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| Name | Class |
|---|---|
| Aristotle University Of Thessaloniki | OTHER |
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The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.
The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of:
More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients treated with amda® | Active Comparator | two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization. |
|
| patients treated with buccal mini-implants | Active Comparator | from initiation of treatment until completion of maxillary molar distalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Molar Distalization Appliance (amda®) | Device | AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization |
| Measure | Description | Time Frame |
|---|---|---|
| Anteroposterior position changes of upper first molars. | Anteroposterior position movement in mm of the upper first molars | 8-12 months |
| Measurements on the lateral cephalograms and digital 3D model casts. | Angular measurements of the lateral cephalograms and digital models | 8-12 months |
| Measurements on the lateral cephalograms and digital 3D model casts. | Linear measurements of the lateral cephalograms and digital models | 8-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos Karvelas, PhD student | Contact | +40 759481645 | karvelas93@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Karvelas, PhD student | Grigore T Popa University, Department of Orthodontics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy "Grigore T. Popa" | Recruiting | Iași | 70015 | Romania |
The data will be availaible upon request
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Two arm parallel randomized controlled trial with 1:1 allocation ratio
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| Buccal mini-implants | Device | Buccal mini-implants for maxillary molar distalization |
|
| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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