COVID-19-Related Health and Practices Among Dental Hygienists

• Sponsor: American Dental Association (Other)
• Overall Status: Completed
• CT.gov ID: NCT04542915
• Collaborator: American Dental Hygienists Association (Other)
• Enrollment: 6,976
• Location: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 631.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV Infection; Anxiety; Depression; Occupational Problems; Severe Acute Respiratory Syndrome; Coronavirus Infection	Other: No intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 6976 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: COVID-19-Related Health and Practices Among Dental Hygienists
• Actual Study Start Date: Sep 29, 2020
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
U.S. licensed dental hygienists Dental hygienists licensed in the United States. No intervention will be administered.	Other: No intervention; No intervention.

Outcome Measures

Primary Outcome Measures

1. COVID-19 probable or confirmed case [18 months]

   2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody

Secondary Outcome Measures

1. Anxiety [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.

2. Depression [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.

3. Dental practice infection control efforts [12 months]

   Self-reports of infection control efforts in the respondents' primary dental practices.

4. Personal protective equipment [12 months]

   Availability, frequency of use, and frequency of reuse of personal protective equipment

5. Employment status [12 months]

   Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Dental Association	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• American Dental Association
• American Dental Hygienists Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cameron Estrich, Health research analyst, American Dental Association
• ClinicalTrials.gov Identifier: NCT04542915
• Other Study ID Numbers: ADA20-11
• First Posted: Sep 9, 2020
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Coronavirus Infections; Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Sep 16, 2021