<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/NCT04423770</url>
  </required_header>
  <id_info>
    <org_study_id>20-08</org_study_id>
    <nct_id>NCT04423770</nct_id>
  </id_info>
  <brief_title>COVID-19 Related Health and Infection Control Practices Among Dentists</brief_title>
  <official_title>COVID-19 Related Health and Infection Control Practices Among Dentists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Dental Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Dental Association</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>
      As dentists begin reopening their practices during a global pandemic, the risk of COVID-19&#xD;
      infection that dentists face in providing dental care remains unknown. Estimating the&#xD;
      occupational risk of COVID-19, and producing evidence on the types of infection control&#xD;
      practices and dental practices that may affect COVID-19 risk, is therefore imperative. The&#xD;
      goal of the proposed study is to understand U.S.-based dentists' health and dental-practice&#xD;
      reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These&#xD;
      findings could be used to describe the prevalence and incidence of COVID-19 among dentists,&#xD;
      determine what infection control steps dentists take over time, and estimate whether&#xD;
      infection control adherence in dental practice is related to COVID-19 incidence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">June 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 probable or confirmed case</measure>
    <time_frame>18 months</time_frame>
    <description>COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dental practice infection control efforts</measure>
    <time_frame>12 months</time_frame>
    <description>Self-reports of infection control efforts in the respondents' primary dental practices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dentists' use of personal protective equipment</measure>
    <time_frame>12 months</time_frame>
    <description>Self-reports of personal protective equipment use</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2196</enrollment>
  <condition>Severe Acute Respiratory Syndrome Coronavirus 2</condition>
  <arm_group>
    <arm_group_label>U.S. dentists</arm_group_label>
    <description>Dentists in the United States</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention; this is a purely observational study</description>
    <arm_group_label>U.S. dentists</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Dentists in the United States&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary dental practice is in United States&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Dentist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •Answered &quot;no&quot; to ADA survey sent May 2020 that read &quot;As part of ongoing efforts to monitor&#xD;
        the effect of COVID-19 on the dental team, the ADA is interested in collecting data related&#xD;
        to infection rates. Would you also be willing to participate in a separate, longitudinal&#xD;
        study that would require you to report whether you or your staff have exhibited symptoms of&#xD;
        COVID-19, and whether you have been tested or diagnosed? The study would be anonymous and&#xD;
        under IRB protocols.&quot;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cameron G Estrich, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Dental Association Science and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Dental Association</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American Dental Association</investigator_affiliation>
    <investigator_full_name>Cameron Estrich</investigator_full_name>
    <investigator_title>Health Research Analyst</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>survey</keyword>
  <keyword>dentistry</keyword>
  <keyword>infection control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</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/NCT04423770
org study id: 20-08
nct id: NCT04423770
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As dentists begin reopening their practices during a global pandemic, the risk of COVID-19
      infection that dentists face in providing dental care remains unknown. Estimating the
      occupational risk of COVID-19, and producing evidence on the types of infection control
      practices and dental practices that may affect COVID-19 risk, is therefore imperative. The
      goal of the proposed study is to understand U.S.-based dentists' health and dental-practice
      reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These
      findings could be used to describe the prevalence and incidence of COVID-19 among dentists,
      determine what infection control steps dentists take over time, and estimate whether
      infection control adherence in dental practice is related to COVID-19 incidence.
observational model: Ecologic or Community
time perspective: Prospective
measure: COVID-19 probable or confirmed case
time frame: 18 months
description: COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen
measure: Anxiety
time frame: 12 months
description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.
measure: Depression
time frame: 12 months
description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.
measure: Dental practice infection control efforts
time frame: 12 months
description: Self-reports of infection control efforts in the respondents' primary dental practices
measure: Dentists' use of personal protective equipment
time frame: 12 months
description: Self-reports of personal protective equipment use
arm group label: U.S. dentists
description: Dentists in the United States
intervention type: Other
intervention name: No intervention
description: No intervention; this is a purely observational study
arm group label: U.S. dentists
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cameron G Estrich, MPH, PhD
role: Principal Investigator
affiliation: American Dental Association Science and Research Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: American Dental Association
investigator full name: Cameron Estrich
investigator title: Health Research Analyst
mesh term: Infections
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: Undecided