Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers
Phase: NA
Conditions: SARS-CoV2 Infection
Sponsor: Rutgers, The State University of New Jersey

Tool Summary Sheet Page 1
Tool Revision History:
Version
Number
Date
Summary of Revisions Made:
5.0
1/20/21
Removed PCR testing as Rutgers DHCW do saliva PCR testing weekly so logistics 
do not need to be determined and window for End-of-Study visit has been 
expanded to +/-14 days as POC test expire 2/8/21
6.0
11/3/2021
Removed Dr. Amy Davidow and Priyanka Unnam from the study as they are no 
longer at the institution
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NCT05607147
Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing (PREDICT-DHCW)
Document Approval Date: 11/11/2021

Pragmatic Return to Effective Dental Infection Control
Version DHCW /6.00
Protocol X01 DE030407-01
11/3/2021
________________________________________________________________________________________________________
Tool Summary Sheet Page ii
Pragmatic Return to Effective Dental Infection 
Control through Triage and Testing
(PREDICT)
Rutgers Single Site
Dental Health Care Worker Subjects 
NIDCR Protocol Number: TBD  
NIDCR Grant Number:  X01 DE030407 – 01
Principal Investigator:  Cecile A. Feldman, DMD, MBA
Grantee Institution:  Rutgers University, School of Dental Medicine
NIDCR Program Official:  Dena Fischer, DDS, MSD, MS
NIDCR Medical Monitor:  N/A
Draft or Version Number:  Vr. DHCW 6.00
November 3, 2021
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Tool Summary Sheet Page 1
STATEMENT OF COMPLIANCE
The study will be conducted in accordance with the International Council for Harmonisation guidelines for 
Good Clinical Practice (GCP) (ICH E6) and the Code of Federal Regulations on the Protection of Human 
Subjects (45 CFR Part 46). National Institutes of Health (NIH)-funded investigators and clinical trial site 
staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training.
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SIGNATURE PAGE
The signature below constitutes the approval of this protocol and the attachments, and provides the 
necessary assurances that this study will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory requirements 
and applicable US federal regulations and ICH guidelines.
Principal Investigator:
Signed:
Date:
Name:  Cecile A. Feldman, DMD
Title:   Dean and Professor, Rutgers University, School of Dental Medicine
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TABLE OF CONTENTS
PAGE
STATEMENT OF COMPLIANCE...................................................................................................................1
SIGNATURE PAGE .......................................................................................................................................2
TABLE OF CONTENTS .................................................................................................................................3
LIST OF ABBREVIATIONS...........................................................................................................................5
PROTOCOL SUMMARY ...............................................................................................................................7
1
KEY ROLES AND CONTACT INFORMATION....................................................................................9
2
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .......................11
2.1
Background Information..........................................................................................................11
2.2
Rationale ...............................................................................................................................12
2.3
Potential Risks and Benefits.....................................................................................................12
2.3.1
Potential Risks...........................................................................................................12
2.3.2
Potential Benefits.......................................................................................................13
3
OBJECTIVES AND OUTCOME MEASURES......................................................................................14
3.1
Primary..................................................................................................................................15
3.2
Secondary ..............................................................................................................................15
3.3
Tertiary/Exploratory ...............................................................................................................16
4
STUDY DESIGN ................................................................................................................................17
5
STUDY POPULATION.......................................................................................................................20
5.1
Participant Inclusion Criteria ...................................................................................................20
5.2
Participant Exclusion Criteria ..................................................................................................20
5.3
Strategies for Recruitment and Retention ..................................................................................20
5.4
Participant Withdrawal or Discontinuation from Study Procedures/Intervention ...........................21
5.4.1
Reasons for Participant Withdrawal or Discontinuation from Study 
Procedures/Intervention..............................................................................................21
5.4.2
Handling of Participant Withdrawals from Study or Participant Discontinuation of 
Study Intervention .....................................................................................................21
5.5
Premature Termination or Suspension of Study .........................................................................21
6
STUDY SCHEDULE...........................................................................................................................22
7
STUDY PROCEDURES/EVALUATIONS............................................................................................23
7.1
Study Procedures/Evaluations..................................................................................................23
7.2
Laboratory Procedures/Eavluations ..........................................................................................24
8
ASSESSMENT OF SAFETY ...............................................................................................................27
8.1
Specification of Safety Parameters ...........................................................................................27
9.1.1
Unanticipated Problems..............................................................................................27
9.1.2
Adverse Events..........................................................................................................28
9.1.3
Serious Adverse Events..............................................................................................28
8.2
Reporting Procedures..............................................................................................................28
8.2.1
Unanticipated Problem Reporting................................................................................28
9
STUDY OVERSIGHT.........................................................................................................................29
10
CLINICAL SITE MONITORING.........................................................................................................30
11
STATISTICAL CONSIDERATIONS ...................................................................................................31
11.1
Study Hypotheses ...................................................................................................................31
11.2
Sample Size Considerations.....................................................................................................31
12.3
Final Analysis Plan .................................................................................................................31
12
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ......................................33
13
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................................34
14
ETHICS/PROTECTION OF HUMAN SUBJECTS ................................................................................35
14.1
Ethical Standard .....................................................................................................................35
14.2
Institutional Review Board ......................................................................................................35
14.3
Informed Consent Process .......................................................................................................35
14.4
Exclusion of Women, Minorities, and Children (Special Populations)..........................................35
14.5
Subject Confidentiality............................................................................................................35
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14.6
Future Use of Stored Specimens and Other Identifiable Data ......................................................36
15
DATA HANDLING AND RECORD KEEPING....................................................................................37
15.1
Data Management Responsibilities...........................................................................................37
15.2
Data Capture Methods.............................................................................................................37
15.3
Types of Data.........................................................................................................................37
15.4
Schedule and Content of Reports..............................................................................................37
15.5
Study Records Retention .........................................................................................................37
15.6
Protocol Deviations.................................................................................................................38
16
PUBLICATION/DATA SHARING ......................................................................................................39
17
LITERATURE REFERENCES.............................................................................................................40
SUPPLEMENTAL MATERIALS ..................................................................................................................42
APPENDICES ..............................................................................................................................................43
APPENDIX A: SCHEDULE OF EVENTS......................................................................................................44
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LIST OF ABBREVIATIONS
AE
Adverse Event/Adverse Experience
PBRN
Practice Based Research Network
CFR
Code of Federal Regulations
CSI
Clinical Site Investigator
CIOMS
Council for International Organizations of Medical Sciences
CONSORT
Consolidated Standards of Reporting Trials
CRF
Case Report Form
CRO
Contract Research Organization
DCC
Data Coordinating Center
DHCW
Dental Health Care Workers
DHHS
Department of Health and Human Services
DMFS
Decayed, missing, and filled tooth surfaces
DSMB
Data and Safety Monitoring Board
eCRF
Electronic Case Report Form
FDA
Food and Drug Administration
FFR
Federal Financial Report
FWA
Federalwide Assurance
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
ICF
Informed Consent Form
ICH
International Council for Harmonisation
ICMJE
International Committee of Medical Journal Editors
IRB
Institutional Review Board
ISM
Independent Safety Monitor
LAB
Laboratory Based Saliva-Based COVID-19 Test
MOP
Manual of Procedures
N
Number (typically refers to participants)
NIDCR
National Institute of Dental and Craniofacial Research, NIH, DHHS
NIH
National Institutes of Health
OCTOM
Office of Clinical Trials Operations and Management, NIDCR, NIH
OHRP
Office for Human Research Protections
PHI
Protected Health Information
PI
Principal Investigator
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PO
Program Official, NIDCR, NIH
POC
Point-of-Care Veritor COVID-19 Test
PREDICT
Pragmatic Return to Effective Dental Infection Control through Triage and 
Testing
PS
Project Scientist, NIDCR, NIH
QA
Quality Assurance
QC
Quality Control
QoL
Quality of Life
SAE
Serious Adverse Event/Serious Adverse Experience
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
WHO
World Health Organization
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PROTOCOL SUMMARY
Title:
Pragmatic Return to Effective Dental Infection Control through Triage and 
Testing
Précis:
We will conduct a feasibility study to develop and test out procedures for 
improved triage and COVID-19 testing in dental practices so as to improve 
the safety of Dental Health Care Workers (DHCW.)   This is one of several 
feasibility studies to be conducted in Rutgers dental clinics and in dental 
offices which participate in the National Dental Practice Based Research 
Network (PBRN).  These studies will assess the feasibility of implementing 
COVID-related procedures in the dental setting and may provide 
preliminary data to inform a larger network-wide study grant application.
Objectives:
Primary:  The primary objective of this study is to determine willingness of 
dental health care workers to participate in a study and to test survey 
instruments and logistics developed for a NIH clinical study evaluating the 
impact of COVID-19 testing and enhanced triage in dental offices.  
Population:
This study will take place at Rutgers University School of Dental Medicine.  
Up to twenty (20) DHCW (faculty and staff) will be recruited in the Rutgers 
School of Dental Medicine’s dental clinics.  Only adults will be recruited.  
Number of Sites:
One (1)  
Description of 
Intervention:
Viral, antigen and antibody COVID-19 tests will be administered to Dental 
Care Health Workers (DCHW).  In addition, the use of pulse oximeters will 
be added to the dental health care worker triage protocol.   
Study Duration:
8 months (6 months for data collection; 2 months for analysis)
Subject Participation 
Duration:
DHCW subjects will participate in the study for one month with up to an 
additional four weeks from time of signed consent to start-of-study 
timepoint.  
Estimated Time to 
Complete Enrollment:
Six (6) months
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Schematic of Study Design for Dental Health Care Worker Subjects:
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1
KEY ROLES AND CONTACT INFORMATION
Principal Investigator:  
Cecile A. Feldman, DMD, MBA
Dean and Professor
Rutgers University, School of Dental Medicine
110 Bergen Street
Newark, NJ 07103
Phone:  (973) 972-4634
Fax:  (973) 972-3689
feldman@rutgers.edu
NIDCR Program Officer:
Dena Fischer, DDS, MSD, MS
National Institute of Dental & Craniofacial Research
6701 Democracy Boulevard, MSC 4878
Bethesda, MD  20892-4878
Phone: (301) 594-4876
Dena.fischer@nih.gov
Grants Management Specialist:
Mr. Gabe Hidalgo
National Institute of Dental & Craniofacial Research
6701 Democracy Boulevard, MSC 4878
Bethesda, MD  20892-4878
Phone:  (301) 827-4630
gabriel.hidalgo@nih.gov
Other Key Personnel:
Chief Oral Biology (and Co-PI):
Daniel Fine, DMD
Rutgers University, School of Dental Medicine
110 Bergen Street
Newark, NJ 07103
Phone:  (973) 972-7056
finedh@sdm.rutgers.edu
Chief Clinical Protocol and Co-Investigator:
Janine Fredericks-Younger, DMD
Rutgers University, School of Dental Medicine
110 Bergen Street, Room D813
Newark, NJ   07101
Phone:  (973) 972-1679
Fax:  (973) 972-5040
frederja@sdm.rutgers.edu
Chief Epidemiologist and Co-Investigator:  
Modupe Coker
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815 
Newark, NJ 07101
Phone:  (973) 762-4430
Fax:  (908) 477-0056
mc2190@sdm.rutgers.edu
Clinic Director and Co-Investigator:  
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Gayathri Subramanian
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815 
Newark, NJ 07101
Phone:  (973) 762-4430
Fax:  (908) 477-0056
subramga@sdm.rutgers.edu
Clinic Assistant Director and Co-Investigator:  
Sowmya Ananthan
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815 
Newark, NJ 07101
Phone:  (973) 762-4430
Fax:  (908) 477-0056
ananths1@sdm.rutgers.edu
Co-Investigator:  
Maria Gennaro
Rutgers University, New Jersey Medical School
NJMS-PHRI Center
225 Warren Street 
Newark, NJ 07101
Phone:  (973) 854-3210
marila.gennaro@rutgers.edu
Clinic Assistant Director and Co-Investigator:  
Raphael Figueroa
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815 
Newark, NJ 07101
Phone:  (973) 762-4430
Fax:  (908) 477-0056
figuerr4@sdm.rutgers.edu
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2
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1
Background Information
Description of Problem:  
        The COVID-19 pandemic: COVID-19 has created serious concerns about the safety of patients and 
dental professionals as they return to a practice environment. The spread of this ubiquitous virus was first 
thought to be through droplets but soon it became clear that the virus could be spread by aerosols [5,6]. 
Many dental procedures require the mechanical preparation of hard and soft tissue using high speed 
handpieces which are water cooled and generate significant aerosolized sprays. The extent to which 
dentally-generated aerosols linger within operatories has not been clearly tested but it is certain that both 
dentists, dental assistants and hygienists will be exposed to significant aerosol sprays derived from patients’ 
oral cavities [7]. As we learn more about COVID-19 and viral transmission we understand that infection and 
spread of the virus is due to the viral load (or dose) and the time of contact [8,9]. 
Uniqueness of Dental Practice:  Unlike many procedures in medicine, dental/patient contact is eye 
to eye and the close proximity between patient and dental professionals is unavoidable [10]. Furthermore, 
a dental procedure can often take as long as 1 hour and prolonged close contact between dentist and 
patient is inevitable. Despite personal protective equipment (PPE) that includes N95 masks, face shields, 
gowns, and high-speed suction, viral spread from infected patients is unavoidable. This suggests that the 
only safe solution for maintaining the health and well-being of dental professionals in the time of COVID-19 
pandemic is removing virus infected patients from their offices [11]. 
    Waiting Rooms and Airflow: Obvious issues confronting dental practices have been discussed, 
however, waiting rooms with patients, bathrooms and passageways are all additional areas within offices 
that can be of concern. Further, the airflow in confined office spaces where patients can be waiting for 30 
minutes or more can be hazardous if an asymptomatic but SARS-CoV-2 infected patient is in close proximity 
to a susceptible patient. Patients in a dental office can be at risk for infection that can have varied 
presentation and severity, and may be life threatening especially in patients with pre-existing conditions 
[21-23].  
    Solutions: One way of providing the security that dental offices are safe for both the dental professional 
and patient is by excluding anyone who harbors the SARS-CoV-2 virus. This of course would necessitate 
testing every patient at every visit or by establishing the fact that patients are safe if they have neutralizing 
antibody to the SARS-CoV-2 virus.  These solutions, at this moment, appear to be impractical particularly 
if the virus affects a very small percentage of the population and testing is inaccurate. A solution to this 
problem is imperative both for the safety and security both the patient and dental professional. But what’s 
to be done? How do we achieve our goal of providing a safe and secure environment that allows for routine 
dental care? 
Several challenges exist to routine and comprehensive testing: the costs, turnaround time (maximum 
practical utility is perhaps derived from a simple, rapid, accurate, inexpensive point-of-care test that is not 
technically demanding, such a test has not yet been validated). This proposal compares the use of one 
such candidate POC test with the current screening gold-standard.
     Conclusions: Every day that goes by, patients are not receiving dental services because of a SARS-
CoV-2  transmission concern. Understanding risk associated with SARS-CoV-2 transmission in a dental 
practice and the effective use of testing and other practice modifications could dramatically reduce the risk, 
making both dental health care providers and patients comfortable with seeking/providing essential dental 
services.  This proposal is designed to develop procedures that address this serious problem and test the 
feasibility of these procedures in a pragmatic manner to address with this existing insurmountable problem 
that can affect the future of dental practice and the dental health we have come to expect. 
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2.2
Rationale
    Typical dental protocols recommend twice yearly visits to dentists for prevention and maintenance of oral 
health [12,13]. Dental patients who may be asymptomatic for medical problems are seen routinely in dental 
offices and can be screened for the early phases of medical disease during routine dental visits. For 
example, blood pressure monitoring and simple blood test for glycosylated hemoglobin (HbA1c) levels can 
be performed in dental offices for referral to physicians for further assessment [18,19]. This ready access 
to vulnerable patients can be considered as value-added should dental health professionals provide 
augmented diagnostic benefit to patients who are unaware of their need for medical intervention. However, 
in this time of uncertainty dentistry has been impacted by fear and poorly defined strategies to mitigate 
COVID-19, that can compromise the willingness of dental professionals to open their dental practices [20]. 
    Little is Known Regarding the Effectiveness COVID-19 Triage in Dental Practice:  Little is known 
about the effectiveness of triage protocols which have been recommended by the CDC.  For example, most 
offices are using temporal thermometers, yet many are uncalibrated.  In addition, screening questions 
continue to evolve, and the veracity of patient responses remains unverified. 
    Little is Known Regarding the Impact of COVID-19 Testing in Dental Practice:  Little is known about 
the value of testing and about the willingness of DHCW to implement SARS-CoV-2 testing in a dental office 
or the most effective use of such testing. 
The following questions need to be answered:

Perception of safety and comfort: Will patients and DHCW in an office with testing feel safer and 
be more comfortable delivering care during a COVID-19 or other infectious disease pandemic?  

Testing preference: Do DHCW and patients prefer POC testing rather than testing that requires 
laboratory processing? 

Effectiveness of triage: Is the triage protocol being followed today effective or do patients and 
DHCW respond negatively to COVID-19 symptoms because of the fear of not being seen or 
being turned away from work?

Effectiveness of triage methods: Are objective measures such as temperature and pulse oximeter 
readings effective in identifying “asymptomatic” cases?
2.2.1
Potential Risks
This research involves testing procedures with varying degrees of risk to the study participants. 

Saliva Test- minimal risk.  The saliva test is non-invasive, requires spitting into a tube, and is 
completed independently, without interaction with a member of the healthcare team.

Nasal swab- minimal risk. The nasal swab involves insertion of a swab into the forward part of the 
nasal cavity by a member of the healthcare team, which may cause slight discomfort to the 
participant.  

Tongue swab – minimal risk.  The tongue swab involves running a tongue cell collector across 
the top of the tongue which may cause slight discomfort to the participant.

Finger prick- minimal risk. A finger prick test is a procedure in which a finger is pricked with a 
lancet to obtain a small quantity of capillary blood for testing. The site, free of surface arterial 
flow, where the blood is to be collected is sterilized with a topical germicide, and the skin is 
pierced with a sterile lancet.  There is a slight risk of discomfort from the lancet stick and irritation 
or infection in the area the lancet punctured the skin.
In addition, different SARS-CoV-2 test types have varying degrees of sensitivity and specificity, which 
may result in false negative and false positive test results. While a false negative result may give a 
participant a false sense of security, this would not pose additional risks to patients or DHCW, as they 
would have been treated with each office’s infection control protocol regardless of participation in the 
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study.  On the other hand, a false positive result will prompt the DHCW or patient to undergo additional 
testing by their primary health care provider.  Should they test positive again, they would need to follow 
their local health department recommendations which may require quarantine.  
There is a risk of loss of confidentiality for all study participants. Precautions will be in place to minimize 
this risk, such as collecting only minimal identifying information, using unique study codes for participants, 
collecting data using encrypted computers, and maintaining electronic data files on a password-protected 
computer drive, and storing data on encrypted computers or in locked cabinets (located in locked offices). 
Individual identifier numbers that are linked to participant contact information will be stored separately 
from the data. Compliance with all IRB regulations concerning data collection, data analysis, data 
storage, and data destruction will be strictly observed.
2.2.2
Potential Benefits
There is no benefit to DHCW and patients participating in this study beyond the fact that DHCW and 
patients would receive the results of the free SARS-CoV-2 tests they undergo.  
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3
OBJECTIVES AND OUTCOME MEASURES
3.0
Rutgers DHCW Feasibility Study Outcomes
PILOT Objectives 
Brief Description/Justification of 
Outcome Measure
Outcome Measured By 
Time Frame
To Determine DHCW 
Willingness to Participate
Willingness to participate is 
important in determining whether 
dental offices, DHCW would be 
willing to participate in a large-scale 
study

Ratio of DHCW agreeing to participate as 
compared to all DHCW asked to 
participate
Thoroughness of consent process and 
ability to ask questions 
Willingness to Participate: 

DHCW – at time of consent by 
DHCW consent
To Determine DHCW and 
Willingness/Ability to follow 
through with Triage, Testing 
and Survey Administration 
Procedures
Determining willingness and ability to 
follow thru with triage, testing and 
survey administration procedures is 
important for refining the survey 
procedures
% who complete the study
% who complete surveys
o Start-of-Study DHCW Survey
o End-Of-Study DHCW Survey
% who feel testing (Saliva, PCR, POC, and 
ELISA Antibody) procedure was easy to 
comply with
o
Specimen collection
o
Specimen preparation for shipping
o
Specimen storage (till assay)
o
Timeliness of results
o
Reporting of results
% Complete Study: 

For DHCW - At time End-of-
Study (Day 28)
% All Surveys Completed: 

For DHCW - At time End-of-
Study (Day 28)
% Feel Testing Protocol was Easy 
to Comply With: 

For DHCW - At time End-of-
Study (Day 28)
To Determine Ease of Use with 
REDCap Survey Instruments
Dental Health Care Worker 
Subject
o Start-of-Study Survey
o End-of-Study Survey
o Triage Survey
Determining the ease of use and 
completeness of the REDCap 
instruments enables refinement of 
the system
% who feel surveys are easy to complete 
due to administration method:
o
Start-of-Study DHCW Survey
o
End-of-Study DHCW Survey
o
Triage Case Report
% who feel survey questions were 
understandable:
o
Start-of-Study DHCW Survey
o
End-of-Study DHCW Survey
o
Triage Case Report
% completed surveys:
o
Start-of-Study DHCW Survey
o
End-of-Study DHCW Survey
o
Triage Case Report
% indicating surveys were easy to 
complete due to administration 
method:

For DHCW - At time End-of-
Study (Day 28)
% indicating survey questions 
were easy to understand: 

For DHCW - At time End-of-
Study (Day 28)
% Surveys Completed: 

For DHCW - At time End-of-
Study (Day 28)
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3.1
Primary Outcomes for Full Study (Data Collection is Being Performed to 
Determine Instrument Feasibility)   
Full Study Objective
Brief Description/Justification of 
Outcome Measure
Outcome Measured By 
Time Frame
Objective 1 – Dental health 
care personnel feel safe in the 
dental office 
Safety Culture Evaluation Survey for 
DHCW is a 6-item survey using a 4 
point Likert scale seeking the 
agreement with 6 criteria associated 
high performing safety organization 
characteristics.
Willingness to Come to Work reflects 
a DHCW’s safety in the workplace.
Willingness to Refer Other Patients 
reflects DHCW’s safety of the dental 
practice.
DHCW - Safety Culture Evaluation Survey:  6 
item survey.  Numeric responses to each 
item using a four-point Likert Scale are 
summed for a score which reflects the level 
of safety in the organization.  (1=strongly 
agree, 2=agree, 3=disagree, 4=strongly 
disagree.)
DHCW- Safety:  How safe to do feel coming 
to work? 5 Point Likert scale
DHCW Willingness to Refer Other Patients:  
How likely would you refer a family or friend 
to this dental office?  5 Point Likert Scale
DHCW Willingness to Come to Work:  how 
comfortable are you coming to work each 
day?  5 Point Likert Scale
Sense of Safety for Dental Health 
Personnel:

Start of study

End of study
Willingness to Refer Other 
Patients: 

DHCW – Start of study

DHCW – End of study
Willingness to Come to Work: 

Start of study

End of study
3.2
Secondary Outcomes for Full Study (Data Collection is Being Performed 
to Determine Instrument Feasibility)
Objective
Brief Description/ Justification of 
Outcome Measure
Outcome Measured By 
Time Frame
Objective 2:   Determine the 
Efficiency and Effectiveness 
of:

Efficiency of DHCW Triage 
Protocols

Efficiency of Patient 
Triage Protocols

Effectiveness Patient 
Testing Protocols
Efficiency of Triage Protocols:  

Acceptability of triage protocols 
is based upon resources (time 
and effort and facilities) 
required to implement the 
protocol 
Effectiveness of Triage Protocols
Dentist’s willingness to continue 
use of triage protocols is based 
upon the usefulness/outcomes of 
the triage.  
Efficiency of Testing Protocols:  

Acceptability of testing protocols 
is based upon resources (time 
and effort and facilities) 
required to implement the 
protocol 
Effectiveness of Testing Protocols
Dentist’s willingness to implement 
testing protocols is likely to be 
based upon testing’s ability to 
identify asymptomatic DHCW and 
patients.
Efficiency of Triage Protocols:  

Time needed to complete triage survey
Effectiveness of Triage Protocols
Comparison of number of DHCW not able to 
report to work due to LAB or POC test results
Comparison of Triage Survey to Medical 
History consistent with COVID-19 symptoms 
for DHCW
Efficiency of Testing Protocols:  

Time and supplies needed to conduct LAB vs. 
POC test
Effectiveness of Testing Protocols
Comparison of number of DHCW not able to 
report to work 
Comparison of number of patients not able 
to report for their patient visits 
Efficiency of Triage Protocols:  
End of study
Effectiveness of Triage Protocols
End of study
Efficiency of Testing Protocols:  
End-of-Study
Effectiveness of Testing Protocols
End-of-Study
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3.3
Tertiary/Exploratory Outcomes for Full Study (Data Collection is Being 
Performed to Determine Instrument Feasibility) 
Objective
Brief Description/Justification of 
Outcome Measure
Outcome Measured By 
Time Frame
Objective 3 (exploratory):  
Examine SARS-CoV-2 Positivity 
Rate and Immuno-Conversion 
Rate

DHCW positivity rate 

DHCWs with IgG

DHCWs with IgM

DHCWs who immune-convert  
Positivity Rate:  

POC antigen with a nasal swab

PCR with a saliva or tongue 
scraping specimen
Immuno-conversion Rate

ELISA with Capillary Blood 
specimen
DHCW Positivity Rate:  

POC antigen

PCR viral test
DHCW Immuno-conversion Rate

ELISA antibody
DHCW Positivity Rate:  

Start of Study

Every 2 weeks

End of Study
DHCW Immuno-conversion Rate

Start-of-Study

Every 2 Weeks

End-of-Study
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4
STUDY DESIGN
Description:  This study will assess the feasibility of implementing SARS-CoV-2 testing-related 
procedures and instruments in the dental setting to ensure the safety of DHCWs and patients. Results 
from this study may provide preliminary data to inform a larger network-wide study grant application.
Two patient SARS-CoV-2 testing protocols will be assessed for feasibly along with one dental health care 
worker protocol.  
Study Population: The study population for this study will be dentists, hygienists, dental assistants and 
dental office staff at the Rutgers School of Dental Medicine.  
Important Outcomes:  
For this study, important outcomes include percent of DHCW willing to participate and percent completing 
the protocol.
Single or Multicenter:  Single- this study will utilize the Rutgers School of Dental Medicine’s Newark 
facility.  
Number of Study Groups/Arms: There are one (1) study group of Dental Health Care Workers 
(DHCW). 
Expected Duration of Subject Participation:  Up to 4 weeks might elapse between signing of consent 
forms and start of study (in order to batch data collection for feasibility and ease). However, data 
collection from the initial visit to the final visit will take 4 weeks to complete. Hence, while subject 
participation in study will last 4 weeks, the total duration that the subject is involved in the study (from 
being on study (consent form signature) to completion of data collection may take up to 8 weeks (two 
months). 
Sequence of Procedures and Duration of Study Period:  
Consent Process for DHCW Participants
DHCWs who indicate interest will complete the consent process.  The consent will clearly outline 
participant expectations and offer the opportunity for potential participants to contact the office for more 
information as needed.  Participants who fully understand the study and elect to participate will affirm their 
willingness to participate by signing the consent form.  Consent will be registered electronically on 
REDCap at enrollment. The participants will be provided an iPad to register their consent directly on to 
REDCap. REDCap is a HIPAA-compliant database that is password protected and secure. 
Study Procedures for DHCW Participants
Prior to study initiation (Up to 4 weeks prior)

Complete consent
Day 1

Complete an electronic survey: DHCW Start of Study Survey 
o
Questions include demographics, PPE used in the office, work practice controls used in 
the office, importance of triage and testing, importance of PPE measures, perceptions of 
safety and comfort in the workplace, safety culture in the office, SARS-CoV-2 testing 
preferences, dentists role in SARS-CoV-2 testing, and willingness to test in the office
o
20 questions

Undergo a three-part COVID-19 triage screening*
o
Symptom questions 

Presence or absence of:
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
fever or chills

cough

shortness of breath or difficulty breathing

fatigue

muscle and body aches

headache

loss of taste

loss of smell

sore throat

congestion or runny nose

nausea or vomiting

diarrhea
o
Temperature check
o
Pulse oximeter reading

Complete two COVID-19 related tests**
o
SARS-CoV-2 POC test 

A nasal swab will sweep the inside of the participant’s nose to collect your 
specimen for the SARS-CoV-2 test

The office staff will process the specimen
o
ELISA Antibody test

A small lancet will create a finger prick to collect a small blood sample

The sample will be processed by the Public Health Research Institute PHRI lab
Mid-Study- Day 14 (+/- 7 days) 

Undergo a COVID-19 triage screening in the office*

Complete a SARS-CoV-2 POC test** 
o
A nasal swab will sweep the inside of the participant’s nose to collect your specimen for 
the SARS-CoV-2 test
o
The office staff will process the specimen
End of Study- Day 28 (+/- 14 days) 

Undergo a three-part COVID-19 triage screening*
o
Symptom questions
o
Temperature check
o
Pulse oximeter reading

Complete two SARS-CoV-2 tests**
o
SARS-CoV-2 POC test 

A nasal swab will sweep the inside of the participant’s nose to collect your 
specimen for the SARS-CoV-2 test

The office staff will process the specimen
o
ELISA Antibody test

A small lancet will create a finger prick to collect a small blood sample

The sample will be sent to and processed by the PHRI lab

Complete two electronic surveys: 
o
DHCW End of Study Survey- Questions include importance of triage and testing, 
importance of PPE measures, perceptions of safety and comfort in the workplace, safety 
culture in the office, SARS-CoV-2 testing preferences, dentists role in SARS-CoV-2  
testing, willingness to test in the office, and vaccinations
o
DHCW Participation Survey- Questions explore perceptions related to study participation 
including survey and testing logistics
o
29 questions in the two surveys put-together
If any aspect of the COVID-19 triage screening is positive, the DHCW will be excused from work and 
referred to their primary care physician for further testing. 
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
Positive screening include having one or more symptoms 

A positive temperature is considered greater than 100.4 degrees F

A positive pulse oximeter is considered when the blood oxygen saturation level is below 95%
The results of the POC test and the lab processed SARS-CoV-2 antibody test will be recorded in the 
Testing Case Report form in REDCap.

 If POSITVE: The Clinic Director or one of the co-investigators will communicate positive results 
to the participant upon receipt.  Positive participants will be dismissed from duties and instructed 
to consult with their primary care provider for further testing.

If NEGATIVE: The Clinic Director or one of the co-investigators will communicate negative results 
to the participant.
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5
STUDY POPULATION
5.1
Participant Inclusion Criteria
A Dental Health Care Worker must meet all of the following criteria to be eligible to participate in the 
study:

Work at the Rutgers School of Dental Medicine

Be 18 years or older 

Be able to understand the informed consent.

Provide signed and dated informed consent form

Be able to understand all instructions for data collection instruments in English

Be willing and able to comply with all study procedures and be available for the duration of the 
study 
5.2
Participant Exclusion Criteria
Participants would be excluded if they participated in the feasibility study previously or if they are unwilling 
to have their de-identified data made available to other researchers.
5.3
Strategies for Recruitment and Retention
Target Sample Size: 20 dental care health workers.
Target Sample Size by Gender, Race, Ethnicity, and Age:  Study population will be drawn from faculty 
and staff at the Rutgers School of Dental Medicine.  All will be English speaking.  Age range will be 
between 18 and 100 years of age.  Racial and ethnicity background will be reflective of the respective 
populations at the Rutgers Schools of Dental Medicine with about 52% being African American and 33% 
Hispanic.
Study Population:  The DHCW study population will be residents, faculty and staff working at the 
Rutgers School of Dental Medicine.  
Inclusion of Women and Minorities and Individuals of All Ages: 
Women:  Women will be included in this study.  Pregnant women are not excluded from 
participating.
Minorities:  Minorities will be included in this study.  
Recruitment Strategies:  All the DHCWs participating in this pilot feasibility study are staff/faculty at 
Rutgers School of Dental Medicine- mirroring the future design where the dental director of the 
participating practice-based research network will reach out to his staff to enroll study subjects, here too, 
the clinic director (GS) and coinvestigators (SA and RF) will reach out staff/faculty in the same clinic to 
invite study participants. The study aspects will be discussed in department clinical discussions- there are 
some overlapping aspects with adaptations to the ongoing pandemic. If DHCWs express interest, copies 
of the consent form will be handed for them to review and questions will be answered. Co-investigators 
GS, SA and RF as well as the research staff, PU are all in the same department and are approachable for 
any clarifications. In addition, flyers will be displayed in the department office and clinic space. Enrollment 
and study participation will be strictly voluntary. 
If 20 dental health care workers cannot be recruited in the Oral Medicine clinic, recruitment will expand to 
the school’s other clinics.  It is not anticipated that there will be difficulties recruiting sufficient dental 
health care workers and patients.  
Participants will be batched in groups of 5-10 and scheduled for study start at a convenient time in the 
clinic (in a manner that does not disrupt patient care). Thus, at that time itself, it will be feasible to identify 
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and communicate every time point in the study. Because the enrolled participants are expected to be 
present at work otherwise (unless scheduled out, in which case, the flexibility in scheduling the time 
points will allow re-scheduling a particular missed time-point), contacting a subject to schedule/remind of 
a study visit will be convenient. 
Retention:  In order to minimize loss of study participants and/or incomplete data collection, the following 
activities will take place:

The Research Clinical Director will work with the Research Assistants responsible for enrolling 
subjects and enable completion of surveys on REDCap. Both the director, coinvestigators (GS, 
SA and RF) and research staff (PU) are part of the same clinic and hence are optimally situated 
to discuss about the study. 2 iPads and ‘crayons’ are available for use by the study participants. 
The coinvestigators and research staff will provide iPads for collecting survey responses. Each 
participant will be able to log their responses in REDCap under the appropriate subject ID.

Participants will receive compensation.  
Compensation and Scheduled Payments:  Dental Health Care Workers who complete the protocol, 
including the end-of-study survey will receive $125 each. Compensation depends on completing all of the 
time-points of the study- both assessments and surveys. Given the 7 day flexibility for each time-point, 
any study participant who may test positive for COVID-19 may still be able to complete study time-point 
even if required to self-isolate per his/her physician’s advice. If not the testing, at least the surveys can be 
completed at return to work. Completion of all study-related surveys will enable full compensation.
Additional Plans to Minimize Loss of Follow-up and Missing Data:  The following will minimize loss of 
follow-up and/or missing data:

When appropriate, REDCap survey data fields are set to “required”.  

REDCAP validation rules on data fields to limit responses to valid responses
5.4
Participant Withdrawal or Discontinuation from Study 
Procedures/Intervention
5.4.1
Reasons for Participant Withdrawal or Discontinuation from Study 
Procedures/Intervention
Participants are free to withdraw from participation in the study at any time upon request.
An investigator may discontinue an individual’s participation in an intervention or withdraw an individual 
from the study if:

The participant has a serious adverse event requiring hospitalization.

Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant.

The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation.
5.4.2
Handling of Participant Withdrawals from Study 
Participants may withdraw participation consent at any time, either verbally or in writing. Participants who 
further withdraw their consent for the use of data already collected must do so in writing. The Research 
Clinical Director or Research Assistant will interview the participant and document the withdrawal of 
consent using the Consent Withdrawn Received Form in the REDCap system.  Participants who withdraw 
will not be replaced.
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Documentation includes the date, the reason for participant withdrawal, as well as, the upload of any 
written withdrawal request. Upon withdrawal, all study procedures would cease, however, the participant 
would be offered continued care as part of the normal standard of care.
5.5
Premature Termination or Suspension of Study
This study may be suspended or prematurely terminated if there is sufficient reasonable cause.  Written 
notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to Dr. Cecile Feldman and the funding agency (NIDCR). The principal 
investigator will also promptly inform the IRB and NIDCR and will provide the reason(s) for the termination 
or suspension. 
Circumstances that may warrant termination include, but are not limited to:

Determination of unexpected, significant, or unacceptable risk to participants.

Insufficient adherence to protocol requirements.  

Data that are not sufficiently complete and/or evaluable. 

Determination of futility.
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6
STUDY SCHEDULE
6.1
Dental Health Care Worker Subjects
The following is the schedule of events for Dental Health Care Worker Subjects
Visit
Day
Dental Health Care Worker Subjects
Activities Performed
Enrollment
Day -28 
(+/- 29 days)
Obtain written Informed Consent
Start-of-Study
Day 0 
Complete Start-of-Study Survey
Complete Start-of-Study Triage Case Report
Undergo POC (antigen) COVID-19 test
Provide specimen for ELISA (antibody) test
Mid-Study
Day 14  
(+/- 7 days)
Complete Mid-Study Triage Case Report
Undergo POC Covid-19 Test
End-of-Study
Day 28
(+/- 14 days)
Complete End-of-Study Triage Case Report
Undergo POC COVID-19 Test
Provide specimen for ELISA (antibody) test
Complete End-of-Study Survey
Complete DHCW Participation Questionnaire
6.2
Withdrawal Visit
Not applicable.  If a subject withdraws early, there is no withdrawal visit.  
6.3
Unscheduled Visit
Not applicable.
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7
STUDY PROCEDURES/EVALUATIONS
As part of this study, COVID-19 triage case report will be completed, SARS-CoV-2 testing will be 
performed and perception and attitude surveys will be administered.  The DHCS Start-of-Visit, Mid-Visit 
and End-of-Visit will include recording of temperatures and pulse oximeter reading.  
For the purpose of this study, a SARS-CoV-2 positive result is not considered an adverse event though 
results of this test will be recorded.  
Dental Health Care Worker subjects who test antigen positive or who triage positive without any 
preexisting medical condition will be instructed to speak to their physicians for a definitive diagnosis and 
follow-up.  If a dental health care worker is back to work in-time for the mid-study testing, the mid-study 
protocol will be followed.  Similarly, if a dental health worker can return to work in time for the end-of-study 
testing, the end-of-study protocol will be followed.  In either case, a follow-up call will be made 1 week 
after (and 2 weeks after if necessary,) learning of the research study protocol call viral or antigen positive 
test results to record any confirmatory tests which were obtained based upon the advice of the worker’s 
physician.  
7.1
Study Procedures/Evaluations
The following study procedures will be completed
Dental Health Care Worker Subjects
Procedure and Evaluations
Purpose
Completed 
as Part of 
Study
When Completed
Who Completes
Complete Consent
Complete 
informed 
consent 
Yes
Prior to Enrollment
Study investigators meet with 
subjects and document consent in 
REDCap
Start-of-study DHCW Survey

PPE used

Environmental Controls 
Used

Perception of Importance

Comfort

Safety

SARS-CoV-2 Testing 
Preferences  

Vaccination Opinions
Collect baseline 
Outcomes 
measures
Yes
Start-of-Study (day 0)
Data entered via REDCap self-
administered survey.
Triage Case Reports
Collect COVID-
19 screening 
data
Yes
Start-of-Study (Day 0)
Mid-Study (Day 14)
End of Study (Day 28)
Data entered into REDCap via eCRF 
by Research Clinical Director who 
interviews subject
Testing Case Reports
Collect 
information on 
outcomes of 
SARS-CoV-2 
testing 
Yes
Start-of-Study (Day 0)
Mid-Study (Day 14)
End of Study (Day 28)
POC Test - Data entered into 
REDCap via eCRF by Research 
Clinical Director 
Eliza Ab test – Data entered into 
REDCap eCRF by Research Clinical 
Director or Laboratory Technicians 
running ELISA procedures.  If 
positive, PI or Research Co-
Investigator calls DHCW.  DHCS will 
be referred to their primary care 
MD.
End-of-Study DHCW Survey
Collect 
payment 
information
Yes
End-of-Study (Day 28)
Data entered via REDCap self-
administered survey.
Dental Health Care 
Participation Questionnaire
Collect 
feasibility 
Yes
End-of-Study (Day 28)
Data entered via REDCap self-
administered survey.
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information on 
surveys and 
logistics
7.2
Laboratory Procedures/Evaluations
7.2.1
Clinical Laboratory Evaluations
Dental health care worker subjects (dentists, hygienist, assistants and front desk personnel) will be tested 
for SARS-CoV-2.  DHCW will be administered POC and ELISA Antibody Test.  
POC Test
(Antigen)
DHCW
ELISA Antibody Test
Test Description
Company
BD Veritor System COVID-19 
Test Kits
Rutgers
Sample collected via
Nasal swab via BD Veritor 
nasal collection system
Capillary blood sample via 
Neoteryx Mitra Cartridge
What is being Tested
SARS-CoV-2 Nucleocapsid 
Antigen
IgG and IgM
Test Administration
(specimen collection)
Nasal swab performed by 
Research Clinical Director or 
co-investigator
Capillary blood collection 
performed by Research 
Clinical Director or co-
investigator
Test Administration
(specimen processing) 
Veritor test performed by 
Research Clinical Director in 
dental clinic
Mitra Cartridge is processed 
at ICPH-PHRI center, New 
Jersey Medical School, 
Newark, NJ
Results
Dichotomous (+ or -)
Quantitative
With regard to the quality of the SARS-CoV-2 test specimen, the following will be used to assess the 
quality of the specimen.
POC Test
ELISA Antibody Test
Indication of Proper 
Processing
The Veritor instrument will 
report if a sample is not able 
to be processed.  This 
feedback will be used to 
identify insufficient training 
or unanticipated problems.  
ICPH will report if a sample 
is not able to be processed.  
This feedback will be used 
to identify insufficient 
training or unanticipated 
problems.  
Compliance with study protocols will be based upon the PI and the co-investigators following the REDCap 
dashboard.  The dashboard exhibits red indicators for instruments which have been started and not 
completed, yellow indicators for instruments which have been completed and not verified and green 
indicators for instruments which have been completed and reviewed.  The PI or Chief of Clinical Protocol 
will be responsible for reviewing each instrument and changing the status from unverified to verified.  Any 
issues with compliance with the study protocol identified by the PI or Chief of Clinical Protocol will be 
reviewed with the co-investigators and be used to identify any unanticipated problems and 
develop/implement any necessary corrective action plans.
7.2.2
Specimen Preparation, Handling, and Storage
The following details specimen preparation, handling and storage. 
POC Test
ELISA Antibody Test
Sample Collection & 
Shipping
Sample Collection Materials
Becton Dickenson via Henry 
Schein --  Nasal swab 
Capillary blood sample via 
Mitra Cartridge
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included in BD Veritor 
system
Storage of Specimen 
Collection Supplies and POC 
Test Kits
Clinical Research Center (D 
level of Dental School) and 
dental clinic dispensaries in 
the dental school
ICPH-PHRI center, 2nd floor 
enhanced BSL2 facility.
Transport Media
Not applicable (POC Test)
Sponge with capillary blood 
is transported with 
desiccant)
Packaging Specimen for 
Shipping/Transport
Not applicable (POC Test)
Post sampling, Mitra 
Cartridges are inserted into 
specimen bag which contain 
a dry card that absorbs 
moistures, sealed the bag 
shut, and stored in a secure 
container
Sample Processing 
(Performing the Test)
Processing Supplies
Included in point-of-care BD 
Veritor kit
96 well plate, ELISA reagents
Processing Time
15 minutes
Overnight extraction at 4C, 
followed by automated 
ELISA
Conditions for Stability 
and Transport Condition
Stability prior to Use 
No special storage 
conditions required
No special storage 
conditions required 
Dry blood on Mitra Cartridge 
stable at room temperature 
for 28 days.
Stability during shipping
Not applicable (POC Test)
Yes due to desiccant
Storage prior to processing
Not applicable (POC Test)
PHRI Laboratory
Stability prior to processing
Stable at room temperature
Stable at room temperature
Tracking
Labeling
Not applicable (POC Test)
Specimen ID (bar code)
Subject ID (bar code)
Subject Name
Date of Specimen
Tracking of Specimen 
Collection Kits
Not applicable (POC Test)
REDCap System and/or Excel 
Worksheet 
Tracking of Tests 
Administered 
Completion of REDCap SARS-
CoV-2 Test Order and 
Results Form (which enables 
the generation of a 
Specimen Tracking Log)
Completion of REDCap SARS-
CoV-2 Test Order and 
Results Form (which enables 
the generation of a 
Specimen Tracking Log)
Reporting of Results
Time from specimen 
collection to reporting of 
results
15 minutes
Results are available within 1 
week
Results Reporting
Via posting in REDCap by 
Research Coordintor
Via secure e-mail and then 
posted into REDCap via 
Research Clinical Director
7.2.3
Specimen Shipment/Transport
The Mitra Cartridge includes a desiccant or sample preservation.  All can be stored at room temperature 
for at least one week. For the purposes of Rutgers DHCW study, the specimen will not be mailed but will 
be picked up by PHRI lab personnel on the day of collection.
POC Test
ELISA Antibody Test
Shipment Method and 
Frequency
Not applicable  
Specimens will be 
despatched to PHRI for 
processing.  
Packaging Specimen for 
Shipping
Not applicable (POC Test)
Post sampling, Mitra 
Cartridges are inserted into 
specimen bag which contain 
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a dry card that absorbs 
moisture, seal the bag shut, 
and insert into a shipping 
envelope.
Shipping Address
Not applicable
Rutgers University
New Jersey Medical School 
ICPH-PHRI 
225 Warren Street
Newark, NJ  07103
Contact Information for 
Laboratory Personnel
Not applicable
Dr. Maria Gennaro
Phone:  (973) 854-=3210
Marila.gennaro@rutgers.edu
Days and Times 
shipments/Trnasport are 
allowed
Not applicable
Monday thru Thursday
9:00 am to 5:00 pm
Labeling Requirements for 
Specimen Shipping
Not applicable
Subject Number, Subject 
Name and Mitra Cartridge 
ID/Bar Code
Special Instruction for 
Specimen Collection
No special instructions
Clean area for finger prick 
with alcohol gauze prior to 
pricking finger
Special Instructions for 
Specimens for 
Shipment/Transport  (i.e. 
dry ice, wet ice)
Not applicable
No special instructions
Completion of Specimen-
Tracking Log
Completion of REDCap 
COVID-19 Test Order and 
Results Form (which enables 
the generation of a 
Specimen Tracking Log)
Completion of REDCap 
COVID-19 Test Order and 
Results Form (which enables 
the generation of a 
Specimen Tracking Log)
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8
ASSESSMENT OF SAFETY
8.1
Definitions and Specifications of Safety Parameters
Safety monitoring for this study will focus on unanticipated problems involving risks to participants, 
including unanticipated problems that meet the definition of a serious adverse event.  
Event
Definition
Form
Who completes 
REDCap form
Time Frame 
For Reporting 
to IRB
Additional 
Reports to
Unanticipated 
Problems
Any problem or event which in the 
opinion of the local investigator was 
unanticipated, reflects new or increased 
risk to the subjects and was possibly 
related to the research procedures.
This includes any serious adverse event 
that is defined as an event which 
requires hospitalization and/or causes 
mortality
Unanticipated 
Problem Form
Site Director or 
Clinical Research 
Clinical Director
5 business days 
from the date of 
discovery
24 hours for 
hospitalization
24 hours for 
fatalities
Rutgers IRB
Protocol 
Deviations
Any change, divergence, or departure 
from the study design or procedures of 
a research protocol that is under the 
investigator's control and that has not 
been approved by the IRB.
Protocol 
Deviation/ 
Violation Form
Site Director or 
Clinical Research 
Clinical Director
5 business days 
from the date of 
discovery
Rutgers IRB
Protocol 
Violation
Any deviation from the IRB approved 
protocol that may affect the subject's 
rights, safety, or well-being and/or the 
completeness, accuracy and reliability 
of the study data
Protocol 
Deviation/ 
Violation Form
Site Director or 
Clinical Research 
Clinical Director
5 business days 
from the date of 
discovery
Rutgers IRB
Study procedures are limited to surveys and collecting samples.  We therefore expect few, if any study 
related serious adverse events.  In the rare event that a serious adverse event were to occur, an 
Unanticipated Problem form would be completed and SAE reporting timelines would be followed. 
8.1.1
Unanticipated Problems
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria:

unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the subject population being studied;

related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and

suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.
8.1.2
Serious Adverse Events
A serious adverse event (SAE) is one that meets one or more of the following criteria:

Results in death

Is life-threatening (places the subject at immediate risk of death from the event as it occurred)

Results in inpatient hospitalization or prolongation of existing hospitalization

Results in a persistent or significant disability or incapacity

Results in a congenital anomaly or birth defect  
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
An important medical event that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, the 
event may jeopardize the subject and may require medical or surgical intervention to prevent one 
of the outcomes listed in this definition.
If a SAE becomes known, the Research Clinical Director will immediately notify the study PI. The 
Research Clinical Director will record the event in the REDCap Unanticipated Problem Form based upon 
information obtained.  
8.2
Reporting Procedures
8.2.1
Unanticipated Problem Reporting 
Incidents or events that meet the Office of Human Research Protection (OHRP) criteria for UPs require 
the creation and completion of a UP report form.  
OHRP recommends that investigators include the following information when reporting an adverse event, 
or any other incident, experience, or outcome as an unanticipated problem to the IRB:

appropriate identifying information for the research protocol, such as the title, investigator’s name, 
and the IRB project number;

a detailed description of the adverse event, incident, experience, or outcome; 

an explanation of the basis for determining that the adverse event, incident, experience, or 
outcome represents an unanticipated problem; 

a description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the unanticipated problem.
To satisfy the requirement for prompt reporting, UPs will be reported that are not SAEs will be reported 
using the following timeline:  

Unanticipated problems that are SAEs will be reported to the IRB as soon as possible, and no 
later than within 24 hours of the investigator becoming aware of the event. 

Any other UP will be reported to the IRB within 5 business days of the investigator becoming 
aware of the problem.

All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and OHRP within one 
month of the IRB’s receipt of the report of the problem from the investigator.
. All unanticipated problems will be reported to NIDCR concurrently with reporting to the IRB. These 
reports will be made to NIDCR’s centralized reporting system via the Clinical Research Operations and 
Management Support (CROMS) contractor.
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9
STUDY OVERSIGHT
The investigator will be responsible for study oversight, including monitoring safety, ensuring that the 
study is conducted according to the protocol and ensuring data integrity.  The PI will review the data for 
safety concerns and data trends at regular intervals, and will promptly submit reportable events to the IRB 
and NIDCR that arise during the conduct of the study.
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10 CLINICAL SITE MONITORING
No outside clinical site monitoring will be employed for this study. The Principal Investigator(s) and staff 
will closely monitor the subjects as they progress through the study. They will monitor and evaluate study 
processes and documentation based on the International Council for Harmonisation (ICH), E6: Good 
Clinical Practice guidelines (GCP), and internal quality management plans. The NIDCR reserves the right 
to conduct independent clinical site monitoring as necessary.
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11 STATISTICAL CONSIDERATIONS
11.1
Study Hypotheses.
For this study, we hypothesize:

Dental health care workers will be willing to participate

Surveys will be easy to complete

Testing protocols will be easy to complete
Analyses will be performed to test these hypotheses.
11.2
Sample Size Considerations
This is a feasibility study to refine trial logistics.  No sample size calculations are being performed.  
11.3
Final Analysis Plan
Data to be collected includes:  
Item
Type of Variable
Willingness to Participate

Dentist, Hygienist, Assistant and Front Desk 
personnel willing to participate
Willingness to participate (Binary – Yes/No)
Triage Survey
Ease of Administration (3 point Likert Scale)
o Very easy to complete survey due to administration 
method
o Easy to administer complete survey due to 
administration method
o Not easy to complete survey due to survey 
administration method
Completeness (Binary – Yes/No)
Question understandability (3 point Likert Scale)
o Very clear to understand
o Understandable with some clarification provided by 
the administrator
o Not clear to understand
Safety Perception Survey 

Start-of-Study DHCW Survey

End-of-Study DHCW Survey
Administration method (3 point Likert Scale)
o Very easy to complete survey due to administration 
method
o Easy to complete survey due to administration 
method
o Not easy to complete survey due to administration 
method
Completeness (Binary – Yes/No)
Question understandability (3 point Likert Scale)
o Very clear to understand
o Understandable with some clarification provided by 
the administrator
o Not clear to understand
Testing Logistics

POC – BD Veritor SARS-CoV-2 antigen test

ELISA antibody SARS-CoV-2 test
Specimen Collection  (3 point Likert Scale)
o Very easy to collect
o Easy to collect
o Not easy to collect
Specimen preparation for shipping  (3 point Likert Scale)
o Very easy to prepare
o Easy to prepare
o Not easy to prepare
Specimen storage  until processing (Binary – Easy/Not 
Easy)
o Easy to Store
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o Not easy to store
Timeliness of results  (3 point Likert Scale)
o Very timeless access to results
o Timely access to results
o Access to results not timely
Reporting of results  (3 point Likert Scale)
o Very easy to access results
o Easy to access results
o Not easy to access results
Testing Case Report
Completeness (Binary – Yes/No)
Descriptive statistics (frequencies) for all variables will be analyzed.  
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12 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
All study survey information will be captured electronically and stored on secure, encrypted Rutgers 
University servers.  

Consents will be captured and recorded directly into the REDCap system.

All DHCW surveys will be recorded directly into REDCap via the following REDCap  forms:
DHCW Participants
Start-of-Study DHCW Survey
Triage Survey Case Report
End-of-Study DHCW Survey
DHCW Participation Questionnaire
Testing Case Report

Testing results will be captured in the REDCap Testing Case Report in the following ways:
POC
ELISA
Original Source 
Document
N/A – Results appear on 
BD Veritor Screen and 
directly recorded into 
REDCap 
Excel Spreadsheet 
posted onto SDM 
PREDICT box drive
Storage of Original 
Source Document
Not Applicable
Electronically stored on 
Rutgers server
Responsibility for 
Entering into REDCap
Research Clinical 
Director
Or Research Assistant
Research Clinical 
Director or Research 
Assistant
Verification of Correct 
Entry into REDCap
Not Applicable
PI or Chief of Clinical 
Protocol
All paper based study source documents will be maintained in the Rutgers School of Dental Medicine 
Clinical Research Center which is located on the D Level of the Dental School Building.  All documents 
will be secured in a locked file cabinet in the center.  Access to the Clinical Research Center is limited to 
research center personnel via a card reader.
Study staff will maintain appropriate medical and research records for this study, in compliance with ICH 
E6, Section 4.9 and regulatory and institutional requirements for the protection of confidentiality of 
participants. Study staff will permit authorized representatives of NIDCR and regulatory agencies to 
examine (and when required by applicable law, to copy) research records for the purposes of quality 
assurance reviews, audits, and evaluation of the study safety, progress, and data validity.  
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13 QUALITY CONTROL AND QUALITY ASSURANCE
Quality Management (QM) measures will occur throughout this study to ensure adherence to protocol and 
collection of high quality data.  QM activities include those measures done as part of daily standard 
operating procedures by staff at each site and by the data management controls built into the PREDICT 
REDCap to ensure adherence to the protocol and collection of complete and accurate data.  QM activities 
will include activities undertaken at defined intervals to check that QM activities are taking place and 
study-related documents are up-to-date.  
Staff Training
Training of all staff will be conducted and recorded in training logs.  Each staff member has been 
identified by role.  Records of completed training will be maintained in each study member’s study 
personnel file kept on the SDM PREDICT box drive, Personnel Qualifications folder.  
Training Modules
Who Will be Trained
Human Subjects, HIPAA
All Study Personnel
General Clinical Research Training 
(Human Subjects, HIPAA)
PI, Chief of Clinical Protocol
General Overall 
(Study Purpose, Goals and Protocol)
All Study Personnel
REDCap System Training
Research Clinical Directors and Research Assistants
Daily Operating Procedures
Quality management measures have been built into Clinical Protocol Core and site procedures.  
Subject Completion Review
As this is a feasibility study, reviews of surveys and case reports to ensure completeness will not be 
completed, rather the number/percentage of incomplete survey’s and forms will be analyzed as an 
outcome measure.  Consent forms will be reviewed for completeness at the mid-study visit for DHCW 
subjects and as part of the end-of-visit survey for patient subjects.
Data Management Controls
REDCap is a rich system which enables privileging, required data element entry and required data 
validation to be embedded into daily operations.  

Privileging:  Every study staff member will be assigned a role which carries specific 
read/write/edit/delete privileges.  Staff member will be assigned a role providing minimal rights 
sufficient to perform his/her responsibilities.

Structured Data:  Whenever possible, data will be collected via structured data responses rather 
than free-text.  Structured data requires a respondent to check a valid response.  

Data Validation:  Data fields will be established limiting responses to those that are reasonable.  
For example, year of birth would have a range of 2002 (corresponding to age 18 – the youngest 
eligible) to 1920 (corresponding to age 100 – more than sufficient to cover the age range of 
individuals having impacted 3rd molars extracted.)

Required Fields:  Whenever appropriate, fields have been made required so as to ensure 
completed forms and questionnaires.
Structured responses are required for the CRFs so only valid responses can be recorded.  In addition, 
REDCap has been programmed with all responses being required at time of completion. Validation rules 
are employed where possible.
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14 ETHICS/PROTECTION OF HUMAN SUBJECTS
14.1
Ethical Standard
The investigator will ensure that this study is conducted in full conformity with the principles set forth in 
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 
as drafted by the US National Commission for the Protection of Human Subjects of Biomedical and 
Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6. 
14.2
Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is enrolled.  Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented in the study.  
14.3
Informed Consent Process
Informed consent is a process that is initiated prior to the individual agreeing to participate in the study 
and continues throughout study participation. Extensive discussion of risks and possible benefits of study 
participation will be provided to participants and their families, if applicable. A consent form describing in 
detail the study procedures and risks will be given to the participant. Consent forms will be IRB-approved, 
and the participant is required to read and review the document or have the document read to him or her. 
The investigator or designee will explain the research study to the participant and answer any questions 
that may arise. 
All DHCWs participants will review and sign the informed consent document prior to any study-related 
assessments or procedures.  Prior to any other research activity, written consent will be obtained upon 
arrival at the clinic prior to any other study-related assessments or procedures.  
Participants will be given the opportunity to think about participating prior to agreeing to participate. They 
may withdraw consent at any time throughout the course of the study. A copy of the signed informed 
consent document will be given to participants for their records. The rights and welfare of the participants 
will be protected by emphasizing to them that the quality of their clinical care will not be adversely 
affected if they decline to participate in this study.
The consent process will be documented in the REDCap research record.  
14.4
Exclusion of Women, Minorities, and Children (Special Populations)
Women and minorities will be eligible to participate.  Children less than 18 years will not be able 
participate.
14.5
Subject Confidentiality
Subject confidentiality is strictly held in trust by the investigators, study staff, and the study sponsor(s) and 
their agents. This confidentiality is extended to cover testing of biological samples and genetic tests in 
addition to any study information relating to participants.
The study protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any unauthorized third 
party without prior written approval of the study sponsor.
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The study monitor or other authorized representatives of NIDCR may inspect all study documents and 
records required to be maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) for the study participants. The clinical study site will permit access to such records.
Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical, 
or other human subjects research funded wholly or in part by the federal government. Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy  (https://humansubjects.nih.gov/coc/index - Certificates of 
Confidentiality (CoC) – Human Subjects).  As set forth in   45 CFR Part 75.303(a) and NIHGPS Chapter 
8.3, recipients conducting NIH-supported research covered by this Policy are required to establish and 
maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that 
the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of 
award. It is the NIH policy that investigators and others who have access to research records will not 
disclose identifying information except when the participant consents or in certain instances when federal, 
state, or local law or regulation requires disclosure. NIH expects investigators to inform research 
participants of the protections and the limits to protections provided by a Certificate issued by this Policy.
NIH Data Sharing Policies 
As described in section 17, it is NIH policy that the results and accomplishments of the activities that it 
funds should be made available to the public (see https://grants.nih.gov/policy/shring.htm - NIH Sharing 
Policies and Related Guidance on NIH-Funded Research Resources).  PIs and funding recipient 
institutions will ensure that all mechanisms used to share data include proper plans and safeguards to 
protect the rights and privacy of individuals who participate in NIH-sponsored research. 
14.6
Future Use of Stored Specimens and Other Identifiable Data
No residual specimens will be maintained after this project is completed.  All Identifiable data will be 
destroyed 6 years after the study is completed.    
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15 DATA HANDLING AND RECORD KEEPING
The Research Clinical Director and Research Assistant is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. All source documents should be completed 
in a neat, legible manner to ensure accurate interpretation of data. The investigators will maintain 
adequate case histories of study participants, including accurate case report forms (CRFs), and source 
documentation.
15.1
Data Management Responsibilities
Data collection and accurate documentation are the responsibility of Research Clinical Director and 
Research Assistant.  
15.2
Data Capture Methods
Other than the Testing Case Report, all data for the study be electronically captured.  Various devices will 
be used including:

Laptop and desktop computers to complete surveys and forms directly into REDCap, the 
electronic data capture system for the study

iPads to complete surveys, forms and capture electronic signatures directly into REDCap

Bar code scanner to label study specimens
All study data will be centrally stored on the Rutgers REDCap data management system, and study-
related documentation will be maintained on RSDM PREDICT Box drive. REDCap is a secure web 
application which is password protected and compliant with 21 CFR Part 11. Study data and 
documentation will be available to the study PI and core personnel in real time, per allowable 
permissions.  
15.3
Types of Data
Types of data to be collected include DHCW and patient perceptions and attitudes, medical history, 
COVID-19 like symptoms, temperature, pulse oximeter readings and COVID-19 test results.  
15.4
Schedule and Content of Reports
The following reports/dashboards will be developed:
Report/
Dashboard
Frequency
Purpose
Content
Reviewed by
Unanticipated 
Problem 
(including 
Serious 
Adverse events 
and protocol 
deviations) 
Report
End of Study
To review unanticipated 
problems and provide an 
opportunity to refine protocol
Listing of unanticipated problem 
reports
Frequency of types of UP’s
PI
Chief of Clinical Protocol
Study Co-Investigators
Research Assistant
There will be no interim analysis performed.  Data analysis is detailed in Section 12.4.  
15.5
Study Records Retention
Per Rutgers Research Regulatory Affairs, research that involves collection of protected health information 
(PHI) is subject to the HIPAA regulations. Research records including signed consent forms that contain 
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the HIPAA authorization must be retained for 6 years after the date on which the subject signed the 
consent form or the date when it last was in effect, whichever is later.
15.6
Protocol Deviations
A protocol deviation is any change, divergence, or departure from the study design or procedures of a 
research protocol that is under the investigator's control and that has not been approved by the IRB. 
Upon discovery, the Principal Investigator is responsible for reporting protocol deviations to the IRB.
A protocol violation is a deviation from the IRB approved protocol that may affect the subject's rights, 
safety, or well-being and/or the completeness, accuracy and reliability of the study data. Protocol 
Violations must be submitted for Full Board IRB review. If the deviation meets any of the following criteria, 
it is considered a protocol violation.
Protocol deviations and protocol violations can be broken down into the following two categories: Minor 
deviation or violation OR Major deviation or violation.

Minor Deviations and/or Minor Violations: A minor deviation or minor violation is viewed by the 
IRB as an event that does not impact subject safety, compromise the integrity of study data 
and/or affect a subject’s willingness to participate in the study. Minor deviations or violations will 
be reviewed under expedited procedures by a single reviewer. The reviewer will determine 
whether the event is accepted as a minor deviation/violation and can recommend a corrective 
course of action. The deviation will be sent to the fully convened IRB meeting where the board 
will discuss and determine if any additional actions are required, where applicable and as 
necessary. If the event meets any of the following criteria, it is considered a minor deviation or 
minor violation: Examples (Minor)

Major Deviations and/or Major Violations: A major deviation or violation is viewed by the IRB as 
an event that may impact subject safety, affect the integrity of study data and/or affect a subject’s 
willingness to participate in the study. Major protocol deviations/violations are treated as 
noncompliance. These reports will be reviewed at the fully convened IRB meeting where the 
board will discuss the major deviations and/or major violations and determine of the appropriate 
course of action. If the event meets any of the following criteria, it is considered a major deviation 
or major violation: Examples (Major)
All deviations and violations from the protocol will be recorded on the Protocol Deviation/Violation 
Reporting Form no later than 5 business days after study staff become aware of the deviation and 
forwarded to the study PI for review and reported promptly to the IRB.   All protocol deviations and 
violations will be reviewed monthly during the PREDICT Steering Committee Meeting.
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16 PUBLICATION/DATA SHARING 
This study will comply with all applicable NIH Data Sharing Policies. See 
https://grants.nih.gov/policy/sharing.htm for policies and resources.
Dissemination at Scientific Meetings:  Presentations at scientific meetings will be delivered to assist in 
dissemination of results as soon as possible when final results pertaining to the primary variables are 
available.  Meetings at which presentations will be made include, but will not be limited to, American 
and International Association of Dental Research (AADR and IADR), the American Dental Association 
(ADA), and International Association for the Study of Pain (IASP) and addiction meetings. NIH grant 
support will be acknowledged during all presentations.
Publication and Authorship Policies:
Findings will be published in peer-reviewed journals. Journals selected will be indexed in PubMed.  
Accepted manuscripts will be submitted to PubMed Central as per NIH policy.  Examples of journals in 
which final results may be published include the Journal of Dental Research and the Journal of the 
American Dental Association.   Other medical journals, including journals on pain and addiction will be 
considered for manuscript publications.  Final versions of the peer reviewed manuscripts will be made 
available to the public, generally within 3 months but no later than 12 months after the official date of 
publication.  NIH grant support will be acknowledged in all publications.
Proposals from study investigators for writing and submitting abstracts and manuscripts for publication will 
be presented to a committee for approval, comprised of the study PI, chief clinical officer, and chief 
pharmacology officer Included in the proposal is data needed for the publication, analyses to be 
performed, proposed authorship and order of authorship, and/or journal in which the manuscript will be 
published.  If a submission for an approved proposal is not completed within 11 months of approval, other 
authors can submit a similar proposal to the committee for approval.
The following ICMJE guidelines will be adopted and followed in determining authorship:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or 
interpretation of data for the work; AND

Drafting the work or revising it critically for important intellectual content; AND

Final approval of the version to be published; AND

Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved.
NIH Public Access Policy
The NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts that 
arise from NIH funds to PubMed Central immediately upon acceptance for publication. This ensures that 
the public has access to the published results of NIH funded research. 
The PI will share the individual non-identified subject data no later than acceptance for the publication’s 
main findings from the final data analysis or 18 months after completion of the study, whichever is 
earlier.   As NIDCR does not have a data repository at the initiation of this feasibility study, data will be 
provided to the PBRN resource center who will have the responsibility for posting the data.  All study 
data will be collected in REDCAP with the REDCap project along with all non-identified data collected.  
The PBRN resource center will convert the data into both SAS and ASCII formats for posting.  Data to 
be posted will include the study protocol and the data set in both SAS and ASCII formats, and data 
dictionary.  
Upon written request to the PI, survey instruments or other materials developed for use during the 
clinical trial will be made electronically available to other researchers.   
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17 LITERATURE REFERENCES
1.
American Dental Association. ADA Coronavirus (COVID-19) Center for Dentists. Available online: 
https://success.ada.org/en/practice-management/patients/infectious-diseases-2019-novel-
coronavirus? (accessed on 27 April 2020).
2.
COVID-19 resources from the ADA, visit the ADA Coronavirus (COVID-19) Center for Dentists at 
ADA.org/virus.
3.
CDC guidelines: https://www.cdc.gov/oralhealth/infectioncontrol/statement-COVID.html
4.
ADA.org May 27, 2020
5.
Ge Z. et. al., Possible aerosol transmission of COVID-19 and special precautions in dentistry, J 
Zhejiang Univ-Sci B (Biomed & Biotechnol) https://doi.org/10.1631/jzus.B2010010.
6.
Odeh, N.D. et. al., COVID-19: Present and Future Challenges for Dental Practice. Int. J. Environ. 
Res. Public Health 2020, 17, 3151; doi:10.3390/ijerph17093151.
7.
Day, M. Covid-19: Four ﬁfths of cases are asymptomatic, China ﬁgures indicate. BMJ 2020, 369, 
m1375.
8.
Kai-Wang To, K. et. al., Temporal profiles of viral load in posterior oropharyngeal saliva samples 
and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. 
Lancet 2020, 20, 565-574.
9.
Rothe, C., et. al., Transmission of 2019-nCoV infection from an asymptomatic contact in 
Germany. N. Engl. J. Med. 2020, 382, 970–971. [CrossRef].
10. Helmy,Y.A. et al., The COVID-19 Pandemic: A Comprehensive Review of Taxonomy, Genetics, 
Epidemiology, Diagnosis, Treatment, and Control. J. Clin. Med. 2020, 9, 1225; 
doi:10.3390/jcm9041225.
11. Giacomelli, A.; et al. Self-reported olfactory and taste disorders in in patients with severe acute 
respiratory coronavirus 2 infection: A cross-sectional study. Clin. Infect. Dis. 2020. [CrossRef].
12. Schmalz et. a., Oral-Health-Related Quality of Life in Adult Patients with Rheumatic Diseases – A 
Systematic Review J. Clin. Med. 2020, 9, 1172; doi:10.3390/jcm9041172.
13. Biju, R.M. ET AL., Oral Health and Quality of Life: Current Concepts. J Clin Diagnos Res, 2017, 
11, 21-26.
14. Soldani FA,et. L.. One-to-one oral hygiene advice provided in a dental setting for oral health. 
Cochrane Database of Systematic Reviews 2018, Issue 10. Art. No.: CD007447. DOI: 
10.1002/14651858.CD007447.pub2.
15. Lamont T, Routine scale and polish for periodontal health in adults.
Cochrane Database of Systematic Reviews 2018, Issue 12. Art. No.: CD004625. DOI: 
10.1002/14651858.CD004625.pub5.
16. Shang, F.M., Liu H.L. Fusobacterium nucelatum and colorectal cancer: A mechanistic overview. 
World J Gastrointest Oncol. 2018 Mar 15;10(3):71-81. doi: 10.4251/wjgo.v10.i3.71.
17. Homlund A,et al., Oral health and cardiovascular disease risk in a cohort of periodontitis patients. 
Atherosclerosis. 2017 Jul;262:101-106. doi: 10.1016/j.atherosclerosis.2017.05.009. Epub 2017 
May 11.
18. Berman CL. Screening by dentists for hypertension. N Engl J Med, 1971, 286(26):1416. doi: 
10.1056/nejm197206292862616.
19. Genco, R.J. et al. Screening for diabetes mellitus in dental practices: a field trial. J Am Dent 
Assoc. 2014 Jan;145(1):57-64. doi: 10.14219/jada.2013.7.
20. Huh, S. How to train health personnel to protect themselves from SARA-CoV-2 (novel 
coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof 2020; 
17:10 • https://doi.org/10.3352/jeehp.2020.17.10
21. WHO. Coronavirus Disease (COVID-2019) Situation Reports-48. Available online: 
https://www.who.int/docs/ default-source/coronaviruse/situation-reports/20200308-sitrep-48-
covid-19.pdf?sfvrsn=16f7ccef_4 (accessed on 10 March 2020).
22. WHO. Clinical Management of Severe Acute Respiratory Infection When Novel Coronavirus 
(nCoV) Infection Is Suspected. Available online: https://www.who.int/publications-detail/clinical-
management-of-severeacute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-
suspected (accessed on 17 March 2020).
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23. Selvan, M.E. Risk factors for death from COVID-19. Nature Reviews Immunology | 
https://doi.org/10.1038/s41577-020-0351-0 | Published online: 27 May 2020.
24. Cantrill, JA et al., Indicators of the appropriateness of long term prescribing in general practice in 
the United Kingdom: consensus development, face and content validity, feasibility, and reliability. 
Quality in Health Care 1998;7:130–135.
25. Tibshirani, R. Regression Shrinkage and Selection via the lasso. J Royal Stat Soc Series B. Wiley 
1996,  58: 267-288.
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SUPPLEMENTAL MATERIALS
None
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APPENDICES
Table of Contents
Appendix
  Page
Appendix A:  Schedule of Events – Dental Health Care Workers Subjects
45
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APPENDIX A: SCHEDULE OF EVENTS
Dental Health Care Workers
Procedures
Prior to Enrollment 
Day -28 (+/- 29 days)
Start-of-Study (Baseline)
Day 0 
Mid-Study
Day 14 (+/- 7 days)
End-of-Study
Day 28 (+/- 7 days)
Obtain Written Consent
X
Start-of-Study Survey
X
Triage Survey
X
X
X
End-of-Study Survey
X
DHCW Participation Questionnaire
X
POC Antigen Test
X
X
X
ELISA Antibody Test
X
X
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