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Clinical Trials/NCT06135116
NCT06135116
Completed
Not Applicable

CD4+CD25+High FOXp3+ Regulatory T Cell With Related Interleukins and Vitamin D-binding Protein in Periodontal Disease Progression : Synergy or Cocaphony

Al-Azhar University1 site in 1 country60 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Al-Azhar University
Enrollment
60
Locations
1
Primary Endpoint
Treg cells frequency
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

T Regulatory cells which suppressor subset of T cells and related cytokines remain in blood and infiltrates into the tissue under need. The role of Treg and related cytokines in succession of periodontal inflammation is recently a subject of research interest. Chronic gingivitis and periodontitis being chronic inflammatory diseases can upregulate various cytokines in the systemic circulation and gingival crevicular fluid. This study aimed to compare levels of Tregs with Interleukin-21, 22, 33, 35 and vitamin D-binding protein in blood and GCF of periodontally healthy persons, chronic gingivitis patients, and severe chronic periodontitis patients.

Detailed Description

T regs infiltration might reveal a trial to control tissue damage, however it also might be suggestive of a destructive effect of Tregs in periodontitis . Tregs can actually play a damaging role as this cells can annoyingly weaken the immune reaction towards infectious agents that could be possibly harmful in a periodontal environment . Immunopathology of Treg cell mediated via its pro-inflammatory cytokines during inflammatory conditions. IL-33 "recent member of pro-inflammatory IL-1 category" was recognized as placard in the stability of Foxp3+ Treg cell at mucosal sites. IL-33 has either pro- or anti-inflammatory property according to the disease and the model. It was speculated that IL-33 could improve the propagation from suppressive to dysregulated Treg cells in a dose-dependent manner . Interleukin (IL)-21 which member of the type I (ℽ chain) cytokine family has the ability to minimize FoxP3 expression and restraining Treg suppressor function and homeostasis . The purpose from this study was to assess the role of circulating and localized Treg with their related cytokines in patients with inflammation of periodontal tissues and to correlate their levels with disease progression.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asem Mohammed Kamel Ali

lecturer ,Oral medicine and periodontology

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • periodontally healthy persons without any signs of periodontal disease. This was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm.
  • persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss.
  • persons having severe generalized form of chronic periodontitis exhibiting PPD ≥ 6 mm, CAL ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph.

Exclusion Criteria

  • Patients with systemic diseases according to Modified Cornell Medical Index criteria
  • Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
  • Patients subjected to previous periodontal therapy 6 months before sampling.
  • Patients with systemic or local inflammatory conditions other than periodontal disease.
  • The smokers.
  • Neither lactating nor pregnant.

Outcomes

Primary Outcomes

Treg cells frequency

Time Frame: baseline(through clinical diagnosis completion)

evaluation of frequency of systemic and GCF levels of T regs in patients (periodontitis and gingivitis) and healthy group.Regulatory T cells were quantitively estimated using fluoroisothiocyanate (FITC)-conjugated Foxp3 (e Bioscience, USA), phycoerythrin (PE) conjugated CD25 (IQ Product, The Netherland) and peridinium-chlorophyll-protein (Per-CP)-conjugated CD4 (Becton Dickinson, Bioscience, USA).

Cytokines levels (IL-22, IL-21, IL-35, IL-33) and vitamin D binding protien

Time Frame: baseline(through clinical diagnosis completion)

comparative evaluation of systemic and GCF levels of cytokines in different periodontal conditions; healthy, gingivitis and periodontitis.they were measured by a commercially available enzyme-linked immunosorbent assay kits as following; ELISA kit (Legend Max, BioLegend, San Diego, CA, USA) with undetectable level below 20 pg/ml for IL-21, ELISA kit (RayBiotech. Norcross, Georgia, USA) with undetectable level below 8 pg/ml for IL-22, ELISA kit (GenWay Biotech Inc. San Diego, CA, USA) with undetectable level below 0.7ng/ml for IL-33, ELISA kit (Glory Science CO., Ltd, Del Rio, TX, USA) for IL-35 and finally ELISA kit (BioSource Systems, Invitrogen, Grand Island, NY, USA) for DBP.

Secondary Outcomes

  • dental Plaque score(baseline(through clinical diagnosis completion))
  • Probing pocket depth(Baseline(through clinical diagnosis completion))
  • Bleeding on probing (BoP)(Baseline(through clinical diagnosis completion))
  • Attachment level(Baseline(through clinical diagnosis completion))

Study Sites (1)

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