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

NCT06246656 | Recruiting

• 1 other identifier: 1804/2022
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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)

Conditions

Palatal Expansion Technique

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Comparison of midfacial landmark changes during maxillary expansion

  up to six months

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.

  up to 4 weeks

Study Arms (2)

CAD/CAM milled TAD guides

ACTIVE COMPARATOR

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

Procedure: Maxillary Expansion

3D printed guides

ACTIVE COMPARATOR

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

Procedure: Maxillary Expansion

Interventions

Maxillary Expansion PROCEDURE

Palatal Expansion using a CAD/CAM appliance

3D printed guides; CAD/CAM milled TAD guides

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Maxillary transverse deficit,
• Lateral crossbite

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Orthodontics

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Palatal Expansion Technique

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Study Officials

• Xiaohui Rausch-Fan, Prof.

  Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna

  STUDY DIRECTOR

• Alexander Schwärzler, DMD

  Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Erwin Jonke, Prof.

  Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna

  STUDY CHAIR

• Sophia Panwinkler, DMD

  Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Panwinkler, DMD

CONTACT

+431400704301; sophia.panwinkler@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: February 7, 2024
• Study Start: January 2, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)