Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
1
Pegged unpegged hydroxyapatite orbital implantation
干预措施: orbital implant (Procedure)
2
Unpegged hydroxyapatite orbital implantation
干预措施: orbital implant (Procedure)
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