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Joint Diseases and
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Original Article · Open access

Efficacy and safety of recombinant human bone morphogenetic protein-2 biomaterials in promoting bone regeneration: A systematic review and meta-analysis

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Yue Li

Department of Prosthodontics, Tianjin Stomatological Hospital, School of Medicine, Nankai University, Tianjin City, China Tianjin Key Laboratory of Oral and Maxillofacial Function Reconstruction, Tianjin City, China

ORCID: 0009-0008-8229-647X

Jun Zhao

Department of Prosthodontics, Tianjin Stomatological Hospital, School of Medicine, Nankai University, Tianjin City, China

ORCID: 0009-0002-0076-3289

Chunxia Chen

Department of Prosthodontics, Tianjin Stomatological Hospital, School of Medicine, Nankai University, Tianjin City, China

ORCID: 0009-0005-5033-7132

Abstract

Objectives: This study aims to systematically evaluate the efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) in promoting bone regeneration.

Materials and methods: A comprehensive search of PubMed, Embase, Web of Science, and Scopus was conducted from inception to May 2024. Fifteen randomized-controlled trials involving 2,137 cases were included. Traditional and network meta-analyses were performed, machine learning techniques were applied to explore heterogeneity, and subgroup analyses were carried out to assess efficacy across anatomical sites including alveolar sockets, palatal clefts, and spinal fusion.

Results: No significant difference was found in the overall bone healing rate between the rhBMP-2 and control groups (relative risk [RR] = 1.02, 95% confidence interval [CI] 0.87-1.20). However, rhBMP-2 demonstrated a significant advantage in spinal fusion (RR = 1.09, 95% CI 1.01-1.17) and a positive, although not statistically significant, trend in small oral and jaw bone defects. The incidence of serious adverse events was comparable (RR = 0.97, 95% CI 0.66-1.42). Network meta-analysis indicated that the overall success rate of bone regeneration with rhBMP-2 (odds ratio [OR] = 1.53, 95% CI 0.54-4.33) and other bone substitutes (OR = 1.42, 95% CI 0.39- 5.21) did not significantly exceed autograft treatment, although both showed a trend toward superiority. Direct pairwise comparison revealed that rhBMP-2 was significantly more effective than autograft (OR = 1.54, 95% CI 1.02-2.33, p < 0.05), with low heterogeneity (I2 = 0%).

Conclusion: While the overall healing rate was comparable to controls, rhBMP-2 showed significant efficacy in spinal fusion and a favorable safety profile. Its effectiveness was context-specific, influenced by anatomical site and patient factors. These findings support the selective use of rhBMP-2 in specific clinical contexts such as spinal surgery, while further research is needed to optimize its application in other indications.

Declarations

Author Contributions

L.Y.: Conceptualization; L.Y., J.Z., C.C.: Data curation, formal analysis, investigation, methodology, resources, software, writing-original draft, writing-review & editing; L.Y., J.Z.: Supervision; L.Y., C.C.: Validation, visualization. All authors read and approved the final manuscript.

Conflict of Interest

The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.

Financial Disclosure

The authors received no financial support for the research and/or authorship of this article.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

AI Disclosure

The authors declare that artificial intelligence (AI) tools were not used, or were used solely for language editing, and had no role in data analysis, interpretation, or the formulation of conclusions. All scientific content, data interpretation, and conclusions are the sole responsibility of the authors. The authors further confirm that AI tools were not used to generate, fabricate, or ‘hallucinate’ references, and that all references have been carefully verified for accuracy.

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