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NCT Number: NCT07357155

Oral and Salivary Biomarkers Associated With Stroke

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Private Dental Clinic, Constantine

Constantine, 25000, Algeria

Location contact

Abdeldjalil Zitouni, Dental Surgeon

CONTACT

[email protected]

+213554040202

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls.

    Time frame: 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.

Secondary outcomes

  1. Exploratory association between oral microbiota profiles and stroke status

    Time frame: Single time-point assessment at enrollment

    Exploratory analysis of the association between oral microbiota profiles and stroke status using saliva or oral swab samples. The analysis aims to identify bacterial profiles potentially associated with stroke and oral-systemic interactions.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdeldjalil Zitouni, DDS

CONTACT

[email protected]

+213550400202

Sponsors and collaborators

Lead sponsor

University Hospital Center (CHU) of Constantine, Algeria

Other Gov

Registry information

Official study title

An Observational Study of Oral and Salivary Biomarkers Associated With Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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