Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT): A PBRN Feasibility Study on COVID-19 Screening in Dental
Conditions: COVID-19 Infection
Sponsor: Rutgers, The State University of New Jersey

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
Protocol X01 DE030407-01 
8/15/21 
 
________________________________________________________________________________________________________ 
 
Pragmatic Return to Effective Dental Infection 
Control through Triage and Testing 
(PREDICT) 
PBRN Feasibility Study 
NIDCR Protocol Number: 20-067-E   
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. 4.0 
August 15, 2021 
 

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. 
 
 

Pragmatic Return to Effective Dental Infection Control 
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Revision History: 
Version 
Number 
Date 
Summary of Revisions Made: 
1.01 
7/25/21 
Added revision history table; doubled enrollment to account for not all 
consented individuals will go on to complete the protocol; added Abbot 
BinaxNOW Covid‐19 Ag Card and COVID‐19 Antigen SelfTEST as POC tests; 
added collection of tongue cells for PCR testing; removed duplicate patient 
consent; added activities occurring with designated window as outcome 
measures; removed patient triage the night prior to visit; specified event 
performed outside of a window is not considered a protocol deviation; clarified 
nasal, tongue cell and capillary blood specimen collection to self‐collection for 
the PBRN member and by the PBRN practitioner or his/her designee for other 
DHCWs and the patient subjects; changed UPS package drop‐off to be at UPS 
store or drop box rather than the dental office; removed eligibility requirement 
that a DHCW have a smart phone; added eligibility requirement that patient 
subjects have access to a computer or electronic tablet with internet 
connection and that they be computer literate enough to be able to complete 
the consent and survey questionnaires; updated event reporting table 
 
 
 
 
 
 
 
 
 
 
 
 
 

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SIGNATURE PAGE 
The signatures 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 
 
Co-PI: 
Signed: 
 
 
Date: 
 
 
Name:  Daniel Fine, DMD 
Title:    Chair 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..............................................................................................................8 
1 
KEY ROLES AND CONTACT INFORMATION .............................................................10 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE ........................................................................................................................13 
2.1 
Background Information ........................................................................................13 
2.2 
Rationale ..................................................................................................................13 
2.2.1  Potential Risks ............................................................................................14 
2.2.2  Potential Benefits .......................................................................................14 
3 
OBJECTIVES AND OUTCOME MEASURES ...............................................................15 
3.1 
Primary .....................................................................................................................17 
3.2 
Secondary ...............................................................................................................18 
3.3 
Tertiary/Exploratory ................................................................................................20 
4 
STUDY DESIGN.................................................................................................................19 
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 .....................................................22 
5.5 
Premature Termination or Suspension of Study ...............................................22 
6 
STUDY SCHEDULE ..........................................................................................................25 
6.1 
Dental Health Care Worker Subjects ..................................................................25 
6.2 
Patient Subjects ......................................................................................................25 
6.3 
Unscheduled Visit ..................................................................................................26 
7 
STUDY PROCEDURES/EVALUATIONS.......................................................................27 
7.1 
Study Procedures/Evaluations .............................................................................34 
7.2 
Lab Procedures/Evaluations ................................................................................37 
7.2.1  Clinical Laboratory Evaluations ................................................................40 
7.2.2  Specimen Preparation, Handling,and Storage ......................................41 
7.2.3  Specimen Shipment ...................................................................................41 
9 
ASSESSMENT OF SAFETY ............................................................................................41 
8.1 
Specification of Safety Parameters .....................................................................41 
8.1.1  Unanticipated Problems ............................................................................41 
8.1.2  Serious Adverse Events ............................................................................42 
8.2 
Reporting Procedures ............................................................................................42 

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8.2.1  Unanticipated Problem Reporting ............................................................42 
9 
STUDY OVERSIGHT ........................................................................................................44 
10 
CLINICAL SITE MONITORING .......................................................................................44 
11 
STATISTICAL CONSIDERATIONS ................................................................................46 
11.1 
Final Analysis Plan .................................................................................................45 
12 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ........46 
13 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................47 
14 
ETHICS/PROTECTION OF HUMAN SUBJECTS ........................................................50 
14.1 
Ethical Standard .....................................................................................................50 
14.2 
Institutional Review Board ....................................................................................50 
14.3 
Informed Consent Process ...................................................................................50 
14.4 
Exclusion of Women, Minorities, and Children (Special Populations) ...........50 
14.5 
Subject Confidentiality ...........................................................................................50 
14.6 
Future Use of Stored Specimens and Other Identifiable Data ........................51 
15 
DATA HANDLING AND RECORD KEEPING ...............................................................52 
15.1 
Data Management Responsibilities .....................................................................52 
15.2 
Data Capture Methods ..........................................................................................52 
15.3 
Types of Data ..........................................................................................................53 
15.4 
Schedule and Content of Reports .......................................................................53 
15.5 
Study Records Retention ......................................................................................53 
15.6 
Protocol Deviations ................................................................................................53 
16 
PUBLICATION/DATA SHARING .....................................................................................54 
17 
LITERATURE REFERENCES .........................................................................................56 
APPENDIX MATERIALS............................................................................................................58 
 
 
 

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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 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: PBRN Feasibly Study 
Précis: 
We will conduct a feasibility study to develop and assess procedures for 
improved COVID-19 triage and testing in dental practices to increase safety 
and perceptions of safety of Dental Health Care Workers (DHCWs) and 
their patients. Four National Dental Practice-Based Research Network 
(PBRN) member dentists and their office staff will be recruited to participate 
as either as a Point of Care (POC) Office or a LAB office based upon 
preference of the PBRN member dentist. . In the POC offices, we will test 
out procedures for POC/SARS-CoV-2 antigen testing in DHCWs and 
patients of the practice along with enhanced triage using pulse oximeters.  
In the LAB offices, DHCWs and patients will test procedures for a saliva-
based laboratory SARS-CoV-2 viral test (LAB) along with enhanced triage 
methods.  Based on office recruitment (POC or LAB), viral, antigen and/or 
antibody COVID-19 tests will be administered to DCHW and patients 
entering the dental office. In addition, the use of pulse oximeters will be 
added to the DHCW and patient triage protocol.  The feasibility of 
implementing COVID-related testing and enhanced triage procedures in the 
dental setting will provide preliminary data to inform a larger network-wide 
study grant application.    
   
Objectives: 
Primary:  The primary objective of this study is to assess the feasibility of 
procedures for both COVID-19 point-of-care and lab-based testing along 
with enhanced triage in dental offices.   
 
Population: 
This study will take place in  dental offices, each of which with at least one 
National Dental PBRN member dentist.  DHCWs working in a dental office 
with a participating National Dental PBRN dentist and their adult patients 18 
years old and older will be recruited to participate.  In each office, up to 10 
DHCWs (dentists, hygienists, assistants and office staff) including  the 
PBRN member dentists and up to twenty (20) patients will be enrolled.  In 
total, up to forty (40) DHCW (dentists, hygienists, assistants and office staff 
will be enrolled) and eighty (80) patients enrolled.   
Number of Sites: 
Four (4) National Dental PBRN offices 
Study Duration: 
Twelve (12) months 
Subject Participation 
Duration: 
DHCWs in both POC offices and LAB offices will participate in the study for 
1 month.  Patients being seen in POC or LAB offices will participate in the 
study for approximately two (2) weeks.   
Estimated Time to 
Complete Enrollment: 
Six (6) months 
 
 
 

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Schematic of Study Design  
 
 
 
 
 
 
 
 

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1.0 
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 Biologist (and Co-PI): 
 
 
Daniel Fine, DMD 
 
Rutgers University, School of Dental Medicine 
 
110 Bergen Street 
 
Newark, NJ 07103 
 
Phone:  (973) 972-7056 
 
Fax:  (973) 972-0045 
 
finedh@sdm.rutgers.edu 
 
 
 
Chief Clinical Protocol Officer 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 
 
 

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Chief Biostatistician and Co-Investigator: 
 
 
Amy Davidow, PhD 
 
Rutgers University, School of Public Health 
 
683 Hoes Lane 
 
Piscataway, NJ  08854 
 
Phone:  (732) 235-5764 
 
Fax:  (732) 235-5464 
 
davidoal@sph.rutgers.edu 
 
 
Co-Investigator:   
 
 
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 
 
 
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 
 
Program Manager: 
 
Julie Chapman-Greene 
 
Rutgers University, School of Dental Medicine 
 
110 Bergen Street, Room B824 
 
Newark, NJ 01701 
 
Phone: (973) 972-3620 
 
chapmaje@sdm.rutgers.edu 
 
PBRN Regional Node Director (Northeast Region): 
 
Cyril Meyerowitz, DDS, MS 
 
University of Rochester, Eastman Institute for Oral Health  
265 Crittenden Blvd, Box 686, Saunders Research Bldg 
Rochester, NY 14642 
Phone: (585) 275-4935 
cyril_meyerowitz@urmc.rochester.edu 
 
PBRN Regional Node Coordinator (Northeast Region): 
 
Pat Ragusa 
University of Rochester, Eastman Institute for Oral Health 
625 Elmwood Avenue Box 683 
Rochester, NY 14620 
Phone (585) 275-5780 
 
Pat_Ragusa@URMC.Rochester.edu 
 
PBRN Director of the Specialty Node: 
 
Veerasathpurush Allareddy BDS PhD 
 
Department of Orthodontics, College of Dentistry 
University of Illinois at Chicago 

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801 S. Paulina St., 138AD (MC841) 
Chicago, IL 60612-7211 
Phone: (312) 996-1809 
sath@uic.edu 
 
Network Coordinating Center (NCC) Study Manager: 
Sara Gille, MPH 
Kaiser Permanente Northwest 
Center for Health Research 
3800 N Interstate Avenue 
Portland, OR 97227 
Phone:  (971) 232-0939 
Sara.Gille@kpchr.org 
 
Network Coordinating Center (NCC) Director: 
MaryAnn McBurnie 
Kaiser Permanente Northwest 
Center for Health Research 
3800 N Interstate Avenue 
Portland, OR 97227 
Phone:  (503) 335-2400 
maryann.mcburnie@kpchr.org 
 
Network Coordinating Center (NCC) Statistician: 
Ellen Funkhouser, Dr Ph 
Medical Towers 611 
1717 11th Avenue South 
Birmingham, Alabama 35205 
Phone: (205) 934-1120 
Fax: (205) 934-7959 
emfunk@uab.edu 
 
Administrative and Resource Center (ARC) Director: 
Gregg Gilbert, DDS, MBA 
University of Alabama at Birmingham School of Dentistry 
SDB Room 109 
Birmingham, Alabama 35205 
Phone: 205-934-5423 
ghg@uab.edu 
 
Administrative and Resource Center (ARC) Project Manager: 
Andi Mathews Hand, RDH 
University of Alabama at Birmingham School of Dentistry 
SDB Room 109 
Birmingham, Alabama 35205 
Phone: 205-934-2578 
ahmathews@uab.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 clinic 
dental personnel 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 with close proximity between patient and dental professionals [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 likely in the dental setting. This suggests that the only 
safe solution for maintaining the health and safety of dental professionals in the time of COVID-19 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 safety 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 COVID-19 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 taking measures to prevent anyone who harbors the COVID-19 virus from entering the 
office. 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 COVID-19 virus. These solutions, at this moment, 
appear to be impractical particularly if the virus affects a very small percentage of the population, testing is 
inaccurate, and obtaining testing results is not immediate. A solution to this problem is imperative both for 
the safety and security of 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 would perhaps be derived from a simple, rapid, accurate, inexpensive point-of-care test that 
is not technically demanding, and 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: With each day, patients are not receiving dental services because of a COVID-19 
transmission concern. Understanding risk associated with COVID-19 transmission in a dental practice and 
the effective use of testing and other practice modifications could dramatically reduce the risk, facilitating 
dental health care providers and patients to be 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 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 conditions 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, with referral to medical personnel for further assessment [18,19]. This 
medical screening 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 dental health care workers (DHCW) to implement COVID-
19 testing in a dental office, who would pay for the testing, 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 either LAB or POC 
testing feel safer and be more comfortable delivering/receiving 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 (not beyond the nares) by a member of the healthcare team which may cause slight 
discomfort to the participant.   
 
Tongue swab – minimal risk.  The tongue swab involves rolling a small circular brush on the 
tongue to collect epithelial cells 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 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 where 
the lancet punctures the skin. 
 
In addition, different COVID-19 test types have varying degrees of sensitivity and specificity, which may 
result in false negative and false positive test results. A false negative result may give a participant a false 
sense of security, and the patient would have been treated with each office’s infection control protocol 

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regardless of participation in the study.  Regardless, false negative test results may pose additional viral 
transmission risk to DHCW who interact with and treat the patient, and other individuals who come into 
contact with the asymptomatic but infected patient. On the other hand, a false positive result will prompt 
the DHCW or patient to undergo additional testing by their primary health care provider and may cause 
additional anxiety.  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 COVID-19 tests they undergo.   

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3 OBJECTIVES AND OUTCOME MEASURES 
3.0 
Feasibility Study Outcomes 
Objectives  
Brief Description/Justification of 
Outcome Measure 
Outcome Measured By  
Time Frame 
To Determine DHCW and 
Patient Willingness to 
Participate 
Willingness to participate is 
important in determining whether 
dental offices, DHCW and patients 
would be willing to participate in a 
large‐scale study 
 
 Ratio of DHCW agreeing to participate as 
compared to all DHCW asked to 
participate 
 
 Ratio of patients agreeing to participate 
as compared to all patients asked to 
participate 
 
 Thoroughness of consent process and 
ability to ask questions  
Willingness to Participate:  
 DHCW – at time of consent by 
DHCW consent 
 Patients – at time of consent 
by patients 
 
To Determine DHCW and 
Patient  Willingness/Ability to  
Follow Thru 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 
For both DHCW and Patients 
 
 % who complete the study 
 
 % who complete surveys 
o Start‐of‐Study DHCW Survey 
o End‐Of‐Study DHCW Survey 
o Pre‐Visit Patient Survey 
o End‐of‐Visit Patient Survey 
 
 % activities occurring within the defined 
window 
o Consents 
o Start‐of‐Study DHCW Survey, Triage 
and Testing 
o End‐Of‐Study DHCW Survey, Triage 
and Testing 
o Mid‐Study Triage Testing 
o Pre‐Visit Patient Survey 
o End‐of‐Visit Patient Survey 
o Patient Testing 
 
 % 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 
o Timeliness of results 
o Reporting of results 
 
 
% Complete Study:  
 For DHCW ‐ At time End‐of‐
Study (Day 28) 
 Patients – End‐Of‐Visit (Day 1) 
 
% All Surveys Completed:  
 For DHCW ‐ At time End‐of‐
Study (Day 28) 
 Patients – End‐Of‐Visit (Day 1) 
 
% Activities Occurring within the 
defined window:  
 For DHCW – Consent, Start‐of‐
Study Visit, Mid‐Visit, End‐of‐
Study Visit 
 Patients – Consent, LAB 
material receipt, LAB specimen 
sent to laboratory, LAB results, 
Treatment Visit 
 
% Feel Testing Protocol was Easy 
to Comply With:  
 For DHCW ‐ At time End‐of‐
Study (Day 28) 
 Patients – End‐Of‐Visit (Day 1) 

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Objectives  
Brief Description/Justification of 
Outcome Measure 
Outcome Measured By  
Time Frame 
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 
 Patient Subject 
o Start‐of‐Visit Survey 
o End‐of‐Visit Survey 
o Triage Survey 
 
Determining the ease of use and 
completeness of the REDCap 
instruments enables refinement of 
the system 
For both DHCW and Patients 
 
 % who feel surveys are easy to complete 
due to administration method: 
o 
Start‐of‐Study DHCW Survey 
o 
End‐of‐Study DHCW Survey 
o 
Pre‐Visit Patient Survey 
o 
End‐of‐Visit Patient Survey 
o 
Triage Case Report 
 
 % who feel survey questions were 
understandable: 
o 
Start‐of‐Study DHCW Survey 
o 
End‐of‐Study DHCW Survey 
o 
Pre‐Visit Patient Survey 
o 
End‐of‐Visit Patient Survey 
o 
Triage Case Report 
 
 % completed surveys: 
o 
Start‐of‐Study DHCW Survey 
o 
End‐of‐Study DHCW Survey 
o 
Pre‐Visit Patient Survey 
o 
End‐of‐Visit Patient Survey 
o 
Triage Case Report 
 
 
% indicating surveys were easy to 
complete due to administration 
method: 
 For DHCW ‐ At time End‐of‐
Study (Day 28) 
 Patients – End‐Of‐Visit (Day 1) 
 
% indicating survey questions 
were easy to understand:  
 For DHCW ‐ At time End‐of‐
Study (Day 28) 
 Patients – End‐Of‐Visit (Day 1) 
 
% Surveys Completed:  
 For DHCW ‐ At time End‐of‐
Study (Day 28) 
 Patients – End‐Of‐Visit (Day 1) 
 
 
 
 
 
 
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 
 
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 
 

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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 
 
 
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 observational study will assess the feasibility of implementing COVID-related testing 
and triage procedures 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. 
 
This study will be conducted in four (4) private practice dental offices, each of which with at least one 
National Dental Practice Based Research Network (PBRN) member dentist. Based upon preference of 
the Practice Based Research Network dentist, offices will participate as either a Point of Care (POC) 
Office (2 offices) or a LAB office (2 offices). In the POC offices, we will test procedures for POC/SARS-
CoV-2 antigen testing in DHCWs and patients of the practice along with enhanced triage using pulse 
oximeters.  In the LAB offices, DHCWs and patients will test procedures for a saliva-based laboratory 
SARS-CoV-2 viral test (LAB) along with enhanced triage methods. The National Dental PBRN dentist and 
office will choose to participate in either the POC or LAB group; offices will not be assigned to study 
groups.  
 
Study Population: The study population for this study will be all dentists, hygienists, dental assistants 
and dental office personnel (e.g., dentists, hygienists, dental assistants, front office staff) working in a 
participating dental office, as well as patients being treated in the participating dental office.   
 
Important Outcomes:  For this study, important outcomes include percent of both DHCW and patients 
willing to participate percent completing the protocol. See Section 3 for more detail. 
 
Number of Study Groups: Four (4) 
1. DHCW in POC Offices 
2. Patients in POC Offices 
3. DHCW in Lab Offices 
4. Patients in Lab Offices 
 
Expected Duration of Subject Participation:   
 
DHCWs (in POC or LAB Offices) - 1 month 
 
Patients (in POC or LAB Offices) - 2 weeks 
 
Sequence of Procedures and Duration of Study Period:  See Section 7. 
 
 

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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: 
 
Be 18 years or older  
 
Be a National Dental PBRN member dentist or work in a dental office with a National Dental 
PBRN member dentist who consents to study participation 
 
Be able to understand the informed consent. 
 
Provide signed and dated informed consent form 
 
Be able to understand all instructions for data collection instruments  
 
Be willing and able to comply with all study procedures, including COVID-19 testing, and be 
available for the duration of the study  
 
A Patient must meet all of the following criteria to be eligible to participate in the study: 
 
Be 18 years or older 
 
Be able to understand the informed consent. 
 
Have a computer or electronic tablet with internet access 
 
Able to complete consent and questionnaire on a computer or electronic tablet 
 
Provide signed and dated informed consent form 
 
Be able to understand all instructions for data collection instruments  
 
Be willing and able to comply with all study procedures, including having a COVID-19 test 
performed 
 
5.2 
Participant Exclusion Criteria 
Participants would be excluded if they participated in the feasibility study previously conducted at Rutgers 
University. 
5.3 
Strategies for Recruitment and Retention 
Target Sample Size: 40 dental care health workers and 80 patients. 
Target Sample Size by Gender, Race, Ethnicity, and Age:  Study population will be drawn from 
National Dental PBRN dentist members, their co-workers and patients seen in their office.  Any adult 18 
years and older meeting the inclusion criteria and not meeting any exclusion criteria will be eligible to 
participate.  It is expected that the mix of gender, race and ethnicity will reflect the patient mix of the 
participating dental offices. 
 
Study Population:  The DHCW study population will be dentists, hygienists, assistants and office staff 
who work in an office with a National Dental PBRN member dentist.  The patient study population will be 
drawn from the dental practice with the National Dental PBRN member dentist.   
 
Inclusion of Women and Minorities and Individuals of All Ages:  
Women:  Women will be included in this study.   
Minorities:  Minorities will be included in this study.   
 
Recruitment Strategies:  Four (4) National Dental PBRN practitioners who have 4 or more DHCW in 
their office will be recruited to participate by the National Dental PBRN Node Coordinator.  The Node 
Coordinator will then recruit DHCWs within the practice to participate.  If a practice is unable to consent at 
least 5 DHCWs, the practice will not participate in the study.  Another National Dental PBRN practice will 
be recruited to participate.   
 

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Patients will be sent a letter about 4 weeks prior introducing the study by the PBRN practitioner.  The 
PBRN practitioner or PBRN investigators in the office will reach out to patients by phone about 2 weeks 
prior to the dental visit.  The study will be explained and if the patient is interested, an e-mail link will be 
sent which will allow the patient to review the informed consent.  A phone number will be provided to 
answer questions. 
 
Recruitment Protocol (All Study Groups):  
 
The PRBN Node Research Coordinator will recruit PBRN dentist members to participate in the protocol.  
The PBRN Node Research Coordinator will contact PBRN dentist members to introduce the study and 
gauge initial interest.  The dental office will be enlisted if the PBRN dentist member and 4-9 additional 
office DHCWs of the practice are willing to participate and the PBRN member is willing to perform the 
responsibilities of the protocol including enrolling and completing 10 patients. The PBRN practitioner’s 
preference will determine which protocol (POC or LAB) will be followed in the office. In total, two POC 
offices will participate, and two LAB offices will participate. 
 
Office  
Study Group
Protocol
COVID-19 Related Tests (Method)
POC 
1- DHCW in POC Offices 
 
POC DHCW Protocol 
 
Antigen (nasal swab) 
 
Antibody (capillary blood) 
2- Patients in POC Offices 
POC Patient Protocol 
 
Antigen (nasal swab) 
LAB 
3- DHCW in Lab Offices 
LAB DHCW Protocol 
 
Virus (saliva and/or tongue) 
 
Antibody (capillary blood) 
4- Patients in LAB Offices 
LAB Patient Protocol 
 
Virus (saliva) 
 
 
Retention:  In order to minimize loss of study participants and/or incomplete data collection, the following 
activities will take place: 
 
Node Coordinators will work with National Dental PBRN study participants responsible for 
recruiting subjects and completing surveys to encourage patient enrollment and study completion. 
 
Participants will receive compensation.   
 
Compensation and Scheduled Payments:  DHCWs who complete the study procedures including the 
end-of-study survey will receive $125 each.  Patients who complete the LAB study procedures including 
the post-visit survey will be provided $100 and patients who complete the POC study procedures 
including the post-visit survey will be provided $50.   
 
Additional Plans to Minimize Missing or Incomplete Data:  The following will minimize missing or 
incomplete data: 
 
When appropriate, REDCap survey data fields are set to “required”.   
 
REDCap validation rules on data fields to limit responses to those which are valid  
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. 

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 
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 Node 
Coordinator will interview the participant and document the withdrawal of consent using the Consent 
Withdrawn Received Form in the REDCap system.  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. 
 
Participants who withdraw will not be replaced. 
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 sIRB 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 in the POC Offices.   
 
Visit 
 
Day 
Dental Health Care Worker Subjects 
Activities Performed 
Enrollment 
(15 minutes) 
Day ‐28  
(+/‐ 29 days) 
 Obtain written Informed Consent 
Start‐of‐Study 
(35 minutes) 
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 
(20 minutes) 
Day 14   
(+/‐ 7 days) 
 Complete Mid‐Study Triage Case Report 
 Undergo POC Covid‐19 Test 
End‐of‐Study 
(40 minutes) 
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 
The following is the schedule of events for Dental Health Care Worker Subjects in the LAB Offices.   
 
Visit 
 
Day 
Dental Health Care Worker Subjects 
Activities Performed 
Enrollment 
(15 minutes) 
Day ‐28  
(+/‐ 29 days) 
 Obtain written Informed Consent 
Start‐of‐Study 
(35 minutes) 
Day 0  
 
 Complete Start‐of‐Study Survey 
 Complete Start‐of‐Study Triage Case Report 
 Provide specimen(s) for PCR (viral) test 
 Provide specimen for ELISA (antibody) test 
Mid‐Study 
(20 minutes) 
Day 14   
(+/‐ 7 days) 
 Complete Mid‐Study Triage Case Report 
 Undergo POC Covid‐19 Test 
End‐of‐Study 
(40 minutes) 
Day 28 
(+/‐14 days) 
 Complete End‐of‐Study Triage Case Report 
 Provide specimen(s) for PCR (viral) test 
 Provide specimen for ELISA (antibody) test 
 Complete End‐of‐Study Survey 
 Complete DHCW Participation Questionnaire 
6.2 
Patient Subjects 
The following is the schedule of events for patients participating in the POC Offices.   
 
Visit 
 
Day 
POC Subjects 
Activities Performed in POC Offices 
4 Weeks Prior 
(5 minutes) 
Day ‐28 
(+/‐ 14 days) 
 Letter sent to providing study background to patient 
2 Weeks Prior 
(15 minutes) 
Day ‐14  
(+/‐ 14 days) 
 Potential subjects contacted to introduce and determine interest in the study 
 Obtain electronic consent signature 
 Complete Patient Pre‐Visit Survey 
Visit  
(35 minutes) 
Day 1 
 Complete Start‐of‐Visit Triage Case Report 
 Undergo POC Test 
 (Provision of Dental Treatment ‐ not part of research protocol) 
 Complete Patient End‐of‐Visit Survey 
 Complete Patient Participation Questionnaire 
 
 
 

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The following is the schedule of events for patients participating in the LAB Offices.   
 
Visit 
 
Day 
POC Subjects 
Activities Performed in LAB Offices 
4 Weeks Prior 
(5 minutes) 
Day ‐28 
(+/‐ 14 days) 
 Letter sent to providing study background to patient 
2 Weeks Prior 
(15 minutes) 
Day ‐14  
(+/‐ 7 days) 
 Potential subjects contacted to introduce and determine interest in the study 
 Obtain electronic consent signature 
 Complete Patient Pre‐Visit Survey 
1 Week Prior 
(30 ‐ 60 minutes) 
Day ‐7  
(+/‐ 5 days) 
 Provide specimen for PCR (viral) test 
 Drop specimen off at a UPS store or UPS Dropbox 
Visit  
(20 minutes) 
Day 1 
 Complete Start‐of‐Visit Triage Case Report 
  (Provision of Dental Treatment ‐ not part of research protocol) 
 Complete Patient End‐of‐Visit Survey 
 Complete Patient Participation Questionnaire 
 
6.3 
Unscheduled Visit 
 
Not applicable.  For dental patient participants, the study takes place during 1 patient dental visit.  For 
Dental Healthcare Workers, data collection occurs at three specific times over a one-month period: start, 
mid-month, end of month. 

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7 STUDY PROCEDURES/EVALUATIONS 
In general, the study will include completion of COVID-19 triage case reports, completion of COVID-19 
testing, and administration of perception and attitude surveys.  The DHCW Start-of-Visit, Mid-Visit and 
End-of-Visit and the Patient Start-of-Visit triage case report will include recording of temperatures and 
pulse oximeter reading for participants in both POC and LAB offices.  During day 1, the dental visit, 
normal patient care will be provided to the patient subject.   
 
Group 1- DHCWs in POC Office 
 
Consent Process for Group 1- DHCWs in POC Offices 
Within 4 weeks prior to study initiation in the dental office, the National Dental PBRN Node Coordinator 
will consent the DHCWs in the participating office. The consent will clearly outline participant expectations 
and offer the opportunity for potential participants to contact the National Dental PBRN Node Coordinator 
for more information as needed.  DHCWs who elect to participate will affirm their willingness to participate 
by signing the consent form.  
 
Study Procedures for Group 1- DHCWs in POC Offices  
Prior to study initiation (Up to 4 weeks prior) 
 
Complete consent for all DHCW participants 
 
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 
 
Undergo a three-part COVID-19 triage screening* 
o 
Symptom questions  
 
Presence or absence of: 
 
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  (administered by the PBRN practitioner or designated 
investigator) 
 
A nasal swab will be swept inside the participant’s nose (not beyond the nares) to 
collect the specimen for the SARS-CoV-2 test 
 
The office staff will process the specimen in the dental office 
o 
ELISA Antibody test (specimen collected by the PBRN practitioner, designated 
investigator or self) 
 
A small lancet will create a finger prick to collect a small blood sample for 
collection using a Mitra cartridge (blood specimen collection device) 

Pragmatic Return to Effective Dental Infection Control 
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Page 26  
 
The Mitra cartridge will be packaged by the DHCW and placed in the practice 
collection box to await shipment to Rutgers 
 
The sample will be processed by the Public Health Research Institute (PHRI) Lab 
at Rutgers 
 
Mid-Study- Day 14 (+/- 7 days)  
 
Undergo a COVID-19 triage screening in the office* 
 
Complete a SARS-CoV-2 POC test**  (administered by the PBRN practitioner or designated 
investigator)  
o 
A nasal swab will sweep the inside of the participant’s nose (not beyond the nares) to 
collect your specimen for the SARS-CoV-2 test 
o 
The office staff will process the specimen 
 
End of Study- Day 28 (+/- 7 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 (administered by PBRN practitioner or designated investigator) 
 
A nasal swab will be swept inside the participant’s nose (not beyond the nares) to 
collect the specimen for the SARS-CoV-2 test 
 
The office staff will process the specimen in the dental office 
o 
ELISA Antibody test (specimen collected by the PBRN practitioner, designated 
investigator or self ) 
 
A small lancet will create a finger prick to collect a small blood sample for 
collection using a Mitra cartridge (blood specimen collection device) 
 
The Mitra cartridge will be packaged by the DHCW and placed in the practice 
collection box to await shipment to Rutgers 
 
The sample will be processed by the Public Health Research Institute (PHRI) Lab 
at Rutgers 
 
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 
 
*If any aspect of the COVID-19 triage screening is positive without any preexisting condition which could 
explain the positive screening (i.e.. a history of hay fever which likely explains sneezing or a report of 
physical activity which likely explains muscle soreness), the DHCW will be referred to their primary care 
physician for further testing.  
 
Positive screening includes having one or more symptoms of unknown origin 
 
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% 
 
**If the POC COVID-19 test is positive, the DHCW may be dismissed from duties and instructed to 
consult with their primary care provider for further testing. 

Pragmatic Return to Effective Dental Infection Control 
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Page 27  
 
 
 
 
Group 2- Patients in POC Offices 
 
Consent Process for Group 2- Patients in POC Offices 
Three weeks (+/- 20 days) prior to visit, patients will get an introductory/interest letter, informing them 
about the study and that they may be receiving a phone call to determine their interest.  About two weeks 
prior to their scheduled dental visit, patients will be contacted by the dental office to determine their 
willingness to participate in the study.  Patients who indicate interest will be sent an email link, which 
opens the consent.  Patients will be able to speak to the PBRN practitioner or approved staff member with 
any questions or seek clarifications.  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 elect to participate will affirm their willingness to participate by clicking the “I agree to take part in this 
study” button at the end of the consent form.   
 
Study Procedures for Group 2- Patients in POC Offices  
Study participants will be asked to do the following: 
 
Two weeks before the dental visit 
o 
Complete and sign electronic consent 
o 
Complete an electronic survey: Patient Pre-Visit Survey  
 
Questions explore perceptions of safety and comfort, reasons for delaying dental 
care, concerns about returning to dental care, safety precautions valued, 
importance of triage and testing, and demographics 
 
Launched automatically after the completed consent 
 
At the start of the Dental Visit 
o 
Undergo a COVID-19 triage screening in the office* 
 
Screening includes symptom questions, temperature check, and pulse oximeter 
reading 
o 
Complete COVID-19 POC test** (administered by PBRN practitioner or designated 
investigator) 
 
A nasal swab will be swept inside the participant’s nose (not beyond the nares)  
to collect the specimen for the COVID-19 test 
 
The PBRN Practitioner or their designee will process the specimen 
 
At the End of the Dental Visit 
o 
Complete two electronic surveys 
 
Patient End-of-Visit Survey  
 
Questions explore perceptions with testing preferences, PPE observed, 
environmental controls observed, concerns about returning to dental 
care, safety precautions valued, importance of triage and testing, 
likelihood of reporting symptoms, dentist’s role in COVID-19 testing and 
vaccinations 
 
Patient Participation Survey 
 
Questions explore perceptions related to study participation including 
survey and testing logistics 

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
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Page 28  
 
*If any aspect of the COVID-19 triage screening is positive without any preexisting condition which could 
explain the positive screening (i.e.. a history of hay-fever which likely explains sneezing or a report of 
physical activity which likely explains muscle soreness), appointment will be postponed, and the 
participant will be referred to their primary care physician for further testing.  
 
A Positive screening by reporting one or more symptoms of unknown origin  
 
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% 
 
**If the POC COVID-19 test is positive, the dental visit may be postponed, and the positive patient 
participant will be instructed to consult with their primary care provider for further testing.  
 
 
 
 
Group 3- DHCWs in LAB Offices 
 
Consent Process for Group 3- DHCWs in LAB Offices 
Within 4 weeks prior to study initiation in the dental office, the National Dental PBRN Node Coordinator 
will consent the DHCWs in the participating office. The consent will clearly outline participant expectations 
and offer the opportunity for potential participants to contact the National Dental PBRN Node Coordinator 
for more information as needed.  DHCWs who elect to participate will affirm their willingness to participate 
by signing the consent form. 
 
Study Procedures for Group 3- DHCW in LAB Offices  
Prior to study initiation (Up to 4 weeks prior) 
 
Complete consent for all DHCW participants 
 
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 
 
Undergo a three-part COVID-19 triage screening* 
o 
Symptom questions  
 
Presence or absence of: 
 
fever or chills 
 
cough 
 
shortness of breath or difficulty breathing 
 
fatigue 
 
muscle and body aches 
 
headache 
 
loss of taste 

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
Protocol X01 DE030407-01 
8/15/21 
 
 
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Page 29  
 
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 PCR viral test  
o 
Saliva (self-collected) and tongue specimens (collected by PBRN practitioner, designated 
investigator or self)   
o 
ELISA Antibody test (specimen collected by PBRN practitioner, designated investigator 
or self) 
 
A small lancet will create a finger prick to collect a small blood sample for 
collection using a Mitra cartridge (blood specimen collection device) 
 
The Mitra cartridge will be packaged by the DHCW and placed in the practice 
collection box to await shipment to Rutgers 
 
The sample will be processed by the Public Health Research Institute (PHRI) Lab 
at Rutgers 
 
Mid-Study- Day 14 (+/- 7 days)  
 
Undergo a COVID-19 triage screening in the office* 
 
Complete a SARS-CoV-2 PCR Viral test**  
o 
Saliva (self-collected) 
 
End of Study- Day 28 (+/- 7 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 PCR viral test  
o 
Saliva (self-collected) and tongue specimens (collected by PBRN practitioner, designated 
investigator or self)  
o 
ELISA Antibody test (specimen collected by PBRN practitioner, designated investigator 
or self) 
 
A small lancet will create a finger prick to collect a small blood sample for 
collection using a Mitra cartridge (blood specimen collection device) 
 
The Mitra cartridge will be packaged by the DHCW and placed in the practice 
collection box to await shipment to Rutgers 
 
The sample will be processed by the Public Health Research Institute (PHRI) Lab 
at Rutgers 
 
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 
 
*If any aspect of the COVID-19 triage screening is positive without any preexisting condition which could 
explain the positive screening (i.e., a history of hay-fever which likely explains sneezing or a report of 
physical activity which likely explains muscle soreness), the DHCW will be referred to their primary care 
physician for further testing.  

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
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Page 30  
 
Positive screening includes having one or more symptoms of unknown origin 
 
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% 
 
**If the lab processed SARS-CoV-2 test is positive, the DHCW may be dismissed from duties and 
instructed to consult with their primary care provider for further testing. 
 
 
 
 
Group 4- Patients in LAB Offices 
 
Consent Process for Group 4 - Patients in LAB Offices 
Three weeks (+/- 14 days) prior to a scheduled dental visit, patients will get an introductory/interest letter, 
informing patients about the study and that they may be receiving a phone call to determine their interest.  
About two weeks prior to their scheduled dental visit, patients will be contacted by the dental office to 
determine their willingness to participate in the study.  Patients who indicate interest will be sent an email 
link, which opens the consent.  Patients will be able to speak to the PBRN practitioner or approved staff 
member with any questions or seek clarifications.  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 elect to participate will affirm their willingness to participate by clicking the “I agree to 
take part in this study” button at the end of the consent form.   
 
Study Procedures for Group 4 - Patients in LAB Offices  
Study participants will be asked to do the following: 
 
Two weeks before the dental visit 
o 
Complete and sign electronic consent 
o 
Complete an electronic survey: Patient Pre-Visit Survey  
 
Questions explore perceptions of safety and comfort, reasons for delaying dental 
care, concerns about returning to dental care, safety precautions valued, 
importance of triage and testing, and demographics 
 
Launched automatically after the completed consent 
o 
Receive a saliva collection kit by mail 
 
One week before the dental visit 
o 
Complete a COVID-19 saliva test 
 
Spit into a tube  
 
Package as directed 
o 
Drop off the completed test kit at a UPS Store or drop-off box  
 
At the start of the Dental Visit 
o 
Undergo a COVID-19 triage screening in the office* 
 
Screening includes symptom questions, temperature check, and pulse oximeter 
reading 
 
At the End of the Dental Visit 
o 
Complete two electronic surveys 
 
Patient End-of-Visit Survey  

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
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8/15/21 
 
 
Based on NIDCR Interventional Protocol Template v5.0–20190311 
Page 31  
 
Questions explore perceptions with testing preferences, PPE observed, 
environmental controls observed, concerns about returning to dental 
care, safety precautions valued, importance of triage and testing, 
likelihood of reporting symptoms, dentist’s role in COVID-19 testing and 
vaccinations 
 
Patient Participation Survey 
 
Questions explore perceptions related to study participation including 
survey and testing logistics 
 
*If any aspect of the COVID-19 triage screening is positive without any preexisting condition which could 
explain the positive screening (i.e., a history of hay-fever which likely explains sneezing or a report of 
physical activity which likely explains muscle soreness), the appointment will be postponed, and the 
participant will be referred to their primary care physician for further testing.  
 
A Positive screening by reporting one or more symptoms of unknown origin 
 
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% 
 
**If the lab processed SARS-CoV-2 test is positive, the dental visit may be postponed, and the positive 
patient participant will be instructed to consult with their primary care provider for further testing. 
 
 
 
Reporting and Notification 
The results of the POC, LAB, and/ Elisa test will be recorded in the Testing Case Report form in REDCap. 
The PI and/or Chief Protocol Officer will notify the Practitioner of test results.  The National Dental PBRN 
dentist member of the practice will be considered the “Practitioner” of the office and assume the 
responsibility of notifying test results to the DHCWs and patients in the practice.  
For the purpose of this study, a COVID-19 positive result is not considered an adverse event though 
results of this test will be recorded.   
DHCW subjects who test antigen or viral 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 
DHCW is back to work in time for the mid-study testing, the mid-study protocol will be followed.  Similarly, 
if a DHCW 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 by the PBRN practitioner or designated investigator will be made 
approximately 1 week after the positive triage finding or test result to record any confirmatory tests which 
were obtained based upon the advice of the DHCW’s physician.   
Patient subjects who are COVID-19 antigen or viral positive or who triage positive without any preexisting 
medical condition, will not be seen for their scheduled dental visit.   The subject will be referred to their 
physician for a definitive diagnosis and follow-up.     

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
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8/15/21 
 
 
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Page 32  
 
 

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Page 33  
7.1 
Study Procedures/Evaluations 
The following study procedures will be completed 
Group 1- DHCW Subjects in POC Offices 
 
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 
 COVID‐19 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 the Practitioner  
Testing Case Reports 
 
Collect 
information on 
outcomes of 
COVID‐19 
testing  
Yes 
Start‐of‐Study (Day 0) 
Mid‐Study (Day 14) 
End of Study (Day 28) 
POC Test  
POC SARS‐CoV‐2 antigen test results 
entered into REDCap by the 
Practitioner or designated 
investigator for all DHCWs 
 
ELISA Ab test  
For Practitioner‐ Data entered into 
REDCap eCRF by the PI and/or Chief 
Clinical Officer 
 
For other DHCWs‐ Data entered into 
REDCap eCRF by the PI and/or Chief 
Clinical Officer  
 
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 
information on 
surveys and 
logistics 
Yes 
End‐of‐Study (Day 28) 
Data entered via REDCap self‐
administered survey. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
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Page 34  
 
Group 2- Patient Subjects in POC Offices 
 
Procedure and Evaluations 
 
Purpose 
Completed 
as Part of 
Study 
 
When Performed 
 
How Completed 
Obtain Informed Consent 
Complete 
informed 
consent  
Yes
2 Weeks Prior (day ‐14 +/‐14
days) 
 
Electronic consent and signatures 
obtained prior to initiating Pre‐Visit 
Patient Survey 
Patient Start‐of‐Visit Survey 
 Safety and Comfort 
 COVID‐19 Testing 
Preferences 
 Perception of Importance 
 Medical history 
Likelihood to report COVID‐19 
symptoms 
Collect 
outcome 
measures 
Yes
2 Weeks Prior (day ‐14 +/‐ 14 
days) 
Data entered via REDCap self‐
administered survey. 
Triage Case Report 
 
Collect COVID‐
19 screening 
data 
Yes 
Visit (day 1) 
Data entered into REDCap via eCRF by 
the Practitioner or their investigator 
designee 
Testing Case Reports 
 
Collect 
information on 
outcomes of 
COVID‐19 
testing  
 
Visit (day 1) 
POC SARS‐CoV‐2 antigen test results 
entered into REDCap via eCRF by the 
Practitioner or their investigator 
designee 
Dental Procedures Performed 
Maintain 
patient oral 
health 
NO 
Visit 
Completed by Dental Health Care 
Workers 
End‐of‐Visit Patient Survey 
 PPE observed in office 
 Environmental controls 
observed in office 
Collect 
outcome 
measures 
Yes
Visit (day 1)
Data entered via REDCap self‐
administered survey. 
Patient Participation 
Questionnaire 
Collect 
feasibility 
information on 
surveys and 
logistics 
Yes 
End of Study (Day 28) 
Data entered via REDCap self‐
administered survey. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pragmatic Return to Effective Dental Infection Control 
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Page 35  
 
Group 3- DHCW Subjects in LAB Offices 
 
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 
 COVID‐19 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 the Practitioner or designated 
investigator  
Testing Case Reports 
 
Collect 
information on 
outcomes of 
COVID‐19 
testing  
Yes 
Start‐of‐Study (Day 0) 
Mid‐Study (Day 14) 
End of Study (Day 28) 
PCR Viral and ELISA Ab tests 
For the Practitioner‐ Data entered 
into REDCap eCRF by the PI and/or 
Chief Clinical Officer 
 
For the other DHCWs‐Data entered 
into REDCap eCRF by the PI and/or 
Chief Clinical Officer 
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 
information on 
surveys and 
logistics 
Yes 
End‐of‐Study (Day 28) 
Data entered via REDCap self‐
administered survey. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pragmatic Return to Effective Dental Infection Control 
Version PBRN Feasibility Study. Vr. 4.0 
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Page 36  
 
Group 4- Patient Subjects in LAB Offices 
 
Procedure and Evaluations 
 
Purpose 
Complete
d as Part 
of Study 
 
When Performed 
 
How Completed 
Obtain Informed Consent 
Complete informed 
consent  
Yes
2 Weeks Prior (day‐
14 +/‐7 days) 
Electronic consent and signatures 
obtained prior to initiating Pre‐Visit 
Patient Survey 
Patient Start‐of‐Visit Survey 
 Safety and Comfort 
 COVID‐19 Testing Preferences 
 Perception of Importance 
 Medical history 
Likelihood to report COVID‐19 
symptoms 
Collect outcome 
measures 
Yes 
2 Weeks Prior (day‐
14 +/‐7 days) 
Data entered via REDCap self‐
administered survey. 
Triage Case Report 
 
Collect COVID‐19 
screening data 
Yes 
Visit (day 1) 
Data entered into REDCap by the PI 
and/or Chief Clinical Officer 
Testing Case Reports 
 
Collect information 
on outcomes of 
COVID‐19 testing  
 
Day Prior (day ‐2 +/‐ 
2 days 
Saliva Viral SARS‐CoV‐2 test results 
entered into REDCap via eCRF by the 
Practitioner or their investigator 
designee 
Dental Procedures Performed 
Maintain patient oral 
health 
NO 
Visit 
Completed by Dental Health Care 
Workers 
Patient End‐of‐Visit Survey 
 PPE observed in office 
 Environmental controls observed 
in office 
Collect outcome 
measures 
Yes 
Visit (day 1) 
Data entered via REDCap self‐
administered survey. 
Patient Participation Questionnaire 
Collect feasibility 
information on 
surveys and logistics 
Yes 
End of Study (Day 
28) 
Data entered via REDCap self‐
administered survey. 
 
 
 

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7.2 
Laboratory Procedures/Evaluations 
7.2.1 
Clinical Laboratory Evaluations 
DHCW (dentists, hygienist, assistants and front desk personnel) and patient subjects will be tested for 
COVID-19.  DHCW will be administered POC, PCR Viral Test and/or ELISA Antibody Test.  LAB patient 
subjects will be administered the LAB test and POC patient subjects will be administered the POC test.    
 
POC Test 
(Antigen) 
DHCW 
PCR Viral Test 
DHCW 
ELISA Antibody Test 
Test Description 
 
 
 
Company 
BD Veritor System or Abbott 
COVID-19 antigen card test 
Kits 
Rutgers 
Rutgers 
Sample collected via 
Nasal swab  
Saliva collection tube with 
buffer and/or tongue cells via 
cytology brush 
Capillary blood sample via 
Neoteryx Mitra Cartridge 
What is being Tested 
SARS-CoV-2 Nucleocapsid 
Antigen 
SARS-CoV-2 RNA 
IgG and IgM 
Test Administration 
(specimen collection) 
Nasal swab performed by 
PBRN Practitioner or 
designated investigator (not 
beyond the nares) 
Performed by PBRN 
Practitioner, designated 
investigator or self 
Performed by PBRN 
Practitioner, designated 
investigator or self 
Test Administration 
(specimen processing)  
BD Veritor or Abbott COVID-
19 antigen card test 
performed by PBRN 
Practitioner or designated 
investigator 
Department of Oral Biology, 
Rutgers School of Dental 
Medicine and/or Genomics 
Laboratory, New Jersey 
Medicine School 
Mitra Cartridge is processed 
at ICPH-PHRI center, New 
Jersey Medical School, 
Newark, NJ 
Results 
Dichotomous (+ or -) 
Quantitative 
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 
 
PCR Viral Test 
 
ELISA Antibody Test 
Indication of Proper 
Processing 
The Veritor instrument will 
report if a sample is not able 
to be processed or control 
line on the Abbot COVID-19 
antigen card will not be able 
to be seen.  This feedback 
will be used to identify 
insufficient training or 
unanticipated problems.   
The Oral Biology Lab and/or 
Genomics Laboratory 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.   
7.2.2 
Specimen Preparation, Handling, and Storage 
The following details specimen preparation, handling and storage.  
 
POC Test 
PCR Viral Test 
ELISA Antibody Test 
Sample Collection & Shipping 
Sample 
Collection 
Materials 
Nasal swab included in 
BD Veritor or Abbott 
COVID-19 antigen card 
system 
Saliva collection kit via 
Spectrum and/or Tongue 
cell collection kit via Oral 
Biology Laboratory 
Capillary blood sample via Mitra Cartridge 
Storage of 
Specimen 
Collection 
Supplies and 
Test Kits 
National Dental PBRN 
Office after kits are mail to 
them from the Clinical 
Research Center at the 
Rutgers School of Dental 
Medicine 
National Dental PBRN 
Office after kits are mail to 
them from the Clinical 
Research Center at the 
Rutgers School of Dental 
Medicine 
National Dental PBRN Office after kits are mail to 
them from the Clinical Research Center at the 
Rutgers School of Dental Medicine 

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Transport 
Media 
Not applicable (POC 
Test) 
Buffer solution 
Sponge with capillary blood is transported with 
desiccant 
Packaging 
Specimen for 
Shipping 
Not applicable (POC 
Test) 
Sealed biohazard plastic 
bag placed into a 95 kPa 
bio-hazard bag  with 
absorbent which is placed 
into a UN3373 Category B 
certified box. 
Post sampling, the closed Mitra Cartridge is  
inserted into sealed specimen bag which contains a 
decedent that absorbs moisture, and inserted in a 
shipping UN3373 Category B certified box. 
Sample Processing (Performing the Test) 
Processing 
Supplies 
Included in point-of-care 
BD Veritor or Abbott 
COVID-19 antigen card 
RNA extraction, followed 
by RT-PCR 
96 well plate, ELISA reagents 
Processing 
Time 
15 minutes 
About four hours 
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 
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 transport media 
Yes due to desiccant 
Storage prior 
to 
processing 
Not applicable (POC 
Test) 
Oral Biology Laboratory 
and/or Genomics 
Laboratory 
PHRI Laboratory 
Stability 
prior to 
processing 
Stable at room 
temperature 
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 
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 
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) 
Completion of REDCap SARS-CoV-2 Test Order 
and Results Form (which enables the generation of 
a Specimen Tracking Log) 
Results 
Processing 
Time 
15 minutes 
Results are available 
within 1 week. 
Results are available within 1 week 
Recording 
Results in 
REDCap 
Via posting in REDCap by 
PBRN Practitioner or 
designated investigator  
Via secure e-mail and web 
site and then posted into 
REDCap by the Rutgers 
research staff  
 
Via secure e-mail and then posted into REDCap by 
the Rutgers research staff  
 
Notifying 
participants 
National Dental PBRN 
Practitioner or designated 
investigator 
PBRN Practitioner 
results- by the PI and/or 
Clinical Chief  
DHCW and Patient 
results- by the National 
Dental PBRN Practitioner 
or designee 
PBRN Practitioner results- by the PI and/or 
Clinical Chief  
DHCW and Patient results- by the National Dental 
PBRN Practitioner or designated investigator 
Reporting to 
State 
Department 
of Health 
PI, Chief Clinical Officer, 
PBRN Practitioner or 
designated investigator 
Genomics Laboratory 
Not Applicable 
 

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7.2.3 
Specimen Shipment 
Saliva for LAB, and nasal swab for the PCR Viral Test specimens are collected and immediately placed 
into a preservative.  The Mitra Cartridge includes a desiccant or sample preservation.  All can be stored at 
room temperature for at least one week. 
 
 
POC Test 
 
PCR Viral Test 
 
ELISA Antibody Test 
Shipment Method 
and Frequency 
Not applicable   
Samples will be obtained from 
subjects Monday and 
Wednesday and sent to the 
Rutgers School of Dental 
Medicine via UPS or Federal 
Express.   
Specimens will be mailed via UPS or 
Federal Express.   
 
 
Packaging Specimen 
for Shipping 
Not applicable (POC 
Test) 
Specimens are placed into 
biohazard plastic bag, sealed 
then placed into a 95 kPa bio-
hazard bag  with absorbent, 
sealed and then placed into a 
UN3373 Category B certified 
box. 
Post sampling, the closed Mitra Cartridge 
is  inserted into sealed specimen bag 
which contains a decedent that absorbs 
moisture then placed into a 95 kPa bio-
hazard bag with absorbent and inserted in 
a shipping UN3373 Category B certified 
box. 
Shipping Address 
Not applicable 
Rutgers University 
School of Dental Medicine 
110 Bergen Street 
Newark, NJ  07103 
Rutgers University 
School of Dental Medicine 
110 Bergen Street 
Newark, NJ  07103 
Contact Information 
for Laboratory 
Personnel 
Not applicable 
Dr. Daniel Fine 
Phone:  (973) 972-7056 
finedh@sdm.rutgers.edu 
Dr. Patricia Soteropoulos 
Phone: (973) 972- 3890 
soteropa@njms.rutgers.edu 
 
Dr. Maria Gennaro 
Phone:  (973) 854-=3210 
Marila.gennaro@rutgers.edu 
Days and Times 
shipments are 
allowed 
Not applicable 
Monday thru Friday 
9:00 am to 5:00 pm 
Monday thru Thursday 
9:00 am to 5:00 pm 
Labeling 
Requirements for 
Specimen Shipping 
Not applicable 
Subject Number, Subject 
Name, and Collection Tube 
ID/Bar Code 
Subject Number, Subject Name and Mitra 
Cartridge ID/Bar Code 
Special Instruction 
for Specimen 
Collection 
No special instructions 
Subject should not eat or drink 
for 30 minutes prior to saliva 
and tongue cell specimen 
collection 
Clean area for finger prick with alcohol 
gauze prior to pricking finger 
Special Instructions 
for Specimens for 
Shipment  (i.e., dry 
ice, wet ice) 
Not applicable 
No special instructions 
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) 
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 sIRB 
Additional 
Reports  
 
Unanticipated 
Problems 
Any problem or event which was:  
1. Unexpected (in nature, severity, or 
frequency)  
AND 
2. Is related or possibly related to 
participation in the research  
AND  
3. Reflects new increased risk to the 
subjects  
Unanticipated 
Problem Form 
 
 
 
 
 
 
 
 
National 
Dental PBRN 
Node 
Coordinator 
or Node 
Director 
If the UP is also 
an SAE, submit 
the UP form within 
5 working days to 
the CIRB directly  
 
If the UP is not an 
SAE, submit to 
CIRB and to 
NIDCR within 2 
weeks of 
becoming aware 
of the problem.  
 
 
 
 
 
 
 
NIDCR via 
Rho Product 
Safety 
(Simultaneously 
with IRB) 
Adverse Event 
When an investigator receives a report of an 
external adverse event, the investigator 
should review the report and assess 
whether it identifies the adverse event as 
being: 
1. unexpected; 
2. related or possibly related to 
participation in the research; and 
3. serious or otherwise one that 
suggests that the research places 
subjects or others at a greater risk of 
physical or psychological harm than 
was previously known or recognized.  
 
If the responses to the above are “yes” then 
it should be reported as an unanticipated 
problem (or an SAE, if the answer to 3. Is 
“yes.”)  
Adverse Events 
Form 
National 
Dental PBRN 
Node 
Coordinator 
or Node 
Director 
Only required to 
submit to CIRB if 
UP or SAE.  
Not required 
unless UP or 
SAE. 
Serious Adverse 
Event 
Serious adverse event (includes serious 
adverse drug or biological experience and 
unanticipated adverse device experiences 
under FDA regulations) is any adverse event 
temporally associated with the subject's 
participation in research that meets any of 
the following criteria: 
• Results in death 
• Is life-threatening (places the subject at 
immediate risk of death from the event 
as it occurred) 
• Requires inpatient hospitalization or 
prolongation of existing hospitalization 
• Results in a persistent or significant 
disability/incapacity 
• Results in a congenital anomaly/birth 
defect 
• Any other adverse event that, based upon 
appropriate medical judgment, may 
jeopardize the subject's health and may 
require medical or surgical intervention 
Unanticipated 
Problem Form AND 
Serious Adverse 
Events Form 
National 
Dental PBRN 
Node 
Coordinator 
Submit SAE form 
within 24 hours if 
incident caused 
death or life 
threatening injury 
or within 72 hours 
for all other results 
to the NIDCR 
safety committee 
(rho_productsafet
y@rhoworld.com).  
NIDCR via 
Rho Product 
Safety 
(Simultaneously 
with IRB), 
Regional IRB 

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to prevent one of the other outcomes 
listed in this definition.  
Protocol 
Deviation/ 
Violation 
Deviations: Any change, divergence, or 
departure from the study procedures 
described in the IRB-approved clinical 
protocol 
 
Violation: Any deviation from the sIRB 
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 
National 
Dental PBRN 
Node 
Coordinator 
or Node 
Director 
10 business days 
from the date of 
discovery 
Other study 
Sites 
 
Monthly to 
NIDCR on the 
first of the 
month via 
NIDCR Reports 
@rhoworld.com 
 
Study procedures are limited to surveys and collection of biospecimens: saliva samples, capillary blood 
samples via finger prick, superficial tongue scraping, and nasal swab (not beyond the nares) samples.  
We therefore expect few, if any study related serious adverse events (SAEs).  In the rare event that a 
SAE 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 sIRB-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   
 
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 National Dental PBRN Practitioner or designated investigator will 
immediately notify the National Dental PBRN Node Coordinator who will then notify study PI. The 
National Dental PBRN Node Coordinator will record the event in the REDCap Unanticipated Problem 
form and Serious Adverse Event Form based upon information obtained.   
8.1.3 
Protocol Deviations/Violations 
As the purpose of this pilot is to determine if the study windows are appropriate, activities taking place 
outside of a specified window will not be considered a protocol deviation or violation.  In addition, any 
missed or incomplete surveys or forms will not be considered protocol deviation or violation as these are 
outcome measures for the pilot study. 
 

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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 sIRB: 
 
appropriate identifying information for the research protocol, such as the title, investigator’s name, 
and the sIRB 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 sIRB as soon as possible, and no 
later than within 5 business days of the investigator becoming aware of the event.  
 
Any other UP will be reported to the sIRB as soon as possible but within 10 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 sIRB’s receipt of the report of the problem from the investigator. 
 
All unanticipated problems will be reported to NIDCR concurrently with reporting to the sIRB. These 
reports will be made to NIDCR’s centralized reporting system via the Clinical Research Operations and 
Management Support (CROMS) contractor. 
● 
Product Safety Fax Line (US):  1-888-746-3293 
● 
Product Safety Fax Line (International):  919-287-3998 
● 
Product Safety Email:  rho_productsafety@rhoworld.com 
General questions about SAE reporting can be directed to the Rho Product Safety Help Line (available 
8:00AM – 5:00PM Eastern Time):   
● 
US:  1-888-746-7231 
● 
International: 919-595-6486   
 
 

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9 STUDY OVERSIGHT 
The PI 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 sIRB 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 PI and staff will closely monitor 
adherence to the study protocol and study processes throughout the study. They will ensure that quality 
management activities occur and will 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 
This is a feasibility study to assess feasibility to conduct study procedures and refine trial study logistics.  
No sample size calculations are being performed.   
11.1 
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 
 Patient willingness 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 
 Start‐of‐Visit Patient Survey 
 End‐of‐Visit Patient 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 
 LAB – saliva SARS‐CoV‐2 viral test 
 POC – BD Veritor COVID‐19 antigen test 
 PCR viral SARS‐CoV‐2 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  (Binary – Easy/Not Easy) 
o Easy to Store 
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 performed.   

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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.   
 
Patient consents will be captured and recorded directly into the REDCap system. 
 
All Patient and DHCW surveys will be recorded directly into REDCap via the following REDCap  
forms: 
 
 
DHCW Participants 
Patient Participants 
Start‐of‐Study DHCW Survey 
Triage Case Report 
Triage Survey Case Report 
Pre‐Visit Patient Survey
End‐of‐Study DHCW Survey 
End‐of‐Visit Patient Survey 
DHCW Feasibility Study Participation Questionnaire 
Patient Feasibility Study Participation Questionnaire 
Testing Case Report 
Testing Case Report 
 
 
Testing results will be captured in the REDCap Testing Case Report in the following ways: 
 
 
 
POC 
PCR 
 
ELISA 
Original Source 
Document 
N/A – Results appear on BD 
Veritor Screen or Abbott COVID‐
19 antigen test card and directly 
recorded into REDCap  
Excel Spreadsheet posted onto 
SDM PREDICT box drive 
Excel Spreadsheet posted onto SDM 
PREDICT box drive 
Storage of Original 
Source Document 
Not Applicable 
Electronically stored on Rutgers 
server 
Electronically stored on Rutgers 
server 
Responsibility for 
Entering into REDCap 
National Dental PBRN Practitioner 
or their investigator designee 
Rutgers PI, Clinical Protocol Chief 
or their designee 
Rutgers PI, Clinical Protocol Chief or 
their designee 
Verification of Correct 
Entry into REDCap 
Not Applicable 
PI or Chief of Clinical Protocol or 
their designee 
PI or Chief of Clinical Protocol or 
their designee 
 
 
At the end of the study, deidentified data will be provided to the National Coordinating Center. 
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 complete and accurate 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.  QM activities will include activities undertaken at defined intervals to ensure that all 
study personnel have undergone training prior to initiating the protocol, QM activities are occurring, 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 by the node coordinator on the NCC 
Hub.   
 
 
Training Modules 
Who Will be Trained 
Human Subjects, HIPAA 
 All Study Personnel 
General Clinical Research Training  
(Human Subjects, HIPAA) 
 PI, Chief of Clinical Protocol, PBRN practitioners and designated 
investigators 
General Overall  
(Study Purpose, Goals and Protocol) 
 All Study Personnel 
 
REDCap System Training 
 National Dental PBRN Practitioners and Designated Investigators 
Daily Operating Procedures 
The PI and the Chief of Clinical Protocol will follow the REDCap dashboard to ensure compliance with 
study procedures.  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 National Dental PBRN Practitioner and be used to identify any unanticipated problems 
and develop/implement any necessary corrective action plans. 
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 surveys 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 

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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 which will trigger 
an error message, but subjects can save their responses without all responses being completed. 
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 sIRB 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 sIRB 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 sIRB-
approved, and the participant is required to read and review the document or have the document read to 
him or her. The investigator or their investigator designee will explain the research study to the participant 
and answer any questions that may arise.  
All DHCWs and patient participants will review and electronically sign the informed consent document 
prior to any study-related assessments or procedures.  For LAB and POC patient subjects, an electronic 
consent and signature will be obtained before the Pre-Visit-Triage survey is completed.   
Participants will be given the opportunity to discuss the study with their surrogates or think about it 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 clinical or 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 monitors 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 study PI 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 
 
The PIs in collaboration with the NCC will review reports of data completeness and accuracy as well as 
protocol compliance on an ongoing basis throughout the study. 
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 
 
Patients will use their own computer of personal electronic device to sign the consent form and answer 
the pre-visit survey.  DHCW will use their own computer, electronic device, an office computer electronic 
device or the study provided electronic pads for consents.  All other forms and surveys to be completed 
DHCW or patient subjects by using study provided electronic pads.   
 
REDCap will be used to collect and maintain all study data.   
 
 
DHCW 
Method of Collection  
DHCW
Entered By 
Whom 
PATIENTS
Method of 
Collection 
PATIENTS
Entered by Whom 
Surveys 
Survey administered 
via REDCap with 
responses entered 
directly into REDCap 
By study 
participant on 
office iPad 
Survey administered 
via REDCap with 
responses entered 
directly into 
REDCap 
By study participant 
on computer or 
other electronic 
device at home 
Triage Survey 
Case Report 
Survey administered 
via REDCap form with 
responses entered 
directly into REDCap 
By PBRN 
Practitioner or 
Investigator 
designee 
REDCap form  
By PBRN 
Practitioner or 
Investigator 
designee 
POC Test Results 
Case Report 
Data from Veritor 
Reader or Abbott 
COVID-19 Ag Card 
By PBRN 
Practitioner or 
Investigator 
designee 
Data from Veritor 
Reader or Abbott 
COVID-19 Ag Card 
By PBRN 
Practitioner or 
Investigator 
designee 
PCR Test Results 
Case Report 
Data entered directly of 
e-mail of results into 
REDCap Form upon 
receipt of secure e-mail 
from lab 
Rutgers PI, Chief 
of Protocol or 
Designee 
Data entered 
directly into 
REDCap Form upon 
receipt of secure e-
mail from lab 
Rutgers PI, Chief of 
Protocol or 
Designee 
ELISA Antibody 
Test Results Case 
Report 
Data entered directly 
from e-mail of results 
into REDCap Form 
upon receipt of secure 
e-mail from lab 
Rutgers PI, Chief 
of Protocol or 
Designee 
Data entered 
directly into 
REDCap Form upon 
receipt of secure e-
mail from lab 
Rutgers PI, Chief of 
Protocol or 
Designee 
 

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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 (of unknown origin), temperature, pulse oximeter readings and biospecimens 
that will generate 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 
Quarterly 
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 
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 sIRB.  
Since the purpose of this feasibility study is for protocol refinement, any of the following will not be 
considered protocol violations unless the subject was put at additional risk as a result of the divergence 
from the protocol. 
 
Incomplete visits 
 
Activities occurring outside of the specified windows 
 
Missing surveys/forms or data 
Upon discovery of a protocol deviation, the Principal Investigator is responsible for reporting protocol 
deviations to the sIRB. 
 
A protocol violation is a deviation from the sIRB 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 sIRB review. If the deviation meets any of the following 
criteria, it is considered a protocol violation. 
 
All deviations and violations from the protocol will be recorded on the Protocol Deviation/Violation 
Reporting Form no later than 10 business days after study staff become aware of the deviation and 

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forwarded to the study PI for review and reported promptly to the sIRB.   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, chief 
pharmacology officer and chief statistician.  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. 
 
The National Dental PBRN Publications and Presentations Policy is publicly available at 
http://www.nationaldentalpbrn.org/publications/. 
 
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.   
 

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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.. 
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 A1:  Schedule of Events – Dental Health Care Workers Subjects 
?? 
 
 
Appendix B:  Schedule of Events – POC Patient Subjects 
?? 
 
 

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APPENDIX A1: 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 
PCR Viral Test 
 
X 
 
X 
ELISA Antibody Test 
 
X 
 
X 
 
 

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APPENDIX B: SCHEDULE OF EVENTS 
POC Patient Subject 
Procedures 
2 Weeks Prior to 
Visit (Day -14 +/- 
14 days) 
Day Prior to Visit 
Day -2 (+/- 2 days) 
Visit 
Day 1  
Obtain Informed Consent 
X 
 
 
POC Antigen Test 
 
 
X 
Triage Survey 
 
X 
X 
Start-of-Visit Survey 
X 
 
 
End-of Visit Survey 
 
 
X 
Patient Participation Questionnaire 
 
 
X 
Provision of Dental Care (Not part of study) 
 
 
X