NCT04542915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,976

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 8, 2020

Last Update Submit

September 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Secondary Outcomes (5)

  • Anxiety

    12 months

  • Depression

    12 months

  • Dental practice infection control efforts

    12 months

  • Personal protective equipment

    12 months

  • Employment status

    12 months

Study Arms (1)

U.S. licensed dental hygienists

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

Other: No intervention

Interventions

No intervention.

U.S. licensed dental hygienists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dental hygienists licensed in the United States

You may qualify if:

  • Dental hygienist
  • Licensed in the United States
  • years of age or older

You may not qualify if:

  • Not employed as a dental hygienist as of March 1, 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Dental Association

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeAnxiety DisordersDepressionCoronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health research analyst

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 9, 2020

Study Start

September 29, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations