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The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invisalign® System with Mandibular Advancement | Experimental | all participants will receive the study device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invisalign® System with mandibular advancement featuring occlusal blocks | Device | Class II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort and fit | Measured using quality of life surveys at the insertion, interim, and end of study visits. Measured on a scale which the subject rates from 1-Always to 5-Never on their current experience. | Through the study completion of up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Class II correction | measured through analysis of intraoral scans | Through the study completion of up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Class II correction | measured through analysis of cephalometric radiographs | Through the study completion of up to 2 years |
Inclusion Criteria:
• Subject must be eligible for Invisalign treatment with mandibular advancement
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Mossing | Contact | 4083940304 | amossing@aligntech.com | |
| Karen Srour | Contact | kgarcia@aligntech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astra Orthodontics | Recruiting | Richmond | British Columbia | BC V7C 5L9 | Canada |
Data is planned to be shared with Sponsor and Investigators only
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| ID | Term |
|---|---|
| D057887 | Overbite |
| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| MacKenzie Orthodontics | Recruiting | Saint John | New Brunswick | E2L 1G5 | Canada |
|
| Discover Orthodontics | Recruiting | Brampton | Ontario | L6Z 4N5 | Canada |
|