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临床试验/NCT05385133
NCT05385133已完成不适用

Condyle Repositioning Using Patient Specific Guides and Prebent Plates Osteosynthesis Versus Conventional Mandibular Bilateral Sagittal Split Osteotomy Set-back Surgery: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8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
已完成
入组人数
20
试验地点
1
主要终点
Condylar deviation

研究概览

简要总结

Patients with skeletal class III malocclusion were allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group.

详细描述

Twenty patients with skeletal class III malocclusion were randomly allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group. Accuracy of condylar position was assessed using computed tomography.

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 (Outcomes Assessor)

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients complaining of skeletal class III malocclusion that require BSSO for correction of their deformity

排除标准

  • •Patients require bi-maxillary orthognathic surgery
  • •patients with temporomandibular joint dysfunction

研究组 & 干预措施

Computer guided condylar position

Experimental

post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates

干预措施: Computer guided condylar position (Procedure)

Manual condylar position

Experimental

post-osteotomy condylar position was performed using the conventional free hand approach

干预措施: Manual condylar position (Procedure)

结局指标

主要结局

Condylar deviation

时间窗: 1 week postoperatively

Change of condyle position postoperative from preoperative position

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherif Ali

Associate Professor

Cairo University

研究点 (1)

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