xml: <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/NCT05979636</url>
    </required_header>
    <id_info>
      <org_study_id>0286-09/2021</org_study_id>
      <nct_id>NCT05979636</nct_id>
    </id_info>
    <brief_title>Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children</brief_title>
    <official_title>Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hams Hamed Abdelrahman</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</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>
        Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk&#xD;
        children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans&#xD;
        in the plaque of high caries-risk children.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 6, 2022</start_date>
    <completion_date type="Actual">January 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in bacterial count in dental plaque</measure>
      <time_frame>1 week, 2 weeks and 4 weeks</time_frame>
      <description>The samples will be collected from all children in the study and the level of S.mutans will be recorded.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">36</enrollment>
    <condition>Dental Plaque</condition>
    <condition>Dental Caries</condition>
    <arm_group>
      <arm_group_label>Test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Novamin containing toothpaste</intervention_name>
      <description>children's teeth will be brushed using Novamin containing toothpaste.</description>
      <arm_group_label>Test group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fluoride containing toothpaste</intervention_name>
      <description>children's teeth will be brushed using Fluoride containing toothpaste.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Medically healthy children.&#xD;
  &#xD;
            -  No erupting first permanent molars.&#xD;
  &#xD;
            -  High caries risk children; Have visible cavities or have a visible plaque on their&#xD;
               teeth.&#xD;
  &#xD;
            -  Cooperative (Positive or definitely positive), according to Frankl's Behavior Rating&#xD;
               Scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of intake of antibiotics for the past 3-4 weeks.&#xD;
  &#xD;
            -  History of professional fluoride treatment over 2 weeks before the study.&#xD;
  &#xD;
            -  Children with tooth structure defects.&#xD;
  &#xD;
            -  Children unable to return for recall visits&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alexandria Faculty of Dentistry</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
      <investigator_title>Assistant lecturer of DPH and Clinical statistician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
      <mesh_term>Dental Plaque</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorides</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979636
  org study id: 0286-09/2021
  nct id: NCT05979636
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk
        children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans
        in the plaque of high caries-risk children.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Change in bacterial count in dental plaque
  time frame: 1 week, 2 weeks and 4 weeks
  description: The samples will be collected from all children in the study and the level of S.mutans will be recorded.
  arm group label: Test group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Novamin containing toothpaste
  description: children's teeth will be brushed using Novamin containing toothpaste.
  arm group label: Test group
  intervention type: Other
  intervention name: Fluoride containing toothpaste
  description: children's teeth will be brushed using Fluoride containing toothpaste.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 6 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Alexandria University
  investigator full name: Hams Hamed Abdelrahman
  investigator title: Assistant lecturer of DPH and Clinical statistician
  mesh term: Dental Caries
  mesh term: Dental Plaque
  mesh term: Fluorides