Oral and Salivary Biomarkers Associated With Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity Hospital Center (CHU) of Constantine, Algeria
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients will be recruited from multiple regions within Algeria, reflecting a diverse national population.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Stroke group
Group B: Healthy control group
Trial outcomes
Primary outcomes
1
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 enrollmentSecondary outcomes
1
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 enrollment2
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 enrollment3
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 strokeSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: