A Prospective Randomized-controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Integration Success of the Implant
研究概览
简要总结
This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.
详细描述
This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study.
Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.
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 of any race, 18 years of age or older
- •patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla
排除标准
- •patients who are known to be pregnant
研究组 & 干预措施
Osseotite implant
Osseotite dental implant
干预措施: Osseotite dental implant (Device)
Nanotite implant
Nanotite dental implant
干预措施: Nanotite dental implant (Device)
结局指标
主要结局
Integration Success of the Implant
时间窗: 1 year
次要结局
未报告次要终点