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Completed

NCT Number: NCT05607147

Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

About this study

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)..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous participation

Treatment and study plan

Testing for SARS CoV2 Antigen and Antibody

Device

Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for adoption of risk mitigation practices and for perceptions of safety

Primary outcomes

  1. 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

  2. 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

  3. DHCW Test Completion

    Time frame: Day 28

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

  4. 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

  5. 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

Secondary outcomes

  1. SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive

    Time frame: 28 days

    Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing

  2. Positive Antibody Testing

    Time frame: 28 days

    Number of participants who tested positive for antibody to SARS-CoV2

  3. Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work

    Time frame: 28 days

    Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Acronym: PREDICT-DHCW

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2022
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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