The Clinical Efficacy and Safety of ErhBMP-2/BioCaP/β-TCP as a Novel Bone Substitute Using the Tooth-Extraction-Socket-Healing Model: A Proof-of-Concept Randomized Controlled Trial

Lingfei Wei; Yuanyuan Sun; Dedong Yu; Herman Pieterse; Daniel Wismeijer; Yuelian Liu; Yiqun Wu

doi:10.1111/jcpe.14084

The Clinical Efficacy and Safety of ErhBMP-2/BioCaP/β-TCP as a Novel Bone Substitute Using the Tooth-Extraction-Socket-Healing Model: A Proof-of-Concept Randomized Controlled Trial

Lingfei Wei, Yuanyuan Sun, Dedong Yu, Herman Pieterse, Daniel Wismeijer, Yuelian Liu^*, Yiqun Wu^*

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Aim: This first randomized controlled trial in humans aimed to assess the efficacy and safety of low-dosage Escherichia coli-derived recombinant human bone morphogenetic protein 2 (ErhBMP-2)-incorporated biomimetic calcium phosphate coating-functionalized β-TCP (ErhBMP-2/BioCaP/β-TCP) as a novel bone substitute using the tooth-extraction-socket-healing model.

Materials and Methods: Forty patients requiring dental implants after single-root tooth extraction were enrolled in this study and randomly assigned into three groups: ErhBMP-2/BioCaP/β-TCP (N = 15), β-TCP (N = 15) and natural healing (N = 10). New bone volume density from histomorphometric analyses was evaluated 6 weeks post-operatively as the primary outcome, and other histomorphometric analyses, alveolar bone and soft-tissue changes were the secondary outcomes. Safety parameters included adverse events, soft-tissue healing, oral health impact profile, serum BMP-2 concentrations and other laboratory tests.

Results: The findings revealed a significant increase in new bone volume density in patients treated with ErhBMP-2/BioCaP/β-TCP compared to those receiving β-TCP alone. The required bone augmentation procedures during implant placement surgery in the ErhBMP-2/BioCaP/β-TCP group were significantly less than in the natural healing group. There were no significant differences in safety parameters among the three groups.

Conclusion: This clinical trial primarily proved the safety and efficacy of ErhBMP-2/BioCaP/β-TCP as a promising bone substitute.

Original language	English
Pages (from-to)	299-309
Number of pages	11
Journal	Journal of Clinical Periodontology
Volume	52
Issue number	2
Early online date	31 Oct 2024
DOIs	https://doi.org/10.1111/jcpe.14084
Publication status	Published - Feb 2025

Bibliographical note

Publisher Copyright:
© 2024 The Author(s). Journal of Clinical Periodontology published by John Wiley & Sons Ltd.

Funding

This work was supported by the National Natural Science Foundation of China: No. 82100965; ZonMW Project: No. 40‐43600‐98‐14006; Natural Science Foundation of Shandong Province: No. ZR2020QH162; Natural Science Foundation of Yantai: No. 2021MSGY051; Shanghai Clinical Research Center for Oral Diseases: No. 19MC1910600; Shanghai Municipal Key Clinical Specialty: No. shslczdzk01601; Shanghai’s Top Priority Research Center: No. 2022ZZ01017; CAMS Innovation Fund for Medical Sciences(CIFMS): No. 2019‐I2M‐5‐037. Funding: Funding: This work was supported by the National Natural Science Foundation of China: No. 82100965; ZonMW Project: No. 40-43600-98-14006; Natural Science Foundation of Shandong Province: No. ZR2020QH162; Natural Science Foundation of Yantai: No. 2021MSGY051; Shanghai Clinical Research Center for Oral Diseases: No. 19MC1910600; Shanghai Municipal Key Clinical Specialty: No. shslczdzk01601; Shanghai’s Top Priority Research Center: No. 2022ZZ01017; CAMS Innovation Fund for Medical Sciences(CIFMS): No. 2019-I2M-5-037. We thank Dr. Wentao Shi, Dr. Pauline Meewisse, Prof. Klaas de Groot, Prof. Ernst B Hunziker, Dr. Arjan van Wijk and Dr. Brigit Witte for their assistance in this study. We also thank the Shanghai Rebone Biomaterials Co. Ltd. for manufacturing bone substitutes and Straumann AG for the free dental implants.

Funders	Funder number
Chinese Academy of Meteorological Sciences
Shanghai Rebone Biomaterials Co. Ltd.
Shanghai’s Top Priority Research Center	2022ZZ01017
Natural Science Foundation of Shandong Province	ZR2020QH162
Shanghai Municipal Key Clinical Specialty	shslczdzk01601
Natural Science Foundation of Yantai	2021MSGY051
Shanghai Clinical Research Center	19MC1910600
ZonMw	40‐43600‐98‐14006
CIFMS	2019‐I2M‐5‐037
National Natural Science Foundation of China	82100965

Keywords

biomimetic
bone morphogenetic protein 2
bone regeneration
randomized controlled trial
tooth-extraction-socket healing

Access to Document

10.1111/jcpe.14084

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Cite this

@article{bcaecb4f9936454e99d2b3ecb1ee0887,

title = "The Clinical Efficacy and Safety of ErhBMP-2/BioCaP/β-TCP as a Novel Bone Substitute Using the Tooth-Extraction-Socket-Healing Model: A Proof-of-Concept Randomized Controlled Trial",

abstract = "Aim: This first randomized controlled trial in humans aimed to assess the efficacy and safety of low-dosage Escherichia coli-derived recombinant human bone morphogenetic protein 2 (ErhBMP-2)-incorporated biomimetic calcium phosphate coating-functionalized β-TCP (ErhBMP-2/BioCaP/β-TCP) as a novel bone substitute using the tooth-extraction-socket-healing model. Materials and Methods: Forty patients requiring dental implants after single-root tooth extraction were enrolled in this study and randomly assigned into three groups: ErhBMP-2/BioCaP/β-TCP (N = 15), β-TCP (N = 15) and natural healing (N = 10). New bone volume density from histomorphometric analyses was evaluated 6 weeks post-operatively as the primary outcome, and other histomorphometric analyses, alveolar bone and soft-tissue changes were the secondary outcomes. Safety parameters included adverse events, soft-tissue healing, oral health impact profile, serum BMP-2 concentrations and other laboratory tests. Results: The findings revealed a significant increase in new bone volume density in patients treated with ErhBMP-2/BioCaP/β-TCP compared to those receiving β-TCP alone. The required bone augmentation procedures during implant placement surgery in the ErhBMP-2/BioCaP/β-TCP group were significantly less than in the natural healing group. There were no significant differences in safety parameters among the three groups. Conclusion: This clinical trial primarily proved the safety and efficacy of ErhBMP-2/BioCaP/β-TCP as a promising bone substitute.",

keywords = "biomimetic, bone morphogenetic protein 2, bone regeneration, randomized controlled trial, tooth-extraction-socket healing",

author = "Lingfei Wei and Yuanyuan Sun and Dedong Yu and Herman Pieterse and Daniel Wismeijer and Yuelian Liu and Yiqun Wu",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s). Journal of Clinical Periodontology published by John Wiley \& Sons Ltd.",

year = "2025",

month = feb,

doi = "10.1111/jcpe.14084",

language = "English",

volume = "52",

pages = "299--309",

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issn = "0303-6979",

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The Clinical Efficacy and Safety of ErhBMP-2/BioCaP/β-TCP as a Novel Bone Substitute Using the Tooth-Extraction-Socket-Healing Model: A Proof-of-Concept Randomized Controlled Trial. / Wei, Lingfei; Sun, Yuanyuan; Yu, Dedong et al.
In: Journal of Clinical Periodontology, Vol. 52, No. 2, 02.2025, p. 299-309.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - The Clinical Efficacy and Safety of ErhBMP-2/BioCaP/β-TCP as a Novel Bone Substitute Using the Tooth-Extraction-Socket-Healing Model

T2 - A Proof-of-Concept Randomized Controlled Trial

AU - Wei, Lingfei

AU - Sun, Yuanyuan

AU - Yu, Dedong

AU - Pieterse, Herman

AU - Wismeijer, Daniel

AU - Liu, Yuelian

AU - Wu, Yiqun

PY - 2025/2

Y1 - 2025/2

N2 - Aim: This first randomized controlled trial in humans aimed to assess the efficacy and safety of low-dosage Escherichia coli-derived recombinant human bone morphogenetic protein 2 (ErhBMP-2)-incorporated biomimetic calcium phosphate coating-functionalized β-TCP (ErhBMP-2/BioCaP/β-TCP) as a novel bone substitute using the tooth-extraction-socket-healing model. Materials and Methods: Forty patients requiring dental implants after single-root tooth extraction were enrolled in this study and randomly assigned into three groups: ErhBMP-2/BioCaP/β-TCP (N = 15), β-TCP (N = 15) and natural healing (N = 10). New bone volume density from histomorphometric analyses was evaluated 6 weeks post-operatively as the primary outcome, and other histomorphometric analyses, alveolar bone and soft-tissue changes were the secondary outcomes. Safety parameters included adverse events, soft-tissue healing, oral health impact profile, serum BMP-2 concentrations and other laboratory tests. Results: The findings revealed a significant increase in new bone volume density in patients treated with ErhBMP-2/BioCaP/β-TCP compared to those receiving β-TCP alone. The required bone augmentation procedures during implant placement surgery in the ErhBMP-2/BioCaP/β-TCP group were significantly less than in the natural healing group. There were no significant differences in safety parameters among the three groups. Conclusion: This clinical trial primarily proved the safety and efficacy of ErhBMP-2/BioCaP/β-TCP as a promising bone substitute.

AB - Aim: This first randomized controlled trial in humans aimed to assess the efficacy and safety of low-dosage Escherichia coli-derived recombinant human bone morphogenetic protein 2 (ErhBMP-2)-incorporated biomimetic calcium phosphate coating-functionalized β-TCP (ErhBMP-2/BioCaP/β-TCP) as a novel bone substitute using the tooth-extraction-socket-healing model. Materials and Methods: Forty patients requiring dental implants after single-root tooth extraction were enrolled in this study and randomly assigned into three groups: ErhBMP-2/BioCaP/β-TCP (N = 15), β-TCP (N = 15) and natural healing (N = 10). New bone volume density from histomorphometric analyses was evaluated 6 weeks post-operatively as the primary outcome, and other histomorphometric analyses, alveolar bone and soft-tissue changes were the secondary outcomes. Safety parameters included adverse events, soft-tissue healing, oral health impact profile, serum BMP-2 concentrations and other laboratory tests. Results: The findings revealed a significant increase in new bone volume density in patients treated with ErhBMP-2/BioCaP/β-TCP compared to those receiving β-TCP alone. The required bone augmentation procedures during implant placement surgery in the ErhBMP-2/BioCaP/β-TCP group were significantly less than in the natural healing group. There were no significant differences in safety parameters among the three groups. Conclusion: This clinical trial primarily proved the safety and efficacy of ErhBMP-2/BioCaP/β-TCP as a promising bone substitute.

KW - biomimetic

KW - bone morphogenetic protein 2

KW - bone regeneration

KW - randomized controlled trial

KW - tooth-extraction-socket healing

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