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

Jeong Joon Han1,2, Ah. Ryum Chang1, Jaemyung Ahn3, Seunggon Jung4, Jongrak Hong3, Hee-Kyun Oh4, Soon Jung Hwang2,5
1Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul, Republic of Korea
2Dental Research Institute, Seoul National University, Seoul, Republic of Korea
3Department of Oral and Maxillofacial Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
4Department of Oral and Maxillofacial Surgery, Dental Science Research Institute, School of Dentistry, Chonnam National University, Gwangju, Republic of Korea
5Hwang Soon Jung’s Dental Clinic for Oral and Maxillofacial Surgery, Seoul, Republic of Korea

Tóm tắt

The 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. Eighty-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. Both 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. The 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. Clinicaltrials.gov , NCT02714829 , Registered 22 March 2016

Tài liệu tham khảo

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