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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542915
Recruitment Status : Completed
First Posted : September 9, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
American Dental Hygienists Association
Information provided by (Responsible Party):
Cameron Estrich, American Dental Association

Tracking Information
First Submitted Date September 8, 2020
First Posted Date September 9, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date September 29, 2020
Actual Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2020)
  • 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.
  • 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.
  • Dental practice infection control efforts [ Time Frame: 12 months ]
    Self-reports of infection control efforts in the respondents' primary dental practices.
  • Personal protective equipment [ Time Frame: 12 months ]
    Availability, frequency of use, and frequency of reuse of personal protective equipment
  • Employment status [ Time Frame: 12 months ]
    Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19-Related Health and Practices Among Dental Hygienists
Official Title COVID-19-Related Health and Practices Among Dental Hygienists
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Dental hygienists licensed in the United States
Condition
  • SARS-CoV Infection
  • Anxiety
  • Depression
  • Occupational Problems
  • Severe Acute Respiratory Syndrome
  • Coronavirus Infection
Intervention Other: No intervention
No intervention.
Study Groups/Cohorts U.S. licensed dental hygienists
Dental hygienists licensed in the United States. No intervention will be administered.
Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 15, 2021)
6976
Original Estimated Enrollment
 (submitted: September 8, 2020)
5000
Actual Study Completion Date August 31, 2021
Actual Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04542915
Other Study ID Numbers ADA20-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Cameron Estrich, American Dental Association
Original Responsible Party Same as current
Current Study Sponsor American Dental Association
Original Study Sponsor Same as current
Collaborators American Dental Hygienists Association
Investigators Not Provided
PRS Account American Dental Association
Verification Date September 2021