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NCT07758725
Effect of Proximal Segment Positioning on Condylar Remodeling
Conditions: Orthognathic Surgical Procedures
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Bezmialem Vakif University
Location: Bezmialem Vakif University Istanbul Fatih
Summary
This study aims to evaluate postoperative condylar remodeling in patients undergoing bimaxillary orthognathic surgery by comparing two different proximal segment positioning techniques used during mandibular osteotomy. Condylar remodeling will be assessed using preoperative, immediate postoperative, and 6-month postoperative computed tomography (CT) scans together with clinical findings.
Eligibility Criteria
Inclusion Criteria:
1. Patients with skeletal Class III dentofacial deformity scheduled to undergo bimaxillary orthognathic surgery.
2. Age between 18 and 65 years.
3. Patients who have completed preoperative orthodontic treatment.
4. Patients in whom the mandibular distal segment demonstrates a maximum counterclockwise rotation of 4° after bilateral sagittal split osteotomy (BSSO) when positioned in the final planned occlusion.
Exclusion Criteria:
1. History of temporomandibular joint surgery, orthognathic surgery, or tumor resection.
2. Presence of facial asymmetry.
3. Patients with cleft lip and/or palate, craniofacial syndromes, or a history of maxillofacial trauma.
4. Patients in whom the mandibular distal segment requires more than 4° of counterclockwise rotation after BSSO to achieve the final planned position, as the amount of inferior border (basal) resection required would exceed the clinically acceptable limit.
Source: ClinicalTrials.gov (NCT07758725). StuddyBuddy aggregates publicly available trial information.