<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/NCT03791632</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0386</org_study_id>
    <nct_id>NCT03791632</nct_id>
  </id_info>
  <brief_title>Oral Health Among Children</brief_title>
  <acronym>OHAC</acronym>
  <official_title>Oral Health Knowledge and Practice Among 8-9 Years Old Children.</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>
      The aim of this study is to identify the knowledge and behavior on dental health and hygiene&#xD;
      among adolescents. In most cases, the investigators know tooth decay can be prevented and&#xD;
      reversed at an early stage by observing good oral hygiene. Few studies have been done among&#xD;
      adolescents.&#xD;
&#xD;
      This study could justify the implementation of public health actions in terms of prevention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Test group&#xD;
Classes with a classical lecture style presentation&#xD;
classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)&#xD;
classes with digital media intervention</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>comparison of children's notes before and after a prevention intervention</measure>
    <time_frame>1 day</time_frame>
    <description>The main result will be calculated with the total score to the questions. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25.&#xD;
We will compare the evolution of the averages obtained by the control group and by all three other groups with Student test</description>
  </primary_outcome>
  <other_outcome>
    <measure>Compare the evolution of children's grades according to the type of intervention</measure>
    <time_frame>before and after the explanation as well as one month and 6 months after the intervention</time_frame>
    <description>For the secondary objective, we will compare the evolution of the averages obtained between the three groups with intervention with ANOVA test.&#xD;
Each question corresponds to a point. The minimum score is 0 and the maximum score is 25.&#xD;
before and after the explanation as well as one month and 6 months after the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>Determine the timeframe by which children forget the information they have been given</measure>
    <time_frame>before and after the explanation as well as one month and 6 months after the intervention</time_frame>
    <description>A questionnaire to know the oral knowledge will be distributed to the children before and after the explanation as well as one month and 6 months after the intervention</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Schoolboy</condition>
  <arm_group>
    <arm_group_label>witness</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>2 control CE2 classes without oral sensitization actions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group intervention 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 CE2 classes with a classical lecture style presentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group intervention 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 CE2 classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group intervention 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 CE2 classes with digital media intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>classical lecture style presentation</intervention_name>
    <description>classical lecture style presentation</description>
    <arm_group_label>group intervention 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>an intervention in the form of fun workshops</intervention_name>
    <description>an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)</description>
    <arm_group_label>group intervention 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>digital media intervention</intervention_name>
    <description>digital media intervention</description>
    <arm_group_label>group intervention 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - All children of classrooms selectionned&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Children absent on the day of the intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camille INQUIMBERT, PhD student</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>March 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03791632
org study id: RECHMPL18_0386
nct id: NCT03791632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to identify the knowledge and behavior on dental health and hygiene
      among adolescents. In most cases, the investigators know tooth decay can be prevented and
      reversed at an early stage by observing good oral hygiene. Few studies have been done among
      adolescents.

      This study could justify the implementation of public health actions in terms of prevention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Test group
Classes with a classical lecture style presentation
classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
classes with digital media intervention
primary purpose: Other
masking: Single (Participant)
measure: comparison of children's notes before and after a prevention intervention
time frame: 1 day
description: The main result will be calculated with the total score to the questions. Each question corresponds to a point. The minimum score is 0 and the maximum score is 25.
We will compare the evolution of the averages obtained by the control group and by all three other groups with Student test
measure: Compare the evolution of children's grades according to the type of intervention
time frame: before and after the explanation as well as one month and 6 months after the intervention
description: For the secondary objective, we will compare the evolution of the averages obtained between the three groups with intervention with ANOVA test.
Each question corresponds to a point. The minimum score is 0 and the maximum score is 25.
before and after the explanation as well as one month and 6 months after the intervention
measure: Determine the timeframe by which children forget the information they have been given
time frame: before and after the explanation as well as one month and 6 months after the intervention
description: A questionnaire to know the oral knowledge will be distributed to the children before and after the explanation as well as one month and 6 months after the intervention
arm group label: witness
arm group type: No Intervention
description: 2 control CE2 classes without oral sensitization actions
arm group label: group intervention 1
arm group type: Experimental
description: 2 CE2 classes with a classical lecture style presentation
arm group label: group intervention 2
arm group type: Experimental
description: 2 CE2 classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
arm group label: group intervention 3
arm group type: Experimental
description: 2 CE2 classes with digital media intervention
intervention type: Other
intervention name: classical lecture style presentation
description: classical lecture style presentation
arm group label: group intervention 1
intervention type: Other
intervention name: an intervention in the form of fun workshops
description: an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
arm group label: group intervention 2
intervention type: Other
intervention name: digital media intervention
description: digital media intervention
arm group label: group intervention 3
criteria: 
gender: All
minimum age: 7 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Camille INQUIMBERT, PhD student
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC