NCT01529736已完成不适用
Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- primary stability countertorque measures
研究概览
简要总结
Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.
详细描述
Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.
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 a minimum of 3 implants 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
High torque insertion
Experimental
High torque insertion
干预措施: High torque insertion (Procedure)
Low torque insertion
Active Comparator
Low torque insertion
干预措施: Low torque insertion (Procedure)
结局指标
主要结局
primary stability countertorque measures
时间窗: 4 months
resistance to countertorque measures showing primary stability success of implants
次要结局
- cumulative success rate(1 year)
研究者
研究点 (1)
Loading locations...
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