Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.

Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06246656

Enrollment

Registered

2024-02-07

Start date

2025-01-02

Completion date

2026-09-01

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palatal Expansion Technique

Keywords

CAD/CAM, Orthodontics, Maxillary Expansion, Soft Tissue Change

Brief summary

* 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)

Detailed description

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.

Interventions

PROCEDUREMaxillary Expansion

Palatal Expansion using a CAD/CAM appliance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 26 Years

Healthy volunteers

Yes

Inclusion criteria

* Maxillary transverse deficit, * Lateral crossbite

Exclusion criteria

* Previous orthodontic treatment, * Craniofacial anomalies, * Severe facial asymmetries, * Pregnancy, * Periodontal lesions

Design outcomes

Primary

Measure	Time frame	Description
Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.	up to six months	Comparison of midfacial landmark changes during maxillary expansion

Secondary

Measure	Time frame	Description
CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.	up to 4 weeks	Transfer accuracy of milled and 3D printed drilling templates

Countries

Austria

Contacts

Primary ContactSophia Panwinkler, DMD

sophia.panwinkler@meduniwien.ac.at+431400704301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026