Evidence map›Paper›PMID 26895633›Full record

Trial reportStem cell research & therapy2016

Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

Fa-Ming Chen, Li-Na Gao, Bei-Min Tian, Xi-Yu Zhang, Yong-Jie Zhang, Guang-Ying Dong, Hong Lu, Qing Chu, Jie Xu, Yang Yu and 4 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01357785 (Periodontal Tissue Regeneration Using Autologous Periodontal Ligament Stem Cells), which is not on this map. Cited by 186 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
186citing papers in PubMed, 9 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.

NCT01357785 phase1unknown statusnot on this map

Periodontal Tissue Regeneration Using Autologous Periodontal Ligament Stem Cells: Randomized Controlled Clinical Trial

TypeinterventionalSponsorAir Force Military Medical University, ChinaRan2011 to 2014Enrolled35ConditionsPeriodontal PocketArmsCell therapy
3 · Its place in the literature

Who cites it

186 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  6. Periodontal Cell Therapy: A Systematic Review and Meta-analysis.Advances in experimental medicine and biology · 2022
    Pooled it
  7. Periodontal Cell Therapy: A Systematic Review and Meta-analysis.Advances in experimental medicine and biology · 2022
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126 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Fa-Ming ChenState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China. cfmsunhh@fmmu.edu.cn.
Li-Na GaoState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Bei-Min TianState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Xi-Yu ZhangState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Yong-Jie ZhangState Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Guang-Ying DongState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Hong LuState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Qing ChuState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Jie XuState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Yang YuState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Rui-Xin WuState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Yuan YinState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
Songtao ShiDepartment of Anatomy and Cell Biology, School of Dental Medicine, University of Pennsylvania, 240 South 40th Street, Philadelphia, PA, 19104, USA. songtaos@dental.upenn.edu.
Yan JinState Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China. yanjin@fmmu.edu.cn.

Funding

OSTEOGENIC MECHANISMS OF SHEDR01DE017449 · NIDCR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI SHI, SONGTAO · 2007 to 2017
$3.5M
NIDCR NIH HHS R01 DE017449
6 · The paper itself

Abstract

backgroundPeriodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry.

methodsWe conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure.

resultsA total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p < 0.001). However, no statistically significant differences were detected between the Cell group and the Control group (p > 0.05).

conclusionsThis study demonstrates that using autologous PDLSCs to treat periodontal intrabony defects is safe and does not produce significant adverse effects. The efficacy of cell-based periodontal therapy requires further validation by multicenter, randomized controlled studies with an increased sample size.

trial registrationNCT01357785 Date registered: 18 May 2011.

Indexed as

Stem Cell TransplantationAdolescentAdultAdult Stem CellsAgedBone RegenerationCells, CulturedFemaleHumansJaw DiseasesMaleMiddle AgedPeriodontal LigamentPeriodontitisRadiographyRegenerative Medicine

Identifiers

PMID26895633
PMCPMC4761216

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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 OpenQuestion graph.