跳至主要内容
临床试验/NCT03577210
NCT03577210Unknown不适用

The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9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
20
试验地点
2
主要终点
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm

研究概览

简要总结

computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.

详细描述

augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.

研究设计

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

入排标准

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

入选标准

  • Adult male or female patients.
  • Patients with retruded chin or with chin asymmetry.
  • Patients with good oral hygiene.

排除标准

  • Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
  • Patients with medical condition that may compromise the healing process.
  • Patients with medical condition that is contraindicated for general anaesthesia.
  • Presence of pathological lesion related to chin area.

研究组 & 干预措施

computer-guided augmentation genioplasty

Other

patient-specific PEEK implant

干预措施: augmentation genioplasty (Procedure)

结局指标

主要结局

degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm

时间窗: two weeks postoperative

degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm

次要结局

  • patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire(6 months postoperative)

研究者

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

Salma Hassan Abd el-Aty

Assistant lecturer

Cairo University

研究点 (2)

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