Regulatory T Cell With Related Interleukins in Periodontal Disease Progression

NCT06135116 | Completed DMC

• 1 other identifier: Treg in periodontitis
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Gingivitis

Keywords

inflammation; Periodontitis; Cytokines; Vitamin D-Binding Protein; Interleukin-33; nterleukin-21

Outcome Measures

Primary Outcomes (2)

• Treg cells frequency

  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).

  baseline(through clinical diagnosis completion)

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

  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.

  baseline(through clinical diagnosis completion)

Secondary Outcomes (4)

• dental Plaque score

  baseline(through clinical diagnosis completion)

• Bleeding on probing (BoP)

  Baseline(through clinical diagnosis completion)

• Probing pocket depth

  Baseline(through clinical diagnosis completion)

• Attachment level

  Baseline(through clinical diagnosis completion)

Study Arms (3)

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.

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

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.

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

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

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

Interventions

Flow Cytometric Detection of Regulatory T Cells and Cytokines analysis by ELISA 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; chronic periodontitis; periodontally healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sixty persons will be selected from the attendance of the out-patient clinic, Oral Medicine and Periodontology Department, Faculty of Dentistry, Al-Azhar University, Assiut. They divided according to the periodontal health status into three groups.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

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

Asyut, Asyut Governorate, 71111, Egypt

Location

Related Publications (3)

• 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.

  PMID: 22803589 BACKGROUND

• 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.

  PMID: 15972593 BACKGROUND

• 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.

  PMID: 24762896 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Gingivitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer ,Oral medicine and periodontology

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: December 23, 2023
• Study Completion: January 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)