<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/NCT03817437</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0401</org_study_id>
    <nct_id>NCT03817437</nct_id>
  </id_info>
  <brief_title>Correlation Study Between Socio-economical Deprivation and Oral Health in Children of 9 Years of Age</brief_title>
  <acronym>PRECA-6</acronym>
  <official_title>Correlation Study Between Socio-economical Deprivation and Oral Health in in French Children of 9 Years of Age in 2017. A Nationwide Database Retrospective Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Retrospective, observational cohort study.&#xD;
&#xD;
      Objectives :&#xD;
&#xD;
      To search for correlations between socio-economical deprivation and oral health in french&#xD;
      children of 9 years of age.&#xD;
&#xD;
      To study the annual use of oral and dental care of children from 6 to 9 years of age&#xD;
      depending on their geographical and socio-economical environment, and the medical demography&#xD;
      ; To identify and study the share of the cohort not using oral and dental care, and the&#xD;
      socio-economical and geographical factors implicated in this non-use of care.&#xD;
&#xD;
      The study will use data from the french nationwide healthcare systems database (SNDS) and&#xD;
      data from the french national institute of statistics and economic studies (INSEE).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlations (odds-ratios) between several socio-economical indicators and oral care use</measure>
    <time_frame>36 months</time_frame>
    <description>Correlations (odds-ratios) between several socio-economical indicators and oral care use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment</measure>
    <time_frame>36 months</time_frame>
    <description>Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment, and the medical demography</description>
  </secondary_outcome>
  <enrollment type="Actual">600000</enrollment>
  <condition>Tooth Decay</condition>
  <condition>Missing Tooth/Teeth</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients born in 2008&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Being born in 2008&#xD;
&#xD;
          -  Being covered by the mandatory french national health insurance plan without&#xD;
             discontinuity between 2014 and 2017&#xD;
&#xD;
          -  Living in France without discontinuity between 2014 and 2017&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume BOUREL, MsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral health</keyword>
  <keyword>Odontology</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Public health</keyword>
  <keyword>Deprivation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</mesh_term>
    <mesh_term>Anodontia</mesh_term>
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</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/NCT03817437
org study id: RECHMPL18_0401
nct id: NCT03817437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective, observational cohort study.

      Objectives :

      To search for correlations between socio-economical deprivation and oral health in french
      children of 9 years of age.

      To study the annual use of oral and dental care of children from 6 to 9 years of age
      depending on their geographical and socio-economical environment, and the medical demography
      ; To identify and study the share of the cohort not using oral and dental care, and the
      socio-economical and geographical factors implicated in this non-use of care.

      The study will use data from the french nationwide healthcare systems database (SNDS) and
      data from the french national institute of statistics and economic studies (INSEE).
observational model: Cohort
time perspective: Retrospective
measure: Correlations (odds-ratios) between several socio-economical indicators and oral care use
time frame: 36 months
description: Correlations (odds-ratios) between several socio-economical indicators and oral care use
measure: Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment
time frame: 36 months
description: Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment, and the medical demography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guillaume BOUREL, MsC
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Tooth Loss
mesh term: Anodontia
mesh term: Dental Caries
sharing ipd: Undecided
ipd description: NC