Clinical trial NCT06135116: Regulatory T Cell With Related Interleukins in Periodontal Disease Progression
Official title: CD4+CD25+High FOXp3+ Regulatory T Cell With Related Interleukins and Vitamin D-binding Protein in Periodontal Disease Progression : Synergy or Cocaphony
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Gingivitis
Keywords: inflammation
Periodontitis
Cytokines
Vitamin D-Binding Protein
Interleukin-33
nterleukin-21
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Treg cells frequency
timeFrame: baseline(through clinical diagnosis completion)
measure: Cytokines levels (IL-22, IL-21, IL-35, IL-33) and vitamin D binding protien
timeFrame: baseline(through clinical diagnosis completion)
Secondary outcomes:
measure: dental Plaque score
timeFrame: baseline(through clinical diagnosis completion)
measure: Bleeding on probing (BoP)
timeFrame: Baseline(through clinical diagnosis completion)
measure: Probing pocket depth
timeFrame: Baseline(through clinical diagnosis completion)
measure: Attachment level
timeFrame: Baseline(through clinical diagnosis completion)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Department of oral medicine, Periodontology, Oral diagnosis and dental radiology Faculty of dental medicine
state: Asyut
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.