NCT02714829已完成不适用
Clinical Study to Evaluate Efficacy and Safety of "Inject BMP(Beta-TCP Containing rhBMP-2)" for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.
BioAlpha Inc.0 个研究点目标入组 88 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- compared the changed height and standard height by computed tomography.
研究概览
简要总结
This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).
详细描述
Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons without periodontal disease
排除标准
- •Women who are pregnant or plan to be pregnant within study period
研究组 & 干预措施
Inject BMP
Experimental
ExcelOS-inject containing rhBMP-2
干预措施: Inject BMP (Device)
ExcelOS-inject
Active Comparator
ExcelOS-inject without rhBMP-2
干预措施: ExcelOS-inject (Device)
结局指标
主要结局
compared the changed height and standard height by computed tomography.
时间窗: at 12 weeks after surgery
次要结局
未报告次要终点
研究者
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