口腔医学研究 ›› 2017, Vol. 33 ›› Issue (7): 782-786.DOI: 10.13701/j.cnki.kqyxyj.2017.07.023

• 临床研究论著 • 上一篇    下一篇

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

罗正文, 刘济远, 李佳, 潘剑*   

  1. 口腔疾病研究国家重点实验室,四川大学华西口腔医院口腔外科 四川 成都 610041
  • 收稿日期:2017-01-14 出版日期:2017-07-20 发布日期:2017-07-27
  • 通讯作者: 潘剑,电话:028-85501440
  • 作者简介:罗正文(1990~ ),男,广东人,硕士在读,主要从事口腔颌面外科的临床治疗工作。

Clinical Trial of Guided Tissue Regeneration Membrane in Repairing Alveolar Bone Defect Secondary to Tooth Extraction.

LUO Zheng-wen, LIU Ji-yuan, LI Jia, PAN Jian*.   

  1. State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.
  • Received:2017-01-14 Online:2017-07-20 Published:2017-07-27

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。

关键词: 拔牙, 牙槽骨缺损, 引导骨再生术, 引导组织再生膜, 临床试验

Abstract: Objective: To explore the efficacy and safety of suided tissue regeneration membrane (GTRM) in repairing alveolar bone defect secondary to tooth extraction. Methods: A randomized, open, parallel, positively controlled (Bio-gide) clinical trial was performed. The major index for evaluating efficacy was imaging examination. The secondary indexes for evaluating efficacy were surgical wound healing, rejection reaction, changes of bone metabolism, and bone infection signs. The incidence of adverse reaction was recorded for safety evaluation. Results: Forty cases were included and 39 cases completed the clinical trial. The effective rates of imaging examination in GTRM and Bio-gide group were 89.47% and 95%, respectively. The wound healing time of both groups was less than 12 days. No rejection reaction, bone metabolic change, and bone infection sign were observed. The incidences of adverse events in ADM group and Bio-gide group were 5.00% and 0.00%, respectively. Conclusion: No significant difference was found as to efficacy and safety in repairing bone defect secondary to tooth extraction between GTRM group and Bio-gide group.

Key words: Tooth extraction , Defect of alveolar bone, Guided bone regeneration, Guided tissue regeneration membrane, Clinical trial

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