Evidence map›Paper›PMID 39478364›Full record

Trial reportJournal of clinical periodontology2025

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

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical periodontology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Lingfei WeiDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology; Research Unit of Oral and Maxillofacial Regenerative Medicine, Chinese Academy of Medical Sciences, Shanghai, China.ORCID 0000-0001-5035-4817
Yuanyuan SunDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology; Research Unit of Oral and Maxillofacial Regenerative Medicine, Chinese Academy of Medical Sciences, Shanghai, China.
Dedong YuDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology; Research Unit of Oral and Maxillofacial Regenerative Medicine, Chinese Academy of Medical Sciences, Shanghai, China.
Herman PieterseProfess Medical Consultancy BV, Heerhugowaard, The Netherlands.
Daniel WismeijerTPE, Private Practice, Ellecom, The Netherlands.
Yuelian LiuDepartment of Oral Cell Biology, Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-5472-6849
Yiqun WuDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology; Research Unit of Oral and Maxillofacial Regenerative Medicine, Chinese Academy of Medical Sciences, Shanghai, China.

Funding

CAMS Innovation Fund for Medical Sciences (CIFMS) 2019-I2M-5-037National Natural Science Foundation of China 82100965Natural Science Foundation of Shandong Province ZR2020QH162Natural Science Foundation of Yantai 2021MSGY051Shanghai Clinical Research Center for Oral Diseases 19MC1910600Shanghai Municipal Key Clinical Specialty shslczdzk01601Shanghai's Top Priority Research Center 2022ZZ01017ZonMW Project 40-43600-98-14006
6 · The paper itself

Abstract

aimThis 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

methodsForty 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.

resultsThe 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.

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

Indexed as

Bone Morphogenetic Protein 2Bone SubstitutesCalcium PhosphatesTooth ExtractionTooth SocketAdultAgedBone DensityCeramicsFemaleHumansMaleMiddle AgedProof of Concept StudyRecombinant ProteinsTransforming Growth Factor betabeta-tricalcium phosphateBone Morphogenetic Protein 2Bone SubstitutesCalcium Phosphatesrecombinant human bone morphogenetic protein-2Recombinant ProteinsTransforming Growth Factor betabiomimeticbone morphogenetic protein 2bone regenerationrandomized controlled trialtooth‐extraction‐socket healing

Identifiers

PMID39478364
PMCPMC11743062

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.