口腔医学研究

口腔医学研究 ›› 2022, Vol. 38 ›› Issue (9): 848-853.DOI: 10.13701/j.cnki.kqyxyj.2022.09.011

• 口腔颌面外科学研究 • 上一篇    下一篇

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

巨佳1, 刘玉华2, 赵继志3, 赵吉宏4, 李宏卫5, 王宝彦6, 王虎7, 张欢1, 冯斌1*, 胡开进8*   

  1. 1. 军事口腔医学国家重点实验室,国家口腔疾病临床医学研究中心,陕西省口腔生物工程技术研究中心,第四军医大学口腔医院国家药物临床试验机构,第四军医大学口腔医院药剂科 陕西 西安 710032;
    2. 北京大学口腔医院口腔修复科 北京 100050;
    3. 中国医学科学院北京协和医院口腔颌面外科 北京 100005;
    4. 武汉大学口腔医院口腔颌面外科 湖北 武汉 430079;
    5. 南京医科大学附属口腔医院口腔颌面外科 江苏 南京 210000;
    6. 西安交通大学口腔医院牙周黏膜科 陕西 西安 710032;
    7. 四川大学华西口腔医院口腔放射科 四川 成都 610041;
    8. 军事口腔医学国家重点实验室,国家口腔疾病临床医学研究中心,陕西省口腔疾病临床医学研究中心,第四军医大学口腔医院口腔外科 陕西 西安 710032
  • 收稿日期:2021-11-04 发布日期:2022-09-26
  • 通讯作者: *冯斌,E-mail:kqlcjg@163.com;胡开进,E-mail:hukaijin2015@126.com.
  • 作者简介:巨佳(1988~ ),女,陕西咸阳人,硕士,主管药师,研究方向:临床药学、药物/医疗器械临床试验管理。

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

JU Jia1, LIU Yuhua2, ZHAO Jizhi3, ZHAO Jihong4, LI Hongwei5, WANG Baoyan6, WANG Hu7, ZHANG Huan1, FENG Bin1*, HU Kaijin2*   

  1. 1. State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Medical Institution Conducting Clinical Trials for Human Used Drug, Department of Pharmacy, School of Stomatology, The Fourth Military Medical University, Xi’an 710032, China;
    2. Department of Prosthodontics, Peking University Stomatological Hospital, Beijing 100050, China;
    3. Department of Oral and Maxillofacial Surgery, Peking Union Hospital, Chinese Academy of Medical Sciences, Beijing 100005, China;
    4. Department of Oral and Maxillofacial Surgery, Hospital of Stomatology Wuhan University, Wuhan 430079, China;
    5. Department of Oral and Maxillofacial Surgery, Stomatological Hospital of Nanjing Medical University, Nanjing 210000, China;
    6. Department of Periodontal Mucosa, Hospital of Stomatology Xi'an Jiaotong University, Xi'an 710032, China;
    7. Department of Oral Radiology, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China;
    8. State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Oral Surgery, School of Stomatology, The Fourth Military Medical University, Xi’an 710032, China.
  • Received:2021-11-04 Published:2022-09-26

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摘要： 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。

关键词: 猪小肠黏膜下层, 牙槽骨, 软组织, 修复重建, 临床研究

Abstract: 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.

Key words: SIS absorbable biofilms, alveolar bone, soft tissue, reconstruction, clinical research