The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement
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
CTI is titanium mesh
干预措施: CTI (Device)
Control: Collagen membrane
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
Hsun-Liang Chan
Clinical Assistant Professor
University of Michigan
