猪小肠黏膜下层(SIS)可吸收生物膜用于牙槽骨和/或软组织修复重建的临床研究

Clinical Trial of Small Intestinal Submucosa Absorbable Bio-films in Reconstruction of Alveolar Bone and/or Soft Tissues

目的:评价猪小肠黏膜下层(SIS)可吸收生物膜用于牙槽骨和/或软组织修复重建的有效性和安全性。方法:采用随机、单盲、平行对照、多中心、非劣效临床试验设计。主要评价指标为术后0 d及180 d术区牙槽嵴最大长度、最大高度和最大宽度的改变。次要观察指标为术区牙槽骨增生和吸收变化,牙槽骨基质边缘线变化,试验用膜是否破损,手术切口愈合,排异反应及填充后症状。通过不良事件发生频率和严重程度评价SIS可吸收生物膜安全性。结果:本研究共入组280例,完成272例,脱落8例,脱落率为2.86%。180天影像学有效率FAS(PPS),试验组83.57%(91.34%)、对照组81.43%(92.62%),试验组率-对照组率率差(95%CI),FAS结果为2.14%(-6.75%,11.04%),PPS结果为-1.28%(-8.03%,5.46%),组间差别无统计学意义。180 d牙槽骨增生和吸收变化、牙槽骨基质边缘线变化,术后12 d试验用膜破损情况、临床手术切口愈合情况,各访视点排异反应和填充状况组间无显著性差异。两组治疗不良事件及严重不良事件发生情况组间差别无统计学意义。结论:SIS可吸收生物膜对于引导牙槽骨和/或软组织修复重建的效果非劣于Bio-Gide可吸收生物膜。

Objective:To evaluate the efficacy and safety of small intestinal submucosa(SIS)absorbable biofilms in reconstructing alveolar bone and/or soft tissue.Methods:Randomized,single-bind,parallel-control,multicenter,non-inferiority trial design was used.The main measures were the changes of the maximum length,height,and width in alveolar bone 0 and 180 days after operation.Secondary measures included changes in alveolar bone hyperplasia and resorption,changes in alveolar bone matrix marginal line,damage of biofilm,surgical incision healing,rejection reaction,and post-filling symptoms.The safety of SIS absorbable biofilms was evaluated by frequency and severity of adverse events.Results:A total of 280 cases were included in this study.Two hundred and seventy-two cases completed the trial and the abscission rate was 2.86%(8 cases).The imaging effective rate of FAS(PPS)after 180 days was 83.57%(91.34%)in the experimental group and 81.43%(92.62%)in the control group,and 95%CI was 2.14%(-6.75%,11.04%)in FAS and-1.28%(-8.03%,5.46%)in PPS(P>0.05).The changes of alveolar bone growth and resorption,alveolar bone matrix marginal line,experimental membrane damage 12 days after surgery,clinical incision healing,rejection reaction,and filling status of each visiting point had no significant differences between two groups(P>0.05).The incidence of adverse events and serious adverse events during the treatment had no significant difference(P>0.05).Conclusion:SIS absorbable biofilms were non-inferior to Bio-Gide absorbable biofilms in reconstructing alveolar bone and/or soft tissue.