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- 2017
引导组织再生生物膜应用于拔牙术后牙槽骨缺损修复的临床研究
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Abstract:
摘要 目的:观察和评价引导组织再生生物膜应用于牙槽骨缺损修复的有效性和安全性。方法:采用随机、开放、平行、阳性对照(Bio-Gide可吸收生物膜)临床试验设计。主要评价指标为骨缺损部位的影像学检查,次要评价指标为:手术伤口愈合情况、排异反应、骨代谢变化、骨感染征象。安全性评价指标为不良反应发生率。结果:本临床试验共入组40例受试者,完成试验39例,脱落1例。主要有效性评价指标影像学检查有效率:试验组89.47％、对照组95.00％。次要疗效评价2组材料植入后伤口愈合时间均小于12 d,2组均无排异反应、无骨代谢变化、无骨感染征象。不良事件发生率试验组:5.00%,对照组:0.00%。结论:引导组织再生生物膜应用于拔牙术后牙槽骨缺损修复的疗效和安全性非劣效于Bio-Gide可吸收生物膜
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