Evidence map›Paper›PMID 40844304›Full record

Trial reportClinical oral implants research2025

Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial.

Mariano Sanz, Cecilie Gjerde, Bjørn Tore Gjertsen, Alberto Ortiz-Vigón, Nerea Sanchez, Alain Hoornaert, Jordi Caballe-Serrano, Maria Giralt-Hernando, Frederick Gaultier, Nicoleta Reinald and 10 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Clinical oral implants research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT03373052 no registry record found
NCT04297813 phase3completednot on this map

Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting

TypeinterventionalSponsorUniversity of BergenRan2020 to 2024Enrolled48ConditionsAlveolar Bone AtrophyArmsAdvanced medicinal Therapy (MSC combined with biomaterial), Autologous bone graft
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
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

20 authors.

Mariano SanzEtiology and Therapy of Periodontal and Periimplant Diseases (ETEP) Research Group, Faculty of Odontology, Complutense University, Madrid, Spain.ORCID 0000-0002-6293-5755
Cecilie GjerdeCenter of Translational Oral Research - Tissue Engineering, Department of Clinical Dentistry, Faculty of Medicine, University of Bergen (UiB), Bergen, Norway.ORCID 0000-0002-7581-6413
Bjørn Tore GjertsenDepartment of Clinical Science, Faculty of Medicine, University of Bergen (UiB), Bergen, Norway.ORCID 0000-0001-9358-9704
Alberto Ortiz-VigónEtiology and Therapy of Periodontal and Periimplant Diseases (ETEP) Research Group, Faculty of Odontology, Complutense University, Madrid, Spain.ORCID 0000-0002-1863-5907
Nerea SanchezEtiology and Therapy of Periodontal and Periimplant Diseases (ETEP) Research Group, Faculty of Odontology, Complutense University, Madrid, Spain.ORCID 0000-0003-1681-428X
Alain HoornaertCHU Nantes, UIC 11 Odontologie, Université de Nantes, Nantes, France.ORCID 0000-0002-8779-512X
Jordi Caballe-SerranoDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universitat Internacional de Catalunya (UIC), Barcelona, Spain.ORCID 0000-0003-4684-4770
Maria Giralt-HernandoDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universitat Internacional de Catalunya (UIC), Barcelona, Spain.ORCID 0000-0003-3329-4845
Frederick GaultierOral Surgery, Hôpital Henri Mondor APHP, Université Paris Cité, Paris, France.ORCID 0000-0003-3595-4464
Nicoleta ReinaldOral Surgery, Hôpital Henri Mondor APHP, Université Paris Cité, Paris, France.
Else Marie PinholtOral and Maxillofacial Surgery Department, Syddansk Universitet SDU, Odense, Denmark.ORCID 0000-0002-4002-0095
Markus RojewskiInstitute for Transfusion Medicine and Immunogenetic Ulm, University Hospital Ulm (IKT Ulm) and German Red Cross Blood Transfusion Servise Baden-Württenberg-Hessen, Ulm, Germany.
Helen RouardEtablissement Français du Sang and Univ Paris Est Creteil, INSERM IMRB, Centre d'Investigation Clinique 1430, AP-HP, Hôpital Henri Mondor, Creteil, France.
Nathalie ChevallierEtablissement Français du Sang and Univ Paris Est Creteil, INSERM IMRB, Centre d'Investigation Clinique 1430, AP-HP, Hôpital Henri Mondor, Creteil, France.
Samih Mohamed-AhmedCenter of Translational Oral Research - Tissue Engineering, Department of Clinical Dentistry, Faculty of Medicine, University of Bergen (UiB), Bergen, Norway.ORCID 0000-0002-2909-8895
Xieqi ShiCenter of Translational Oral Research - Tissue Engineering, Department of Clinical Dentistry, Faculty of Medicine, University of Bergen (UiB), Bergen, Norway.ORCID 0000-0001-6967-4407
Tie-Jun ShiCenter of Translational Oral Research - Tissue Engineering, Department of Clinical Dentistry, Faculty of Medicine, University of Bergen (UiB), Bergen, Norway.ORCID 0000-0002-8736-0329
Hubert SchrezenmeierInstitute for Transfusion Medicine and Immunogenetic Ulm, University Hospital Ulm (IKT Ulm) and German Red Cross Blood Transfusion Servise Baden-Württenberg-Hessen, Ulm, Germany.
Pierre LayrolleInserm | INSERM/UPS UMR1214, Tonic CHU PURPAN. Pavillon Baudot - Place du Dr Baylac, Toulouse, France.ORCID 0000-0001-9800-5210
Kamal MustafaCenter of Translational Oral Research - Tissue Engineering, Department of Clinical Dentistry, Faculty of Medicine, University of Bergen (UiB), Bergen, Norway.ORCID 0000-0002-2968-2856

Funding

European Union 779322
6 · The paper itself

Abstract

objectivesTo assess the efficacy and safety of a cell-based therapy for 3D bone augmentation of severe alveolar bone defects prior to dental implant placement. MATERIALS AND

methodsA Phase 2 randomized controlled clinical trial evaluated the safety and efficacy of a cell therapy using expanded autologous iliac crest-derived mesenchymal cells seeded on a synthetic bioabsorbable bone substitute covered with a non-resorbable membrane. The control group received an autogenous bone block graft. After 5 months, CBCT scans were compared to measure the bone volume changes achieved after the regenerative surgery. Subsequently, dental implants were placed in the regenerated areas.

resultsA total of 48 patients were included and randomized (36 patients in the test group and 12 in the control group). However, seven patients did not reach the minimum required number of expanded MSCs and were therefore unable to be treated. The tested intervention demonstrated significantly greater gains in bone volume, with a mean difference of 480.01 mm

conclusionsThe cell-based therapy resulted in significant changes in bone volume compared to the control treatment, enabling dental implants in all patients. The procedure was associated with minimal adverse effects and patient morbidity.

trial registrationClinicalTrials.gov: NCT03373052, NCT04297813.

Indexed as

Alveolar Bone LossAlveolar Ridge AugmentationBone SubstitutesMesenchymal Stem Cell TransplantationAdultAgedBone RegenerationCone-Beam Computed TomographyDental Implantation, EndosseousFemaleHumansMaleMiddle AgedTreatment OutcomeBone Substitutesalveolar ridge augmentationbone regenerationcell therapymesenchymal cells dental implants

Identifiers

PMID40844304
PMCPMC12598908

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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 Socratic graph.