StrokeNCT07357155
Oral and Salivary Biomarkers Associated With Stroke
An observational study of Stroke, run by University Hospital Center (CHU) of Constantine, Algeria at 2 sites in Algeria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 120 participants
- Where
- 2 sitesAlgeria
- Study dates
- 20 Dec 2026to Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from multiple regions within Algeria, reflecting a diverse national population.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Algeria2 sites
Private Dental Clinic, Constantine
Constantine, 25000
University Hospital Center (CHU) of Constantine
Constantine, 25017
Boubekeur seddik Fekraoui, Professor, 0559375365, neurology.departement25@gmail.com
About this study
Official title: An Observational Study of Oral and Salivary Biomarkers Associated With Stroke
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.
Read the detailed description
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.
- Conditions
- Stroke
- Keywords
- Stroke, Oral health, Salivary biomarkers, Cerebrovascular disease, Observational study, Streptococcus mutans, Cnm-positive Streptococcus mutans, Cnm gene, Oral microbiota
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | Patients diagnosed with stroke. | |
| Healthy control group | Healthy participants without a history of stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single time-point assessment at enrollment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 90 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Dec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center (CHU) of Constantine, Algeria
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdeldjalil ZITOUNI, University Hospital Center (CHU) of Constantine, Algeria
- Investigators
- Abdeldjalil Zitouni, DDS, Principal investigator, Independent Researcher, Constantine, Algeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357155
- Sponsor's protocol ID
- CHU-STROKE-001
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Publications
Miyatani F, et al. Collagen-binding activity of Streptococcus mutans and cerebral microbleeds. Stroke. 2015.