<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/NCT03240666</url>
  </required_header>
  <id_info>
    <org_study_id>PSS2016/PARO-PROTO-BISSON/ER</org_study_id>
    <nct_id>NCT03240666</nct_id>
  </id_info>
  <brief_title>Protozoans in Biofilm From Patients With Periodontitis</brief_title>
  <acronym>Paro-Proto</acronym>
  <official_title>Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      The buccal cavity is colonized by numerous microorganisms whose the number and composition&#xD;
      could be modified with medical background (diseases and drugs) and the level of oral hygiene&#xD;
      of the patients. Among all microorganisms identified in the periodontium, few of them are&#xD;
      implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria&#xD;
      are identified for their ability to degrade periodontal tissues.&#xD;
&#xD;
      Although the periodontitis is established to be the consequence of bacterial virulence and&#xD;
      immune dysfunction, these factors fail to explain the refractory periodontitis of some&#xD;
      patients to etiologic treatment .&#xD;
&#xD;
      Others microorganisms such as protozoans could have an impact on this disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 10, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>presence of protozoans</measure>
    <time_frame>6 months after the last inclusion: DNA samples were frozen and identified later.</time_frame>
    <description>identification of protozoans by molecular technique (PCR) -</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periodontal pocket depth (PPD in mm)</measure>
    <time_frame>One day: measure realised during examination of the patient for periodontal treatment.</time_frame>
    <description>Measure of PPD thanks to periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment Loss (CAL in mm)</measure>
    <time_frame>One day: measure realied during clincal examination of patient.</time_frame>
    <description>Measure of CAL with periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque and gingival index</measure>
    <time_frame>One day: measure of index during the clinical examination of patient.</time_frame>
    <description>Measure of plaque and gingival index (Loe and Silness, Silness and Loe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility of tooth</measure>
    <time_frame>One day: measure of tooth mobility during the clinical examination of patient.</time_frame>
    <description>Measure of tooth mobility: Yes or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding On Probing (BOP)</measure>
    <time_frame>One day: measure of BOP during the clinical examination of patient.</time_frame>
    <description>Measure of BOP : Yes or not</description>
  </secondary_outcome>
  <enrollment type="Anticipated">231</enrollment>
  <condition>Periodontitis, Adult</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non applicable</intervention_name>
    <description>non applicable</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bacterial DNA, protozoan DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients consulting to periodontal department of CHRU (Nancy-Nice- Toulouse) presenting at&#xD;
        least two PPD of 5mm and more, without any medecines which could modify microbiota were&#xD;
        included in this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults &gt; 18 years-old&#xD;
&#xD;
          -  consulting in periodontal department of CHRU&#xD;
&#xD;
          -  Patients with moderate to severe periodontitis&#xD;
&#xD;
          -  At least 2 periodontal sites with PPD ≥ 5mm and one healthy site&#xD;
&#xD;
          -  No scaling root planing in the last 6 months&#xD;
&#xD;
          -  Patients insured under the Franch social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnants patients&#xD;
&#xD;
          -  Patients with antibiotic therapy and/ or all medecines which could modify the buccal&#xD;
             microbiota in the last 6 months&#xD;
&#xD;
          -  Tooth with endodontics periapical lesion&#xD;
&#xD;
          -  Patients having a scaling root planing in the last 6 months&#xD;
&#xD;
          -  Patients with guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>El Mehdi SIAGHY</last_name>
    <phone>+33 383 15 52 85</phone>
    <email>m.siaghy@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Catherine BISSON</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine BISSON, DDS</last_name>
      <phone>+33 383852952</phone>
      <email>catherine.bisson@univ-lorraine.fr</email>
    </contact>
    <investigator>
      <last_name>Severine VINCENT-BUGNAS, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sara LAURENCINS, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>non applicable</ipd_description>
  </patient_data>
  <!-- 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/NCT03240666
org study id: PSS2016/PARO-PROTO-BISSON/ER
nct id: NCT03240666
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The buccal cavity is colonized by numerous microorganisms whose the number and composition
      could be modified with medical background (diseases and drugs) and the level of oral hygiene
      of the patients. Among all microorganisms identified in the periodontium, few of them are
      implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria
      are identified for their ability to degrade periodontal tissues.

      Although the periodontitis is established to be the consequence of bacterial virulence and
      immune dysfunction, these factors fail to explain the refractory periodontitis of some
      patients to etiologic treatment .

      Others microorganisms such as protozoans could have an impact on this disease.
observational model: Cohort
time perspective: Other
measure: presence of protozoans
time frame: 6 months after the last inclusion: DNA samples were frozen and identified later.
description: identification of protozoans by molecular technique (PCR) -
measure: Periodontal pocket depth (PPD in mm)
time frame: One day: measure realised during examination of the patient for periodontal treatment.
description: Measure of PPD thanks to periodontal probe
measure: Clinical attachment Loss (CAL in mm)
time frame: One day: measure realied during clincal examination of patient.
description: Measure of CAL with periodontal probe
measure: Plaque and gingival index
time frame: One day: measure of index during the clinical examination of patient.
description: Measure of plaque and gingival index (Loe and Silness, Silness and Loe)
measure: Mobility of tooth
time frame: One day: measure of tooth mobility during the clinical examination of patient.
description: Measure of tooth mobility: Yes or not
measure: Bleeding On Probing (BOP)
time frame: One day: measure of BOP during the clinical examination of patient.
description: Measure of BOP : Yes or not
intervention type: Other
intervention name: non applicable
description: non applicable
Bacterial DNA, protozoan DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: El Mehdi SIAGHY
phone: +33 383 15 52 85
email: m.siaghy@chru-nancy.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: Undecided
ipd description: non applicable