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NCT Number: NCT07758725

Effect of Proximal Segment Positioning on Condylar Remodeling

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location status: Recruiting

Location contact

Taha Pergel, Assit. Prof

CONTACT

[email protected]

+905316350088

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proximal Segment Rotation

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Taha Pergel, Asist Prof

CONTACT

[email protected]

+905316350088

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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