Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 in Socket Preservation: A Randomized Controlled Clinical and Sequential Human Histological Trial (BMP-2 TRIAL)

重组人骨形态发生蛋白-2在牙槽窝保存中的有效性:一项随机对照临床和序贯人体组织学试验(BMP-2试验)

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Abstract

OBJECTIVES: The aim of this study was to evaluate the effectiveness of recombinant human bone morphogenetic protein-2 (rhBMP-2) coated biphasic calcium phosphate (BCP) in socket preservation in comparison to BCP. MATERIAL AND METHODS: Patients who underwent extraction of maxillary premolars were randomized to receive rhBMP-2/BCP (n = 15) and BCP alone (n = 15). All sites were primarily closed using a pedicled connective tissue flap. Biopsy was carried out in patients at 3 (n = 10), 6 (n = 10), and 9 (n = 10) months. RESULTS: At 3 months, BMP and non-BMP groups had 3.17% and 3.12% new bone formation, respectively, and 3.8% and 37.85% of residual grafts, respectively, and 25.86% and 25.99% connective tissue component, respectively. At 6 months, both groups revealed 67.42% and 16.55% essential bone growth, 1.74% and 3.04% of residual graft, and 1.3% and 67% connective tissue component, respectively. At 9 months, the BMP group revealed 93.6% new bone formation, 0.68% residual graft, and 1.9% connective tissue component, while the non-BMP groups had 23.35% new bone formation, 4.45% residual graft, and 44.06% connective tissue component. CONCLUSION: This study demonstrated that rhBMP-2 coated BCP significantly enhanced early graft substitution in socket preservation sites compared to BCP alone. There was a significantly higher percentage of new bone formation in the rhBMP-2/BCP group both at 6 and 9 months. Additionally, the rhBMP-2/BCP group exhibited faster resorption of the graft material and earlier maturation of newly formed bone. These findings strongly suggest that rhBMP-2/BCP can be an effective treatment modality for socket preservation, promoting predictable and accelerated bone regeneration.

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