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临床试验/NCT07563192
NCT07563192进行中(未招募)不适用

Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

Suleyman Demirel University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
113
试验地点
1
主要终点
Relative mRNA expression levels of TLR1,TLR4 and TLR6

研究概览

简要总结

This study investigates the impact of smoking on pyroptosis and inflammatory signaling pathways in systemically healthy individuals with various periodontal conditions. The research compares smokers and non-smokers across three clinical categories, resulting in six study groups: Healthy Control, Gingivitis, and Periodontitis. The study specifically evaluates the levels of IL-1beta, IL-18, and NLRP3 through ELISA, and the gene expression of TLR1, TLR4, and TLR6 through RT-PCR, to understand how cigarette smoke modulates innate immune responses in the absence of other systemic diseases.

详细描述

The aim of this research is to clarify the molecular link between tobacco use and pyroptotic cell death pathways in the pathogenesis of periodontal disease. To eliminate systemic bias, only systemically healthy participants are included. The study design consists of 6 distinct groups based on a 2x3 matrix (Smoking Status: Yes/No × Periodontal Status: Healthy/Gingivitis/Periodontitis).

Protein levels of the NLRP3 inflammasome and pro-inflammatory cytokines (IL-1beta, IL-18) are measured in periodontal tissues using the ELISA method. Furthermore, the mRNA expressions of Toll-like receptors (TLR1, TLR4, and TLR6) are analyzed via RT-PCR. These findings will help determine how smoking influences tissue destruction mechanisms specifically through the pyroptosis pathway in different stages of gum disease.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who voluntarily agreed to participate in the study,
  • Smokers (gingivitis and stage 3/4 generalized periodontitis) and non-smokers (gingivitis and stage 3/4 generalized periodontitis) who applied to the Periodontology Clinical of Suleyman Demirel University Faculty of Dentistry,
  • Individuals without any systemic diseases and without using any medications that affect periodontal health were included.

排除标准

  • Individuals who refuse to participate in the study or who cannot comply with the study protocol,
  • Individuals participating in another clinical trial concurrently, Individuals who have received periodontal treatment within the last 6 months,
  • Individuals who have used medications (antibiotics, anti-inflammatory drugs, etc.) that may affect periodontal parameters within the last 3 months,
  • Individuals with systemic diseases that may affect the periodontium,
  • Individuals with systemic diseases presenting with oral symptoms,
  • Individuals with malignant disease,
  • Pregnant or lactating women,
  • Individuals with psychological or physical disabilities,
  • Individuals with substance abuse,
  • Individuals with severe malocclusion, undergoing orthodontic treatment, using appliances, or using removable dentures,
  • Individuals with acute dental infection or pain (cavities, abscesses, etc.).

研究组 & 干预措施

Healthy Non-Smoker

Systemically healty individulas with clinically healthy periodontal tissues who have never smoked or have not smoked for least 5 years.

Gingivitis Non-Smoker

Systemically healty individulas diagnosed with gingivitis who are non-smokers.

Periodontitis Non-Smoker

Systemically healty individulas diagnosed with Stage III or IV periodontitis who are non-smokers.

Healthy Smoker

Systemically healty individulas with clinically healthy periodontal tissues who have been smoking least 10 cigarettes per day for at least 1 year.

Gingivitis Smoker

Systemically healty individulas with gingivitis who have been smoking least 10 cigarettes per day for at least 1 year.

Periodontitis Smoker

Systemically healty individulas diagnosed with Stage III or IV periodontitis who who have been smoking least 10 cigarettes per day for at least 1 year.

结局指标

主要结局

Relative mRNA expression levels of TLR1,TLR4 and TLR6

时间窗: Baseline (At the clinical examination)

Metric:Fold change (2\^-ΔΔCt method). Measurement of gene expression levels in gingival tissues using the RT-PCR method.

Protein concerntrations of NLRP3, IL-18 and IL-1β

时间窗: Baseline (At the time of clinical examinat

Metric: Picograms per milliliter (pg/mL). Evaluation of protein concentrations in gingival tissue samples using the ELISA method.

次要结局

  • Periodontal Inflamed Surface Area (PISA)(Baseline (At the time of clinical examination))
  • Periodontal Clinical Measurements (PD and CAL)(Baseline (At the time of clinical examination))
  • Periodontal Indices (PI and GI)(Baseline (At the time of clinical examination))

研究者

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

Meryem KOKSALAN

Principal Investigator

Suleyman Demirel University

研究点 (1)

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