Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial
한정준, Chang Ah-Ryum, 안재명, 정승곤, 홍종락, 오희균, 황순정,
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한정준 ( Han Jeong-Joon ) - Seoul National University School of Dentistry Department of Oral and Maxillofacial Surgery
( Chang Ah-Ryum ) - Seoul National University School of Dentistry Department of Oral and Maxillofacial Surgery
안재명 ( Ahn Jae-Myung ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Oral and Maxillofacial Surgery
정승곤 ( Jung Seung-Gon ) - Chonnam National University School of Dentistry Department of Oral and Maxillofacial Surgery
홍종락 ( Hong Jong-Rak ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Oral and Maxillofacial Surgery
오희균 ( Oh Hee-Kyun ) - Chonnam National University School of Dentistry Department of Oral and Maxillofacial Surgery
황순정 ( Hwang Soon-Jung ) - Seoul National University Dental Research Institute
Abstract
Background: 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.
Materials and methods: 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.
Results: 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.
Conclusions: 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.
키워드
Alveolar ridge preservation; Socket preservation; rhBMP-2; β-TCP; Clinical trial
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