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...
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