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临床试验/NCT01529801
NCT01529801已完成不适用

A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success

ZimVie1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年2月最近更新:
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
80
试验地点
1
主要终点
Primary stability countertorque measures

研究概览

简要总结

A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

详细描述

This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

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

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

Primary stability countertorque measures

时间窗: 6 weeks

Resistance to countertorque measures showing primary stability and success of the implant

次要结局

  • Cumulative success rate(2 years)

研究者

发起方
ZimVie
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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