Clinical trial NCT06246656: Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
Official title: Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palatal Expansion Technique
Keywords: CAD/CAM
Orthodontics
Maxillary Expansion
Soft Tissue Change
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Maxillary transverse deficit,
* Lateral crossbite

Exclusion Criteria:

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

Primary outcomes:
measure: Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
timeFrame: up to six months
Secondary outcomes:
measure: CAD/CAM is milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Orthodontics
Study officials:
affiliation: Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna
name: Xiaohui Rausch-Fan, Prof.
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
name: Alexander Schwärzler, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
name: Erwin Jonke, Prof.
role: STUDY_CHAIR
affiliation: Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
name: Sophia Panwinkler, DMD
role: PRINCIPAL_INVESTIGATOR
References: