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临床试验/NCT03855072
NCT03855072Unknown不适用

Patient Satisfaction Following Vertical Ramus Osteotomy After Mandibular Setback Fixed With Patients Specific Osteosynthesis and Immediate Mobilization Versus Vertical Ramus Osteotomy Fixed With MMFin Patients With Mandibular Prognanthism

Cairo University0 个研究点目标入组 24 人开始时间: 2019年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Patient Satisfaction

研究概览

简要总结

Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate

详细描述

Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate

Interventions:

General operative procedures

Eligible patients will be randomized in equal proportions between the study group (customized plate fixation of VRO) and the control group (maxillomandibular fixation of VRO).

Patients of Both groups will be subjected to:

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

入选标准

  • All subjects were required:
  • Patients with mandibular prognanthism indicated for mandibular setback.
  • All ages >18 years
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  • Patients with good general condition allowing surgical procedure under general anesthesia.
  • Patients with physical and psychological tolerance

排除标准

  • History of mandibular trauma
  • Previous orthognathic surgery
  • Degenerative disease of temporomandibular joint
  • Craniofacial syndrome such as cleft lip or palate
  • Follow up period will be less than 6 months

研究组 & 干预措施

Customized plate fixation

Experimental

Customized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback

  • intervention:
  • All cases will undergo one surgery under general anesthesia.
  • Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
  • 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
  • The customized fixation plate is positioned to fix the proximal and distal segment together

干预措施: customized fixation plate (Procedure)

maxillomandibular fixation

Active Comparator

Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation

  • intervention:
  • All cases will undergo one surgery under general anesthesia
  • incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
  • Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint

干预措施: maxillomandibular fixation (Procedure)

结局指标

主要结局

Patient Satisfaction

时间窗: immediately postoperative

Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied

次要结局

  • stability of Mandible(pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative)

研究者

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

Marwa Sayed Abbass Ali

associate lecturer

Cairo University

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