Severe Acute Respiratory Syndrome Coronavirus 2NCT04423770
COVID-19 Related Health and Infection Control Practices Among Dentists
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2, run by American Dental Association at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- How many people
- 2,196 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 8 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dentists in the United States
Who may be able to join
- Primary dental practice is in United States
- 18 years of age or older
- Dentist
Who cannot join
- •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."
Trial locations and contacts
1 site in 1 country.
United States1 site
American Dental Association
Chicago, Illinois, 60611
About this study
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.
- Being tested
- No intervention
- Keywords
- SARS-CoV-2, COVID-19, survey, dentistry, infection control
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention; this is a purely observational study
| Study group | Role | What they receive |
|---|---|---|
| U.S. dentists | Dentists in the United States Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: 12 months
Dental practice infection control efforts
Self-reports of infection control efforts in the respondents' primary dental practices
Measured: 12 months
Dentists' use of personal protective equipment
Self-reports of personal protective equipment use
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Jun 2020
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Dental Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Estrich, American Dental Association
- Investigators
- Cameron G Estrich, MPH, PhD, Principal investigator, American Dental Association Science and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423770
- Sponsor's protocol ID
- 20-08
- Status last verified
- Jul 2021
- First submitted
- 8 Jun 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eldridge LA, Estrich CG, Gurenlian JR, Battrell A, Lynch A, Vujicic M, Morrissey R, Dershewitz S, Geisinger ML, Araujo MWB. US dental health care workers' mental health during the COVID-19 pandemic. J Am Dent Assoc. 2022 Aug;153(8):740-749. doi: 10.1016/j.adaj.2022.02.011.
PubMed 35902154Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.
PubMed 33071007
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Related Health and Infection Control Practices Among Dentists
- ClinicalTrials.gov ID
- NCT04423770
- Acronym / sponsor ID
- 20-08
- Keywords
- SARS-CoV-2, COVID-19, survey, dentistry, infection control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,196 participants (actual)
- Lead sponsor
- American Dental AssociationUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. dentists | – | Other: No interventionDentists in the United States |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dentists in the United States
Key inclusion criteria (3 listed)
- Primary dental practice is in United States
- 18 years of age or older
- Dentist
Key exclusion criteria (1 listed)
- •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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention; this is a purely observational study | Other | U.S. dentists |
Primary outcome
COVID-19 probable or confirmed case
Time frame: 18 months
COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen
4 secondary outcomes
Anxiety
Time frame: 12 months
Depression
Time frame: 12 months
Dental practice infection control efforts
Time frame: 12 months
Dentists' use of personal protective equipment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 35902154Eldridge LA, Estrich CG, Gurenlian JR, Battrell A, Lynch A, Vujicic M, Morrissey R, Dershewitz S, Geisinger ML, Araujo MWB. US dental health care workers' mental health during the COVID-19 pandemic. J Am Dent Assoc. 2022 Aug;153(8):740-749. doi: 10.1016/j.adaj.2022.02.011.
- Derived from this study: PubMed 33071007Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron G Estrich, MPH, PhD principal investigator
American Dental Association Science and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2, run by American Dental Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 probable or confirmed case (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.