Effect of Proximal Segment Positioning on Postoperative Condylar Remodeling in Bimaxillary Orthog… (NCT06897787) | Clinical Trial Compass
By InvitationNot Applicable
Effect of Proximal Segment Positioning on Postoperative Condylar Remodeling in Bimaxillary Orthognathic Surgery
Turkey (Türkiye)40 participantsStarted 2025-03-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients planned to undergo bimaxillary orthognathic surgery with Class III skeletal deformity
. Patients aged 18-65
. Patients who have undergone preoperative orthodontic treatment
. 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
. Patients with a history of joint surgery, orthognathic surgery, or tumor resection
. Patients with facial asymmetry
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with cleft lip and palate syndrome, craniofacial syndrome, or trauma
. 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).