A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Cumulative success rate
研究概览
简要总结
Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.
详细描述
In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points
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 (Investigator)
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
研究组 & 干预措施
New abutment connection implant
Implant with new abutment connection
干预措施: New Abutment Connection implant (Device)
Nanotite Certain Tapered implant
Nanotite Certain Tapered (standard abutment connection) implant
干预措施: Nanotite Certain Tapered implant (Device)
结局指标
主要结局
Cumulative success rate
时间窗: 2 years
Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)
次要结局
未报告次要终点