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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04423770
Other study ID # 20-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2020
Est. completion date June 8, 2021

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2196
Est. completion date June 8, 2021
Est. primary completion date June 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primary dental practice is in United States - 18 years of age or older - Dentist Exclusion Criteria: •Answered "no" to ADA survey sent May 2020 that read "As part of ongoing efforts to monitor the effect of COVID-19 on the dental team, the ADA is interested in collecting data related to infection rates. Would you also be willing to participate in a separate, longitudinal study that would require you to report whether you or your staff have exhibited symptoms of COVID-19, and whether you have been tested or diagnosed? The study would be anonymous and under IRB protocols."

Study Design


Related Conditions & MeSH terms

  • Infection
  • Severe Acute Respiratory Syndrome
  • Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Other:
No intervention
No intervention; this is a purely observational study

Locations

Country Name City State
United States American Dental Association Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
American Dental Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 probable or confirmed case COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen 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 Dentists' use of personal protective equipment Self-reports of personal protective equipment use 12 months
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