NCT01529775已完成不适用
A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Cumulative Success Rate
研究概览
简要总结
This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.
详细描述
The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either sex and older than 18 years of age
- •patients needing at least one dental implant to treat partial edentulism
- •patients physically able to tolerate surgical and restorative dental procedures
- •patients agreeing to all protocol visits
排除标准
- •patients with infection or severe inflammation at the intended treatment sites
- •patients smoking greater than 10 cigarettes per day
- •patients with uncontrolled diabetes mellitus
- •patients with uncontrolled metabolic diseases
- •patients who received radiation treatment to the head in the past 12 months
- •patients needing bone grafting at the intended treatment sites
- •patients known to be pregnant at screening visit
- •patients with para-functional habits like bruxing and clenching
结局指标
主要结局
Cumulative Success Rate
时间窗: 3 years
An implant will be considered successful if it is immobile when tested at various study time point
次要结局
- Crestal Bone Regression(3 years)
研究者
研究点 (1)
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