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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05607147
Acronym
PREDICT-DHCW
Enrollment
10
Registered
2022-11-07
Start date
2021-01-26
Completion date
2021-02-11
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV2 Infection

Keywords

Dental Healthcare Worker, Testing, Seroprevalence, Perception of Safety, Adoption of risk mitigation practice

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)..

Interventions

DEVICETesting for SARS CoV2 Antigen and Antibody

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

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Pilot study to assess feasibility of testing dental healthcare workers for seropositivity and antigen positivity for SARS-CoV-2 (Rapid Antigen point-of-care testing).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Previous participation

Design outcomes

Primary

MeasureTime frameDescription
Number of DHCW With Complete SurveysThrough study completion (3 months)Number of participants with complete Start-of-study, Triage and End-of-Study surveys
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and TestingDay 28Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing
DHCW Test CompletionDay 28Percentage of DHCWs with completed SARS-CoV-2 test completed
DHCW Ease of Complying With ProtocolDay 28Number 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
Dental Health Care Worker (DHCW) Willingness to Participate in the StudyDay 1Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study

Secondary

MeasureTime frameDescription
Positive Antibody Testing28 daysNumber of participants who tested positive for antibody to SARS-CoV2
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work28 daysPercentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive28 daysNumber of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing

Countries

United States

Participant flow

Recruitment details

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. Study participation ranged from January- February 2021.

Participants by arm

ArmCount
SARS-CoV-2 Testing
There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral Antigen and antibody to the virus as described. Testing for SARS CoV2 Antigen and Antibody: Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for the adoption of risk mitigation practices and for perceptions of safety
10
Total10

Baseline characteristics

CharacteristicSARS-CoV-2 Testing
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
Age, Continuous39.9 years
STANDARD_DEVIATION 14.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
4 Participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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

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

Time frame: Day 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingDental Health Care Worker (DHCW) Willingness to Participate in the Study10 Participants
Primary

DHCW Ease of Complying With Protocol

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

Time frame: Day 28

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingDHCW Ease of Complying With Protocol9 Participants
Primary

DHCW Test Completion

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

Time frame: Day 28

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingDHCW Test Completion10 Participants
Primary

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

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

Time frame: Day 28

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingDHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing10 Participants
Primary

Number of DHCW With Complete Surveys

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

Time frame: Through study completion (3 months)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingNumber of DHCW With Complete Surveys10 Participants
Secondary

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

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

Time frame: 28 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingNumber of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work10 Participants
Secondary

Positive Antibody Testing

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

Time frame: 28 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingPositive Antibody Testing5 Participants
Secondary

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

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

Time frame: 28 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SARS-CoV-2 TestingSARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026