AimThis first randomized controlled trial in humans aimed to assess the efficacy and safety of low‐dosage Escherichia coli‐derived recombinant human bone morphogenetic protein 2 (ErhBMP‐2)‐incorporated biomimetic calcium phosphate coating‐functionalized β‐TCP (ErhBMP‐2/BioCaP/β‐TCP) as a novel bone substitute using the tooth‐extraction‐socket‐healing model.Materials and MethodsForty patients requiring dental implants after single‐root tooth extraction were enrolled in this study and randomly assigned into three groups: ErhBMP‐2/BioCaP/β‐TCP (N = 15), β‐TCP (N = 15) and natural healing (N = 10). New bone volume density from histomorphometric analyses was evaluated 6 weeks post‐operatively as the primary outcome, and other histomorphometric analyses, alveolar bone and soft‐tissue changes were the secondary outcomes. Safety parameters included adverse events, soft‐tissue healing, oral health impact profile, serum BMP‐2 concentrations and other laboratory tests.ResultsThe findings revealed a significant increase in new bone volume density in patients treated with ErhBMP‐2/BioCaP/β‐TCP compared to those receiving β‐TCP alone. The required bone augmentation procedures during implant placement surgery in the ErhBMP‐2/BioCaP/β‐TCP group were significantly less than in the natural healing group. There were no significant differences in safety parameters among the three groups.ConclusionThis clinical trial primarily proved the safety and efficacy of ErhBMP‐2/BioCaP/β‐TCP as a promising bone substitute.

中文翻译：

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ErhBMP-2/BioCaP/β-TCP 作为使用拔牙窝愈合模型的新型骨替代品的临床疗效和安全性：一项概念验证随机对照试验


目的这是第一个在人体中进行的随机对照试验，旨在评估低剂量大肠杆菌衍生的重组人骨形态发生蛋白 2 （ErhBMP-2） 掺入仿生磷酸钙涂层功能化 β-TCP （ErhBMP-2/BioCaP/β-TCP） 作为使用牙齿-拔牙-牙槽愈合模型的新型骨替代品的疗效和安全性。材料和方法纳入 40 例单根牙拔除后需要种植牙的患者，随机分为 ErhBMP-2/BioCaP/β-TCP （N = 15）、β-TCP （N = 15） 和自然愈合 （N = 10） 三组。术后 6 周评估来自组织形态学分析的新骨体积密度作为主要结局，其他组织形态学分析、牙槽骨和软组织变化是次要结局。安全性参数包括不良事件、软组织愈合、口腔健康影响概况、血清 BMP-2 浓度和其他实验室测试。结果研究结果显示，与单独接受 β-TCP 的患者相比，接受 ErhBMP-2/BioCaP/β-TCP 治疗的患者新骨体积密度显着增加。ErhBMP-2/BioCaP/β-TCP 组种植体植入手术中所需的骨增量手术显著少于自然愈合组。三组间安全性参数差异无统计学意义。结论该临床试验初步证明了 ErhBMP-2/BioCaP/β-TCP 作为一种有前途的骨替代品的安全性和有效性。