Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Maxillary transverse deficit,
- •Lateral crossbite
Exclusion Criteria
- •Previous orthodontic treatment,
- •Craniofacial anomalies,
- •Severe facial asymmetries,
- •Pregnancy,
- •Periodontal lesions
Arms & Interventions
CAD/CAM milled TAD guides
The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling.
Intervention: Maxillary Expansion (Procedure)
3D printed guides
The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology.
Intervention: Maxillary Expansion (Procedure)
Outcomes
Primary Outcomes
Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
Time Frame: up to six months
Comparison of midfacial landmark changes during maxillary expansion
Secondary Outcomes
- CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.(up to 4 weeks)
Investigators
Alexander Schwaerzler, DMD
Principal Investigator
Medical University of Vienna