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Not yet recruiting NCT07357155

Oral and Salivary Biomarkers Associated With Stroke

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Algeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Observational Study of Oral and Salivary Biomarkers Associated With Stroke

Overview

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.

Detailed description

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.

Primary outcome measures

  • Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls. [Time frame: Single time-point assessment at enrollment]
Secondary outcome measures (1)
  • Exploratory association between oral microbiota profiles and stroke status [Time frame: Single time-point assessment at enrollment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Algeria · 1 center
  • Private Dental Clinic, Constantine — Constantine

Publications

  • Miyatani F, et al. Collagen-binding activity of Streptococcus mutans and cerebral microbleeds. Stroke. 2015.

Identifiers

NCT: NCT07357155 · CHU-STROKE-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗