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

Medical University of Vienna

Status: Enrolling

Conditions: Palatal Expansion Technique

Treatments: Procedure: Maxillary Expansion

Study type: Interventional

Funder types: Other

Identifiers

NCT06246656

1804/2022

Details and patient eligibility

About

• 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)

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 12 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Maxillary transverse deficit,
• Lateral crossbite

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

CAD/CAM milled TAD guides

Active Comparator group

Description:

The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling.

Treatment:

Procedure: Maxillary Expansion

3D printed guides

Active Comparator group

Description:

The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology.

Treatment:

Procedure: Maxillary Expansion