Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial
Official title:
COVID-19 Related Health and Infection Control Practices Among Dentists
| 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 |
| Verified date | July 2021 |
| Source | American Dental Association |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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." |
| Country | Name | City | State |
|---|---|---|---|
| United States | American Dental Association | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| American Dental Association |
United States,
| 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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