MedDataX Logo

Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study

NCT ID: NCT03767023

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aorta Abdominal aneurism (AAA) is a chronic degenerative disorder leading to the dilation and eventually to the rupture of the aortic wall. The pathology presents risk factors such as aging, atherosclerosis, male gender, cigarette smoking, pulmonary emphysema and high blood pressure.The vascular wall destruction is characterized by a remodeling of the extracellular matrix (ECM), the presence of an inflammatory infiltrate of macrophages and lymphocytes associated increase in production of MMPs. A similar destruction mechanisms is found in periodontitis a chronic inflammatory diseases characterized by gram-negative bacteria species that are able to degrade ECM of the tooth supporting tissues and leading finally to tooth loss .Moreover, relationships between periodontitis and cardiovascular disease have already been demonstrated. These associations are considered to be initiated by transient or prolonged bacteremia due to dissemination of oral bacteria or their products into the bloodstream . The periopathogens, more specifically Porphyromonas gingivalis (Pg), were observed in atherosclerosis and aneurysm specimens as well as in coronary heart disease and endocarditis The association between periodontitis and Abdominal Aortic Aneurysms (AAA) has not often been studied especially from a clinical aspect. The mechanisms that induce the initiation, the development or the recurrence and the rupture of AAA after a period of quiescence not well studied and are therefore still unknown.

The aim of this clinical observational case controlled study is to search for a possible relationship between periodontal disease and rapid growth of AAA. Patients presenting stable or unstable AAA will be screened for the degree of periodontitis, for the type of oral microbiology and periodontopathogen markers present in the blood stream.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

31 consecutive dentulous patients diagnosed for AAA requiring a cardiovascular surgery (instable AAA) and 31 consecutive dentulous patients with stable AAA (no need for cardiovascular surgery) will be recruited from the Cardiovascular Surgery Department of the University Hospital of Liège (Faculty of Medicine, University of Liège, Belgium - Pr. N. Sakalihasan). The 62 patients will be subjected to:

1. Full clinical periodontal parameter assessment
2. Microbiological analyses of saliva,
3. Supra- and sub- gingival microbiological test
4. Blood test for biomarker analysis.
5. Imaging (echography, CT-Scans)measurments

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Aorta Aneurism Periodontitis Dentulous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stable AAA

= patients with a small abdominal aortic aneursym diameter \< 55 mm "

cross sectional

Intervention Type OTHER

instable AAA

=patients with a large abdominal aortic aneursym diameter \> 55 mm and/or AAA with rapid growth who needs open surgery or EndoVascular Aneurysm Repair "EVAR

cross sectional

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cross sectional

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* AAA
* dentulous
* ability to come in Hospital

Exclusion Criteria

* diseases of connective tissue: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerodermia, Crohn disease, Marfan syndrome, Heler Danlos syndrome, polymyosite/dermatomyosite, mix connectivite (MCDT)
* aneurysms of the lower limbs (femoral or popliteal)
* contraindication to the scanner
* participation of another clinical trial 30 days before baseline
* patient with risk oslerien
* taking antibiotics during the 3 months preceding the inclusion
* obese patients (BMI ≥ 30 kg/m2)
* immunosuppressant drugs or chemotherapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leila Salhi

Doctor of Dental Surgery (DDS), Master of sciences (MS), PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H2014-3 AAA

Identifier Type: -

Identifier Source: org_study_id