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临床试验/NCT02120495
NCT02120495Unknown不适用

Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection

Peking University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
21
试验地点
1
主要终点
complications of condylectomy

研究概览

简要总结

This study will apply the digital techniques to do the condylectomy through an intraoral approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and increase the precision of the operation procedure.

详细描述

In this study we will use the digital techniques such as pre-surgical visual treatment planning, real time surgical navigation system, endoscope techniques, to do the intraoral condylectomy via coronoid process resection. After the condyle lesion resection, the coronoid process will be reimplanted and fixed by stainless steel wire. By using these techniques we can safely and precisely cut proper size and position of the condyle lesion as we pre-surgically designed, and at the same time greatly maintain the temporomandibular joint anatomy structure. Since we don't need to do the mandible vertical ramus osteotomy, and no conventional extraoral incision will be needed, the surgical injury will be minimized and the TMJ function will recover soon postoperatively. Additionally, the intraoral approach can avoid the risk of facial nerve injury, salivary fistula and skin scar, so it has better aesthetic results than the preauricular approach and the submandibular approach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with mandible condylar hyperplasia or osteoma who need to do the condylectomy to prevent the active growth of the affected mandible condyle and the consequence progressive facial asymmetry
  • •Usually the patients have TMJ functional disorder; and the SPECT shows difference greater than 20% (pixel count) between the affected side and the contralateral normal side.

排除标准

  • •Patients with contradictions to do the operation procedure and general anesthesia, patients refuse to accept the condylectomy, or patients can't afford the extra cost for the application of digital techniques are excluded from this study

研究组 & 干预措施

intraoral condylectomy via coronoid process resction

Experimental

This procedure has no facial nerve injury and skin scar,little injury to TMJ anatomy and function.

干预措施: condylectomy (Procedure)

结局指标

主要结局

complications of condylectomy

时间窗: post-operative day 7 and 6 months

to record the complications of the operation and the TMJ function recovering.

次要结局

未报告次要终点

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

wang xiaoxia

associate professor

Peking University

研究点 (1)

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