Dentofacial DeformitiesDentofacial Anomalies [Including Malocclusion] and Other Disorders of Jaw (M26-M27)
Investigational drug(s) / intervention(s)
manuel positioning groupmandibular basis osteotomy
manuel positioning group: As Prof. Reyneke does, mandibular base and proximal segment leveling are performed first, followed by fixation.
mandibular basis osteotomy: After the mandibular sagittal split, secure the proximal segment in its preoperative position and remove the bone piece for leveling. After that, fixation is performed.
Study summary
Bimaxillary orthognathic surgery is a surgical procedure that involves simultaneous corrections to both the maxilla (upper jaw) and mandible (lower jaw). This surgery is performed to correct facial and jaw deformities, improve occlusion, and enhance facial symmetry. The need for orthognathic surgery typically arises in cases where there is a significant discrepancy between the upper and lower jaws or severe malocclusion.
In bimaxillary orthognathic surgery, following mandibular osteotomies, the lower jaw is divided into two segments: the distal segment, which contains the teeth, and the proximal segment, which includes the condylar head. While the distal segment is positioned according to the ideal occlusion planned in collaboration with orthodontists using digital design, the management of the proximal segment varies among surgeons. Some surgeons leave the proximal segment in its original position without mobilization, whereas others reposition it through rotational movements.
This study aims to evaluate condylar remodeling by comparing these two surgical approaches in patients divided into two groups, assessing how each technique affects postoperative outcomes.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Patients planned to undergo bimaxillary orthognathic surgery with Class III skeletal deformity
2. Patients aged 18-65
3. Patients who have undergone preoperative orthodontic treatment
4. Patients who, after mandibular distal segment sagittal split osteotomy, exhibit a maximum of 4 degrees of counterclockwise rotation when brought to the final position
Exclusion Criteria:
1. Patients with a history of joint surgery, orthognathic surgery, or tumor resection
2. Patients with facial asymmetry
3. Patients with cleft lip and palate syndrome, craniofacial syndrome, or trauma
4. Patients who, after mandibular distal segment sagittal split osteotomy, exhibit more than 4 degrees of counterclockwise rotation when brought to the final position (as the amount of base resection required in this case would exceed feasible limits).
Primary outcome measure(s)
mandibular condyle position superimposition — 2 year During bimaxillary orthognathic surgery, proximal segment positioning devices will be used in both groups to ensure that the condylar position remains at the location determined during virtual surgical planning. These devices will be custom-designed for each patient by the researchers using the virtual surgical planning software and printed using an in-house 3D printer. These positioning devices will maintain the condyle in its initial position during mandibular fixation. Postoperative DICOM data obtained from computed tomography images will be used to superimpose the condylar positions, and the amount of displacement in three planes (x, y, z) will be measured in millimeters (mm). Additionally, condylar volume changes will be calculated in cubic centimeters (cm³) using the superimposition method, and differences between the groups will be evaluated.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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