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

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

作者信息

Reddy Saravanan Sampoornam Pape, Francis Delfin Lovelina, Thirumoorthi Harshini, Rathi Manish, Singh Harjeet, Karmakar Shaswata, Pradhan Shaili

机构信息

Department of Periodontology, Army Dental Centre (Research & Referral), New Delhi, India.

Saveetha Dental College & Hospitals, Saveetha University, Saveetha Institute of Medical and Technical Sciences (SIMATS), Chennai, Tamil Nadu, India.

出版信息

Clin Exp Dent Res. 2025 Jun;11(3):e70134. doi: 10.1002/cre2.70134.

DOI:10.1002/cre2.70134
PMID:40388262
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12087511/
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.

摘要

目的

本研究旨在评估重组人骨形态发生蛋白-2(rhBMP-2)涂层双相磷酸钙(BCP)与BCP相比在牙槽窝保存中的有效性。

材料与方法

将接受上颌前磨牙拔除术的患者随机分为两组,分别接受rhBMP-2/BCP(n = 15)和单纯BCP(n = 15)治疗。所有术区均首先使用带蒂结缔组织瓣进行封闭。在术后3个月(n = 10)、6个月(n = 10)和9个月(n = 10)对患者进行活检。

结果

在3个月时,BMP组和非BMP组的新骨形成率分别为3.17%和3.12%,剩余移植物比例分别为3.8%和37.85%,结缔组织成分比例分别为25.86%和25.99%。在6个月时,两组的主要骨生长率分别为67.42%和16.55%,剩余移植物比例分别为1.74%和3.04%,结缔组织成分比例分别为1.3%和67%。在9个月时,BMP组的新骨形成率为93.6%,剩余移植物比例为0.68%,结缔组织成分比例为1.9%;而非BMP组的新骨形成率为23.35%,剩余移植物比例为4.45%,结缔组织成分比例为44.06%。

结论

本研究表明,与单纯BCP相比,rhBMP-2涂层BCP在牙槽窝保存部位显著增强了早期移植物替代。在6个月和9个月时,rhBMP-2/BCP组的新骨形成百分比均显著更高。此外,rhBMP-2/BCP组的移植物材料吸收更快,新形成骨的成熟更早。这些发现强烈表明,rhBMP-2/BCP可作为牙槽窝保存的一种有效治疗方式,促进可预测且加速的骨再生。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/62705bc65f39/CRE2-11-e70134-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/3611fa344ee8/CRE2-11-e70134-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/5dba6dc92cf0/CRE2-11-e70134-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/8d03a3e45308/CRE2-11-e70134-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/7c07e128e6cd/CRE2-11-e70134-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/62705bc65f39/CRE2-11-e70134-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/3611fa344ee8/CRE2-11-e70134-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/5dba6dc92cf0/CRE2-11-e70134-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/8d03a3e45308/CRE2-11-e70134-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/7c07e128e6cd/CRE2-11-e70134-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54f4/12087511/62705bc65f39/CRE2-11-e70134-g005.jpg

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Biphasic calcium phosphate recruits Tregs to promote bone regeneration.双相磷酸钙招募 Tregs 促进骨再生。
Acta Biomater. 2024 Mar 1;176:432-444. doi: 10.1016/j.actbio.2024.01.001. Epub 2024 Jan 6.
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Radiographic and histological evaluation of bone formation induced by rhBMP-2-incorporated biomimetic calcium phosphate material in clinical alveolar sockets preservation.
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Int J Implant Dent. 2023 Oct 16;9(1):37. doi: 10.1186/s40729-023-00491-1.
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Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial.重组人骨形态发生蛋白/β-磷酸三钙用于牙槽嵴保存的有效性和安全性:一项多中心、随机、开放标签、对照、研究者设盲的临床试验。
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