Skip to main content
Clinical Trials/NCT05607147
NCT05607147CompletedNot Applicable

Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers

Rutgers, The State University of New Jersey2 sites in 1 country10 target enrollmentStarted: January 26, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
Dental Health Care Worker (DHCW) Willingness to Participate in the Study

Study Overview

Brief Summary

10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.

Detailed Description

10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine

Exclusion Criteria

  • Previous participation

Outcomes

Primary Outcomes

Dental Health Care Worker (DHCW) Willingness to Participate in the Study

Time Frame: Day 1

Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study

Number of DHCW With Complete Surveys

Time Frame: Through study completion (3 months)

Number of participants with complete Start-of-study, Triage and End-of-Study surveys

DHCW Test Completion

Time Frame: Day 28

Percentage of DHCWs with completed SARS-CoV-2 test completed

DHCW Ease of Complying With Protocol

Time Frame: Day 28

Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study

DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing

Time Frame: Day 28

Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing

Secondary Outcomes

  • SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive(28 days)
  • Positive Antibody Testing(28 days)
  • Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecile A. Feldman, DMD

Professor

Rutgers, The State University of New Jersey

Study Sites (2)

Loading locations...

Similar Trials

Rutgers Pilot for Dental Health Care... | Clinical Trial