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/NCT05980273</url>
    </required_header>
    <id_info>
      <org_study_id>health education -Oral Health</org_study_id>
      <nct_id>NCT05980273</nct_id>
    </id_info>
    <brief_title>Effectiveness of Oral Health Education Programs Among School Children, Their Mothers and Teachers in Fayyum: Cohort Study</brief_title>
    <official_title>Effectiveness of Oral Health Education Programs Among School Children, Their Mothers and Teachers in Fayyum: Cohort Study</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>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>
        Cohort study to evaluate the effect of oral health educational program effect on oral health&#xD;
        of school children, their mothers and teachers&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Scientific Background:&#xD;
  &#xD;
        One of the most common disorders in the world is oral disease, which is mostly avoidable. In&#xD;
        industrialized nations, dental caries affects 60-90% of schoolchildren and the majority of&#xD;
        adults; it is becoming more common in developing nations and is particularly common in&#xD;
        various Asian and Latin American nations .&#xD;
  &#xD;
        Severe periodontitis affects 5-15% of the majority of people worldwide, and it is&#xD;
        unmistakably linked to diabetes and weakened immune systems. Dental caries is common in&#xD;
        India, where they affect 63.1% of 15-year-olds and up to 80.2% of individuals between the&#xD;
        ages of 35 and 44, according to the National Oral Health Survey. Between the ages of 35 and&#xD;
        44, the prevalence of periodontal diseases increases to 89.6%, affecting 67.7% of&#xD;
        15-year-olds.&#xD;
  &#xD;
        According to estimates, this chronic illness affects 60% to 90% of children who are of school&#xD;
        age. This percentage fluctuates widely depending on the population, with the Middle East and&#xD;
        other developing nations seeing higher rates of dental caries than wealthy nations do.&#xD;
  &#xD;
        Any civilization that wants to give its citizens a fair standard of living should priorities&#xD;
        preventing disease, disability, and pain. The most economical strategy and one that has the&#xD;
        biggest influence on a community or population, whether it be a school, neighborhood, or&#xD;
        country, is prevention on a community or population-based level. A planned action that delays&#xD;
        the beginning of a disease among a population is known as an effective community preventative&#xD;
        programs. There are many various ways to avoid dental diseases, but health education is the&#xD;
        most economical one.&#xD;
  &#xD;
        Numerous research on intermediate school students' awareness of oral health issues and use of&#xD;
        preventative measures have been carried out. Rural Chinese pupils lacked understanding about&#xD;
        fluoride use, gum disease, and dental caries. In Spain, 61.1% of 12-year-old children had at&#xD;
        least one tooth that was decaying, filled, or missing, and they had little understanding of&#xD;
        gingivitis. When knowledge in schoolchildren rose in the United Arab Emirates, practice also&#xD;
        increased, demonstrating the connection between information and practice.&#xD;
  &#xD;
        Only a few epidemiological studies of dental caries among Egyptians have been published,&#xD;
        despite the significant frequency of dental caries in the community. Additionally, the&#xD;
        majority of the information is in the form of grey literature and is not accessible through&#xD;
        standard search engines. In 2014, the (WHO) and the Egyptian Ministry of Health conducted the&#xD;
        most recent epidemiological assessment on the state of oral health in Egypt. Additionally,&#xD;
        the majority of epidemiological research and only one ( focused on children.&#xD;
  &#xD;
        To create and implement an effective children's oral health agenda and awareness programs for&#xD;
        parents and school teachers that will enhance oral health, the prevalence of dental caries&#xD;
        should be regularly monitored. Therefore, this study aimed to evaluate the prevalence of&#xD;
        dental caries and periodontal diseases in mothers and children in fayoum, Egypt.&#xD;
        Additionally, to evaluate the oral hygiene knowledge in mothers and children with enhancing&#xD;
        prevention program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 9, 2023</start_date>
    <completion_date type="Anticipated">October 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>oral health questionnaire</measure>
      <time_frame>through one year</time_frame>
      <description>Arabic version of a modified HU-DBI questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>decayed,missed,filled teeth / decayed , extracted , filled teeth</measure>
      <time_frame>through one year</time_frame>
      <description>decayed,missed,filled</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Periodontal health/oral health status using BPE for mothers and teachers</measure>
      <time_frame>through one year</time_frame>
      <description>Code 0 Healthy Code 1 Bleeding on probing. No plaque retention factors or pockets greater than 3.5 mm Code 2 Presence of calculus or plaque retention factor. No pockets greater than 3.5 mm Code 3 Pockets of 3.5 to 5.5 mm Code 4 Pockets greater than 5.5 mm&#xD;
  * Furcation involvement</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1800</enrollment>
    <condition>Dental Caries</condition>
    <arm_group>
      <arm_group_label>school children, their mothers and teachers</arm_group_label>
      <description>educational session program</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational sessions</intervention_name>
      <description>session for oral health education</description>
      <arm_group_label>school children, their mothers and teachers</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          school children (7-14 years old) Their mothers children&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all students , their mothers &amp; teachers will be included in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no exclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yomna S Khallaf, PhD</last_name>
      <phone>01006781076</phone>
      <email>yomna.sayed@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Olfat E Hassanein, Professor</last_name>
      <phone>0201005688816</phone>
      <email>olfat.hassanein@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>yomna sayed khallaf</investigator_full_name>
      <investigator_title>lecturer at faculty of dentistry Cairo university</investigator_title>
    </responsible_party>
    <keyword>oral health</keyword>
    <keyword>Educational health program</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_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/NCT05980273
  org study id: health education -Oral Health
  nct id: NCT05980273
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Cohort study to evaluate the effect of oral health educational program effect on oral health
        of school children, their mothers and teachers
  Scientific Background:
  
        One of the most common disorders in the world is oral disease, which is mostly avoidable. In
        industrialized nations, dental caries affects 60-90% of schoolchildren and the majority of
        adults; it is becoming more common in developing nations and is particularly common in
        various Asian and Latin American nations .
  
        Severe periodontitis affects 5-15% of the majority of people worldwide, and it is
        unmistakably linked to diabetes and weakened immune systems. Dental caries is common in
        India, where they affect 63.1% of 15-year-olds and up to 80.2% of individuals between the
        ages of 35 and 44, according to the National Oral Health Survey. Between the ages of 35 and
        44, the prevalence of periodontal diseases increases to 89.6%, affecting 67.7% of
        15-year-olds.
  
        According to estimates, this chronic illness affects 60% to 90% of children who are of school
        age. This percentage fluctuates widely depending on the population, with the Middle East and
        other developing nations seeing higher rates of dental caries than wealthy nations do.
  
        Any civilization that wants to give its citizens a fair standard of living should priorities
        preventing disease, disability, and pain. The most economical strategy and one that has the
        biggest influence on a community or population, whether it be a school, neighborhood, or
        country, is prevention on a community or population-based level. A planned action that delays
        the beginning of a disease among a population is known as an effective community preventative
        programs. There are many various ways to avoid dental diseases, but health education is the
        most economical one.
  
        Numerous research on intermediate school students' awareness of oral health issues and use of
        preventative measures have been carried out. Rural Chinese pupils lacked understanding about
        fluoride use, gum disease, and dental caries. In Spain, 61.1% of 12-year-old children had at
        least one tooth that was decaying, filled, or missing, and they had little understanding of
        gingivitis. When knowledge in schoolchildren rose in the United Arab Emirates, practice also
        increased, demonstrating the connection between information and practice.
  
        Only a few epidemiological studies of dental caries among Egyptians have been published,
        despite the significant frequency of dental caries in the community. Additionally, the
        majority of the information is in the form of grey literature and is not accessible through
        standard search engines. In 2014, the (WHO) and the Egyptian Ministry of Health conducted the
        most recent epidemiological assessment on the state of oral health in Egypt. Additionally,
        the majority of epidemiological research and only one ( focused on children.
  
        To create and implement an effective children's oral health agenda and awareness programs for
        parents and school teachers that will enhance oral health, the prevalence of dental caries
        should be regularly monitored. Therefore, this study aimed to evaluate the prevalence of
        dental caries and periodontal diseases in mothers and children in fayoum, Egypt.
        Additionally, to evaluate the oral hygiene knowledge in mothers and children with enhancing
        prevention program.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: oral health questionnaire
  time frame: through one year
  description: Arabic version of a modified HU-DBI questionnaire
  measure: decayed,missed,filled teeth / decayed , extracted , filled teeth
  time frame: through one year
  description: decayed,missed,filled
  measure: Periodontal health/oral health status using BPE for mothers and teachers
  time frame: through one year
  description: Code 0 Healthy Code 1 Bleeding on probing. No plaque retention factors or pockets greater than 3.5 mm Code 2 Presence of calculus or plaque retention factor. No pockets greater than 3.5 mm Code 3 Pockets of 3.5 to 5.5 mm Code 4 Pockets greater than 5.5 mm
  * Furcation involvement
  arm group label: school children, their mothers and teachers
  description: educational session program
  intervention type: Behavioral
  intervention name: Educational sessions
  description: session for oral health education
  arm group label: school children, their mothers and teachers
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yomna S Khallaf, PhD
  phone: 01006781076
  email: yomna.sayed@dentistry.cu.edu.eg
  last name: Olfat E Hassanein, Professor
  phone: 0201005688816
  email: olfat.hassanein@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: yomna sayed khallaf
  investigator title: lecturer at faculty of dentistry Cairo university
  mesh term: Dental Caries