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.

• 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)

Study Overview

• Status: Not yet recruiting
• Conditions: Palatal Expansion Technique
• Intervention / Treatment: Procedure: Maxillary Expansion

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 Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Panwinkler, DMD; Phone Number: +431400704301; Email: sophia.panwinkler@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Maxillary transverse deficit,
• Lateral crossbite

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CAD/CAM milled TAD guides; The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling.	Procedure: Maxillary Expansion; Palatal Expansion using a CAD/CAM appliance
Active Comparator: 3D printed guides; The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology.	Procedure: Maxillary Expansion; Palatal Expansion using a CAD/CAM appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Director: Xiaohui Rausch-Fan, Prof., Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna; Principal Investigator: Alexander Schwärzler, DMD, Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna; Study Chair: Erwin Jonke, Prof., Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna; Principal Investigator: Sophia Panwinkler, DMD, Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CAD/CAM; Orthodontics; Maxillary Expansion; Soft Tissue Change
• Other Study ID Numbers: 1804/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No