<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767023</url>
  </required_header>
  <id_info>
    <org_study_id>H2014-3 AAA</org_study_id>
    <nct_id>NCT03767023</nct_id>
  </id_info>
  <brief_title>Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study</brief_title>
  <official_title>Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aorta Abdominal aneurism (AAA) is a chronic degenerative disorder leading to the dilation and&#xD;
      eventually to the rupture of the aortic wall. The pathology presents risk factors such as&#xD;
      aging, atherosclerosis, male gender, cigarette smoking, pulmonary emphysema and high blood&#xD;
      pressure.The vascular wall destruction is characterized by a remodeling of the extracellular&#xD;
      matrix (ECM), the presence of an inflammatory infiltrate of macrophages and lymphocytes&#xD;
      associated increase in production of MMPs. A similar destruction mechanisms is found in&#xD;
      periodontitis a chronic inflammatory diseases characterized by gram-negative bacteria species&#xD;
      that are able to degrade ECM of the tooth supporting tissues and leading finally to tooth&#xD;
      loss .Moreover, relationships between periodontitis and cardiovascular disease have already&#xD;
      been demonstrated. These associations are considered to be initiated by transient or&#xD;
      prolonged bacteremia due to dissemination of oral bacteria or their products into the&#xD;
      bloodstream . The periopathogens, more specifically Porphyromonas gingivalis (Pg), were&#xD;
      observed in atherosclerosis and aneurysm specimens as well as in coronary heart disease and&#xD;
      endocarditis The association between periodontitis and Abdominal Aortic Aneurysms (AAA) has&#xD;
      not often been studied especially from a clinical aspect. The mechanisms that induce the&#xD;
      initiation, the development or the recurrence and the rupture of AAA after a period of&#xD;
      quiescence not well studied and are therefore still unknown.&#xD;
&#xD;
      The aim of this clinical observational case controlled study is to search for a possible&#xD;
      relationship between periodontal disease and rapid growth of AAA. Patients presenting stable&#xD;
      or unstable AAA will be screened for the degree of periodontitis, for the type of oral&#xD;
      microbiology and periodontopathogen markers present in the blood stream.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      31 consecutive dentulous patients diagnosed for AAA requiring a cardiovascular surgery&#xD;
      (instable AAA) and 31 consecutive dentulous patients with stable AAA (no need for&#xD;
      cardiovascular surgery) will be recruited from the Cardiovascular Surgery Department of the&#xD;
      University Hospital of Liège (Faculty of Medicine, University of Liège, Belgium - Pr. N.&#xD;
      Sakalihasan). The 62 patients will be subjected to:&#xD;
&#xD;
        1. Full clinical periodontal parameter assessment&#xD;
&#xD;
        2. Microbiological analyses of saliva,&#xD;
&#xD;
        3. Supra- and sub- gingival microbiological test&#xD;
&#xD;
        4. Blood test for biomarker analysis.&#xD;
&#xD;
        5. Imaging (echography, CT-Scans)measurments&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pocked depth correlated with AAA stability</measure>
    <time_frame>june 2017</time_frame>
    <description>Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior</measure>
    <time_frame>March 2018</time_frame>
    <description>Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with abdominal aortic aneurysm diametres such as anterior -posterior (AP,millimeter)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">61</enrollment>
  <condition>Abdominal Aorta Aneurism</condition>
  <condition>Periodontitis</condition>
  <condition>Dentulous</condition>
  <arm_group>
    <arm_group_label>Stable AAA</arm_group_label>
    <description>= patients with a small abdominal aortic aneursym diameter &lt; 55 mm &quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>instable AAA</arm_group_label>
    <description>=patients with a large abdominal aortic aneursym diameter &gt; 55 mm and/or AAA with rapid growth who needs open surgery or EndoVascular Aneurysm Repair &quot;EVAR</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cross sectional</intervention_name>
    <arm_group_label>Stable AAA</arm_group_label>
    <arm_group_label>instable AAA</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      saliva, sub-gingival and supra-gingival samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from the Cardiovascular Surgery Department, University Hospital of Liège (Belgium)&#xD;
        and presenting AAA were screened in order to include 31 patients in each group (stable&#xD;
        versus instable AAA) according to the sample size calculation. Sixty-two patients were&#xD;
        therefore included according to the following inclusion and exclusion criteria:&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AAA&#xD;
&#xD;
          -  dentulous&#xD;
&#xD;
          -  ability to come in Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diseases of connective tissue: rheumatoid arthritis, systemic lupus erythematosus,&#xD;
             systemic sclerodermia, Crohn disease, Marfan syndrome, Heler Danlos syndrome,&#xD;
             polymyosite/dermatomyosite, mix connectivite (MCDT)&#xD;
&#xD;
          -  aneurysms of the lower limbs (femoral or popliteal)&#xD;
&#xD;
          -  contraindication to the scanner&#xD;
&#xD;
          -  participation of another clinical trial 30 days before baseline&#xD;
&#xD;
          -  patient with risk oslerien&#xD;
&#xD;
          -  taking antibiotics during the 3 months preceding the inclusion&#xD;
&#xD;
          -  obese patients (BMI ≥ 30 kg/m2)&#xD;
&#xD;
          -  immunosuppressant drugs or chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Leila Salhi</investigator_full_name>
    <investigator_title>Doctor of Dental Surgery (DDS), Master of sciences (MS), PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767023
org study id: H2014-3 AAA
nct id: NCT03767023
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Case-Control
time perspective: Cross-Sectional
measure: pocked depth correlated with AAA stability
time frame: june 2017
description: Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability.
measure: pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior
time frame: March 2018
description: Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with abdominal aortic aneurysm diametres such as anterior -posterior (AP,millimeter)
arm group label: Stable AAA
description: = patients with a small abdominal aortic aneursym diameter < 55 mm "
arm group label: instable AAA
description: =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
intervention type: Other
intervention name: cross sectional
arm group label: Stable AAA
arm group label: instable AAA
saliva, sub-gingival and supra-gingival samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Leila Salhi
investigator title: Doctor of Dental Surgery (DDS), Master of sciences (MS), PhD student
mesh term: Periodontitis
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal