An Observational Study of Oral and Salivary Biomarkers Associated With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls.
研究概览
简要总结
This observational study aims to explore the association between oral and salivary biomarkers and stroke. The study will include adult participants diagnosed with stroke and will analyze clinical, oral, and salivary parameters. The objective is to improve understanding of potential links between oral health, salivary biomarkers, and cerebrovascular disease. No experimental intervention will be performed.
详细描述
Stroke is a major cause of morbidity and mortality worldwide. Growing scientific evidence suggests that oral health and salivary biomarkers may reflect systemic inflammatory and vascular conditions.
This observational study is designed to evaluate associations between oral clinical findings, salivary biomarkers, and stroke. Participants with a confirmed diagnosis of stroke will be enrolled. Data collection will include demographic information, medical history, oral examination findings, and salivary samples.
Analyses will focus on identifying correlations between oral and salivary parameters and clinical characteristics of stroke. This study does not involve any therapeutic intervention or experimental treatment. The findings may contribute to a better understanding of the oral-systemic relationship in cerebrovascular diseases and support future preventive strategies.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 90 years.
- •Patients diagnosed with stroke (ischemic or hemorrhagic) confirmed by clinical and imaging criteria for the stroke group.
- •Healthy volunteers without a history of stroke or cerebrovascular disease for the control group.
- •Ability to provide written informed consent.
排除标准
- •inflammatory disease at the time of sampling.
- •Chronic autoimmune or malignant disease.
- •Recent major surgery or trauma within the last 3 months.
- •Pregnancy or breastfeeding.
- •Inability or refusal to provide saliva samples.
研究组 & 干预措施
Healthy control group
Healthy participants without a history of stroke.
Stroke group
Patients diagnosed with stroke.
结局指标
主要结局
Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls.
时间窗: Single time-point assessment at enrollment
Assessment of salivary inflammatory and neuroendocrine biomarkers, including salivary cortisol and selected inflammatory cytokines (e.g., IL-6 and/or hs-CRP), to identify biomarker patterns associated with stroke.
次要结局
- Exploratory association between oral microbiota profiles and stroke status(Single time-point assessment at enrollment)
研究者
Abdeldjalil ZITOUNI
Principal Investigator
University Hospital Center (CHU) of Constantine, Algeria