NCT00748397终止不适用
An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro
Dentsply Sirona Implants and Consumables7 个研究点 分布在 4 个国家目标入组 54 人开始时间: 1999年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 7
- 主要终点
- Implant survival
研究概览
简要总结
The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.
Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •Sufficient amount of bone to give good support for implants of at least 9 mm length.
- •Willing to give signed informed consent
排除标准
- •Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
- •Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Unable or unwilling to return for follow-up visits
结局指标
主要结局
Implant survival
时间窗: Continuously during 5,5 years after implant placement
次要结局
未报告次要终点
研究者
研究点 (7)
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