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临床试验/NCT07758374
NCT07758374已完成不适用

The Involvement of GFI-1 in the Pathogenesis of Periodontal Disease

Inonu University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1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
GFI1, NLRP3, NF-KB, IL-1beta Gene and Protein Expression

研究概览

简要总结

Gum disease, including gingivitis and its more advanced form, periodontitis, is a common condition that damages the tissues supporting the teeth. This study examines how gum disease affects the expression of specific genes and proteins that regulate communication between internal cell structures and the clearance of damaged material. Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already undergoing. These samples will be used to measure the expression levels of the GFI1, NF-κB, and NLRP3 genes/proteins, along with IL-1beta levels. In a separate laboratory experiment, gum cells will be exposed to a substance produced by bacteria commonly associated with gum disease, to observe how these same genes and protein respond. The goal of this study is to better understand the biological changes that occur in gum tissue as gum disease progresses, which may help guide future research into new treatments.

详细描述

Periodontal disease encompasses a spectrum of inflammatory conditions, from gingivitis to more advanced periodontitis, that progressively damage the tooth-supporting tissues. Although its pathogenesis has been studied extensively, the molecular mechanisms driving the inflammatory response in periodontal tissues are not yet fully understood. Inflammasomes, multiprotein complexes known to regulate inflammatory processes, have been proposed to play a role in this pathogenesis, but the contribution of their regulatory proteins remains unclear. This study investigates the potential role of GFI-1, a regulator of inflammasome activity, in periodontal disease, along with its relationship to NLRP3, IL-1β, and NF-κB, structures known to be involved in inflammasome signaling and inflammatory regulation. The study consists of two complementary components. In the in vitro component, human gingival fibroblast cells will be stimulated with lipopolysaccharide (LPS) derived from Porphyromonas gingivalis and/or ATP to model bacterially driven inflammatory activation. Gene expression levels of GFI-1, NLRP3, IL-1β, and NF-κB will be measured using RT-PCR to characterize how these structures respond to bacterial and inflammatory stimuli. In the clinical component, gingival tissue samples will be collected from patients with periodontal disease as well as from periodontally healthy individuals during dental procedures they are already undergoing. Gene and protein expression levels of GFI-1, NLRP3, IL-1β, and NF-κB in these tissues will be assessed using RT-PCR and Western blotting, and IL-1β protein levels will additionally be quantified by ELISA. By comparing findings from the in vitro and clinical components, this study aims to determine whether GFI-1 is dysregulated at the gene and protein level in periodontal disease and to clarify its potential role in disease pathogenesis. These findings may contribute to a better understanding of the inflammatory mechanisms underlying periodontal disease and help inform future research into targeted therapeutic approaches.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for the Healthy Control group were: presence of ≥ 20 teeth in the mouth, probing pocket depth (PPD) ≤ 3 mm, the percentage of bleeding sites for the whole mouth < 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Gingivitis group were: presence of ≥ 20 teeth in the mouth, PPD ≤ 3 mm, % of bleeding sites for the whole mouth ≥ 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Stage 3 Periodontitis group were: presence of ≥ 15 teeth in the mouth, more than 30% of teeth affected by periodontal disease, affected teeth exhibiting probing depths of 6 mm or more and clinical attachment loss (CAL) of ≥ 5 mm, vertical bone loss of 3 mm or more, class 2 or 3 furcation involvement, and radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth

排除标准

  • Exclusion criteria for all groups were defined as: presence of any systemic disease, regular use of any medication, smoking, pregnancy or lactation, periodontal treatment within the last 6 months, antibiotic use within the last 6 months, and the presence of prosthetic restorations on the teeth to be sampled

研究组 & 干预措施

periodontally healthy

periodontally healthy participants

gingivitis

patients with gingivitis

periodontitis

patients with periodontitis

结局指标

主要结局

GFI1, NLRP3, NF-KB, IL-1beta Gene and Protein Expression

时间窗: January to July 2024

Gene expression (RT-PCR, relative fold change via 2\^-ΔΔCT method) and protein expression (Western blot, band intensity normalized to ACTB) of GFI1, NLRP3, NF-KB, IL-1beta were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis

次要结局

未报告次要终点

研究者

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

Kubra Aral

Associate Professor

Inonu University

研究点 (1)

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