COVID-19-Related Health and Practices Among Dental Hygienists

• ClinicalTrials.gov Identifier: NCT04542915
• Recruitment Status: Completed
• First Posted: September 9, 2020
• Last Update Posted: September 16, 2021
• Sponsor: American Dental Association
• Collaborator: American Dental Hygienists Association
• Information provided by (Responsible Party): Cameron Estrich, American Dental Association

Tracking Information

• First Submitted Date: September 8, 2020
• First Posted Date: September 9, 2020
• Last Update Posted Date: September 16, 2021
• Actual Study Start Date: September 29, 2020
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 8, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2020)

• Anxiety [ Time Frame: 12 months ]
  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.
• Depression [ Time Frame: 12 months ]
  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.
• Dental practice infection control efforts [ Time Frame: 12 months ]
  Self-reports of infection control efforts in the respondents' primary dental practices.
• Personal protective equipment [ Time Frame: 12 months ]
  Availability, frequency of use, and frequency of reuse of personal protective equipment
• Employment status [ Time Frame: 12 months ]
  Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COVID-19-Related Health and Practices Among Dental Hygienists
• Official Title: COVID-19-Related Health and Practices Among Dental Hygienists
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Ecologic or Community; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Dental hygienists licensed in the United States

Condition

• SARS-CoV Infection
• Anxiety
• Depression
• Occupational Problems
• Severe Acute Respiratory Syndrome
• Coronavirus Infection

Intervention

Other: No intervention

No intervention.

Study Groups/Cohorts

U.S. licensed dental hygienists

Dental hygienists licensed in the United States. No intervention will be administered.

Intervention: Other: No intervention

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.
• Estrich 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 15, 2021): 6976
• Original Estimated Enrollment (submitted: September 8, 2020): 5000
• Actual Study Completion Date: August 31, 2021
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04542915
• Other Study ID Numbers: ADA20-11
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cameron Estrich, American Dental Association
• Original Responsible Party: Same as current
• Current Study Sponsor: American Dental Association
• Original Study Sponsor: Same as current
• Collaborators: American Dental Hygienists Association
• Investigators: Not Provided
• PRS Account: American Dental Association
• Verification Date: September 2021