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临床试验/NCT07312552
NCT07312552招募中不适用

The Impact of Periodontal Status and Smoking on Salivary Inflammasome Levels: A Cross-Sectional Study

Uskudar University1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
116
试验地点
1
主要终点
Clinical attachment level

研究概览

简要总结

The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.

详细描述

The aim of this study was to determine the periodontal status and smoking status of the participants, to obtain clinical periodontal records and to explain their relationship with salivary NLRP-3 NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10 levels.

The participants included in the study will be divided into four groups: smokers with periodontal disease, non-smokers with periodontal disease, smokers without periodontal disease, and non-smokers without periodontal disease. Systemic and dental anamnesis of the participants will be taken, smoking habits will be evaluated, medical records and current diagnoses will be examined, intraoral examinations will be performed and periodontal records will be taken. The periodontal status of the participants will be diagnosed according to the 'Classification of Periodontal and Peri-implant Diseases and Conditions' accepted at the 2017 World Workshop, supported by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP).

Saliva samples will be collected before clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analyzed. Salivary NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL1β, and IL-10 levels will be measured using an enzyme-linked immunosorbent assay (ELISA) method.

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

  • systemically healthy,
  • clinical diagnosis of periodontitis,
  • clinical diagnosis of periodontal health

排除标准

  • history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
  • nonsurgical periodontal treatment (previous 6 months);
  • surgical periodontal treatment (previous 12 months);
  • presence of <20 teeth;
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
  • diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.

结局指标

主要结局

Clinical attachment level

时间窗: Baseline

Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time. Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth. In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ. In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.

Probing pocket depth

时间窗: Baseline

Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

Bleeding on probing

时间窗: Baseline

The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).

次要结局

  • Plaque percentage(Baseline)
  • Periodontal inflammatory surface area (PISA)(Baseline)
  • Interleukin-10(Baseline)
  • Inteleukin-1β(Baseline)
  • NLRP-3(Baseline)
  • NLRP-6(Baseline)
  • NLRP-12(Baseline)
  • NLRC-5(Baseline)

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kubra Karaduran

Assistant Professor

Uskudar University

研究点 (1)

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