance (ANCOVA) will be used for single-use brushing PI models to assess whole mouth and 8 other hard-to-reach tooth sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AutoBrush U-shaped power toothbrush, then Manual Toothbrush | Experimental | Participants first received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds; after a 2-day washout period, participants received the ADA reference manual toothbrush for a single brushing use for 2 minutes. |
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| Manual Toothbrush | Experimental | Participants first received the ADA reference manual toothbrush for a single brushing use for 2 minutes; after a 2-day washout period, participants received the AutoBrush U-shaped power toothbrush with fluoride toothpaste for a single brushing use for 30 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: U-shaped Power Toothbrush | Device | Twice daily brushing for 30 seconds with fluoride toothpaste |
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| 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 tooth surfaces of the whole mouth. | Supragingival dental plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index Plaque will be disclosed using a red disclosing solution and each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual), according to the criteria noted below: 0 = No plaque.
| Up to 2 weeks |
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To be eligible for study participation, subjects must meet the following criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc | Fort Wayne | Indiana | 46825 | United States |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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single-use, randomized, two-period, cross-over study
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Examiner and data recorder will not have access to the room for test materials dispensing and instructions.
| Placebo Comparator: Soft Manual Toothbrush | Device | Twice daily brushing for 2 minutes with fluoride toothpaste |
|
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |