上海口腔医学

上海口腔医学 ›› 2023, Vol. 32 ›› Issue (2): 198-202.doi: 10.19439/j.sjos.2023.02.016

• 论著 • 上一篇    下一篇

黄牛煅烧骨填充材料用于拔牙后牙槽骨缺损修复的效果评价

巨佳1, 杨驰2, 武和明3, 赵吉宏4, 成黎霏1, 张欢1, 冯斌1,*, 胡开进5,*   

  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,空军军医大学第三附属医院 国家药物临床试验机构,药剂科, 陕西 西安 710032;
    2.上海交通大学医学院附属第九人民医院 口腔外科,上海 200011;
    3.南京医科大学附属口腔医院 口腔颌面外科,江苏 南京 210000;
    4.武汉大学口腔医院 口腔外科,湖北 武汉 430079;
    5.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,空军军医大学第三附属医院 口腔外科,陕西 西安 710032
  • 收稿日期:2022-01-03 修回日期:2022-03-16 出版日期:2023-04-25 发布日期:2023-06-13
  • 通讯作者: 胡开进,E-mail: hukaijin2015@126.com;冯斌,E-mail: kqlcjg@163.com。*共同通信作者
  • 作者简介:巨佳（1988-）,女,硕士,主管药师,E-mail: jujia143@163.com

Evaluation of the effect of cattle calcined bone grafting material to repair alveolar bone defect after tooth extraction

JU Jia1, YANG Chi2, WU He-ming3, ZHAO Ji-hong4, CHENG Li-fei1, ZHANG Huan1, FENG Bin1, HU Kai-jin5   

  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, Third Affiliated Hospital of Air Force Medical University. Xi'an 710032, Shaanxi Province;
    2. Department of Oral Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. Shanghai 200011;
    3. Department of Oral and Maxillofacial Surgery, Stomatological Hospital of Nanjing Medical University. Nanjing 210000, Jiangsu Province;
    4. Department of Oral and Maxillofacial Surgery, Stomatological Hospital of Wuhan University. Wuhan 430079, Hubei Province;
    5. State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Oral Surgery, Third Affiliated Hospital of Air Force Medical University, Xi'an 710032, Shaanxi Province, China
  • Received:2022-01-03 Revised:2022-03-16 Online:2023-04-25 Published:2023-06-13

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摘要： 目的: 验证黄牛煅烧骨填充材料用于拔牙术后牙槽骨缺损修复的有效性和安全性。方法: 采用随机、盲法、平行、阳性对照、多中心临床试验设计。共选取280例受试者,按照1∶1比例随机分配至试验组（黄牛煅烧骨组）或对照组（Bio-Oss骨粉组）。主要疗效指标为材料植入后24周影像学变化,次要疗效指标是术后切口愈合情况、排异反应、骨代谢变化、填充后症状及骨感染征象。通过不良事件和严重不良事件的发生率评估材料安全性。采用SAS 8.2软件包进行统计学分析。结果: 入组280例,完成267例,脱落13例。材料植入术后24周,牙槽骨缺损修复的有效率全分析集（符合方案集）,试验组为90.58%（97.46%）,对照组为87.05%（95.04%）,试验组有效率-对照组有效率率差（95%CI）,FAS结果为3.53% (-3.88%, 10.94%),PPS结果为2.42% (-2.38%, 7.22%),组间无显著差异。术后2组切口愈合良好,排异反应、骨感染征象、填充后症状及骨代谢变化发生率极低。2组材料不良事件发生率接近,未发生与研究材料有关的严重不良事件。结论: 黄牛煅烧骨填充材料在拔牙术后牙槽骨缺损修复的疗效非劣效于Bio-Oss骨粉,用于牙槽骨缺损修复安全且有效。

关键词: 黄牛煅烧骨填充材料, Bio-Oss骨粉, 拔牙, 牙槽骨缺损

Abstract: PURPOSE: To verify the efficacy and safety of calcined cattle bone grafting material in filling alveolar bone defect after tooth extraction. METHODS: A randomized, bind, parallel, positive-control multicenter clinical trial was conducted. A total of 280 subjects were randomly assigned to either the experimental group (calcined cattle bone group) or control group (Bio-Oss group) equally. The main efficacy indicator was the imaging changes 24 weeks after material implantation. Secondary efficacy indicators were wound healing, rejection, bone metabolism, post-filling symptoms and signs of bone infection. The safety of material was assessed by the incidence of adverse events and serious adverse events. SAS 8.2 software package was used for statistical analysis. RESULTS: A total of 280 cases were included, of them 267 cases completed the study while 13 cases fell off. The effective rate of FAS(PPS) was 90.58%(97.46%) in the experimental group and 87.05% (95.04%) in the control group. The difference of effective rate between the experimental group and control group (95%CI) was 3.53% (-3.88%, 10.94%) of FAS, 2.42% (-2.38%, 7.22%) of PPS, and there was no significant difference between the two groups. The incision healing of the two groups was good, and the incidence of rejection, bone infection signs, post-filling symptoms and bone metabolic changes was very low. The incidence of adverse events was similar in the two groups, and no serious adverse events related to the study materials occurred. CONCLUSIONS: The efficacy of calcined cattle bone grafting material in filling alveolar bone defect after tooth extraction is not inferior to that of Bio-Oss, and it is safe and effective for alveolar bone defect repair.

Key words: Calcined cattle bone grafting material, Bio-Oss, Tooth extraction, Alveolar bone defect

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