Evidence map›Paper›PMID 38847929›Full record

Trial reportClinical oral investigations2024

Inflammatory and bone remodelling related biomarkers following periodontal transplantation of the tissue engineered biocomplex.

Danae A Apatzidou, Jordan M Iliopoulos, Antonis Konstantinidis, Mukul Verma, Philip Hardy, David F Lappin, Christopher J Nile

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical oral investigations, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02449005 (A Phase I/II Double-Blind Randomised Controlled Clinical Trial To Study The Safety and Efficacy Of A Novel Regenerative Treatment Of Infrabony Periodontal Defects Using Autologous Alveolar Bone-Marrow Mesenchymal Stem Cells), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT02449005 phase1 / phase2completednot on this map

A Phase I/II Double-Blind Randomised Controlled Clinical Trial To Study The Safety and Efficacy Of A Novel Regenerative Treatment Of Infrabony Periodontal Defects Using Autologous Alveolar Bone-Marrow Mesenchymal Stem Cells (aBM-MSCs).

TypeinterventionalSponsorAristotle University Of ThessalonikiRan2014 to 2016Enrolled30ConditionsChronic PeriodontitisArmsBM-MSCs/fibrin glue/collagen fleece, Fibrin glue/collagen fleece, Open flap debridement
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
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.

Danae A ApatzidouDepartment of Preventive Dentistry, Periodontology and Implant Biology, School of Dentistry, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece. perioapatzidou@yahoo.gr.
Jordan M IliopoulosSchool of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Antonis KonstantinidisDepartment of Preventive Dentistry, Periodontology and Implant Biology, School of Dentistry, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Mukul VermaFaculty of Medical Sciences, School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.
Philip HardyFaculty of Medical Sciences, School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.
David F LappinOral Sciences Research Group, Dental School, University of Glasgow, Glasgow, UK.
Christopher J NileFaculty of Medical Sciences, School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess gingival crevicular fluid (GCF) levels of inflammatory and bone remodelling related biomarkers following transplantation of a tissue-engineered biocomplex into intrabony defects at several time-points over 12-months. MATERIALS AND

methodsGroup-A (n = 9) received the Minimal Access Flap (MAF) surgical technique combined with a biocomplex of autologous clinical-grade alveolar bone-marrow mesenchymal stem cells in collagen scaffolds enriched with an autologous fibrin/platelet lysate (aFPL). Group-B (n = 10) received the MAF surgery, with collagen scaffolds enriched with aFPL and Group-C (n = 8) received the MAF surgery alone. GCF was collected from the osseous defects of subjects via paper strips/30 sec at baseline, 6-weeks, 3-, 6-, 9-, 12-months post-surgery. Levels of inflammatory and bone remodelling-related biomarkers in GCF were determined by ELISA.

resultsGroup-A demonstrated significantly higher GCF levels of BMP-7 at 6-9 months than baseline, with gradually decreasing levels of pro-inflammatory and pro-osteoclastogenic markers (TNF-α, RANKL) over the study-period; and an overall decrease in the RANKL/OPG ratio at 9-12 months than baseline (all p < 0.001). In comparison, only modest interim changes were observed in Groups-B and -C.

conclusionsAt the protein level, the approach of MAF and biocomplex transplantation provided greater tissue regeneration potential as cell-based therapy appeared to modulate inflammation and bone remodelling in residual periodontal defects. CLINICAL RELEVANCE: Transplantation of a tissue engineered construct into periodontal intrabony defects demonstrated a biochemical pattern for inflammatory control and tissue regeneration over 12-months compared to the control treatments. Understanding the biological healing events of stem cell transplantation may facilitate the design of novel treatment strategies. CLINICAL DATABASE REGISTRATION: ClinicalTrials.gov ID: NCT02449005.

Indexed as

BiomarkersBone RemodelingGingival Crevicular FluidTissue EngineeringTissue ScaffoldsCollagenEnzyme-Linked Immunosorbent AssayHumansSurgical FlapsTreatment OutcomeBiomarkersCollagenGCF biomarkersIntrabony defectsPeriodontal regenerationPeriodontal surgeryPeriodontitisStem cells

Identifiers

PMID38847929

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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.