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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04542915
Other study ID # ADA20-11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 29, 2020
Est. completion date August 31, 2021

Study information

Verified date September 2021
Source American Dental Association
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6976
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
No intervention
No intervention.

Locations

Country Name City State
United States American Dental Association Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
American Dental Association American Dental Hygienists Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 probable or confirmed case 2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody 18 months
Secondary Anxiety 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. 12 months
Secondary Depression 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. 12 months
Secondary Dental practice infection control efforts Self-reports of infection control efforts in the respondents' primary dental practices. 12 months
Secondary Personal protective equipment Availability, frequency of use, and frequency of reuse of personal protective equipment 12 months
Secondary Employment status Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment. 12 months
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