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Clinical Trials in Turkey / NCT07758725
Recruiting Not applicable

Effect of Proximal Segment Positioning on Condylar Remodeling

NCT07758725 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-08-11

Condition(s) studied

Orthognathic Surgical Procedures

Investigational drug(s) / intervention(s)

Proximal Segment RotationInferior Border Osteotomy Without Proximal Segment Rotation

Proximal Segment Rotation: During bimaxillary orthognathic surgery, after bilateral sagittal split osteotomy (BSSO), the proximal mandibular segment is rotated to achieve alignment of the inferior border of the proximal and distal mandibular segments before rigid fixation.

Inferior Border Osteotomy Without Proximal Segment Rotation: During bimaxillary orthognathic surgery, after bilateral sagittal split osteotomy (BSSO), the proximal mandibular segment is maintained in its preoperative position. Alignment of the mandibular inferior border is achieved by performing an additional osteotomy at the inferior border of the proximal segment without rotating the proximal segment before rigid fixation.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Bezmialem Vakif University Istanbul Fatih Recruiting

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Official registry record

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.

View NCT07758725 on ClinicalTrials.gov ↗ ← All trials in Turkey