NCT07758725

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2026

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Orthognathic Surgical Procedures

Keywords

Condylar Remodelingorthognathic surgeryProximal Segment Position

Outcome Measures

Primary Outcomes (1)

  • Three-dimensional condylar axis angular changes

    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.

    From enrollment to the end of treatment at 6 months

Study Arms (2)

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.

Procedure: Proximal Segment Rotation

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.

Procedure: Inferior Border Osteotomy Without Proximal Segment Rotation

Interventions

Proximal Segment RotationPROCEDURE

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.

Proximal Segment Rotation
Inferior Border Osteotomy Without Proximal Segment RotationPROCEDURE

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.

Inferior Border Osteotomy Without Proximal Segment Rotation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Taha Pergel, Asist Prof

CONTACT

+905316350088tahapergel_05@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 28, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)