Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maxillary Expansion.
- Who it may be relevant to
- Registry conditions: Palatal Expansion Technique. Basic parameters: 12 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
Overview
* 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.
Interventions
- Procedure Maxillary Expansion
Palatal Expansion using a CAD/CAM appliance
Primary outcome measures
- Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans. [Time frame: up to six months]
Secondary outcome measures (1)
- CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position. [Time frame: up to 4 weeks]
Eligibility criteria
Inclusion criteria
- Maxillary transverse deficit,
- Lateral crossbite
Exclusion criteria
- Previous orthodontic treatment,
- Craniofacial anomalies,
- Severe facial asymmetries,
- Pregnancy,
- Periodontal lesions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University of Vienna, Department of Orthodontics — Vienna
Identifiers
NCT: NCT06246656 · 1804/2022