NCT03845738已完成不适用
Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice
Dentsply Sirona Implants and Consumables7 个研究点 分布在 6 个国家目标入组 208 人开始时间: 2019年8月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 7
- 主要终点
- Percent of Survived Implants at Time of the Follow-up Visit
研究概览
简要总结
This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ≥ 18 years at time of implant installation.
- •Subject signed and dated the informed consent form.
- •Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016.
排除标准
- •Unlikely to be able to comply with study procedures, according to Investigator's judgement.
- •Subject is not willing to participate in the study or not able to understand the content of the study.
- •Involvement in the planning or conduct of the study.
- •Simultaneous participation in another clinical study that may interfere with the present study.
- •Severe non-compliance to Clinical Investigation Plan (CIP) as judged by the Investigator and/or Dentsply Sirona Implants.
结局指标
主要结局
Percent of Survived Implants at Time of the Follow-up Visit
时间窗: Up to 66 months post-procedure.
Survival defined as implant in situ at time of the follow-up visit. Primary analysis performed on implant level.
次要结局
- Percent of Successful Implants at Time of the Follow-up Visit(Up to 66 months post-procedure.)
- Marginal Bone Levels (MBL)(Up to 66 months post-procedure.)
- Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit(Up to 66 months post-procedure.)
- Percent of Successful Prosthetics at Time of the Follow-up Visit(Up to 66 months post-procedure.)
- Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit(Up to 66 months post-procedure.)
- Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit(Up to 66 months post-procedure.)
- Patient Reported Outcome on Implant Level at Time of Follow-up Visit(Up to 66 months post-procedure.)
研究者
研究点 (7)
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