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

Palatal Expansion Technique Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246656
• Other study ID #: 1804/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: Medical University of Vienna
• Contact: Sophia Panwinkler, DMD
• Phone: +431400704301
• Email: sophia.panwinkler[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: September 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 26 Years

Eligibility

Inclusion Criteria:

• Maxillary transverse deficit,

• Lateral crossbite

Exclusion Criteria:

• Previous orthodontic treatment,

• Craniofacial anomalies,

• Severe facial asymmetries,

• Pregnancy,

• Periodontal lesions

Related Conditions & MeSH terms

• Palatal Expansion Technique

Intervention

Procedure:
• Maxillary Expansion
Palatal Expansion using a CAD/CAM appliance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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