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临床试验/NCT05306860
NCT05306860已完成不适用

Investigation of the Relationships and Clinical Parameters Between IL-6, IL-17 and IL-35 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis

Istanbul University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Measurement of GCF samples

研究概览

简要总结

Periodontitis is an inflammatory disease characterized by periodontal tissue destruction caused by bacterial infection. The immune response plays an important role in the progression of periodontitis. The disease process starts with periodontopathogens in dental plaque, and tissue destruction is mainly caused by the immune response of the host to the etiological microorganism and cytokine profile through various inflammatory cytokines. The cytokine response, which plays a critical role in the pathogenesis of periodontal disease, determines the progression of the disease.

Evaluation of the effects of IL-6, IL-17 and IL-35 levels in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the basis of our study. This study consists of individuals with grad B-C stage III-IV periodontitis and healthy individuals, which is the subtitle of Periodontal and Periimplant Diseases and Conditions in the classification renewed in 2017.

It is aimed to examine the changes and possible correlations in IL-6, IL-17, IL-35 levels as a result of biochemical examination of the samples taken from the gingival crevicular fluid. In our study, according to the new classification of 2017, gingival crevicular fluid samples collected from individuals with grade B-C stage III-IV periodontal disease and healthy individuals under appropriate conditions and techniques were measured for IL-6, IL-17 and IL-35 by enzymatic immunosorbent test (ELISA). It aims to investigate the negative/positive correlations and compare the increases-decreases.

详细描述

IL-35 is a next-generation signaling molecule belonging to the IL 12 cytokine family. It is produced by T-regulatory cells (Treg) consisting of the Α chain (p35). Recent studies have shown that IL-35 is an anti-inflammatory cytokine. It suppresses the immune response through Treg expansion and suppression of Th17 cell growth.

Interleukin-17 (IL-17) is a proinflammatory cytokine secreted by T-17 cells. It is a potent activator of neutrophils as it regulates G-CSF and receptor and chemokine expression. Its increased level has been documented in chronic periodontitis. In the presence of P. gingivalis, an increase in IL-17 and IL-23 is observed. Although periodontal infection (P. gingivalis) induces IL-17, a protective role of IL-17 against bone resorption has also been suggested. IL-17 produces IL-6, IL-8 by affecting fibroblasts.

IL-6 is produced by many cells in response to LPS and has both pro-inflammatory and anti-inflammatory roles. It is involved in inflammatory, regenerative, metabolic and neural processes. IL-6 level has been investigated in different studies in serum, saliva and gingival sulcus fluids. Studies with increased IL-6 levels in the gingival groove fluid in chronic periodontitis and studies with significant decreases in serum after nonsurgical treatment of chronic periodontitis have been reported. However, there are also studies that do not show a significant difference in the levels of various cytokines in the saliva of chronic periodontitis and healthy individuals.

Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Clinical attachment level (CAL), Gingival margin position (DKK), and Mobility parameters. Measurements will be recorded from six different points of all teeth by the same investigator with a Williams-type periodontal probe (Hu-Friedy, USA).

  1. Healthy control groups:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Those with systemic modifying disease affecting periodontal status
  • Have received antibiotic therapy or immunosuppressive therapy in the last 6 months
  • Previously received periodontal treatment in the last 6 months
  • Pregnancy and breastfeeding status
  • Regular use of drugs that will affect systemic health

结局指标

主要结局

Measurement of GCF samples

时间窗: GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove.

Measurement of IL-6, IL-17, IL-35 levels in GCF in grade B-C stage III-IV periodontitis individuals.

次要结局

  • Measurement of GCF samples(GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Müge Ergün

PhD Student

Istanbul University

研究点 (1)

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