NCT00711022已完成不适用
An Open, Prospective, Multicenter Study to Evaluate the Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants, in Patients With Totally Edentulous Maxillas and Poor Bone Quality and Quantity in an Immediate Loading Protocol.
Dentsply Sirona Implants and Consumables4 个研究点 分布在 2 个国家目标入组 51 人开始时间: 2005年5月1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
- 51
- 试验地点
- 4
- 主要终点
- Implant Survival Rate
研究概览
简要总结
The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Aged 20 years and over
- •History of totally edentulous maxilla of at least three months
- •Radiographic finding indicating bone quality class 3 or 4 (Lekholm and Zarb) in the maxilla
- •Radiographic finding indicating bone quantity class C, D or E (Lekholm and Zarb) in the maxilla
- •Presence of natural teeth, partial prosthesis and/or implants in the mandible, within positions 35-45 (according to the FDI digit system)
- •Deemed by the investigator as likely to present an initially stable implant situation suitable for immediate loading.
排除标准
- •Unlikely to be able to comply with study procedures, as judged by the investigator
- •Uncontrolled pathologic processes in the oral cavity
- •Known or suspected current malignancy
- •History of radiation in the head and neck region
- •History of chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Uncontrolled Diabetes Mellitus
- •Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •History of bone augmentation in the maxilla within 6 months prior to surgery
- •Known pregnancy at time of enrolment
- •Present alcohol and/or drug abuse
- •Current use of tobacco or history of tobacco use within 6 months prior to surgery
- •Need for interpreter
结局指标
主要结局
Implant Survival Rate
时间窗: At 5-year follow-up
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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