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Clinical Trials/NCT07758725
NCT07758725RecruitingNot Applicable

The Effect Of Different Proximal Segment Positioning Methods On Postoperative Condylar Remodeling in Patients Undergoing Bimaxillary Orthognathic Surgery

Bezmialem Vakif University1 site in 1 country40 target enrollmentStarted: January 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Three-dimensional condylar axis angular changes

Study Overview

Brief 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.

Detailed Description

Bilateral sagittal split ramus osteotomy (BSSO), performed as part of bimaxillary orthognathic surgery, requires accurate positioning of the proximal mandibular segment to achieve postoperative skeletal stability and preserve temporomandibular joint function. During mandibular repositioning, discrepancies at the inferior border of the mandibular segments may be managed either by rotating the proximal segment to achieve inferior border alignment or by leveling the inferior border without rotating the proximal segment. The influence of these different positioning strategies on postoperative condylar remodeling has not been fully elucidated.

The aim of this study is to compare postoperative condylar remodeling between patients treated with proximal segment rotation for inferior border alignment and those treated with inferior border leveling without proximal segment rotation.

Condylar remodeling will be evaluated using computed tomography (CT) images obtained preoperatively, immediately after surgery, and at the 6-month postoperative follow-up. Radiological findings will be analyzed together with clinical outcomes to assess changes in condylar morphology and postoperative adaptation. The results of this study are expected to provide evidence regarding the effect of different proximal segment positioning methods on condylar remodeling and may contribute to optimizing surgical techniques in orthognathic surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients with skeletal Class III dentofacial deformity scheduled to undergo bimaxillary orthognathic surgery.
  • •Age between 18 and 65 years.
  • •Patients who have completed preoperative orthodontic treatment.
  • •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

  • •History of temporomandibular joint surgery, orthognathic surgery, or tumor resection.
  • •Presence of facial asymmetry.
  • •Patients with cleft lip and/or palate, craniofacial syndromes, or a history of maxillofacial trauma.
  • •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.

Arms & Interventions

Proximal Segment Rotation

Active Comparator

Patients underwent mandibular osteotomy followed by repositioning of the proximal segment. Alignment of the inferior border of the proximal segment with the mandibular inferior border was achieved by rotating the proximal segment before fixation.

Intervention: Proximal Segment Rotation (Procedure)

Inferior Border Osteotomy Without Proximal Segment Rotation

Experimental

Patients underwent mandibular osteotomy with the proximal segment maintained in its preoperative position. Alignment of the mandibular inferior border was achieved by performing an additional osteotomy at the inferior border of the proximal segment without rotating the proximal segment before fixation.

Intervention: Inferior Border Osteotomy Without Proximal Segment Rotation (Procedure)

Outcomes

Primary Outcomes

Three-dimensional condylar axis angular changes

Time Frame: From enrollment to the end of treatment at 6 months

Changes in condylar axis orientation will be assessed using computed tomography (CT) by measuring the condylar axis angle in the axial, coronal, and sagittal planes relative to standardized reference planes. In the axial plane, the angle between the condylar axis and the midsagittal reference plane (MSR) will be measured. In the coronal and sagittal planes, the angle between the condylar axis and the Frankfort Horizontal Plane (FHP) will be measured. Preoperative, immediate postoperative, and 6-month postoperative measurements will be compared to evaluate postoperative condylar remodeling and positional changes.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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