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

December 12, 2018 updated by: Leila Salhi, University of Liege

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

61

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the Cardiovascular Surgery Department, University Hospital of Liège (Belgium) and presenting AAA were screened in order to include 31 patients in each group (stable versus instable AAA) according to the sample size calculation. Sixty-two patients were therefore included according to the following inclusion and exclusion criteria:

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stable AAA
= patients with a small abdominal aortic aneursym diameter < 55 mm "
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pocked depth correlated with AAA stability
Time Frame: june 2017
Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability.
june 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior
Time Frame: 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)
March 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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