NCT03464786已完成不适用
A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Change value of the width of alveolar ridge
研究概览
简要总结
This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~65 years old;
- •Subjects, whose single teeth (adjacent teeth intact) of incisor, canine or premolar is removed and bone graft is needed for alveolar ridge preservation, and need a delayed implant repair in more than 26 weeks.
- •voluntary participation and sign on the informed consent form
排除标准
- •Participated in other clinical trials in 90 days before joined in the trial
- •Having received in 90 days before joined in the trial and / or will receive the head and neck radiation therapy or chemist during the study
- •Having received in 90 days before joined in the trial and / or will receive any drug treatment that may affect bone metabolism;
- •patients with heart disease;
- •patients with abnormal liver and kidney function;
- •poor diabetes control;
- •low or abnormal immunity, anaphylaxis and the researchers judged to be of clinical significance;
- •HIV infected patients;
- •bleeding tendency or coagulation disorders and researchers judged to be of clinical significance;
- •mental disorder;
- •women who are pregnant or breast-feeding or preparing for pregnancy in the next 26 weeks;
- •severe smokers;
- •patients with periodontitis without basic periodontal treatment;
- •the fracture of alveolar process after tooth extraction;
- •The loss of bone wall on any side of alveolar fossa was more than 2/
- •other cases that researchers believe not suitable for the participants of the trial
研究组 & 干预措施
absorbable collagen membrane
Experimental
Subjects randomized in this arm will receive Lando® absorbable collagen membrane after tooth extraction.
干预措施: Lando® absorbable collagen membrane (Device)
Bio-Gide resorbable bilayer membrane
Active Comparator
Subjects randomized in this arm will receive Bio-Gide resorbable bilayer membrane after tooth extraction.
干预措施: Geistlich Bio-Gide resorbable bilayer membrane (Device)
结局指标
主要结局
Change value of the width of alveolar ridge
时间窗: 26 weeks
Change value of the width of alveolar ridge by CT
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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