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.

中文翻译：

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磷酸八钙和胶原复合物在口腔颌面外科中的临床研究。

磷酸八钙及其胶原复合物已被公认为具有骨传导性和生物降解特性的骨替代材料。在一项临床试验中，我们评估了磷酸八钙及其胶原蛋白复合物在大型口腔和颌面外科手术中用于骨骼增强的有效性。磷酸八钙及其胶原蛋白复合物可用于1阶段和2阶段窦底抬高，窝窝保存，囊肿和肺泡裂手术。植入磷酸八钙及其胶原蛋白复合物后，共评估了60位患者的有效性。尽管在1期，囊肿和牙槽裂病例中，窦底抬高符合判断成功的标准，2级和承窝保存组的窦底高程不符合初始评估的标准。但是，再次确认的评估显示了磷酸八钙及其胶原蛋白复合物在这些组中的有效性，所有评估结果最终表明该临床试验的成功。因此，该临床试验表明，磷酸八钙及其胶原蛋白复合物在口腔颌面部手术中的应用是安全有效的，并且磷酸八钙及其胶原蛋白复合物可以替代自体骨而替代骨。所有评估结果最终表明该临床试验的成功。因此，该临床试验表明，磷酸八钙及其胶原蛋白复合物在口腔颌面部手术中的应用是安全有效的，并且磷酸八钙及其胶原蛋白复合物可以替代自体骨而替代骨。所有评估结果最终表明该临床试验的成功。因此，该临床试验表明，磷酸八钙及其胶原蛋白复合物在口腔颌面部手术中的应用是安全有效的，并且磷酸八钙及其胶原蛋白复合物可以替代自体骨而替代骨。