Evaluation of Inflammation-Related Endothelial Barrier Dysfunction in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients before endodontic treatment
研究概览
简要总结
Inflammation is a common factor in chronic periodontitis and systemic diseases. However, to date, there is no scientific evidence supporting a causal effect of inflammation caused by apical periodontitis on endothelial barrier dysfunction.
A case-control study was designed to evaluate serum levels of endothelial barrier dysfunction factors in a sample of healthy patients aged 25 to 55, with or without apical periodontitis, before endodontic treatment and 6 and 12 months after treatment.
The aim of this study is to investigate the potential relationship between the presence of chronic endodontic lesions and inflammation-related alterations of the endothelial barrier that may compromise its integrity, as well as to determine whether endodontic treatment can reduce these factors, thereby preventing changes in endothelial permeability.
详细描述
Systemically healthy, informed, and consenting patients of both sexes under 55 years of age with a diagnosis of apical periodontitis who undergo endodontic treatment will be enrolled as cases and monitored at 6 and 12 months after treatment. Systemically healthy, informed, and consenting patients of both sexes under 55 years of age without apical periodontitis will be enrolled as control subjects.
The study has been designed to assess serum levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-8 (IL-8), as well as the endothelial junctional proteins zonula occludens-1 (ZO-1), claudin-5, and vascular endothelial cadherin (VE-cadherin), using enzyme-linked immunosorbent assay (ELISA).
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-55 years
- •in general health
- •with or without endodontic disease
排除标准
- •under 25 years
- •over 55 years
- •subjects with systemic or oral diseases other than endodontic affections
- •patients who underwent other dental treatments in the previous 6 months
结局指标
主要结局
Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients before endodontic treatment
时间窗: Baseline serum levels dosage of evaluated factors in control group and AP group.
Dosage of serum TNF-α, IL-1β, IL-6, IL-8 and ZO-1, Claudin-5 and VE-cadherin levels by ELISA assays measured as pg/ml of serum in healthy subjects and patients before endodontic treatment - baseline. Data relative to each evaluated serum protein will be aggregated as healthy (control group) versus pathological (AP group) individuals.
Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients after 6 months of endodontic treatment
时间窗: 6 months post-treatment serum levels dosage of evaluated factors in control group and AP group.
Dosage of serum TNF-α, IL-1β, IL-6, IL-8 and ZO-1, Claudin-5 and VE-cadherin levels by ELISA assays measured as pg/ml of serum in healthy subjects and patients- 6 months post-treatment. Data relative to each evaluated serum protein will be aggregated as healthy (control group) versus pathological (AP group) individuals.
Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients after 12 months of endodontic treatment
时间窗: Time Frame: 12 months post-treatment serum levels dosage of evaluated factors in control group and AP group.
Dosage of serum TNF-α, IL-1β, IL-6, IL-8 and ZO-1, Claudin-5 and VE-cadherin levels by ELISA assays measured as pg/ml of serum in healthy subjects and patients- 12 months post-treatment. Data relative to each evaluated serum protein will be aggregated as healthy (control group) versus pathological (AP group) individuals.
次要结局
未报告次要终点