Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
| Registry | NCT06246656 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 38 (Estimated) |
| Sponsor | Medical University of Vienna (Other) |
| Conditions | Palatal Expansion Technique |
| Interventions | Maxillary Expansion (Procedure) |
| Dates | start 2025-01-02, primary completion 2026-01-01 (estimated), completion 2026-09-01 (estimated), first posted 2024-02-07, last updated 2025-09-05 |
| Locations | 1 site in Austria |
Related Papers Related Patents Related Grants Related Experts
All trials for Palatal Expansion Technique All trials of Maxillary Expansion
* Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
* 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)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CAD/CAM milled TAD guides | Active comparator | Procedure: Maxillary Expansion | The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling. |
| 3D printed guides | Active comparator | Procedure: Maxillary Expansion | The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology. |
Sex: All, ages: 12 Years to 26 Years, accepts healthy volunteers
Inclusion Criteria: * Maxillary transverse deficit, * Lateral crossbite Exclusion Criteria: * Previous orthodontic treatment, * Craniofacial anomalies, * Severe facial asymmetries, * Pregnancy, * Periodontal lesions
| Facility | City | Country | Status |
|---|---|---|---|
| Medical University of Vienna, Department of Orthodontics | Vienna, State of Vienna | Austria | Recruiting |