Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19-Related Health and Practices Among Dental Hygienists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542915
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
American Dental Hygienists Association
Information provided by (Responsible Party):
Cameron Estrich, American Dental Association

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists 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. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.

Condition or disease Intervention/treatment
SARS-CoV Infection Anxiety Depression Occupational Problems Severe Acute Respiratory Syndrome Coronavirus Infection Other: No intervention

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: COVID-19-Related Health and Practices Among Dental Hygienists
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
U.S. licensed dental hygienists
Dental hygienists licensed in the United States. No intervention will be administered.
 Other: No intervention
No intervention.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. COVID-19 probable or confirmed case [ Time Frame: 18 months ]
    2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 12 months ]
    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.

  2. Depression [ Time Frame: 12 months ]
    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.

  3. Dental practice infection control efforts [ Time Frame: 12 months ]
    Self-reports of infection control efforts in the respondents' primary dental practices.

  4. Personal protective equipment [ Time Frame: 12 months ]
    Availability, frequency of use, and frequency of reuse of personal protective equipment

  5. Employment status [ Time Frame: 12 months ]
    Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dental hygienists licensed in the United States
Criteria

Inclusion Criteria:

  • Dental hygienist
  • Licensed in the United States
  • 18 years of age or older

Exclusion Criteria:

  • Not employed as a dental hygienist as of March 1, 2020
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542915


Contacts
Layout table for location contacts
Contact: Cameron Estrich, MPH, PhD 17735582606 estrichc@ada.org

Sponsors and Collaborators
American Dental Association
American Dental Hygienists Association
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Cameron Estrich, Health research analyst, American Dental Association
ClinicalTrials.gov Identifier: NCT04542915    
Other Study ID Numbers: ADA20-11
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases