Periodontitis Clinical Trial
Official title:
Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study
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 |
Verified date | December 2018 |
Source | University Hospital of Liege |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Liege | KU Leuven |
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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