Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial

Maxillofacial Plastic and Reconstructive Surgery

Soon Jung Hwang¹  Seunggon Jung²  Hee-Kyun Oh²  Jaemyung Ahn³  Jongrak Hong³  Ah. Ryum Chang⁴  Jeong Joon Han⁵ 

[1] Dental Research Institute, Seoul National University, Seoul, Republic of Korea;Hwang Soon Jung’s Dental Clinic for Oral and Maxillofacial Surgery, 349, Woonam Building 2, 3F, Gangnam-daero, Seocho-gu, 06626, Seoul, Republic of Korea;Department of Oral and Maxillofacial Surgery, Dental Science Research Institute, School of Dentistry, Chonnam National University, Gwangju, Republic of Korea;Department of Oral and Maxillofacial Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul, Republic of Korea;Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul, Republic of Korea;Dental Research Institute, Seoul National University, Seoul, Republic of Korea;

关键词: Alveolar ridge preservation;    Socket preservation;    rhBMP-2;    β-TCP;    Clinical trial;   

DOI  :  10.1186/s40902-021-00328-0

来源: Springer

【 摘 要 】

BackgroundThe aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with β-TCP (rhBMP-2/β-TCP) in alveolar ridge preservation.Materials and methodsEighty-four subjects from three centers were enrolled in this clinical trial. After tooth extraction, rhBMP-2/β-TCP (n = 41, test group) or β-TCP (n = 43, control group) were grafted to the extraction socket with an absorbable barrier membrane for alveolar ridge preservation. Using computed tomography images obtained immediately after and 12 weeks after surgery, changes in the alveolar bone height and width were analyzed for each group and compared between the two groups.ResultsBoth the test and control groups showed a significant decrease in alveolar bone height in the 12 weeks after surgery (both groups, p < 0.0001). However, the test group exhibited a significantly lower decrease in alveolar bone height than the control group (p = 0.0004). Alveolar bone width also showed significantly less resorption in the test group than in the control group for all extraction socket levels (ESL) (p = 0.0152 for 75% ESL; p < 0.0001 for 50% ESL; p < 0.0001 for 25% ESL). There were no statistically significant differences in the incidence of adverse events between the two groups. No severe adverse events occurred in either group.ConclusionsThe results of this study suggest that rhBMP-2/β-TCP is a safe graft material that provides a high alveolar bone preservation effect in patients receiving dental extraction.Trial registrationClinicaltrials.gov, NCT02714829, Registered 22 March 2016

【 授权许可】

CC BY