SARS-CoV InfectionNCT04542915
COVID-19-Related Health and Practices Among Dental Hygienists
An observational study of SARS-CoV Infection and Anxiety, run by American Dental Association at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Anxiety, Depression
- How many people
- 6,976 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 31 Aug 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: Dental hygienists licensed in the United States
Who may be able to join
- Dental hygienist
- Licensed in the United States
- 18 years of age or older
Who cannot join
- Not employed as a dental hygienist as of March 1, 2020
Trial locations and contacts
1 site in 1 country.
United States1 site
American Dental Association
Chicago, Illinois, 60611
About this study
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.
- Conditions
- SARS-CoV Infection, Anxiety, Depression, Occupational Problems, Severe Acute Respiratory Syndrome, Coronavirus Infection
- Being tested
- No intervention
- Medical subject headings
- Severe Acute Respiratory Syndrome, Anxiety Disorders, Depression, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| U.S. licensed dental hygienists | Dental hygienists licensed in the United States. No intervention will be administered. 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
2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody
Measured: 18 months
Secondary outcomes (5)
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
Personal protective equipment
Availability, frequency of use, and frequency of reuse of personal protective equipment
Measured: 12 months
Employment status
Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.
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 Sep 2020
- Study start29 Sep 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 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 SARS-CoV InfectionStudies 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
- 6,976 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Dental Association
- Sponsor type
- University, hospital or other
- Collaborators
- American Dental Hygienists Association
- Responsible party
- Principal investigator, Cameron Estrich, American Dental Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542915
- Sponsor's protocol ID
- ADA20-11
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, Gurenlian JR, Battrell A, Bessner SK, Lynch A, Mikkelsen M, Morrissey R, Araujo MWB, Vujicic M. COVID-19 Prevalence and Related Practices among Dental Hygienists in the United States. J Dent Hyg. 2021 Feb;95(1):6-16.
PubMed 33627448
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19-Related Health and Practices Among Dental Hygienists
- ClinicalTrials.gov ID
- NCT04542915
- Acronym / sponsor ID
- ADA20-11
- Conditions
- SARS-CoV Infection, Anxiety, Depression, Occupational Problems, Severe Acute Respiratory Syndrome, Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,976 participants (actual)
- Lead sponsor
- American Dental AssociationUniversity, hospital or other
- Collaborators
- American Dental Hygienists Association
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 9 Sep 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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. licensed dental hygienists | – | Other: No interventionDental hygienists licensed in the United States. No intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental hygienists licensed in the United States
Key inclusion criteria (3 listed)
- Dental hygienist
- Licensed in the United States
- 18 years of age or older
Key exclusion criteria (1 listed)
- Not employed as a dental hygienist as of March 1, 2020
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. | Other | U.S. licensed dental hygienists |
Primary outcome
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
5 secondary outcomes
Anxiety
Time frame: 12 months
Depression
Time frame: 12 months
Dental practice infection control efforts
Time frame: 12 months
Personal protective equipment
Time frame: 12 months
Employment status
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 16 Sep 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 33627448Estrich CG, Gurenlian JR, Battrell A, Bessner SK, Lynch A, Mikkelsen M, Morrissey R, Araujo MWB, Vujicic M. COVID-19 Prevalence and Related Practices among Dental Hygienists in the United States. J Dent Hyg. 2021 Feb;95(1):6-16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV Infection and Anxiety, 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 16 Sep 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 NCT04542915, 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 16 Sep 2021.