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Participants will undergo orthodontic treatment, including:
This clinical trial aims to evaluate the influence of maxillary expansion using a CAD/CAM-manufactured appliance impact on the soft and hard tissues in the midfacial region in adolescent and adult orthodontic patients.
This study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
The appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.
CAD/CAD milled and 3D printed guides will be used for the placement of the TADs.
The study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.
Intraoral, face, and computed tomography (CT) scans will be used for the investigation. An intraoral and face scanner enables a high-resolution 3D image of the teeth and face. A CBCT Scan is a three-dimensional X-ray image.
These examinations do not involve pain and are performed during regular follow-up appointments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM milled TAD guides | Active Comparator | The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling. |
|
| 3D printed guides | Active Comparator | The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary Expansion | Procedure | Palatal Expansion using a CAD/CAM appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans. | Comparison of midfacial landmark changes during maxillary expansion | up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position. | Transfer accuracy of milled and 3D printed drilling templates | up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Panwinkler, DMD | Contact | +431400704301 | sophia.panwinkler@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Rausch-Fan, Prof. | Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna | Study Director |
| Alexander Schwärzler, DMD | Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Orthodontics | Recruiting | Vienna | State of Vienna | 1090 | Austria |
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| Erwin Jonke, Prof. | Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna | Study Chair |
| Sophia Panwinkler, DMD | Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna | Principal Investigator |
| ID | Term |
|---|---|
| D010155 | Palatal Expansion Technique |
| ID | Term |
|---|---|
| D009971 | Orthodontics, Corrective |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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