Wei Lingfei, Sun Yuanyuan, Yu Dedong, Pieterse Herman, Wismeijer Daniel, Liu Yuelian, Wu Yiqun
Department of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology; Research Unit of Oral and Maxillofacial Regenerative Medicine, Chinese Academy of Medical Sciences, Shanghai, China.
Department of Oral Cell Biology, Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam, The Netherlands.
J Clin Periodontol. 2025 Feb;52(2):299-309. doi: 10.1111/jcpe.14084. Epub 2024 Oct 31.
This 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.
Forty 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.
The 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.
This clinical trial primarily proved the safety and efficacy of ErhBMP-2/BioCaP/β-TCP as a promising bone substitute.
这项针对人类的首次随机对照试验旨在使用拔牙窝愈合模型，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）掺入的仿生磷酸钙涂层功能化β - 磷酸三钙（ErhBMP - 2/BioCaP/β - TCP）作为新型骨替代物的有效性和安全性。
本研究纳入了40名单根牙拔除后需要种植牙的患者，并将其随机分为三组：ErhBMP - 2/BioCaP/β - TCP组（N = 15）、β - TCP组（N = 15）和自然愈合组（N = 10）。术后6周通过组织形态计量分析评估新骨体积密度作为主要结局，其他组织形态计量分析、牙槽骨和软组织变化作为次要结局。安全参数包括不良事件、软组织愈合、口腔健康影响概况、血清BMP - 2浓度和其他实验室检查。
研究结果显示，与单独接受β - TCP治疗的患者相比，接受ErhBMP - 2/BioCaP/β - TCP治疗的患者新骨体积密度显著增加。ErhBMP - 2/BioCaP/β - TCP组种植体植入手术期间所需的骨增量手术明显少于自然愈合组。三组之间的安全参数无显著差异。
这项临床试验初步证明了ErhBMP - 2/BioCaP/β - TCP作为一种有前景的骨替代物的安全性和有效性。
