Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
NCT ID: NCT06246656
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
38 participants
INTERVENTIONAL
2025-01-02
2026-09-01
Brief Summary
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* Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
Participants will undergo orthodontic treatment, including:
* Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)
* Placement of guided orthodontic TADs (Temporary Anchorage Devices)
* Skeletal expansion using CAD/CAM appliance
* Fixed multibracket appliance in the upper and lower jaw
* Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CAD/CAM milled TAD guides
The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling.
Maxillary Expansion
Palatal Expansion using a CAD/CAM appliance
3D printed guides
The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology.
Maxillary Expansion
Palatal Expansion using a CAD/CAM appliance
Interventions
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Maxillary Expansion
Palatal Expansion using a CAD/CAM appliance
Eligibility Criteria
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Inclusion Criteria
* Lateral crossbite
Exclusion Criteria
* Craniofacial anomalies,
* Severe facial asymmetries,
* Pregnancy,
* Periodontal lesions
12 Years
26 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Alexander Schwaerzler, DMD
Principal Investigator
Principal Investigators
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Xiaohui Rausch-Fan, Prof.
Role: STUDY_DIRECTOR
Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna
Alexander Schwärzler, DMD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
Erwin Jonke, Prof.
Role: STUDY_CHAIR
Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
Sophia Panwinkler, DMD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
Locations
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Medical University of Vienna, Department of Orthodontics
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1804/2022
Identifier Type: -
Identifier Source: org_study_id
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