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

Not Applicable

Recruiting

• Conditions: Palatal Expansion Technique
• Interventions: Procedure: Maxillary Expansion

• Registration Number: NCT06246656
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2023-03-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-07
• Study Start: 2025-01-02
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-01-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Maxillary transverse deficit,
• Lateral crossbite

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D printed guides	Maxillary Expansion	The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology.
CAD/CAM milled TAD guides	Maxillary Expansion	The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CAD/CAM is 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

Trial Locations

Locations (1)

Medical University of Vienna, Department of Orthodontics; 🇦🇹 Vienna, Austria