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临床试验/NCT07758725
NCT07758725招募中不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Three-dimensional condylar axis angular changes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Inferior Border Osteotomy Without Proximal Segment Rotation (Procedure)

结局指标

主要结局

Three-dimensional condylar axis angular changes

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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