About this trial
Orthognathic surgery is a surgical procedure performed to correct dentofacial deformities. In recent years, with the use of virtual surgical planning, cutting guides, and patient-specific osteosynthesis plates, highly predictable results can be achieved. While there are many positive reports regarding the use of patient-specific plates in maxillary positioning in orthognathic surgery, there is a lack of sufficient studies comparing the results obtained in mandibular positioning. Additionally, numerous designs of proximal segment positioning devices have been published, but comparative studies on their effectiveness have not been conducted. Therefore, a study comparing these approaches has been planned.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy individuals over 18 years of age
Patients with skeletal Class 2 and Class 3 malocclusion requiring bimaxillary orthognathic surgery
Patients who have undergone orthodontic treatment prior to surgery
Disqualifiers
Patients with cleft lip and palate or craniofacial deformities
Oligodontia
Patients in whom the study protocol could not be continued due to intraoperative complications such as guide mismatch or bad split, or due to reasons such as inability to obtain postoperative CT scans
Patients with pre-existing temporomandibular joint disorders prior to surgery
Trial design
Parallel
Treatments tested in this trial
conventional splints
Deviceonly intermediate and final splint will be used during the surgery
cutting guides and positioning guides
Devicepatient's specific manufacturing cutting guide and positioning guide related with orthognathic surgery
cutting guides and fixation plates
Devicepatient's specific manufacturing cutting guide and fixation plates related with orthognathic surgery
Treatment groups
Trial outcomes
Primary outcomes
mandibular condyle changes
Firstly; The following reference planes and lines will be created on the Mimics (Materialise, Belgium, v21) software: * Frankfort Horizontal Plane (FHD): Right and left side porion and the plane passing through the right side orbitale * Midsagittal Reference Plane (MSR): Perpendicular to FHD, nasion and plane determined to pass through basion points Lateral Condylar Pole (LKK) (Right-Left): the outermost part of the condyle head point * Medial Condylar Pole (MKK) (Right-Left): innermost part of the condyle head point Linear and angular measurements to be made with these planes.
Secondary outcomes
Rate of the virtual surgical planning accuracy
Postoperative CT data will be transferred to Mimics (Materialise, Belgium, v21) software in DICOM format. Here, a 3D head and jaw model will be obtained from this data. For this purpose, 24 cephalometric points will be selected in both models. In this software, an analysis containing these points will be created and the 2-dimensional linear distances between the preoperative and postoperative positions of these points will be calculated. The accuracy between preoperative and postoperative models will be evaluated in the Mimics software.
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