Oral and Salivary Biomarkers Associated With Stroke | NCT07357155

Studies
Oral and Salivary Biomarkers Associated With Stroke

NCT07357155

Sponsor

University Hospital Center (CHU) of Constantine, Algeria

Status

Not yet recruiting

Last Update Posted

Feb 5, 2026Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Algeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jan 13, 2026

First Submission Date that Met QC Criteria

Jan 13, 2026

First Posted Date

Jan 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdeldjalil ZITOUNI, Principal Investigator, University Hospital Center (CHU) of Constantine, AlgeriaPrincipal Investigator

Lead Sponsor

University Hospital Center (CHU) of Constantine, AlgeriaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke group		Patients diagnosed with stroke.
Healthy control group		Healthy participants without a history of stroke.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Single time-point assessment at enrollment

Secondary Outcomes

Measure	Description	Time Frame
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.	Single time-point assessment at enrollment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients will be recruited from multiple regions within Algeria, reflecting a diverse national population.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdeldjalil Zitouni, DDS	Contact	+213550400202		djalil007_dz@yahoo.fr

Overall Officials

Name	Affiliation	Role
Abdeldjalil Zitouni, DDS	Independent Researcher, Constantine, Algeria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Private Dental Clinic, Constantine		Constantine		25000	Algeria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Miyatani F, et al. Collagen-binding activity of Streptococcus mutans and cerebral microbleeds. Stroke. 2015.

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases