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

• Sponsor: University of Liege (Other)
• Overall Status: Completed
• CT.gov ID: NCT03767023
• Collaborator: KU Leuven (Other)
• Enrollment: 61
• Actual Duration (Months): 36.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aorta Aneurism; Periodontitis; Dentulous	Other: cross sectional

Detailed 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

Study Design

• Study Type: Observational
• Actual Enrollment: 61 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Stable AAA = patients with a small abdominal aortic aneursym diameter < 55 mm "	Other: cross sectional
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	Other: cross sectional

Outcome Measures

Primary Outcome Measures

1. pocked depth correlated with AAA stability [june 2017]

   Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability.

Secondary Outcome Measures

1. pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior [March 2018]

   Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with abdominal aortic aneurysm diametres such as anterior -posterior (AP,millimeter)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Liege
• KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leila Salhi, Doctor of Dental Surgery (DDS), Master of sciences (MS), PhD student, University of Liege
• ClinicalTrials.gov Identifier: NCT03767023
• Other Study ID Numbers: H2014-3 AAA
• First Posted: Dec 6, 2018
• Last Update Posted: Dec 14, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of Dec 14, 2018