<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/NCT04460469</url>
  </required_header>
  <id_info>
    <org_study_id>Mai Zakaria 4</org_study_id>
    <nct_id>NCT04460469</nct_id>
  </id_info>
  <brief_title>Anxiety Level and Oral Hygiene Practice in Dental Students During Covid-19 Pandemic</brief_title>
  <official_title>Self-assessment of Anxiety Level and Oral Hygiene Practice in Dental Students of Cairo University During Covid-19 Pandemic</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan&#xD;
      (Hubei province), is now a pandemic announced by World Health Organization, raising concerns&#xD;
      of widespread panic and increasing anxiety in individuals. This outbreak results in mass&#xD;
      quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported&#xD;
      quarantine could bring &quot;post traumatic stress symptoms, confusion, and anger. Stressors&#xD;
      included longer quarantine duration, infection fears, frustration, boredom, inadequate&#xD;
      supplies, inadequate information, financial loss, and stigma.&quot;. Many universities decided to&#xD;
      suspend in-person classes and evacuate students in responding to the intensifying concerns&#xD;
      surrounding Covid-19. This action can lead to negative psychological consequences among&#xD;
      college students. Oral health related behavior and attitudes habits correlate with oral&#xD;
      health status and can be considered to be its predictors . There is a claim of potential&#xD;
      connection between high bacterial load in the mouth and complications associated with&#xD;
      Covid-19 infection. Bacteria present in the meta genome of patients severely infected with&#xD;
      Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually&#xD;
      commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high&#xD;
      bacterial load. Accordingly, the investigators assume that good oral hygiene better to be&#xD;
      maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and&#xD;
      the risk of a bacterial super infection in case of catching the infection .&#xD;
&#xD;
      While there seems to be a common belief that psychosocial stress affects oral hygiene&#xD;
      behavior, this assumption has rarely been proved9 Dental students, as the future providers of&#xD;
      dental care, are ex¬pected to be role models for their patients regarding the oral hygiene&#xD;
      practice and they supposed to be aware of the importance of preserving the oral health. Thus,&#xD;
      we intended to select them as our population to study how the level of anxiety during&#xD;
      pandemic could affect the practice of oral hygien&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cross sectional study (survey) will be conducted among dental students in faculty of&#xD;
      dentistry Cairo University for the duration of one month from June 2020 to July 2020.&#xD;
&#xD;
      The questionnaire has three parts. The first part included demographic details. The second&#xD;
      part included validated general anxiety disorder scale GAD-7. Questionnaire consisting of&#xD;
      seven questions which measures students' anxiety level score. Scores of 5, 10, and 15 are&#xD;
      taken as the cut-off points for mild, moderate and severe anxiety, respectively. The third&#xD;
      part the validated self administered, structured, and close ended 15 questions that assessed&#xD;
      the self reported oral hygiene practices 11. The questionnaire forms were kept anonymous. The&#xD;
      questionnaire was validated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university</measure>
    <time_frame>2 months</time_frame>
    <description>By questionnaire</description>
  </primary_outcome>
  <enrollment type="Actual">1500</enrollment>
  <condition>Anxiety</condition>
  <condition>Covid19</condition>
  <condition>Oral Hygiene</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The questionnaire is going to be disseminated as google form to all the Cairo university&#xD;
        dental students via emails .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Student of faculty of Dentistry, Cairo University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mai Zakaria, Ph</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer Oral Medicine &amp; Periodontology, Faculty of Dentistry, Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>115</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mai Zakaria Ibrahium Mohammed</investigator_full_name>
    <investigator_title>Lecturer Oral Medicine &amp; Periodontology, Faculty of Dentistry, Cairo University</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Covid19</keyword>
  <keyword>Oral Hygiene Practice</keyword>
  <keyword>Dental students</keyword>
  <keyword>questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>individual participant data are not to be shared with other researchers until publication of the study.</ipd_description>
  </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/NCT04460469
org study id: Mai Zakaria 4
nct id: NCT04460469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan
      (Hubei province), is now a pandemic announced by World Health Organization, raising concerns
      of widespread panic and increasing anxiety in individuals. This outbreak results in mass
      quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported
      quarantine could bring "post traumatic stress symptoms, confusion, and anger. Stressors
      included longer quarantine duration, infection fears, frustration, boredom, inadequate
      supplies, inadequate information, financial loss, and stigma.". Many universities decided to
      suspend in-person classes and evacuate students in responding to the intensifying concerns
      surrounding Covid-19. This action can lead to negative psychological consequences among
      college students. Oral health related behavior and attitudes habits correlate with oral
      health status and can be considered to be its predictors . There is a claim of potential
      connection between high bacterial load in the mouth and complications associated with
      Covid-19 infection. Bacteria present in the meta genome of patients severely infected with
      Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually
      commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high
      bacterial load. Accordingly, the investigators assume that good oral hygiene better to be
      maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and
      the risk of a bacterial super infection in case of catching the infection .

      While there seems to be a common belief that psychosocial stress affects oral hygiene
      behavior, this assumption has rarely been proved9 Dental students, as the future providers of
      dental care, are ex¬pected to be role models for their patients regarding the oral hygiene
      practice and they supposed to be aware of the importance of preserving the oral health. Thus,
      we intended to select them as our population to study how the level of anxiety during
      pandemic could affect the practice of oral hygien
A cross sectional study (survey) will be conducted among dental students in faculty of
      dentistry Cairo University for the duration of one month from June 2020 to July 2020.

      The questionnaire has three parts. The first part included demographic details. The second
      part included validated general anxiety disorder scale GAD-7. Questionnaire consisting of
      seven questions which measures students' anxiety level score. Scores of 5, 10, and 15 are
      taken as the cut-off points for mild, moderate and severe anxiety, respectively. The third
      part the validated self administered, structured, and close ended 15 questions that assessed
      the self reported oral hygiene practices 11. The questionnaire forms were kept anonymous. The
      questionnaire was validated.
observational model: Other
time perspective: Cross-Sectional
measure: correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university
time frame: 2 months
description: By questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mai Zakaria, Ph
role: Principal Investigator
affiliation: Lecturer Oral Medicine & Periodontology, Faculty of Dentistry, Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mai Zakaria Ibrahium Mohammed
investigator title: Lecturer Oral Medicine & Periodontology, Faculty of Dentistry, Cairo University
mesh term: COVID-19
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: individual participant data are not to be shared with other researchers until publication of the study.