NCT00519571Unknown不适用
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Innovative Implant Solutions1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device
研究概览
简要总结
To investigate the safety and effectiveness of the ImplantLock device and its contribution to 8.0 mm long root-form endosseous implants stability under immediately applied continuous functional loading.
详细描述
Primary Endpoints
- Serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Serious Adverse Event Form.
- Adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Adverse Event Form.
Secondary Endpoints
- Determine 8.0 mm long endosseous implant stability while using ImplantLock Device. Stability will be routinely assessed.
- Determine the ability to immediately apply continuous functional loading on 8.0 mm long endosseous implant while using ImplantLock Device. The ability to immediately apply continuous functional loading will be routinely assessed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/Female age 18 and up.
- •Subject is schedule for endosseous implantation treatment.
- •Subject able to comprehend and give informed consent for participation in this study.
- •Signed informed consent form.
排除标准
- •Subjects suffering from a disease that might disturb bone regeneration healing process e.g. osteoporosis, anemia, etc.
- •Acute infection requiring intravenous antibiotics at the time of screening.
- •Bleeding disorders.
- •Uncontrolled diabetes mellitus
- •HIV positive or any other immunosuppressive disorder.
- •Renal failure (Serum creatinine >2.0 mg/dl).
- •Subject with allergies to metal alloys.
- •Coagulation disorder.
- •Infection / abscess / pains in treatment target area.
- •Pregnant or nursing woman.
- •Resent history of alcohol or drug abuse (within the last 2 years).
- •Subject is smoking.
- •Subject is suffering extreme general weakness.
- •Subject objects to the study protocol.
- •Known cognitive or psychiatric disorder
- •Concurrent participation in any other clinical study.
- •Physician objection.
结局指标
主要结局
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device
时间窗: 12 months
次要结局
- Determine endosseous implant stability while using ImplantLock Device(12 months)
- Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device(12 months)
研究者
研究点 (1)
Loading locations...
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