NCT00646113已完成不适用
An Open, Prospective, Single Arm, Multi-centre Study Evaluating OsseoSpeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.
Dentsply Sirona Implants and Consumables12 个研究点 分布在 6 个国家目标入组 72 人开始时间: 2008年3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
- 72
- 试验地点
- 12
- 主要终点
- Implant Survival Rate
研究概览
简要总结
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Aged 18-70 years at enrolment
- •History of edentulism in the study area of at least two months
- •Presence of natural tooth roots adjacent to the study implant position
- •Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- •Deemed by the investigator as likely to present an initially stable implant situation
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 therapy in the head and neck region
- •History of chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
- •Uncontrolled diabetes mellitus
- •Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- •Smoking more than 10 cigarettes per day
- •Present alcohol and/or drug abuse
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- •Previous enrolment in the present study
- •Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment
结局指标
主要结局
Implant Survival Rate
时间窗: Evaluated at implant placement and at the 5 years follow-up after implant placement
Overall implant survival rate evaluated clinically and radiographically
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed RidgesJaw, Edentulous, PartiallyNCT00710944Dentsply Sirona Implants and Consumables132
已完成
不适用
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior JawJaw, Edentulous, PartiallyNCT00545818Dentsply Sirona Implants and Consumables97
已完成
不适用
Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese PopulationPartially Edentulous JawNCT01389245Dentsply Sirona Implants and Consumables42
已完成
不适用
Study on OsseoSpeed™ TX Short Implants in a Chinese PopulationPartially Edentulous JawNCT01346696Dentsply Sirona Implants and Consumables45
已完成
不适用
A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate LoadingEdentulismNCT01340170Dentsply Sirona Implants and Consumables168