MedPath

Regulatory T Cell With Related Interleukins in Periodontal Disease Progression

Completed
Conditions
Periodontitis
Gingivitis
Interventions
Diagnostic Test: Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA
Registration Number
NCT06135116
Lead Sponsor
Al-Azhar University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
chronic periodontitisFlow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAtwenty patients 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
periodontally healthyFlow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAtwenty 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.
chronic gingivitisFlow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISAtwenty 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.
Primary Outcome Measures
NameTimeMethod
Treg cells frequencybaseline(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 protienbaseline(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 Outcome Measures
NameTimeMethod
Probing pocket depthBaseline(through clinical diagnosis completion)

it was measured from the gingival margin to the base of the pocket by William's graduated periodontal probe

dental Plaque scorebaseline(through clinical diagnosis completion)

measured by O'Leary Plaque score as following; bacterial deposits where be stained with a disclosing solution to facilitate their detection. Calculation = the number of plaque containing surfaces / the total number of available surfaces. In the rating system, 0% indicates absence of plaque, with 15 %, 20 %, and \> 40% indicating an increased percentage of plaque accumulation.

Bleeding on probing (BoP)Baseline(through clinical diagnosis completion)

By a force of 0.25 N. by a manual pressure of sensitive probe, recorded on distal, facial, mesial, gingival surfaces. Bleeding on probing (BoP) Calculated as following; Number of bleeding surfaces / total number of tooth surface) multiplying in one hundred and expressed in percentage (%). In the rating system, 0 indicates absence of bleeding on probing (healthy), with 15%, 20% (gingivitis) and \>20% indicating an increased percentage of inflammation/infection (periodontitis).

Attachment levelBaseline(through clinical diagnosis completion)

it was measured by subtracting the distance from the cemento-enamel junction to the free gingival margin from the distance from the free gingival margin to the base of the pocket both were properly measured using William's graduated probe and the difference between the two measurements yields the attachment level

Trial Locations

Locations (1)

Department of oral medicine, Periodontology, Oral diagnosis and dental radiology Faculty of dental medicine

🇪🇬

Assiut, Asyut, Egypt

© Copyright 2025. All Rights Reserved by MedPath