<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/NCT03800043</url>
  </required_header>
  <id_info>
    <org_study_id>25/2/18</org_study_id>
    <nct_id>NCT03800043</nct_id>
  </id_info>
  <brief_title>Social Impact of Children's Dental Appearance</brief_title>
  <official_title>Social Impact of Children's Dental Appearance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Göttingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Göttingen</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>
      This study evaluates the social impact of children's dental perception from children with or&#xD;
      without caries experience. For this, children and their parents are shown pictures of child&#xD;
      faces with healthy teeth, decayed teeth and teeth after dental treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Appearance and abnormalities in the face influences the life of children: attractive children&#xD;
      get estimated as more competent and find friends easier than those with a less attractive&#xD;
      appearance. Therefore this study aimes to evaluate the social impact of children's dental&#xD;
      perception from children with or without own caries experience (and their parents). Both&#xD;
      groups (with/without caries experience) are shown pictures of children with different dental&#xD;
      status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete&#xD;
      established questionnaires.The division into the groups is based on photos of the children&#xD;
      with visible teeth.&#xD;
&#xD;
      The results should be evaluated descriptively and graphically. Also the comparison between&#xD;
      the answers of both groups for the three different dental status is planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Children: Evaluation of the whole photos</measure>
    <time_frame>2-3 minutes</time_frame>
    <description>Questionnaire: &quot;How would you feel having a friend looking like this?&quot; (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children: Evaluation of the mouth on the photo</measure>
    <time_frame>2-3 minutes</time_frame>
    <description>Questionnaire: &quot;How would you feel having a friend with a mouth looking like this&quot; (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children: Evaluation of their own teeth</measure>
    <time_frame>1-2 minutes</time_frame>
    <description>Questionnaire: &quot;How do you feel when thinking about your own teeth?&quot; (4 point face scale of Soares et al. 2015)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Why do you feel like this?</measure>
    <time_frame>1-2 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Related parents: Evaluation of the whole photos</measure>
    <time_frame>1-2 minutes</time_frame>
    <description>Questionnaire: Evaluate the pictures with the adjectives: clever, rude, kind, honest, confident, careful, helpful, stupid, naughty (4 point scale. 'strongly agree' = 4; 'agree' = 3; 'disagree' = 2; 'strongly disagree' = 1)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">180</enrollment>
  <condition>Dental Caries in Children</condition>
  <arm_group>
    <arm_group_label>Children with own caries experience</arm_group_label>
    <description>Children with own caries experience (visible on a photo; teeth clearly visible), sufficient compliance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children without own caries experience</arm_group_label>
    <description>Children without own caries experience (visible on a photo; teeth clearly visible), sufficient compliance</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        children with or without caries experience and their parents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (parent of an child of) age 4-9 years&#xD;
&#xD;
          -  sufficient compliance&#xD;
&#xD;
          -  dividable into the two groups (with or without caries experience)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missing agreement to participate in the study&#xD;
&#xD;
          -  insufficient compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Annette Wiegand, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany</name>
      <address>
        <city>Göttingen</city>
        <state>Lower Saxony</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Göttingen</investigator_affiliation>
    <investigator_full_name>Claudia Tschammler</investigator_full_name>
    <investigator_title>Dr. Claudia Tschammler, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Early Childhood Caries</keyword>
  <keyword>children</keyword>
  <keyword>dentistry</keyword>
  <keyword>face perception</keyword>
  <keyword>dental appearance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03800043
org study id: 25/2/18
nct id: NCT03800043
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the social impact of children's dental perception from children with or
      without caries experience. For this, children and their parents are shown pictures of child
      faces with healthy teeth, decayed teeth and teeth after dental treatment.
Appearance and abnormalities in the face influences the life of children: attractive children
      get estimated as more competent and find friends easier than those with a less attractive
      appearance. Therefore this study aimes to evaluate the social impact of children's dental
      perception from children with or without own caries experience (and their parents). Both
      groups (with/without caries experience) are shown pictures of children with different dental
      status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete
      established questionnaires.The division into the groups is based on photos of the children
      with visible teeth.

      The results should be evaluated descriptively and graphically. Also the comparison between
      the answers of both groups for the three different dental status is planned.
observational model: Cohort
time perspective: Prospective
measure: Children: Evaluation of the whole photos
time frame: 2-3 minutes
description: Questionnaire: "How would you feel having a friend looking like this?" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)
measure: Children: Evaluation of the mouth on the photo
time frame: 2-3 minutes
description: Questionnaire: "How would you feel having a friend with a mouth looking like this" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)
measure: Children: Evaluation of their own teeth
time frame: 1-2 minutes
description: Questionnaire: "How do you feel when thinking about your own teeth?" (4 point face scale of Soares et al. 2015)
measure: Why do you feel like this?
time frame: 1-2 minutes
measure: Related parents: Evaluation of the whole photos
time frame: 1-2 minutes
description: Questionnaire: Evaluate the pictures with the adjectives: clever, rude, kind, honest, confident, careful, helpful, stupid, naughty (4 point scale. 'strongly agree' = 4; 'agree' = 3; 'disagree' = 2; 'strongly disagree' = 1)
arm group label: Children with own caries experience
description: Children with own caries experience (visible on a photo; teeth clearly visible), sufficient compliance
arm group label: Children without own caries experience
description: Children without own caries experience (visible on a photo; teeth clearly visible), sufficient compliance
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
last name: Annette Wiegand, Prof. Dr.
role: Study Director
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Göttingen
investigator full name: Claudia Tschammler
investigator title: Dr. Claudia Tschammler, Principal Investigator
mesh term: Dental Caries
sharing ipd: Undecided