NCT01649531进行中（未招募）不适用
Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- radiographic bone level
研究概览
简要总结
The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.
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
- 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
- 否
入选标准
- •male and female patients 18 years to 80 years of age
- •no general medical condition which represents a contraindication to implant treatment
- •two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
- •at least one tooth present adjacent to the edentulous space
- •indication for implant treatment is given
- •at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
- •at least 4 mm of vertical bone height in the maxilla
- •signed informed consent after being informed
排除标准
- •smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
- •poor oral hygiene after hygienic phase (Plaque Index over 30 %)
- •active periodontal disease
- •pregnancy or breastfeeding at date of inclusion
结局指标
主要结局
radiographic bone level
时间窗: 5 years
The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.
次要结局
- Radiographic bone level(1, 3, 7, 10 years)
- rate of technical complication(1, 3, 5, 7, 10 years)
- rate of biological complications(1, 3, 5, 7, 10 years)
- Soft tissue changes(1, 3, 5, 7, 10 years)
- Implant survival and success(1, 3, 5, 7, 10 years)
- Patient morbidity(1, 3, 5, 7, 10 years)
研究者
研究点 (2)
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