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临床试验/NCT02227719
NCT02227719撤回4 期

The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement

University of Michigan1 个研究点 分布在 1 个国家开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
linear bone gain

研究概览

简要总结

A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.

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
是

入选标准

  • •Male or female, age >18
  • •Overall good, stable health
  • •A single missing mandibular 1st molar for at least 3 months

排除标准

  • •Any medical conditions that may contradict implant and bone surgery or influence the outcome (detailed criteria in case report form)
  • •Pregnancy or lactating mothers
  • •Current heavy smokers (>10 cigarettes/day) or previous heavy smokers who have quit less than one year
  • •Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria in case report form)

研究组 & 干预措施

Test: CTI

Experimental

CTI is titanium mesh

干预措施: CTI (Device)

Control: Collagen membrane

Active Comparator

Collagen membrane is used for ridge augmentation

干预措施: Collagen membrane (Device)

结局指标

主要结局

linear bone gain

时间窗: 4 months after surgery

次要结局

  • implant marginal bone level(18 months after baseline surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsun-Liang Chan

Clinical Assistant Professor

University of Michigan

研究点 (1)

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