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| Name | Class |
|---|---|
| Propel Orthodontics, LLC | INDUSTRY |
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The investigators hypothesize that brief, daily application of HFA will increase the efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or discomfort. The investigators will divide subjects into 5 groups changing clear aligners at different time intervals with or without HFA application for 5 minutes/day to assess the effect on: time intervals between aligners, cytokine activity, and pain perception.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14 Day Tray + Sham | No Intervention | Trays worn at 14 day intervals + Sham | |
| 7 Day Tray + Sham | Experimental | Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham |
|
| 5 Day Tray + Sham | Experimental | Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + Sham |
|
| 7 Day Tray + VPro5 | Experimental | Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day |
|
| 5 Day Tray + VPro5 | Experimental | Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days)) + HFV with the VPro5 device at 5 min/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPro5 device | Device | Use of the VPro5 device for 5 minutes a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Aligner Tracking Percentage | Average assessed via measurement of intraoral scan and prediction software | Through study completion, average of 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine Levels | Through study completion, average of 25 days | |
| Pain Perception via Numerical Rating Scale | Day 1 and Day 3 of each aligner |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTOR | Hoboken | New Jersey | 07030 | United States | ||
| Orthodontia Studio |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Deviation from Standard Tray Wear Time (14 Days) | Other | Patients reduced Tray Wear Time Interval (14 Days) |
|
| Hoboken |
| New Jersey |
| 07030 |
| United States |
| House of Orthodontia | Brooklyn | New York | 11201 | United States |
| Atique Orthodontics | San Antonio | Texas | 78259 | United States |