<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/NCT04456335</url>
  </required_header>
  <id_info>
    <org_study_id>2018/269</org_study_id>
    <nct_id>NCT04456335</nct_id>
  </id_info>
  <brief_title>Investigation of Supragingival Plaque Microbiome in Early Childhood Caries</brief_title>
  <official_title>Investigation of Supragingival Plaque Microbiome Using Next Generation Sequencing in Early Childhood Caries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trakya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Commission of Scientific Research Projects of Trakya University (TÜBAP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Trakya University</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study was to characterize the supragingival plaque microbiome in children&#xD;
      with early childhood caries and identify potential microorganisms associated with caries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty children with and without early childhood caries were recruited from Trakya University&#xD;
      Faculty of Dentistry Department of Pediatric Dentistry. Oral examinations were performed by&#xD;
      the same examiner according to diagnostic criteria of World Health Organisation (WHO) and The&#xD;
      International Caries Detection and Assessment System (ICDAS) . Mothers' completed a&#xD;
      structured questionnaire on the socio-demographic informations, child's feeding practices and&#xD;
      oral hygiene habits. After the oral examination, supragingival plaque samples were collected&#xD;
      from the posterior tooth surfaces. Supragingival plaque samples were examined with the&#xD;
      Illumina MiSeq new generation sequencing method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">May 23, 2020</completion_date>
  <primary_completion_date type="Actual">January 3, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>V4-16S rRNA and ITS1 rRNA sequencing</measure>
    <time_frame>6 months</time_frame>
    <description>Supragingival plaque samples were collected from the tooth surfaces using a sterile periodontal curette. DNA extraction was performed at Sugenomik Biotechnology Laboratory for library preparation and paired-end Illumina MiSeq PE250 sequencing of the V4 region of bacterial 16S rRNA and fungal ITS1 (internal transcribed spacer 1) rRNA genes.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Early Childhood Caries</condition>
  <arm_group>
    <arm_group_label>Caries-free</arm_group_label>
    <description>Caries-free children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early childhood caries</arm_group_label>
    <description>Children with early childhood caries</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Collection of supragingival plaque from caries free children</intervention_name>
    <description>Supragingival plaque samples were collected from posterior molar teeth</description>
    <arm_group_label>Caries-free</arm_group_label>
    <arm_group_label>Early childhood caries</arm_group_label>
    <other_name>Collection of supragingival plaque from children with early childhood caries</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Supragingival plaque sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of sixty children with early childhood caries(n=30) and caries free(n=30)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  36-71 months old children&#xD;
&#xD;
          -  No history of any medical problem&#xD;
&#xD;
          -  No history of antibiotic in the three months prior to sampling&#xD;
&#xD;
          -  Any sign of early childhood caries,&#xD;
&#xD;
          -  Caries free children&#xD;
&#xD;
          -  Mothers accepted to complete a structured questionnaire&#xD;
&#xD;
          -  Children who cooperate for dental examination and sample collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children older than 71 months&#xD;
&#xD;
          -  Medically compromised&#xD;
&#xD;
          -  Children with antibiotic use history at last three months&#xD;
&#xD;
          -  Children refused dental examination and plaque collection&#xD;
&#xD;
          -  Mothers' refused to complete questionnare&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Months</minimum_age>
    <maximum_age>71 Months</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Trakya University</investigator_affiliation>
    <investigator_full_name>ŞİRİN GÜNER ONUR</investigator_full_name>
    <investigator_title>Assist. Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Early childhood caries</keyword>
  <keyword>Oral Microbiome</keyword>
  <keyword>Next generation sequencing</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04456335
org study id: 2018/269
nct id: NCT04456335
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to characterize the supragingival plaque microbiome in children
      with early childhood caries and identify potential microorganisms associated with caries.
Sixty children with and without early childhood caries were recruited from Trakya University
      Faculty of Dentistry Department of Pediatric Dentistry. Oral examinations were performed by
      the same examiner according to diagnostic criteria of World Health Organisation (WHO) and The
      International Caries Detection and Assessment System (ICDAS) . Mothers' completed a
      structured questionnaire on the socio-demographic informations, child's feeding practices and
      oral hygiene habits. After the oral examination, supragingival plaque samples were collected
      from the posterior tooth surfaces. Supragingival plaque samples were examined with the
      Illumina MiSeq new generation sequencing method.
observational model: Case-Control
time perspective: Other
measure: V4-16S rRNA and ITS1 rRNA sequencing
time frame: 6 months
description: Supragingival plaque samples were collected from the tooth surfaces using a sterile periodontal curette. DNA extraction was performed at Sugenomik Biotechnology Laboratory for library preparation and paired-end Illumina MiSeq PE250 sequencing of the V4 region of bacterial 16S rRNA and fungal ITS1 (internal transcribed spacer 1) rRNA genes.
arm group label: Caries-free
description: Caries-free children
arm group label: Early childhood caries
description: Children with early childhood caries
intervention type: Genetic
intervention name: Collection of supragingival plaque from caries free children
description: Supragingival plaque samples were collected from posterior molar teeth
arm group label: Caries-free
arm group label: Early childhood caries
other name: Collection of supragingival plaque from children with early childhood caries
Supragingival plaque sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 36 Months
maximum age: 71 Months
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Trakya University
investigator full name: ŞİRİN GÜNER ONUR
investigator title: Assist. Prof. Dr.
sharing ipd: No