富含血小板纤维蛋白/牛无机骨矿物复合物作为大病变根管显微手术中的植骨材料：一项随机对照试验的研究方案。
Platelet-rich fibrin/anorganic bovine bone mineral complex as grafting materials in endodontic microsurgery with a large lesion size: study protocol for a randomised controlled trial.
机构信息
Department of Cariology and Endodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing, China.
Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing, China
出版信息
BMJ Open. 2022 Apr 27;12(4):e057068. doi: 10.1136/bmjopen-2021-057068.
INTRODUCTION
Endodontic microsurgery is a treatment of last resort for preserving natural teeth. According to radiographic evaluation, the percentage of complete healing after endodontic microsurgery is only 74.3%. The use of regenerative techniques in endodontic microsurgery for large lesions (>10 mm diameter) is therefore recommended. The most frequently used bone graft in endodontic microsurgery is anorganic bovine bone mineral (ABBM) but this only has an osteoconductive effect. Thus, when platelet-rich fibrin (PRF), a reservoir of growth factors, is used together with ABBM, it increases the regenerative effect. This study is devoted to comparing the clinical outcomes of PRF with/without ABBM as grafting biomaterials in endodontic microsurgery cases with large lesion size to provide some valuable reference data for dentists.
METHODS AND ANALYSIS
Sixteen patients who are in need of endodontic microsurgery will be recruited. The patients will be randomly assigned to one of two groups: an experimental group, treated with PRF/ABBM complex and collagen membrane, and a control group, treated with ABBM and collagen membrane. Clinical examination including percussion, mobility testing and presence/absence of sinus will be recorded at 7 days, and at 3, 6 and 12 months after endodontic microsurgery. A Visual Analogue Scale will be used by the patients to evaluate pain at 1, 3 and 7 days after endodontic microsurgery. Routine paralleling radiographs will be obtained before and at 3, 6 and 12 months follow-up after endodontic microsurgery. Cone-beam CT (CBCT) scans will be obtained at the 12-month follow-up. Bone formation will be evaluated according to CBCT and paralleling radiographs. The study execute time including follow-ups last from 1 June 2021 to 31 December 2024.
ETHICS AND DISSEMINATION
This study received approval from the Ethics Committee of Peking University School and Hospital of Stomatology. The results will be disseminated through scientific journals.
TRIAL REGISTRATION NUMBER
Research data will be registered with the International Clinical Trials Registry Platform (ICTRP), ID: ChiCTR2100046684.
简介
牙髓显微治疗是保留天然牙齿的最后手段。根据影像学评估，牙髓显微治疗后完全愈合的比例仅为 74.3%。因此，建议在牙髓显微治疗中对于较大的病变（>10mm 直径）使用再生技术。牙髓显微治疗中最常使用的骨移植材料是异体牛骨矿物质（ABBM），但它仅具有骨诱导作用。因此，当将富含血小板的纤维蛋白（PRF），一种生长因子的储存库，与 ABBM 一起使用时，它会增加再生效果。本研究旨在比较 PRF 与/或 ABBM 作为大病变大小的牙髓显微治疗中骨移植材料的临床效果，为牙医提供一些有价值的参考数据。
方法和分析
将招募 16 名需要牙髓显微治疗的患者。患者将被随机分配到两组之一：实验组，用 PRF/ABBM 复合物和胶原膜治疗；对照组，用 ABBM 和胶原膜治疗。临床检查包括叩诊、松动度测试和窦道的存在/缺失，将在牙髓显微治疗后 7 天，以及 3、6 和 12 个月进行记录。患者将在牙髓显微治疗后 1、3 和 7 天使用视觉模拟量表（VAS）评估疼痛。在牙髓显微治疗前后以及随访 3、6 和 12 个月时，将获得常规平行射线照片。在 12 个月的随访时，将进行锥形束 CT（CBCT）扫描。将根据 CBCT 和平行射线照片评估骨形成情况。该研究的执行时间包括 2021 年 6 月 1 日至 2024 年 12 月 31 日的随访。
伦理和传播
本研究得到了北京大学口腔医学院和医院伦理委员会的批准。研究结果将通过科学期刊传播。
试验注册编号
研究数据将在国际临床试验注册平台（ICTRP）上注册，ID：ChiCTR2100046684。
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