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NCT Number: NCT06246656

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

* 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)

Recruiting

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Key information

Age range

12 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Orthodontics

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Alexander Schwärzler DMD Prinzipal Investigator, DMD

CONTACT

[email protected]

+436649222987

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maxillary transverse deficit,
  • Lateral crossbite

Exclusion criteria

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

Treatment and study plan

Maxillary expansion

Procedure

Palatal Expansion using a CAD/CAM appliance

Primary outcomes

  1. Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.

    Time frame: up to six months

    Comparison of midfacial landmark changes during maxillary expansion

Secondary outcomes

  1. CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.

    Time frame: up to 4 weeks

    Transfer accuracy of milled and 3D printed drilling templates

Study contacts

Contact information is provided by the study sponsor or research team.

Sophia Panwinkler, DMD

CONTACT

[email protected]

+431400704301

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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