The Role Oral Microbiome in the Development and Progression of Aorta Aneurysm and Carotid Atherosclerosis

NCT07824921 | Enrolling By Invitation

• 1 other identifier: NNGYK/28930-5/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the microbiome (bacterial al community) of the diseased vascular site and the oral cavity with specific attention to chronic inflammatory periodontitis in patients who have aorta aneurysm or carotid stenosis needing surgical treatment. The main question it aims to answer is whether pathogen members of the oral microbial community, that cause periodontal disease, are also present in the diseased vascular site proving its translocation from the oral cavity to the vascular system. We hypothesize that bacteria causing chronic periodontal disease can be found at the diseased vascular site highlighting the importance of maintaining and restoring oral health as preventive measure for vascular diseases. Participants will be asked to take part in a dental screening before vascular surgery, during which few samples will be taken non-invasively for analysis.

Conditions

Carotid Arteriosclerosis; Aorta Aneurysm

Keywords

aorta aneurysm; carotid arteriosclerosis; periodontitis; saliva; oral cavity

Outcome Measures

Primary Outcomes (1)

• prevalence of oral pathogenic bacteria in vascular samples

  PCR analysis using NGS is used to determine prevalence of periopathogenic bacteria

  within 1 year of surgery

Secondary Outcomes (1)

• relative abundance of oralpathogenic bacteria in vascular samples

  within 1 year of surgery

Study Arms (2)

aorta aneurysm

vascular surgery

carotid arteriosclerosis

vascular surgery

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients attending the clinic

You may qualify if:

• aorta aneurysm or carotid arteriosclerosis needing surgery

You may not qualify if:

• antibiotic intake in last three months

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Center of Heart and Vascular Surgery

Budapest, 1088, Hungary

Location

Biospecimen

Retention: SAMPLES WITH DNA

vascular wall, arteriosclerotic plaque, saliva, buccal epithelial, tonque plaque, periodontal pocket fluid

MeSH Terms

Conditions

Aortic Aneurysm; Carotid Artery Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Péter Sótonyi, M.D., Ph.D.

  Semmelweis University

  PRINCIPAL INVESTIGATOR

• Zsolt M. Lohinai, D.M-D., Ph.D.

  Semmelweis University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: September 17, 2026
• Study Start: May 28, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2030-2035
• Access Criteria: on personal contact after discussing common interest point

Locations

HU (1)