An observational study in Stroke, sponsored by University Hospital Center (CHU) of Constantine, Algeria. Not yet recruiting at 2 sites in Algeria. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University Hospital Center (CHU) of Constantine, Algeria · Observational
This observational study aims to investigate associations between oral and salivary biomarkers and stroke. Adults with stroke and healthy controls will undergo clinical oral assessment and unstimulated saliva collection. Salivary inflammatory biomarkers and oral bacterial profiles will be analyzed, including detection of Streptococcus mutans and the cnm gene by PCR/qPCR. The study will explore associations between these biomarkers and stroke status.
Stroke is a major cause of morbidity and mortality worldwide. Growing evidence suggests that oral health, oral bacterial profiles, and salivary biomarkers may be associated with systemic inflammatory and vascular conditions.
This observational case-control study is designed to evaluate associations between oral clinical findings, salivary inflammatory biomarkers, oral bacterial profiles, and stroke. Adults with a confirmed diagnosis of ischemic or hemorrhagic stroke and healthy controls will be enrolled. Data collection will include demographic and medical information, oral examination findings, and unstimulated saliva samples.
Salivary samples will be analyzed for inflammatory and biochemical biomarkers and oral bacterial DNA. Molecular analysis will include detection of Streptococcus mutans and the cnm gene using PCR/qPCR. The prevalence of Cnm-positive Streptococcus mutans will be compared between stroke patients and healthy controls and explored in relation to cerebrovascular characteristics.
Stroke patients will be prospectively followed for 90 days after the index stroke. Functional outcome at 90 days will be assessed using the modified Rankin Scale (mRS). Associations between baseline oral and salivary biomarkers, including Cnm-positive Streptococcus mutans status, and 90-day functional outcome will be explored.
This study is observational and involves no therapeutic or experimental intervention.
Study Team: This study is led by Dr. Abdeldjalil Zitouni (Principal Investigator) in collaboration with:
Prof. Fekraoui Boubakeur seddik, Head of the Department of Neurology, Prof. Serradj Fatima, Assistant Professor of Neurology, and Dr. Boutbiba Ikrame, Assistant of Neurology, at the University Hospital Center (CHU) of Constantine, Algeria.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 120 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with University Hospital Center (CHU) of Constantine, Algeria as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from multiple regions within Algeria, reflecting a diverse national population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with stroke.
Healthy participants without a history of stroke.
Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls.
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.
Time frame: Single time-point assessment at enrollment
Exploratory association between oral microbiota profiles and stroke status
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.
Time frame: Single time-point assessment at enrollment
Association between salivary Cnm-positive Streptococcus mutans and stroke status
Detection of Streptococcus mutans and the cnm gene in unstimulated saliva using PCR/qPCR. The prevalence of Cnm-positive Streptococcus mutans will be compared between stroke patients and healthy controls to evaluate its association with stroke status.
Time frame: Single time-point assessment at enrollment
Functional outcome at 90 days after stroke
Functional outcome will be assessed at 90 days after stroke using the modified Rankin Scale (mRS). The association between baseline oral and salivary biomarkers, including Cnm-positive Streptococcus mutans status, and 90-day functional outcome will be explored.
Time frame: 90 days after stroke
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality considerations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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