NCT00767169已完成2 期
Bisphosphonate-coated Dental Implants
University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
研究概览
简要总结
Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.
排除标准
- •Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
- •Local exclusion criteria were: previous tumour, trauma and surgery.
- •Also patients with Cawood & Howell class IV - VI maxilla-bone were excluded.
结局指标
主要结局
Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
时间窗: 6 months
次要结局
- Marginal resorption on x-rays(1 year)
研究者
Per Aspenberg
professor
University Hospital, Linkoeping
研究点 (2)
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