NCT01158664已完成不适用
A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To document the outcome of bone remodeling around IBT implants
研究概览
简要总结
Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Periodontally-healthy or periodontally-treated patients
- •Smokers are included
- •All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.
排除标准
- •All other contra indications for implant surgery
- •Guided bone regeneration or use of any substitutes
- •No implantation in regenerated or augmented bone
- •No immediate loading cases
研究组 & 干预措施
0.1 mm tread pitch implant
Experimental
干预措施: 0.1 mm tread pitch implant (Device)
0.6 mm tread pitch implant
Experimental
干预措施: 0.6 mm tread pitch implant (Device)
结局指标
主要结局
To document the outcome of bone remodeling around IBT implants
时间窗: 3 years after implantation
次要结局
- To clinically and radiographically document the placement of both IBT implant thread types in the same patient(over 2 years)
- 3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation(over 2 years)
研究者
研究点 (1)
Loading locations...
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