<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/NCT03006133</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2016-12-171</org_study_id>
    <nct_id>NCT03006133</nct_id>
  </id_info>
  <brief_title>Prevalence of Bruxism in a Group of Preschool Egyptian Children</brief_title>
  <official_title>Prevalence of Bruxism in a Group of Preschool Egyptian Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The protocol is to show the prevalence of bruxism among a group of Egyptian children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many studies are done on children to show the prevalence of bruxism among different ages ,&#xD;
      reports of prevalence range from 8-31% in the general population, the prevalence of bruxism&#xD;
      in Egyptian children is unknown. Several symptoms are commonly associated with bruxism,&#xD;
      including hypersensitive teeth, aching jaw muscles, headaches, tooth wear, damage to dental&#xD;
      restorations (e.g. crowns and fillings) and damage to teeth. However it may cause minimal&#xD;
      symptoms, and therefore people may not be aware of the condition,so this study is important&#xD;
      to determine the prevalence of bruxism of preschool Egyptian children&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Bruxism</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">362</enrollment>
  <condition>Bruxism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        preschool Egyptian children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cooperative children from 3-6 years&#xD;
&#xD;
          2. Children without any Medical problems&#xD;
&#xD;
          3. Children of families who accept to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1- Children with caries in posterior teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manal Ahmed, Ass.Prof.</last_name>
    <phone>+201227332259</phone>
    <email>manal.agha@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Randa Youssef, Ass.Prof</last_name>
    <phone>+201222272010</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Manal Ahmed</name>
      <address>
        <city>Cairo Governorate</city>
        <state>Manial</state>
        <zip>11211</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manal Elsayed, Ass.Prof.</last_name>
      <phone>+201227332259</phone>
      <email>manal.agha@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>February 9, 2017</last_update_submitted>
  <last_update_submitted_qc>February 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Wafik Ismael Mohamed</investigator_full_name>
    <investigator_title>Demonstrator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
  </condition_browse>
  <!-- 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/NCT03006133
org study id: CEBC-CU-2016-12-171
nct id: NCT03006133
lead sponsor: 
has dmc: No
The protocol is to show the prevalence of bruxism among a group of Egyptian children
Many studies are done on children to show the prevalence of bruxism among different ages ,
      reports of prevalence range from 8-31% in the general population, the prevalence of bruxism
      in Egyptian children is unknown. Several symptoms are commonly associated with bruxism,
      including hypersensitive teeth, aching jaw muscles, headaches, tooth wear, damage to dental
      restorations (e.g. crowns and fillings) and damage to teeth. However it may cause minimal
      symptoms, and therefore people may not be aware of the condition,so this study is important
      to determine the prevalence of bruxism of preschool Egyptian children
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of Bruxism
time frame: 1 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manal Ahmed, Ass.Prof.
phone: +201227332259
email: manal.agha@hotmail.com
last name: Randa Youssef, Ass.Prof
phone: +201222272010
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Wafik Ismael Mohamed
investigator title: Demonstrator
mesh term: Bruxism