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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03767023
Other study ID # H2014-3 AAA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date March 2018

Study information

Verified date December 2018
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 2018
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Other:
cross sectional


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of Liege KU Leuven

Outcome

Type Measure Description Time frame Safety issue
Primary pocked depth correlated with AAA stability Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability. june 2017
Secondary pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with abdominal aortic aneurysm diametres such as anterior -posterior (AP,millimeter) March 2018
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