NCT00748670终止不适用
An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality
Dentsply Sirona Implants and Consumables6 个研究点 分布在 2 个国家目标入组 23 人开始时间: 1999年9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
- 23
- 试验地点
- 6
- 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 individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).
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
- •Bone quality class III or IV, (according to Lekholm & Zarb16)
- •Willing to give signed informed consent
排除标准
- •Need for bone augmentation of the maxilla
- •Tobacco smoking more than 5 cigarettes/day
- •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
- •Bruxism or other parafunctional activity
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 (6)
Loading locations...
相似试验
终止
不适用
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage SurgeryJaw, EdentulousNCT00748397Dentsply Sirona Implants and Consumables54
进行中（未招募）
不适用
G7 BiSpherical Acetabular Shell PMCF StudyNoninflammatory Degenerative Joint DiseaseCorrection of Functional DeformityNon-Union FractureFemoral Neck FracturesTrochanteric FracturesRheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT03266874Zimmer Biomet160
已完成
不适用
One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™Type 1 Diabetes MellitusNCT02939118ViaCyte51
进行中（未招募）
不适用
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth RestorationsJaw, Edentulous, PartiallyNCT05315414Dentsply Sirona Implants and Consumables138
已完成
不适用
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant SystemHearing LossNCT04754477Cochlear20