<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/NCT03751189</url>
  </required_header>
  <id_info>
    <org_study_id>07/16</org_study_id>
    <nct_id>NCT03751189</nct_id>
  </id_info>
  <brief_title>Role of Overjet and Trauma in Libyan Children</brief_title>
  <official_title>Trauma to Permanent Incisors and Overjet in Libyan Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>sudhir rama varma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajman 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>
      Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing&#xD;
      anterior tooth in children due to any injury can be a source of considerable physical and&#xD;
      psychological discomfort for the child. These consequences also have significant impact on&#xD;
      parents, who are generally concerned with esthetic and economic aspects of this problem. It&#xD;
      varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth&#xD;
      can be both painful and traumatic to the children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic injuries to anterior teeth have reported by several investigators. In Asia and&#xD;
      Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and&#xD;
      15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and&#xD;
      23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to&#xD;
      graduation . A contributing factors make children susceptible to injuries have been widely&#xD;
      investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to&#xD;
      92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at&#xD;
      home, followed by school and public places.The aim of this study is to assess the mean&#xD;
      overjet value in Libyan children and to examine the relationship between increased overjet&#xD;
      and trauma to permanent incisor teeth&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2016</start_date>
  <completion_date type="Actual">May 10, 2017</completion_date>
  <primary_completion_date type="Actual">January 10, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of school children with overjet</measure>
    <time_frame>From baseline to 10 months</time_frame>
    <description>Presence of overjet among school children, is evaluated by observational method,measured by 1-1mm-3mm;2-3mm-5mm;3-5mm&lt;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dental trauma among school children</measure>
    <time_frame>From baseline to 10 months</time_frame>
    <description>Presence of trauma ,by observational method; Grading done by 0- No trauma;1-trauma related to incisal region;2-trauma related to mid half;3-trauma pertaining to cervical region</description>
  </secondary_outcome>
  <enrollment type="Actual">1900</enrollment>
  <condition>Trauma</condition>
  <condition>Overjet</condition>
  <eligibility>
    <study_pop>
      <textblock>
        . Total of 2015 Libyan school children aged 7 to 16 years from urban (Tobruk) and rural&#xD;
        (Kufra) areas were examined in the main study. The children were of almost equal number of&#xD;
        both sexes from each age group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Libyan children.&#xD;
&#xD;
          -  The permanent incisors are present &amp; sufficiently erupted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non Libyan children.&#xD;
&#xD;
          -  The permanent incisors are absent, or un-sufficiently erupted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ajman University</investigator_affiliation>
    <investigator_full_name>sudhir rama varma</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>trauma</keyword>
  <keyword>overjet</keyword>
  <keyword>libya</keyword>
  <keyword>schoolchildren</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT03751189
org study id: 07/16
nct id: NCT03751189
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing
      anterior tooth in children due to any injury can be a source of considerable physical and
      psychological discomfort for the child. These consequences also have significant impact on
      parents, who are generally concerned with esthetic and economic aspects of this problem. It
      varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth
      can be both painful and traumatic to the children
Traumatic injuries to anterior teeth have reported by several investigators. In Asia and
      Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and
      15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and
      23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to
      graduation . A contributing factors make children susceptible to injuries have been widely
      investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to
      92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at
      home, followed by school and public places.The aim of this study is to assess the mean
      overjet value in Libyan children and to examine the relationship between increased overjet
      and trauma to permanent incisor teeth
observational model: Ecologic or Community
time perspective: Retrospective
measure: Number of school children with overjet
time frame: From baseline to 10 months
description: Presence of overjet among school children, is evaluated by observational method,measured by 1-1mm-3mm;2-3mm-5mm;3-5mm<
measure: Dental trauma among school children
time frame: From baseline to 10 months
description: Presence of trauma ,by observational method; Grading done by 0- No trauma;1-trauma related to incisal region;2-trauma related to mid half;3-trauma pertaining to cervical region
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Ajman University
investigator full name: sudhir rama varma
investigator title: Assistant Professor
mesh term: Wounds and Injuries
sharing ipd: Undecided