Kawai Tadashi, Kamakura Shinji, Matsui Keiko, Fukuda Masayuki, Takano Hiroshi, Iino Mitsuyoshi, Ishikawa Shigeo, Kawana Hiromasa, Soma Tomoya, Imamura Eisaku, Kizu Hideki, Michibata Aya, Asahina Izumi, Miura Keiichiro, Nakamura Norifumi, Kibe Toshiro, Suzuki Osamu, Takahashi Tetsu
Department of Oral Medicine and Surgery, Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry, Sendai, Japan.
Department of Bone Regenerative Engineering, Division of Regenerative and Biomedical Engineering, Tohoku University Graduate School of Biomedical Engineering, Sendai, Japan.
J Tissue Eng. 2020 Jan 23;11:2041731419896449. doi: 10.1177/2041731419896449. eCollection 2020 Jan-Dec.
Octacalcium phosphate and its collagen composite have been recognized as bone substitute materials possessing osteoconductivity and biodegradation properties. We evaluated the effectiveness of octacalcium phosphate and its collagen composite used for bone augmentation in major oral and maxillofacial surgeries in a clinical trial. Octacalcium phosphate and its collagen composite were used in cases of sinus floor elevation in 1- and 2-stage, socket preservation, cyst, and alveolar cleft procedures. A total of 60 patients were evaluated for effectiveness after the implantation of octacalcium phosphate and its collagen composite. Although sinus floor elevation in 1-stage, cyst, and alveolar cleft cases met the criteria for the judgment of success, sinus floor elevation in 2-stage and socket preservation groups did not meet the criteria in the initial evaluation. However, an additional evaluation for reconfirmation revealed the effectiveness of octacalcium phosphate and its collagen composite in those groups, and all evaluation results ultimately indicated the success of this clinical trial. Therefore, this clinical trial suggested that application of octacalcium phosphate and its collagen composite for oral and maxillofacial surgery was safe and effective and that octacalcium phosphate and its collagen composite could be a bone substitute candidate instead of autologous bone.
磷酸八钙及其胶原复合材料已被公认为具有骨传导性和生物降解特性的骨替代材料。我们在一项临床试验中评估了磷酸八钙及其胶原复合材料用于口腔颌面外科主要手术中骨增量的有效性。磷酸八钙及其胶原复合材料用于一期和二期上颌窦底提升、拔牙窝保存、囊肿及牙槽嵴裂手术。总共60例患者在植入磷酸八钙及其胶原复合材料后接受了有效性评估。尽管一期上颌窦底提升、囊肿及牙槽嵴裂病例符合成功判断标准,但二期上颌窦底提升组和拔牙窝保存组在初始评估中未达到标准。然而,再次确认的额外评估显示磷酸八钙及其胶原复合材料在这些组中有效,所有评估结果最终表明该临床试验成功。因此,该临床试验表明,磷酸八钙及其胶原复合材料用于口腔颌面外科手术是安全有效的,并且磷酸八钙及其胶原复合材料可以作为自体骨替代材料的候选者。