复合透明质酸钠可塑型骨修复材料及天然生物膜用于牙槽骨缺损修复的临床效果研究

Clinical effect of composite sodium hyaluronate plastic bone repair material and natural biomembrane for alveolar bone defect repair

目的研究复合透明质酸钠的可塑型骨修复材料及天然生物膜用于牙槽骨缺损修复的临床有效性和安全性。方法收集2017-08-25至2018-09-29就诊于四川大学华西口腔医院、南京医科大学附属口腔医院、湖北省十堰市太和医院、武汉大学口腔医院、浙江大学医学院附属第一医院、华中科技大学同济医学院附属同济医院、中国医科大学附属口腔医院、第四军医大学口腔医院8家临床研究机构的单颗牙齿拔除且需进行植骨术患者294例。采用随机、开放、阳性对照、多中心临床研究设计,将患者随机分为研究组(143例)和对照组(151例),分别使用傲塑^(®)骨填充材料+傲塑^(®)可吸收生物膜和Bio-Oss^(®)Collagen骨填充材料+Bio-Gide^(®)可吸收生物膜。2组主要疗效评价指标为术后第(180±7)天的影像学评价并计算治疗有效率;次要疗效评价指标为术后第(12±2)天生物膜破损、骨填充材料外漏及手术切口愈合情况和术后第(180±7)天排异反应及骨感染征象情况;安全性评价指标为与研究药物肯定或可能相关的不良反应发生率。结果研究组与对照组治疗有效率分别为90.91%、90.07%,2组主要疗效评价等级分布比较,差异无统计学意义(χ^(2)=1.101,P=0.294)。2组各项次要疗效评价指标比较,差异均无统计学意义(均P>0.05)。研究组有2例(1.40%)发生与研究材料肯定或可能有关的不良反应,对照组有2例(1.32%),2组不良反应发生率比较,差异无统计学意义(P>0.999)。结论国产复合透明质酸钠的可塑型骨修复材料和天然生物膜(傲塑?)用于牙槽骨修复的临床效果良好,值得临床推广应用。

Objective To study the clinical efficacy and safety of plastic bone repair material combined with sodium hyaluronate and domestic biomembrane for alveolar bone defect repair.Methods This is a randomized,open,positive control,multicenter clinical study.Two hundred and ninety-four patients receiving single tooth extraction and bone grafting from 8 different hospitals were included in this study.The patients were randomly divided into a study group(143 cases)and a control group(151 cases),using Aosu^(®)bone repair material with Aosu^(®)absorbable biomembrane and Bio-Oss^(®)Collagen with Bio-Gide?absorbable biomembrane,respectively.As a main efficacy evaluation indicator,the effective rate of the two groups was calculated according to the images on(180±7)days after surgery.The secondary efficacy evaluation indicators included biomembrane breakage,bone filling material leakage and surgical incision healing on(12±2)days after surgery as well as rejection and signs of bone infection on(180±7)days after surgery.The incidence of adverse reactions that might be associated with the bone repair material was recorded for safety evaluation.Results The effective rate was 90.91%in the study group,while 90.07%in the control group.There was no significant difference in the main efficacy evaluation indicator between the two groups(χ^(2)=1.101,P=0.294).There was no statistical difference in all secondary efficacy evaluation indicators between the two groups(all P>0.05).Two patients(1.40%)in the study group and 2 cases(1.32%)in the control group experienced adverse reactions which were definitely or possibly related to the study materials.However,the difference was not statistically significant(P>0.999).Conclusion Aosu?bone repair material and biomembrane show satisfactory clinical effect in alveolar bone repair.They are worthy of clinical application and promotion.