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

NCT03767023 | Completed

• 1 other identifier: H2014-3 AAA
• Study Type: observational
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Aorta Aneurism; Periodontitis; Dentulous

Outcome Measures

Primary Outcomes (1)

• pocked depth correlated with AAA stability

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

  june 2017

Secondary Outcomes (1)

• pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior

  March 2018

Study Arms (2)

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

Interventions

cross sectional OTHER

Stable AAA; instable AAA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• AAA
• dentulous
• ability to come in Hospital

You may not qualify if:

• 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
• obese patients (BMI ≥ 30 kg/m2)
• immunosuppressant drugs or chemotherapy

Sponsors & Collaborators

• University of Liege: lead
• KU Leuven: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva, sub-gingival and supra-gingival samples

MeSH Terms

Conditions

Periodontitis

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery (DDS), Master of sciences (MS), PhD student

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: December 6, 2018
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: March 1, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12