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临床试验/NCT00371280
NCT00371280Unknown2 期

Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
2 期
入组人数
50
试验地点
2
主要终点
Changing movement in up gaze: 0.58 mm

研究概览

简要总结

Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • orbital hydroxyapatite implants

排除标准

  • history of systemic disease
  • history of radio therapy
  • secondary hydroxapatite implant
  • complications lead to re-surgery

结局指标

主要结局

Changing movement in up gaze: 0.58 mm

Changing movement in down gaze: 0.83 mm

Changing movement in medial gaze: 0.75 mm

Changing movement in lateral gaze: 1.2 mm

次要结局

未报告次要终点

研究者

研究点 (2)

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