Regulatory T Cell With Related Interleukins in Periodontal Disease Progression

NCT ID: NCT06135116

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-01-01

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.

Conditions

Periodontitis; Gingivitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

periodontally healthy

twenty 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.

Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA

Intervention Type: DIAGNOSTIC_TEST

Gingival crevicular fluid samples collection After removing supragingival plaque, sampling sites were isolated by cotton rolls and dried using air syringe, GCF samples were collected by inserting standardized paper point in the sulcus/ pocket at the proximal-facial line angle of six preselected sites in each patient teeth . Fluid was sucked by paper points for 30 seconds. The samples were immediately placed inside graduated eppendorf vials containing 250µl phosphate-buffered saline (PBS), and transported to the laboratory for subsequent assays .

Blood Samples Collection From control and patient groups and under standard aseptic conditions, the peripheral blood was collected in Ethelene Diamine Tetra Acetic Acid (EDTA) coated vacutainer tubes (K2 EDTA) 5.4mg (BD vacutainer) and transferred immediately to flow cytometric analysis lab.

chronic gingivitis

twenty 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.

Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA

Intervention Type: DIAGNOSTIC_TEST

Gingival crevicular fluid samples collection After removing supragingival plaque, sampling sites were isolated by cotton rolls and dried using air syringe, GCF samples were collected by inserting standardized paper point in the sulcus/ pocket at the proximal-facial line angle of six preselected sites in each patient teeth . Fluid was sucked by paper points for 30 seconds. The samples were immediately placed inside graduated eppendorf vials containing 250µl phosphate-buffered saline (PBS), and transported to the laboratory for subsequent assays .

Blood Samples Collection From control and patient groups and under standard aseptic conditions, the peripheral blood was collected in Ethelene Diamine Tetra Acetic Acid (EDTA) coated vacutainer tubes (K2 EDTA) 5.4mg (BD vacutainer) and transferred immediately to flow cytometric analysis lab.

chronic periodontitis

twenty 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

Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA

Intervention Type: DIAGNOSTIC_TEST

Gingival crevicular fluid samples collection After removing supragingival plaque, sampling sites were isolated by cotton rolls and dried using air syringe, GCF samples were collected by inserting standardized paper point in the sulcus/ pocket at the proximal-facial line angle of six preselected sites in each patient teeth . Fluid was sucked by paper points for 30 seconds. The samples were immediately placed inside graduated eppendorf vials containing 250µl phosphate-buffered saline (PBS), and transported to the laboratory for subsequent assays .

Blood Samples Collection From control and patient groups and under standard aseptic conditions, the peripheral blood was collected in Ethelene Diamine Tetra Acetic Acid (EDTA) coated vacutainer tubes (K2 EDTA) 5.4mg (BD vacutainer) and transferred immediately to flow cytometric analysis lab.

Interventions

Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA

Gingival crevicular fluid samples collection After removing supragingival plaque, sampling sites were isolated by cotton rolls and dried using air syringe, GCF samples were collected by inserting standardized paper point in the sulcus/ pocket at the proximal-facial line angle of six preselected sites in each patient teeth . Fluid was sucked by paper points for 30 seconds. The samples were immediately placed inside graduated eppendorf vials containing 250µl phosphate-buffered saline (PBS), and transported to the laboratory for subsequent assays .

Blood Samples Collection From control and patient groups and under standard aseptic conditions, the peripheral blood was collected in Ethelene Diamine Tetra Acetic Acid (EDTA) coated vacutainer tubes (K2 EDTA) 5.4mg (BD vacutainer) and transferred immediately to flow cytometric analysis lab.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Asem Mohammed Kamel Ali

lecturer ,Oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Asyut, Asyut Governorate, Egypt

Countries

Egypt

References

Zhang X, Meng H, Sun X, Xu L, Zhang L, Shi D, Feng X, Lu R, Chen Z. Elevation of vitamin D-binding protein levels in the plasma of patients with generalized aggressive periodontitis. J Periodontal Res. 2013 Feb;48(1):74-9. doi: 10.1111/j.1600-0765.2012.01505.x. Epub 2012 Jul 18.

Reference Type: BACKGROUND

PMID: 22803589 (View on PubMed)

Nakajima T, Ueki-Maruyama K, Oda T, Ohsawa Y, Ito H, Seymour GJ, Yamazaki K. Regulatory T-cells infiltrate periodontal disease tissues. J Dent Res. 2005 Jul;84(7):639-43. doi: 10.1177/154405910508400711.

Reference Type: BACKGROUND

PMID: 15972593 (View on PubMed)

Hasan A, Palmer RM. A clinical guide to periodontology: pathology of periodontal disease. Br Dent J. 2014 Apr;216(8):457-61. doi: 10.1038/sj.bdj.2014.299.

Reference Type: BACKGROUND

PMID: 24762896 (View on PubMed)

Other Identifiers

Treg in periodontitis

Identifier Type: -

Identifier Source: org_study_id