<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/NCT03802669</url>
  </required_header>
  <id_info>
    <org_study_id>ETH10</org_study_id>
    <nct_id>NCT03802669</nct_id>
  </id_info>
  <brief_title>Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients</brief_title>
  <official_title>Molecular Assessment of Oral Mutans Streptococcus Isolated From Patients With Different Age and Caries Activity Via Selective Media and Protein Pattern.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>October University for Modern Sciences and Arts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>October University for Modern Sciences and Arts</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      90 saliva samples will be isolated from patient who possess different ages and caries&#xD;
      activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then&#xD;
      the determination of the best selective media for mutans streptococcus isolated from saliva&#xD;
      and authenticate the MS via PCR technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>oral mutans streptococcus screening</measure>
    <time_frame>immediately</time_frame>
    <description>screening of oral mutans streptococcus of each group to determine the differences</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>caries free children aged between 3-6</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>caries active children aged between 3-6</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>caries free children aged between 6-12</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>caries active children aged between 6-12</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>caries free adult aged between 18-25</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>caries active adult aged between 18-25</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>oral mutans streptococcus</intervention_name>
    <description>quantitative assessment of mutans streptococcus of each group by using PCR and protein pattern</description>
    <arm_group_label>caries active adult aged between 18-25</arm_group_label>
    <arm_group_label>caries active children aged between 3-6</arm_group_label>
    <arm_group_label>caries active children aged between 6-12</arm_group_label>
    <arm_group_label>caries free adult aged between 18-25</arm_group_label>
    <arm_group_label>caries free children aged between 3-6</arm_group_label>
    <arm_group_label>caries free children aged between 6-12</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients attending out patient clinic of October University for Modern Sciences and Arts.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participant received antimicrobial therapy in previous month.&#xD;
&#xD;
          -  participant who taking xylitol chewing gum or undergo fluoride therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naglaa Ezzeldin, lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>October University for Modern Sciences and Arts</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>October University of Modern Sciences and Arts</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>October University for Modern Sciences and Arts</investigator_affiliation>
    <investigator_full_name>Naglaa Ibrahim Ezz</investigator_full_name>
    <investigator_title>Lecturer of pediatric dentistry department, faculty of dentistry</investigator_title>
  </responsible_party>
  <keyword>human saliva</keyword>
  <keyword>mutans streptococcus</keyword>
  <keyword>PCR</keyword>
  <keyword>caries activity</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>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/NCT03802669
org study id: ETH10
nct id: NCT03802669
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
90 saliva samples will be isolated from patient who possess different ages and caries
      activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then
      the determination of the best selective media for mutans streptococcus isolated from saliva
      and authenticate the MS via PCR technique.
observational model: Case-Control
time perspective: Cross-Sectional
measure: oral mutans streptococcus screening
time frame: immediately
description: screening of oral mutans streptococcus of each group to determine the differences
arm group label: caries free children aged between 3-6
arm group label: caries active children aged between 3-6
arm group label: caries free children aged between 6-12
arm group label: caries active children aged between 6-12
arm group label: caries free adult aged between 18-25
arm group label: caries active adult aged between 18-25
intervention type: Other
intervention name: oral mutans streptococcus
description: quantitative assessment of mutans streptococcus of each group by using PCR and protein pattern
arm group label: caries active adult aged between 18-25
arm group label: caries active children aged between 3-6
arm group label: caries active children aged between 6-12
arm group label: caries free adult aged between 18-25
arm group label: caries free children aged between 3-6
arm group label: caries free children aged between 6-12
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naglaa Ezzeldin, lecturer
role: Principal Investigator
affiliation: October University for Modern Sciences and Arts
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: October University for Modern Sciences and Arts
investigator full name: Naglaa Ibrahim Ezz
investigator title: Lecturer of pediatric dentistry department, faculty of dentistry
mesh term: Dental Caries
sharing ipd: No