Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony
Dentofacial Deformities
About this trial
This is an interventional treatment trial for Dentofacial Deformities focused on measuring orthognathic surgery, virtual planning, customized titanium plates, cutting guides, CAD/CAM
Eligibility Criteria
Inclusion Criteria:
- Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Exclusion Criteria:
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Sites / Locations
- Faculty of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group I (Conventional plates)
Group II (Patient specific plates)
Digital intermediate and final interocclusal wafer splints will be designed to guide the maxilla and mandible in the desired position using CAD software (3-matic 11.0; Materialise NV, Leuven, Belgium). The designed splints will be then exported in stereolithography (STL) file format to the additive CAM machine (FORMIGA P 110 printer; EOS e-manufacturing solutions, Munich, Germany) and manufactured in white polyamide (PA2200; EOS e-manufacturing solutions, Munich, Germany) using fused deposition modelling (FDM) technology.The splints will be cold sterilized by overnight immersion in 2% glutaraldehyde. 2.0 conventional mini plates will be used for fixation of maxilla and mandible in the new position.
The cutting guides will be designed on the maxilla and mandible to orient the osteotomy and mark reference holes to be used later for the repositioning/ fixation plate, using CAD software. The designed guide will be then exported in stereolithography (STL) file format to the additive CAM machine and manufactured in white polyamide using fused deposition modelling (FDM) technology. No finishing or polishing was done in order to maintain accuracy. The guides will be cold sterilized by overnight immersion in 2% glutaraldehyde. The patient-specific osteosynthesis plates will be designed to fix the maxilla and mandible in the desired position making use of the previously established reference holes. The designed plates will be exported in STL file format to be manufactured in grade 5 titanium alloy utilizing selective laser sintering (SLS) technology on an additive CAM machine.