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临床试验/NCT03353116
NCT03353116已完成不适用

The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
the change in maxilla stability

研究概览

简要总结

The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery

详细描述

The investigator will compare the maxillary stability in class III orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery
  • Patients free from any systemic disease
  • Patients who approved to be included in the trial and signed the informed consent
  • Patients with no signs or symptoms of temporomandibular disorders.

排除标准

  • Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)"
  • Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) "
  • Patients who refused to be included in the trial

结局指标

主要结局

the change in maxilla stability

时间窗: 6 months

to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative. the measuring unit is millimeter

次要结局

  • Patient satisfaction(6 month)

研究者

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

Mohamed Hamdy

Assistant lecturer

Cairo University

研究点 (2)

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