Kawai Tadashi, Echigo Seishi, Matsui Keiko, Tanuma Yuji, Takahashi Tetsu, Suzuki Osamu, Kamakura Shinji
1 Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry , Sendai, Japan .
Tissue Eng Part A. 2014 Apr;20(7-8):1336-41. doi: 10.1089/ten.TEA.2013.0508. Epub 2014 Jan 16.
We have previously demonstrated that octacalcium phosphate (OCP) collagen composite (OCP/collagen) promotes bone regeneration in a critical-sized bone defect of a rodent or canine model. This study was designed to investigate the bone regeneration of OCP/collagen in human bone defect as a first clinical trial. Two patients who had a radicular cyst or apical periodontitis consented to participate in our clinical study, and OCP/collagen was implanted into the defects after operation. Radiographic examination showed effective bone healing in each bone defect at 3 or 6 months. Likewise, computed tomography value significantly increased after implantation. Postoperative wound healing was uneventful, and neither infection nor allergic reaction against OCP/collagen was observed for the entire period. This study demonstrated that OCP/collagen would be safely used and enhanced bone regeneration in human bone defects. To reinforce the efficacy of OCP/collagen as a bone substitute material, it should be compared with other suitable comparators in the future.
我们之前已经证明,磷酸八钙(OCP)胶原复合材料(OCP/胶原)可促进啮齿动物或犬类模型临界尺寸骨缺损的骨再生。本研究旨在作为首个临床试验,研究OCP/胶原在人类骨缺损中的骨再生情况。两名患有牙根囊肿或根尖周炎的患者同意参与我们的临床研究,术后将OCP/胶原植入缺损处。X线检查显示,在3个月或6个月时,每个骨缺损处均实现了有效的骨愈合。同样,植入后计算机断层扫描值显著增加。术后伤口愈合顺利,整个期间均未观察到对OCP/胶原的感染或过敏反应。本研究表明,OCP/胶原可安全用于人类骨缺损并促进骨再生。为增强OCP/胶原作为骨替代材料的疗效,未来应将其与其他合适的对照材料进行比较。