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

Pro2
Tool Revision History:
Version
Number
Date
Summary of Revisions Made:
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Pragmatic Return to Effective Dental Infection Control- LAB Patient Subjects
Protocol X01 DE030407-01
Version 1.0
12/9/2020
Pragmatic Return to Effective Dental Infection
Control through Triage and Testing
(PREDICT)
Rutgers Single Site
Laboratory Based Testing (LAB) Patient Subjects
NIDCR Protocol Number: TBD
NIDCR Grant Number: X01 DE030407 – 01
Principal Investigator: Cecile A. Feldman, DMD, MBA
Grantee Institution: Rutgers University, School of Dental Medicine
NIDCR Program Official: Dena Fischer, DDS, MSD, MS
NIDCR Medical Monitor: N/A
Draft or Version Number: Vr. 1.0
December 9, 2020
________________________________________________________________________________________________________
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STATEMENT OF COMPLIANCE
The study will be conducted in accordance with the International Council for Harmonisation guidelines for
Good Clinical Practice (GCP) (ICH E6) and the Code of Federal Regulations on the Protection of Human
Subjects (45 CFR Part 46). National Institutes of Health (NIH)-funded investigators and clinical trial site
staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have
completed Human Subjects Protection and ICH GCP Training.
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SIGNATURE PAGE
The 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
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TABLE OF CONTENTS
TABLE OF CONTENTS
PAGE
STATEMENT OF COMPLIANCE.................................................................................................1
SIGNATURE PAGE .......................................................................................................................2
TABLE OF CONTENTS.................................................................................................................3
LIST OF ABBREVIATIONS..........................................................................................................5
PROTOCOL SUMMARY...............................................................................................................7
1       KEY ROLES AND CONTACT INFORMATION................................................................9
2       INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE11
2.1       Background Information...........................................................................................11
2.2       Rationale ...................................................................................................................12
2.3       Potential Risks and Benefits .....................................................................................12
2.3.1    Potential Risks ..............................................................................................12
2.3.2    Potential Benefits..........................................................................................13
3       OBJECTIVES AND OUTCOME MEASURES ..................................................................14
3.1       Primary......................................................................................................................15
3.2       Secondary..................................................................................................................15
4       STUDY DESIGN..................................................................................................................16
5       STUDY POPULATION.......................................................................................................18
5.1       Participant Inclusion Criteria....................................................................................18
5.2       Participant Exclusion Criteria...................................................................................18
5.3       Strategies for Recruitment and Retention.................................................................18
5.4       Participant Withdrawal or Discontinuation from Study Procedures/ Intervention...19
5.4.1    Reasons for Participant Withdrawal or Discontinuation from Study
Procedures/Intervention................................................................................19
5.4.2    Handling of Participant Withdrawals from Study or Participant
Discontinuation of Study Intervention..........................................................19
5.5       Premature Termination or Suspension of Study.......................................................19
6       STUDY SCHEDULE ...........................................................................................................20
6.1
Patient Subjects........................................................................................................20
6.2       Withdrawal Visit.......................................................................................................20
6.3       Unscheduled Visit.....................................................................................................20
7       STUDY PROCEDURES/EVALUATIONS.........................................................................21
7.1       Study Procedures/Evaluations ..................................................................................21
7.2
Laboratory Procedures/ Evaluations………………………………………......22
7.2.1
Clinical Laboratory Evaluations………...……………………………...22
7.2.2     Specimen Preparation, Handling, and Storage……...………………22
7.2.3      Specimen Shipment………………………………………...………….23
8       ASSESSMENT OF SAFETY...............................................................................................24
8.1       Specification of Safety Parameters...........................................................................24
8.1.1    Unanticipated Problems................................................................................24
8.1.2    Serious Adverse Events ................................................................................24
8.2       Reporting Procedures................................................................................................25
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8.2.1    Unanticipated Problem Reporting.................................................................25
9       STUDY OVERSIGHT..........................................................................................................26
10     CLINICAL SITE MONITORING........................................................................................27
11     STATISTICAL CONSIDERATIONS..................................................................................28
11.1     Study Hypotheses......................................................................................................28
11.2     Sample Size Considerations......................................................................................28
11.3     Final Analysis Plan ...................................................................................................28
12     SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS..............30
13     QUALITY CONTROL AND QUALITY ASSURANCE....................................................31
14     ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................32
14.1     Ethical Standard........................................................................................................32
14.2     Institutional Review Board .......................................................................................32
14.3     Informed Consent Process ........................................................................................32
14.4     Exclusion of Women, Minorities, and Children (Special Populations)....................32
14.5     Subject Confidentiality .............................................................................................32
14.6     Future Use of Stored Specimens and Other Identifiable Data..................................33
15     DATA HANDLING AND RECORD KEEPING ................................................................34
15.1     Data Management Responsibilities...........................................................................34
15.2     Data Capture Methods ..............................................................................................34
15.3
Types of Data…………………………………………………………………….34
15.4     Schedule and Content of Reports..............................................................................34
15.5     Study Records Retention...........................................................................................34
15.6     Protocol Deviations...................................................................................................35
16     PUBLICATION/DATA SHARING.....................................................................................36
17     LITERATURE REFERENCES............................................................................................37
SUPPLEMENTAL MATERIALS ................................................................................................39
APPENDICES ...............................................................................................................................40
APPENDIX A: SCHEDULE OF EVENTS ..................................................................................41
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LIST OF ABBREVIATIONS
AE
PBRN
CFR
CSI
CIOMS
CONSORT
CRF
CRO
DCC
DHCW
DHHS
DMFS
DSMB
eCRF
FDA
FFR
FWA
GCP
HIPAA
ICF
ICH
ICMJE
IRB
ISM
LAB
MOP
N
NIDCR
NIH
OCTOM
OHRP
PHI
PI
Adverse Event/Adverse Experience
Practice Based Research Network
Code of Federal Regulations
Clinical Site Investigator
Council for International Organizations of Medical Sciences
Consolidated Standards of Reporting Trials
Case Report Form
Contract Research Organization
Data Coordinating Center
Dental Health Care Workers
Department of Health and Human Services
Decayed, missing, and filled tooth surfaces
Data and Safety Monitoring Board
Electronic Case Report Form
Food and Drug Administration
Federal Financial Report
Federalwide Assurance
Good Clinical Practice
Health Insurance Portability and Accountability Act
Informed Consent Form
International Council for Harmonisation
International Committee of Medical Journal Editors
Institutional Review Board
Independent Safety Monitor
Laboratory Based Saliva-Based COVID-19 Test
Manual of Procedures
Number (typically refers to participants)
National Institute of Dental and Craniofacial Research, NIH, DHHS
National Institutes of Health
Office of Clinical Trials Operations and Management, NIDCR, NIH
Office for Human Research Protections
Protected Health Information
Principal Investigator
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PO
POC
PREDICT
PS
QA
QC
QoL
SAE
SOP
UP
US
WHO
Program Official, NIDCR, NIH
Point-of-Care Veritor COVID-19 Test
Pragmatic Return to Effective Dental Infection Control through Triage and
Testing
Project Scientist, NIDCR, NIH
Quality Assurance
Quality Control
Quality of Life
Serious Adverse Event/Serious Adverse Experience
Standard Operating Procedure
Unanticipated Problem
United States
World Health Organization
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PROTOCOL SUMMARY
Title:
Précis:
Objectives:
Population:
Number of Sites:
Description of
Intervention:
Study Duration:
Subject Participation
Duration:
Estimated Time to
Complete Enrollment:
Pragmatic Return to Effective Dental Infection Control through Triage and
Testing
We will conduct a feasibility study to develop and test out procedures for
improved triage and COVID-19 testing of patients in dental practices to
improve patient safety. This is one of several feasibility studies to be
conducted in Rutgers dental clinics and in dental offices which participate in
the National Dental Practice Based Research Network (PBRN). These
studies will assess the feasibility of implementing COVID-related
procedures in the dental setting and may provide preliminary data to inform
a larger network-wide study grant application.
Primary: The primary objective of this study is to determine patient
willingness to participate in a study and to test survey instruments and
logistics developed for a NIH clinical study evaluating the impact of COVID-
19 testing and enhanced triage in dental offices.
This study will take place at Rutgers University School of Dental Medicine.
Up to twenty (20) patients will be recruited in the Rutgers School of Dental
Medicine’s dental clinics. Only adults who are patients who are scheduled
for dental appointments will be recruited.
One (1)
Lab-processed saliva tests (Viral PCR SARS-CoV-2 tests) will be
administered to patients coming to the school for care. In addition, the use
of pulse oximeters will be added to the patient COVID-19 symptom triage
protocol.
Twelve (12) months
Two (2) weeks.
Six (6) months
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Schematic Study Design for Patient Subjects:
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1 KEY ROLES AND CONTACT INFORMATION
Principal Investigator:
NIDCR Program Officer:
Grants Management Specialist:
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
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
Mr. Gabe Hidalgo
National Institute of Dental & Craniofacial Research
6701 Democracy Boulevard, MSC 4878
Bethesda, MD 20892-4878
Phone: (301) 827-4630
gabriel.hidalgo@nih.gov
Other Key Personnel:
Chief Oral Biology (and Co-PI):
Daniel Fine, DMD
Rutgers University, School of Dental Medicine
110 Bergen Street
Newark, NJ 07103
Phone: (973) 972-7056
finedh@sdm.rutgers.edu
Chief Clinical Protocol and Co-Investigator:
Janine Fredericks-Younger, DMD
Rutgers University, School of Dental Medicine
110 Bergen Street, Room D813
Newark, NJ 07101
Phone: (973) 972-1679
Fax: (973) 972-5040
frederja@sdm.rutgers.edu
Chief Epidemiologist and Co-Investigator:
Modupe Coker
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815
Newark, NJ 07101
Phone: (973) 762-4430
Fax: (908) 477-0056
mc2190@sdm.rutgers.edu
Clinic Director and Co-Investigator:
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Gayathri Subramanian
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815
Newark, NJ 07101
Phone: (973) 762-4430
Fax: (908) 477-0056
subramga@sdm.rutgers.edu
Clinic Assistant Director and Co-Investigator:
Somaya Ananthan
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815
Newark, NJ 07101
Phone: (973) 762-4430
Fax: (908) 477-0056
ananths1@sdm.rutgers.edu
Co-Investigator:
Maria Gennaro
Rutgers University, New Jersey Medical School
NJMS-PHRI Center
225 
Warren 
Street
Newark, 
NJ 
07101
Phone: (973) 854-3210
marila.gennaro@rutgers.edu
Clinic Assistant Director and Co-Investigator:
Raphael Figueroa
Rutgers University, School of Dental Medicine
110 Bergen Street, Room B815
Newark, NJ 07101
Phone: (973) 762-4430
Fax: (908) 477-0056
figuerr4@sdm.rutgers.edu
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2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
2.1
Background Information
Description of Problem:
The COVID-19 pandemic: COVID-19 has created serious concerns about the safety of patients and
dental professionals as they return to a practice environment. The spread of this ubiquitous virus was first
thought to be through droplets but soon it became clear that the virus could be spread by aerosols [5,6].
Many dental procedures require the mechanical preparation of hard and soft tissue using high speed
handpieces which are water cooled and generate significant aerosolized sprays. The extent to which
dentally-generated aerosols linger within operatories has not been clearly tested but it is certain that both
dentists, dental assistants and hygienists will be exposed to significant aerosol sprays derived from patients’
oral cavities [7]. As we learn more about COVID-19 and viral transmission we understand that infection and
spread of the virus is due to the viral load (or dose) and the time of contact [8,9].
Uniqueness of Dental Practice: Unlike many procedures in medicine, dental/patient contact is eye
to eye and the close proximity between patient and dental professionals is unavoidable [10]. Furthermore,
a dental procedure can often take as long as 1 hour and prolonged close contact between dentist and
patient is inevitable. Despite personal protective equipment (PPE) that includes N95 masks, face shields,
gowns, and high-speed suction, viral spread from infected patients is unavoidable. This suggests that the
only safe solution for maintaining the health and well-being of dental professionals in the time of COVID-19
is removing virus infected patients from their offices [11].
Waiting Rooms and Airflow: Obvious issues confronting dental practices have been discussed,
however, waiting rooms with patients, bathrooms and passageways are all additional areas within offices
that can be of concern. Further, the airflow in confined office spaces where patients can be waiting for 30
minutes or more can be hazardous if an asymptomatic but 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 excluding anyone who harbors the COVID-19 virus. This of course would necessitate
testing every patient at every visit or by establishing the fact that patients are safe if they have neutralizing
antibody to the COVID-19 virus. These solutions, at this moment, appear to be impractical particularly if the
virus affects a very small percentage of the population and testing is inaccurate. A solution to this problem
is imperative both for the safety and security both the patient and dental professional. But what’s to be done?
How do we achieve our goal of providing a safe and secure environment that allows for routine dental care?
Several challenges exist to routine and comprehensive testing: the costs, turnaround time (maximum
practical utility is perhaps derived from a simple, rapid, accurate, inexpensive point-of-care test that is not
technically demanding, such a test has not yet been validated). This proposal compares the use of one
such candidate POC test with the current screening gold-standard.
Conclusions: Every day that goes by, patients are not receiving dental services because of a 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, making
both dental health care providers and patients comfortable with seeking/providing essential dental services.
This proposal is designed to develop procedures that address this serious problem and test the feasibility
of these procedures in a pragmatic manner to address this existing insurmountable problem that can affect
the future of dental practice and the dental health we have come to expect.
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2.2
Rationale
Typical dental protocols recommend twice yearly visits to dentists for prevention and maintenance of oral
health [12,13]. Dental patients who may be asymptomatic for medical problems are seen routinely in dental
offices and can be screened for the early phases of medical disease during routine dental visits. For
example, blood pressure monitoring and simple blood test for glycosylated hemoglobin (HbA1c) levels can
be performed in dental offices for referral to physicians for further assessment [18,19]. This ready access to
vulnerable patients can be considered as value-added should dental health professionals provide
augmented diagnostic benefit to patients who are unaware of their need for medical intervention. However, in
this time of uncertainty dentistry has been impacted by fear and poorly defined strategies to mitigate
COVID-19, that can compromise the willingness of dental professionals to open their dental practices [20].
Little is Known Regarding the Effectiveness COVID-19 Triage in Dental Practice: Little is known
about the effectiveness of triage protocols which have been recommended by the CDC. For example, most
offices are using temporal thermometers yet many are uncalibrated. In addition, screening questions
continue to evolve and the veracity of patient responses remains unverified
Little is Known Regarding the Impact of COVID-19 Testing in Dental Practice: Little is known about
the value of testing and about the willingness of DHCW to implement COVID-19 testing in a dental office or
the most effective use of such testing.
Ultimately, we will perform three feasibility studies (Two patient and one DHCW study) which examine the
following questions:

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 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?
2.3
Rationale
2.3.1
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.
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. While a false negative result may give a participant
a false sense of security, this would not pose additional risks to patients or the DHCWs in the dental
practice, as the patient would have been treated according to the office’s infection control protocol
regardless of participation in the study. On the other hand, a false positive result will prompt the patient to
undergo additional testing by their primary health care provider. Should they test positive again, they
would need to follow their local health department recommendations which may require quarantine.
There is a risk of loss of confidentiality for all study participants. Precautions will be in place to minimize
this risk, such as collecting only minimal identifying information, using unique study codes for participants,
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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.
2.3.2
Potential Benefits
There is no benefit to patients participating in this study beyond the fact that patients would receive the
results of the free COVID-19 tests they undergo.
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3 OBJECTIVES AND OUTCOME MEASURES
3.0
Rutgers Feasibility Study Outcomes
PILOT Objectives
To Determine Patient
Willingness to Participate
To Determine Patient
Willingness/Ability to Follow
Thru with Triage, Testing and
Survey Administration
Procedures
To Determine Ease of Use with
REDCap Survey Instruments
 Patient Subject
o Start-of-Visit Survey
o End-of-Visit Survey
o Triage Survey
Brief Description/Justification of
Outcome Measure
Willingness to participate is
important in determining whether
patients would be willing to
participate in a large-scale study
Determining willingness and ability to
follow thru with triage, testing and
survey administration procedures is
important for refining the survey
procedures
Determining the ease of use and
completeness of the REDCap
instruments enables refinement of
the system
Outcome Measured By
 Ratio of patients agreeing to participate
as compared to all patients asked to
participate
 Thoroughness of consent process and
ability to ask questions
 % who complete the study
 % who complete surveys
o Pre-Visit Patient Survey
o End-of-Visit Patient Survey
 % who feel testing (Saliva 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
 % who feel surveys are easy to complete
due to administration method:
o 
Pre-Visit Patient Survey
o 
End-of-Visit Patient Survey
o 
Triage Case Report
 % who feel survey questions were
understandable:
o 
Pre-Visit Patient Survey
o 
End-of-Visit Patient Survey
o 
Triage Case Report
 % completed surveys:
o 
Pre-Visit Patient Survey
o 
End-of-Visit Patient Survey
o 
Triage Case Report
Time Frame
Willingness to Participate:
     Patients – at time of consent
by patients
     Patients – at End-of-Study
% Complete Study:
     Patients – End-Of-Visit (Day 1)
% All Surveys Completed:
     Patients – End-Of-Visit (Day 1)
% Feel Testing Protocol was Easy
to Comply With:
     Patients – End-Of-Visit (Day 1)
% indicating surveys were easy to
complete due to administration
method:
     Patients – at end of patient
visit
% indicating survey questions
were easy to understand:
     Patients – End-Of-Visit (Day 1)
% Surveys Completed:
     Patients – End-Of-Visit (Day 1)
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3.1
 Primary Outcomes for Full Study (Data Collection is Being Performed to
Determine Instrument Feasibility)
Full Study Objective
Objective 1 – Dental health
care personnel and patients
feel safe in the dental office
Brief Description/Justification of
Outcome Measure
Patient Safety and Comfort Survey
asks patients their concerns about
seeing their dentist and their
perceptions about the value of
different safety precautions.
Willingness to Return for another
Visit reflects a patient’s comfort with
safety practices employed by their
dentist.
Willingness to Refer Other Patients
reflects a patient’s or DHCW’s safety
of the dental practice.
Outcome Measured By
Patients: Patient Safety and Comfort
Survey
4 Items asking about concern on a 4 point
Likert Scale – 1=not concerned at all, 2= mild
concern 3=moderate concern, 4= severe
concern
6 Items asking about safety on a 3 point
scale – Not at All, Not Sure, yes
5 Items asking about Importance of safety
practices on a 5 point Likert Scale –
1=extremely important, 2=important, 3 =
Not important or unimportant, 4 =
unimportant, 5 = very unimportant
How safe to do feel coming to work? 5 Point
Likert scale
Patients --Willingness to Return for another
Visit: How likely are you to return for
another visit within the next 12 months? 5
Point Likert Scale
Willingness to Refer Other Patients: How
likely would you refer a family or friend to
this dental office? 5 Point Likert Scale
Time Frame
Sense of Safety for Patients:
 Day prior to visit
 At end of visit
Willingness to Refer Other
Patients:
 LAB Patients - Day prior to visit
 All Patients - end of visit

3.2
 Secondary Outcomes for Full Study (Data Collection is Being Performed
to Determine Instrument Feasibility)
Objective
Objective 2: Determine the
Efficiency and Effectiveness
of:
     Efficiency of Patient
Triage Protocols
     Effectiveness of LAB
Brief Description/ Justification of
Outcome Measure
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.
Outcome Measured By
Efficiency of Triage Protocols:
 Time needed to complete triage survey
Effectiveness of Triage Protocols
 Comparison of number of patients not able
to have visit completed
 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
Effectiveness of Testing Protocols
 Number of patients not able to report for
their patient visits LAB offices
Time Frame
Efficiency of Triage Protocols:
 LAB Patients: Start of visit
Effectiveness of Triage Protocols
 Patients: End of visit
Efficiency of Testing Protocols:
 Patients: End-of-Visit
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4 STUDY DESIGN
Description: This study will assess the feasibility of implementing one COVID-related testing procedure
in the dental setting. Results from this study may provide preliminary data to inform a larger network-wide
study grant application.
Study Population: The study population for this study will be patients seen at the Rutgers School of
Dental Medicine.
Important Outcomes: For this study, important outcomes include percent of patients willing to
participate and percent completing the protocol.
Single or Multicenter: Single- this study will utilize the Rutgers School of Dental Medicine’s Newark
facility.
Number of Study Groups/Arms: One (1)
Expected Duration of Subject Participation: Subjects will be actively participating in the study for 2
weeks.
Sequence of Procedures and Duration of Study Period:
Consent Process
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. The consent will clearly outline participant expectations and offer the
opportunity for potential participants to contact the office for more information as needed. Participants
who fully understand the study and elect to participate will affirm their willingness to participate by clicking
the “I agree to take part in this study” button at the end of the consent form. Once in the office to provide
their saliva sample, patients will also be asked to provide signed informed consent.
Study Procedures
Study participants will be asked to do the following:

Two weeks before the dental visit
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 the dentist’s office

Day prior to the dental visit
o Undergo a COVID-19 triage screening over the phone*
 Screening includes 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
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
loss of smell

sore throat

congestion or runny nose

nausea or vomiting

diarrhea

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

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, dentists 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, 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

A positive temperature is considered greater than 100.4 degrees F

A positive pulse oximeter is considered when the blood oxygen saturation level is below 95%
The results of the lab processed COVID-19 test will be reported to the Clinic Director or one of the co-
investigators by the lab prior to the scheduled dental visit. Results will be recorded in the Testing Case
Report form in REDCap.

If POSITVE: The Clinic Director or one of the co-investigators will communicate positive results to
the participant upon receipt. Positive participants will be instructed to consult with their primary
care provider for further testing.

If NEGATIVE: The Clinic Director or one of the co-investigators will communicate negative results to
the participant by phone on the day prior to the dental visit after the COVID-19 triage screening is
performed.
Methods for Data Collection
REDCap will be used to collect and maintain all study data. For all surveys and case reports, the
Research Clinical Director or co-investigator will enter data directly into REDCap. Surveys will be entered
by the patient with the Clinical Director or co-investigator’s assistance.
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5 STUDY POPULATION
5.1
Participant Inclusion Criteria
A Patient must meet all of the following criteria to be eligible to participate in the study:

Be a patient being treated at the Rutgers School of Dental Medicine

Be 18 years or older

Be able to understand the informed consent.

Provide signed and dated informed consent form

Be able to understand all instructions for data collection instruments in English

Be willing and able to comply with all study procedures, including having a COVID-19 test
performed
5.2
Participant Exclusion Criteria
Participants would be excluded if they participated in the feasibility study previously or if they are unwilling
to have their de-identified data made available to other researchers.
5.3
Strategies for Recruitment and Retention
Target Sample Size: 20 patients.
Target Sample Size by Gender, Race, Ethnicity, and Age: Study population will be drawn from
patients at the Rutgers School of Dental Medicine. It is estimated that about ½ will be female, ½ male.
All will be English speaking. Age range will be between 18 and 100 years of age. Racial and ethnicity
background will be reflective of the respective populations at the Rutgers Schools of Dental Medicine with
about 52% being African American and 33% Hispanic.
Study Population: The patient study population will be drawn from outpatient dental clinics located at
Rutgers University School of Dental Medicine.
Inclusion of Women and Minorities and Individuals of All Ages:
Women: Women will be included in this study. Pregnant women are eligible to participate.
Minorities: Minorities will be included in this study.
Recruitment Strategies: Patients treated in the Rutgers School of Dental Medicine’s Oral Medicine
clinic will be recruited. If 20 patients cannot be recruited in the Oral Medicine clinic, recruitment will
expand to the school’s other clinics. It is not anticipated that there will be difficulties recruiting sufficient
patients.
Retention: In order to minimize loss of study participants and/or incomplete data collection, the following
activities will take place:

The Research Clinical Director will work with the co-investigators responsible for recruiting
subjects and completing surveys.

Participants will receive compensation.
Compensation and Scheduled Payments: Patients who complete the protocol, including the post-visit
survey will be provided $100.
Additional Plans to Minimize Loss of Follow-up and Missing Data: The following will minimize loss of
follow-up and/or missing data:

When appropriate, REDCap survey data fields are set to “required”.
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
REDCAP validation rules on data fields to limit responses to valid responses
5.4
 Participant Withdrawal or Discontinuation from Study
Procedures/Intervention
5.4.1
 Reasons for Participant Withdrawal or Discontinuation from Study
Procedures/Intervention
Participants are free to withdraw from participation in the study at any time upon request.
An investigator may discontinue an individual’s participation in an intervention or withdraw an individual
from the study if:

The participant has a serious adverse event requiring hospitalization.

Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation
occurs such that continued participation in the study would not be in the best interest of the
participant.

The participant meets an exclusion criterion (either newly developed or not previously
recognized) that precludes further study participation.
5.4.2
Handling of Participant Withdrawals from Study
Participants may withdraw participation consent at any time, either verbally or in writing. Participants who
further withdraw their consent for the use of data already collected must do so in writing. The Research
Clinical Director or co-investigators will interview the participant and document the withdrawal of consent
using the Consent Withdrawn Received Form in the REDCap system. Participants who withdraw will not
be replaced.
Documentation includes the date, the reason for participant withdrawal, as well as, the upload of any
written withdrawal request. Upon withdrawal, all study procedures would cease, however, the participant
would be offered continued care as part of the normal standard of care.
5.5
Premature Termination or Suspension of Study
This study may be suspended or prematurely terminated if there is sufficient reasonable cause. Written
notification, documenting the reason for study suspension or termination, will be provided by the
suspending or terminating party to Dr. Cecile Feldman and the funding agency (NIDCR). The principal
investigator will also promptly inform the IRB and NIDCR and will provide the reason(s) for the termination
or suspension.
Circumstances that may warrant termination include, but are not limited to:

Determination of unexpected, significant, or unacceptable risk to participants.

Insufficient adherence to protocol requirements.

Data that are not sufficiently complete and/or evaluable.

Determination of futility.
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6 STUDY SCHEDULE
6.1
Patient Subjects
The following is the schedule of events for patients participating in the study.
Visit
2 Weeks Prior
1 Week Prior
Day Prior
Visit
Day
Day -14
(+/- 7 days)
Day -7
(+/- 5 days)
Day -2
(+/- 3 days)
Day 1
LAB Subjects
Activities Performed
 Potential subjects contacted to introduce
and determine interest in the study
 Obtain electronic consent
 Complete Pre-Visit Patient Survey
 Obtain informed consent signatures
 Provide saliva specimen
 Perform Prior-Day Triage Survey
 Obtain test results and provide to patient
subject
 Complete Start-of-Visit Survey
 Complete Start-of-Visit Triage Case Report
 (Provision of Dental Treatment - not part
of research protocol)
 Complete End-of-Visit Survey
 Complete Patient Participation
Questionnaire
6.2
Withdrawal Visit
Not applicable. If a subject withdraws early, there is no withdrawal visit.
6.3
Unscheduled Visit
Not applicable.
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7 STUDY PROCEDURES/EVALUATIONS
As part of this study, COVID-19 triage case report will be completed, COVID-19 testing will be performed
and perception and attitude surveys will be administered. During day 1, the dental visit, normal patient
care will be provided to the patient subject.
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.
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. The follow-up call will be made 1 week after (and 2
weeks after if necessary,) learning of the research study protocol call viral or antigen positive test results
to record any confirmatory tests which were obtained based upon the advice of the worker’s physician.
The dental visit will be rescheduled once the subject has fully recovered. In the event of a dental
emergency, care will be rendered via tele dentistry or referral to University Hospital Unit 1 (Oral and
Maxillofacial Surgery/Dental Medicine Clinic) via University Hospital’s Emergency Room.
7.1
Study Procedures/Evaluations
The following study procedures will be completed:
Patient Subjects – LAB Protocol
Procedure and Evaluations
Purpose
Obtain Informed Consent
Complete informed
consent
Completed
as Part of
Study
Yes
When Performed
2 Weeks Prior (day-
14 +/-7 days)
How Completed
Electronic consent obtained prior to
initiating Pre-Visit Patient Survey
Triage Case Reports
Testing Case Reports
Start-of-Visit Patient Survey
 Safety and Comfort
 COVID-19 Testing Preferences
 Perception of Importance
 Medical history
 Likelihood to report COVID-19
symptoms
Dental Procedures Performed
End-of-Visit Patient Survey
 PPE observed in office
 Environmental controls observed
in office
Patient Participation Questionnaire
Collect COVID-19
screening data
Collect information
on outcomes of
COVID-19 testing
Collect outcome
measures
Maintain patient
oral health
Collect outcome
measures
Collect feasibility
information on
surveys and
logistics
1 Week Prior (day-7
+/-5 days)
Yes
Day Prior (day -2 +/-
2 days)
Visit (day 1)
Day Prior (day -2 +/-
2 days
Yes
Visit (day 1)
NO
Visit
Yes
Visit (day 1)
Yes
End of Study (Day
28)
Electronic signatures collected via
REDCap Informed Consent Form when
saliva specimen brought to office
Data entered into REDCap via eCRF by
Clinical Director, co-investigator or
study staff member who interviews
subject
Saliva Viral SARS-CoV-2 test results
entered into REDCap via eCRF by
Research Clinical Director, co-
investigator or study staff member
based on testing result report obtained
from secure e-mail.
Data entered via REDCap self-
administered survey.
Completed by Dental Health Care
Workers
Data entered via REDCap self-
administered survey.
Data entered via REDCap self-
administered survey.
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7.2
Laboratory Procedures/Evaluations
7.2.1
Clinical Laboratory Evaluations
Patient subjects will be tested for COVID-19 using a lab-processed saliva test.
Test Description
Company
Sample collected via
What is being Tested
Test Administration
(specimen collection)
Test Administration
(specimen processing)
Results
Patient
LAB Test
(PCR Viral Test)
Rutgers
Saliva collection tube with buffer
SARS-CoV-2 RNA
Saliva collection performed by subject with saliva collection tube provided by a Research Clinical Director
RT-PCR test performed at ICPH-PHRI center, New Jersey Medical School, Newark, NJ
Dichotomous (+ or -)
With regard to the quality of the COVID-19 test specimen, the following will be used to assess the quality
of the specimen.
Indication of Proper
Processing
LAB Test
Accurate Diagnostic Labs will report if a sample is not able to be processed. This feedback will be used to identify insufficient
training or unanticipated problems.
Compliance with study protocols will be based upon the PI and the Chief of Clinical Protocol following the
REDCap dashboard. The dashboard exhibits red indicators for instruments which have been started and
not completed, yellow indicators for instruments which have been completed and not verified and green
indicators for instruments which have been completed and reviewed. The PI or Chief of Clinical Protocol
will be responsible for reviewing each instrument and changing the status from unverified to verified. Any
issues with compliance with the study protocol identified by the PI or Chief of Clinical Protocol will be
reviewed with the Research Clinical Director and be used to identify any unanticipated problems and
develop/implement any necessary corrective action plans.
7.2.2
Specimen Preparation, Handling, and Storage
The following details specimen preparation, handling and storage.
Sample Collection & Shipping
Sample Collection Materials
Storage of Specimen Collection Supplies and POC
Test Kits
Transport Media
Packaging Specimen for Shipping
Sample Processing (Performing the Test)
Processing Supplies
Processing Time
Conditions for Stability and Transport
Condition
Stability prior to Use
Stability during shipping
Storage prior to processing
Stability prior to processing
Tracking
Labeling
LAB Test
Spectrum Saliva collection system via Accurate Diagnostics
Clinical Research Center (D level of Dental School) and dental clinic dispensaries in the dental school
Buffer solution
Sealed biohazard plastic bag
RNA extraction, followed by RT-PCR
About four hours
No special storage conditions required
Yes due to transport media
PHRI Laboratory
Stable at room temperature
Specimen ID (bar code)
Subject ID (bar code)
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Tracking of Specimen Collection Kits
Tracking of Tests Administered
Reporting of Results
Time from specimen collection to reporting of
results
Results Reporting
Subject Name
Date of Specimen
REDCap System and/or Excel Worksheet
Completion of REDCap COVID-19 Test Order and Results Form (which enables the generation of a
Specimen Tracking Log)
Results are normally available within 1 week
Via secure e-mail and then posted into REDCap via Research Clinical Director
7.2.3
Specimen Shipment
Saliva and immediately placed into a preservative and the tube with the sample then placed into a
biohazard bag.
Shipment Method and Frequency
Packaging Specimen for Shipping
Shipping Address
Contact Information for Laboratory Personnel
Days and Times shipments are allowed
Labeling Requirements for Specimen Shipping
Special Instruction for Specimen Collection
Special Instructions for Specimens for Shipment
(i.e. dry ice, wet ice)
Completion of Specimen-Tracking Log
LAB Test
Samples will be obtained from subjects Monday thru Thursdays. Saliva samples will be placed into the
pick-box located on the B level of the MSB building. )
Sealed plastic biohazard bag
Accurate Diagnostic Labs
3000 Hadley Road
South Plainfield, NJ 07080
Accurate Diagnostic Labs
Phone: (732) 839-3300
Monday thru Friday
9:00 am to 5:00 pm
Subject Number, Subject Name, Birth Date and Collection Tube ID/Bar Code
Subject should not eat or drink for 30 minutes prior to saliva specimen collection
No special instructions
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
Unanticipated
Problems
Protocol
Deviations
Protocol
Violation
Definition
Any problem or event which in the
opinion of the local investigator was
unanticipated, reflects new or increased
risk to the subjects and was possibly
related to the research procedures.
This includes any serious adverse event
that is defined as an event which
requires hospitalization and/or causes
mortality
Any change, divergence, or departure
from the study design or procedures of
a research protocol that is under the
investigator's control and that has not
been approved by the IRB.
Any deviation from the IRB approved
protocol that may affect the subject's
rights, safety, or well-being and/or the
completeness, accuracy and reliability
of the study data
Form
Unanticipated
Problem Form
Protocol
Deviation/
Violation Form
Protocol
Deviation/
Violation Form
Who completes
REDCap form
Site Director or
Clinical Research
Clinical Director
Site Director or
Clinical Research
Clinical Director
Site Director or
Clinical Research
Clinical Director
Time Frame
For Reporting
to IRB
5 business days
from the date of
discovery
24 hours for
hospitalization
24 hours for
fatalities
5 business days
from the date of
discovery
5 business days
from the date of
discovery
Additional
Reports to
Rutgers IRB
Rutgers IRB
Rutgers IRB
Study procedures are limited to surveys and collecting capillary blood samples via finger prick. We
therefore expect few, if any study related serious adverse events. In the rare event that a serious
adverse event were to occur, an Unanticipated Problem form would be completed and SAE reporting
timelines would be followed.
8.1.1
Unanticipated Problems
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to
subjects or others to include, in general, any incident, experience, or outcome that meets all of the
following criteria:

unexpected in terms of nature, severity, or frequency given (a) the research procedures that are
described in the protocol-related documents, such as the IRB-approved research protocol and
informed consent document; and (b) the characteristics of the subject population being studied;

related or possibly related to participation in the research (“possibly related” means there is a
reasonable possibility that the incident, experience, or outcome may have been caused by the
procedures involved in the research); and

suggests that the research places subjects or others at a greater risk of harm (including physical,
psychological, economic, or social harm) than was previously known or recognized.
8.1.2
Serious Adverse Events
A serious adverse event (SAE) is one that meets one or more of the following criteria:

Results in death

Is life-threatening (places the subject at immediate risk of death from the event as it occurred)

Results in inpatient hospitalization or prolongation of existing hospitalization

Results in a persistent or significant disability or incapacity

Results in a congenital anomaly or birth defect
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
An important medical event that may not result in death, be life threatening, or require
hospitalization may be considered an SAE when, based upon appropriate medical judgment, the
event may jeopardize the subject and may require medical or surgical intervention to prevent one
of the outcomes listed in this definition.
If a SAE becomes known, the Research Clinical Director will immediately notify the study PI. The
Research Clinical Director will record the event in the REDCap Unanticipated Problem Form based upon
information obtained.
8.2
Reporting Procedures
8.2.1
Unanticipated Problem Reporting
Incidents or events that meet the Office of Human Research Protection (OHRP) criteria for UPs require
the creation and completion of a UP report form.
OHRP recommends that investigators include the following information when reporting an adverse event,
or any other incident, experience, or outcome as an unanticipated problem to the IRB:

appropriate identifying information for the research protocol, such as the title, investigator’s name,
and the IRB project number;

a detailed description of the adverse event, incident, experience, or outcome;

an explanation of the basis for determining that the adverse event, incident, experience, or
outcome represents an unanticipated problem;

a description of any changes to the protocol or other corrective actions that have been taken or
are proposed in response to the unanticipated problem.
To satisfy the requirement for prompt reporting, UPs will be reported that are not SAEs will be reported
using the following timeline:

Unanticipated problems that are SAEs will be reported to the IRB as soon as possible, and no
later than within 24 hours of the investigator becoming aware of the event.

Any other UP will be reported to the IRB within 5 business days of the investigator becoming
aware of the problem.

All UPs should be reported to appropriate institutional officials (as required by an institution’s
written reporting procedures), the supporting agency head (or designee), and OHRP within one
month of the IRB’s receipt of the report of the problem from the investigator.
All unanticipated problems will be reported to NIDCR concurrently with reporting to the IRB. These reports
will be made to NIDCR’s centralized reporting system via the Clinical Research Operations and
Management Support (CROMS) contractor.
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9 STUDY OVERSIGHT
The investigator will be responsible for study oversight, including monitoring safety, ensuring that the study
is conducted according to the protocol and ensuring data integrity. The PI will review the data for safety
concerns and data trends at regular intervals, and will promptly submit reportable events to the IRB and
NIDCR that arise during the conduct of the study.
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10 CLINICAL SITE MONITORING
No outside clinical site monitoring will be employed for this study. The Principal Investigator(s) and staff
will closely monitor the subjects as they progress through the study. They will monitor and evaluate study
processes and documentation based on the International Council for Harmonisation (ICH), E6: Good
Clinical Practice guidelines (GCP), and internal quality management plans. The NIDCR reserves the right
to conduct independent clinical site monitoring as necessary.
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11 STATISTICAL CONSIDERATIONS
11.1
Study Hypotheses.
For this study, we hypothesize:

Patients in offices with PBRN dentists and hygienists will be willing to participate

Surveys will be easy to complete

Testing protocols will be easy to complete
Analyses will be performed to test these hypotheses.
11.2
Sample Size Considerations
This is a feasibility study to refine trial logistics. No sample size calculations are being performed.
11.3
Final Analysis Plan
Data to be collected includes:
Item
Willingness to Participate
 Patient willingness to participate
Triage Survey
Safety Perception Survey
 Start-of-Visit Patient Survey
 End-of-Visit Patient Survey
Testing Logistics
 LAB – saliva SARS-CoV-2 viral test
Type of Variable
 Willingness to participate (Binary – Yes/No)
 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
 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
 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
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 Timeliness of results (3 point Likert Scale)
o Very timeless access to results
o Timely access to results
o Access to results not timely
 Reporting of results (3 point Likert Scale)
o Very easy to access results
o Easy to access results
o Not easy to access results
Testing Case Report
 Completeness (Binary – Yes/No)
Descriptive statistics (frequencies) for all variables will be analyzed.
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12 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
All study survey information will be captured electronically and stored on secure, encrypted Rutgers
University servers.

Patient consents will be captured and recorded directly into the REDCap system.

All Patient surveys will be recorded directly into REDCap via the following REDCap forms:
Patient Participants
Triage Case Report
Pre-Visit Patient Survey
End-of-Visit Patient Survey
Patient Participation Questionnaire
Testing Case Report

Testing results will be captured in the REDCap Testing Case Report in the following ways:
Original Source
Document
Storage of Original
Source Document
Responsibility for
Entering into REDCap
Verification of Correct
Entry into REDCap
LAB
Secure e-mail
Electronically stored on
Rutgers server
Research Clinical
Director or Co-
Investigator
PI or Chief of Clinical
Protocol
All paper based study source documents will be maintained in the Rutgers School of Dental Medicine
Clinical Research Center which is located on the D Level of the Dental School Building. All documents
will be secured in a locked file cabinet in the center. Access to the Clinical Research Center is limited to
research center personnel via a card reader.
Study staff will maintain appropriate medical and research records for this study, in compliance with ICH
E6, Section 4.9 and regulatory and institutional requirements for the protection of confidentiality of
participants. Study staff will permit authorized representatives of NIDCR and regulatory agencies to
examine (and when required by applicable law, to copy) research records for the purposes of quality
assurance reviews, audits, and evaluation of the study safety, progress, and data validity.
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13 QUALITY CONTROL AND QUALITY ASSURANCE
Quality Management (QM) measures will occur throughout this study to ensure adherence to protocol and
collection of high quality data. QM activities include those measures done as part of daily standard
operating procedures by staff at each site and by the data management controls built into the PREDICT
REDCap to ensure adherence to the protocol and collection of complete and accurate data. QM activities
will include activities undertaken at defined intervals to check that QM activities are taking place and
study-related documents are up-to-date.
Staff Training
Training of all staff will be conducted and recorded in training logs. Each staff member has been
identified by role. Records of completed training will be maintained in each study member’s study
personnel file kept on the SDM PREDICT box drive, Personnel Qualifications folder.
Training Modules
Human Subjects, HIPAA
General Clinical Research Training
(Human Subjects, HIPAA)
General Overall
(Study Purpose, Goals and Protocol)
REDCap System Training
Who Will be Trained
 All Study Personnel
 PI, Chief of Clinical Protocol
 All Study Personnel
 Research Clinical Directors and Research Assistants
Daily Operating Procedures
Quality management measures have been built into Clinical Protocol Core and site procedures.
Subject Completion Review
As this is a feasibility study, reviews of surveys and case reports to ensure completeness will not be
completed, rather the number/percentage of incomplete survey’s and forms will be analyzed as an
outcome measure. Consent forms will be reviewed for completeness as part of the end-of-visit survey for
patient subjects.
Data Management Controls
REDCap is a rich system which enables privileging, required data element entry and required data
validation to be embedded into daily operations.

Privileging: Every study staff member will be assigned a role which carries specific
read/write/edit/delete privileges. Staff member will be assigned a role providing minimal rights
sufficient to perform his/her responsibilities.

Structured Data: Whenever possible, data will be collected via structured data responses rather
than free-text. Structured data requires a respondent to check a valid response.

Data Validation: Data fields will be established limiting responses to those that are reasonable.
For example, year of birth would have a range of 2002 (corresponding to age 18 – the youngest
eligible) to 1920 (corresponding to age 100 – more than sufficient to cover the age range of
individuals having impacted 3rd molars extracted.)

Required Fields: Whenever appropriate, fields have been made required so as to ensure
completed forms and questionnaires.
Structured responses are required for the CRFs so only valid responses can be recorded. In addition,
REDCap has been programmed with all responses being required at time of completion. Validation rules
are employed where possible.
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14 ETHICS/PROTECTION OF HUMAN SUBJECTS
14.1
Ethical Standard
The investigator will ensure that this study is conducted in full conformity with the principles set forth in
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,
as drafted by the US National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6.
14.2
Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all participant materials will be
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must
be obtained before any participant is enrolled. Any amendment to the protocol will require review and
approval by the IRB before the changes are implemented in the study.
14.3
Informed Consent Process
Informed consent is a process that is initiated prior to the individual agreeing to participate in the study
and continues throughout study participation. Extensive discussion of risks and possible benefits of study
participation will be provided to participants and their families, if applicable. A consent form describing in
detail the study procedures and risks will be given to the participant. Consent forms will be IRB-approved,
and the participant is required to read and review the document or have the document read to him or her.
The investigator or designee will explain the research study to the participant and answer any questions
that may arise.
For patient subjects, an electronic consent will be obtained before the Pre-Visit-Triage survey is
completed. Prior to any other research activity, written consent will be obtained upon arrival at the clinic
prior to any other study-related assessments or procedures.
Potential participants will be given the opportunity to 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 monitor or other authorized representatives of NIDCR may inspect all study documents and
records required to be maintained by the investigator, including but not limited to, medical records (office,
clinic, or hospital) for the study participants. The clinical study site will permit access to such records.
Certificate of Confidentiality
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical,
or other human subjects research funded wholly or in part by the federal government. Recipients of NIH
funding for human subjects research are required to protect identifiable research information from forced
disclosure per the terms of the NIH Policy (https://humansubjects.nih.gov/coc/index - Certificates of
Confidentiality (CoC) – Human Subjects). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter
8.3, recipients conducting NIH-supported research covered by this Policy are required to establish and
maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that
the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of
award. It is the NIH policy that investigators and others who have access to research records will not
disclose identifying information except when the participant consents or in certain instances when federal,
state, or local law or regulation requires disclosure. NIH expects investigators to inform research
participants of the protections and the limits to protections provided by a Certificate issued by this Policy.
NIH Data Sharing Policies
As described in section 17, it is NIH policy that the results and accomplishments of the activities that it
funds should be made available to the public (see https://grants.nih.gov/policy/shring.htm - NIH Sharing
Policies and Related Guidance on NIH-Funded Research Resources). PIs and funding recipient
institutions will ensure that all mechanisms used to share data include proper plans and safeguards to
protect the rights and privacy of individuals who participate in NIH-sponsored research.
14.6
Future Use of Stored Specimens and Other Identifiable Data
No residual specimens will be maintained after this project is completed. All Identifiable data will be
destroyed 7 years after the study is completed.
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15 DATA HANDLING AND RECORD KEEPING
The Research Clinical Director and co-investigators are responsible for ensuring the accuracy,
completeness, legibility, and timeliness of the data reported. All source documents should be completed
in a neat, legible manner to ensure accurate interpretation of data. The investigators will maintain
adequate case histories of study participants, including accurate case report forms (CRFs), and source
documentation.
15.1
Data Management Responsibilities
Data collection and accurate documentation are the responsibility of Research Clinical Director and co-
investigators.
15.2
Data Capture Methods
Other than the Testing Case Report, all data for the study be electronically captured. Various devices will
be used including:

Laptop and desktop computers to complete surveys and forms directly into REDCap, the
electronic data capture system for the study

iPads to complete surveys, forms and capture electronic signatures directly into REDCap

Bar code scanner to label study specimens
All study data will be centrally stored on the Rutgers REDCap data management system, and study-
related documentation will be maintained on RSDM PREDICT Box drive. REDCap is a secure web
application which is password protected and compliant with 21 CFR Part 11. Study data and
documentation will be available to the study PI and core personnel in real time, per allowable
permissions.
15.3
Types of Data
Types of data to be collected include patient perceptions and attitudes, medical history, COVID-19 like
symptoms, temperature, pulse oximeter readings and COVID-19 test results.
15.4
Schedule and Content of Reports
The following reports/dashboards will be developed:
Report/
Dashboard
Unanticipated
Problem
(including
Serious
Adverse events
and protocol
deviations)
Report
Frequency
End of Study
Purpose
To review unanticipated
problems and provide an
opportunity to refine protocol
Content
 Listing of unanticipated problem
reports
 Frequency of types of UP’s
Reviewed by
 PI
 Chief of Clinical Protocol
 Study Co-Investigators
 Research Assistant
There will be no interim analysis performed. Data analysis is detailed in Section 12.4.
15.5
Study Records Retention
Per Rutgers Research Regulatory Affairs, research that involves collection of protected health information
(PHI) is subject to the HIPAA regulations. Research records including signed consent forms that contain
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the HIPAA authorization must be retained for 6 years after the date on which the subject signed the
consent form or the date when it last was in effect, whichever is later.
15.6
Protocol Deviations
A protocol deviation is any change, divergence, or departure from the study design or procedures of a
research protocol that is under the investigator's control and that has not been approved by the IRB.
Upon discovery, the Principal Investigator is responsible for reporting protocol deviations to the IRB.
A protocol violation is a deviation from the IRB approved protocol that may affect the subject's rights,
safety, or well-being and/or the completeness, accuracy and reliability of the study data. Protocol
Violations must be submitted for Full Board IRB review. If the deviation meets any of the following criteria,
it is considered a protocol violation.
Protocol deviations and protocol violations can be broken down into the following two categories: Minor
deviation or violation OR Major deviation or violation.

Minor Deviations and/or Minor Violations: A minor deviation or minor violation is viewed by the
IRB as an event that does not impact subject safety, compromise the integrity of study data
and/or affect a subject’s willingness to participate in the study. Minor deviations or violations will
be reviewed under expedited procedures by a single reviewer. The reviewer will determine
whether the event is accepted as a minor deviation/violation and can recommend a corrective
course of action. The deviation will be sent to the fully convened IRB meeting where the board
will discuss and determine if any additional actions are required, where applicable and as
necessary. If the event meets any of the following criteria, it is considered a minor deviation or
minor violation: Examples (Minor)

Major Deviations and/or Major Violations: A major deviation or violation is viewed by the IRB as
an event that may impact subject safety, affect the integrity of study data and/or affect a subject’s
willingness to participate in the study. Major protocol deviations/violations are treated as
noncompliance. These reports will be reviewed at the fully convened IRB meeting where the
board will discuss the major deviations and/or major violations and determine of the appropriate
course of action. If the event meets any of the following criteria, it is considered a major deviation
or major violation: Examples (Major)
All deviations and violations from the protocol will be recorded on the Protocol Deviation/Violation
Reporting Form no later than 5 business days after study staff become aware of the deviation and
forwarded to the study PI for review and reported promptly to the IRB. All protocol deviations and
violations will be reviewed monthly during the PREDICT Steering Committee Meeting.
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16 PUBLICATION/DATA SHARING
This study will comply with all applicable NIH Data Sharing Policies. See
https://grants.nih.gov/policy/sharing.htm for policies and resources.
Dissemination at Scientific Meetings: Presentations at scientific meetings will be delivered to assist in
dissemination of results as soon as possible when final results pertaining to the primary variables are
available. Meetings at which presentations will be made include, but will not be limited to, American
and International Association of Dental Research (AADR and IADR), the American Dental Association
(ADA), and International Association for the Study of Pain (IASP) and addiction meetings. NIH grant
support will be acknowledged during all presentations.
Publication and Authorship Policies:
Findings will be published in peer-reviewed journals. Journals selected will be indexed in PubMed.
Accepted manuscripts will be submitted to PubMed Central as per NIH policy. Examples of journals in
which final results may be published include the Journal of Dental Research and the Journal of the
American Dental Association. Other medical journals, including journals on pain and addiction will be
considered for manuscript publications. Final versions of the peer reviewed manuscripts will be made
available to the public, generally within 3 months but no later than 12 months after the official date of
publication. NIH grant support will be acknowledged in all publications.
Proposals from study investigators for writing and submitting abstracts and manuscripts for publication will
be presented to a committee for approval, comprised of the study PI, chief clinical officer, 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.
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.
Data Sharing
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 Network Coordinating Center who will have the responsibility for posting the
data. All study data will be collected in REDCAP with the REDCap project along with all non-identified
data collected. The PBRN resource center will convert the data into both SAS and ASCII formats for
posting. Data to be posted will include the study protocol and the data set in both SAS and ASCII
formats, and data dictionary.
Upon written request to the PI, survey instruments or other materials developed for use during the
clinical trial will be made electronically available to other researchers.
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17 LITERATURE REFERENCES
1. American Dental Association. ADA Coronavirus (COVID-19) Center for Dentists. Available online:
https://success.ada.org/en/practice-management/patients/infectious-diseases-2019-novel-
coronavirus? (accessed on 27 April 2020).
2. COVID-19 resources from the ADA, visit the ADA Coronavirus (COVID-19) Center for Dentists at
ADA.org/virus.
3. CDC guidelines: https://www.cdc.gov/oralhealth/infectioncontrol/statement-COVID.html
4. ADA.org May 27, 2020
5. Ge Z. et. al., Possible aerosol transmission of COVID-19 and special precautions in dentistry, J
Zhejiang Univ-Sci B (Biomed & Biotechnol) https://doi.org/10.1631/jzus.B2010010.
6. Odeh, N.D. et. al., COVID-19: Present and Future Challenges for Dental Practice. Int. J. Environ.
Res. Public Health 2020, 17, 3151; doi:10.3390/ijerph17093151.
7. Day, M. Covid-19: Four ﬁfths of cases are asymptomatic, China ﬁgures indicate. BMJ 2020, 369,
m1375.
8. Kai-Wang To, K. et. al., Temporal profiles of viral load in posterior oropharyngeal saliva samples
and serum antibody responses during infection by SARS-CoV-2: an observational cohort study.
Lancet 2020, 20, 565-574.
9. Rothe, C., et. al., Transmission of 2019-nCoV infection from an asymptomatic contact in
Germany. N. Engl. J. Med. 2020, 382, 970–971. [CrossRef].
10. Helmy,Y.A. et al., The COVID-19 Pandemic: A Comprehensive Review of Taxonomy, Genetics,
Epidemiology, Diagnosis, Treatment, and Control. J. Clin. Med. 2020, 9, 1225;
doi:10.3390/jcm9041225.
11. Giacomelli, A.; et al. Self-reported olfactory and taste disorders in in patients with severe acute
respiratory coronavirus 2 infection: A cross-sectional study. Clin. Infect. Dis. 2020. [CrossRef].
12. Schmalz et. a., Oral-Health-Related Quality of Life in Adult Patients with Rheumatic Diseases – A
Systematic Review J. Clin. Med. 2020, 9, 1172; doi:10.3390/jcm9041172.
13. Biju, R.M. ET AL., Oral Health and Quality of Life: Current Concepts. J Clin Diagnos Res, 2017,
11, 21-26.
14. Soldani FA,et. L.. One-to-one oral hygiene advice provided in a dental setting for oral health.
Cochrane Database of Systematic Reviews 2018, Issue 10. Art. No.: CD007447. DOI:
10.1002/14651858.CD007447.pub2.
15. Lamont T, Routine scale and polish for periodontal health in adults.
Cochrane Database of Systematic Reviews 2018, Issue 12. Art. No.: CD004625. DOI:
10.1002/14651858.CD004625.pub5.
16. Shang, F.M., Liu H.L. Fusobacterium nucelatum and colorectal cancer: A mechanistic overview.
World J Gastrointest Oncol. 2018 Mar 15;10(3):71-81. doi: 10.4251/wjgo.v10.i3.71.
17. Homlund A,et al., Oral health and cardiovascular disease risk in a cohort of periodontitis patients.
Atherosclerosis. 2017 Jul;262:101-106. doi: 10.1016/j.atherosclerosis.2017.05.009. Epub 2017
May 11.
18. Berman CL. Screening by dentists for hypertension. N Engl J Med, 1971, 286(26):1416. doi:
10.1056/nejm197206292862616.
19. Genco, R.J. et al. Screening for diabetes mellitus in dental practices: a field trial. J Am Dent
Assoc. 2014 Jan;145(1):57-64. doi: 10.14219/jada.2013.7.
20. Huh, S. How to train health personnel to protect themselves from SARA-CoV-2 (novel
coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof 2020;
17:10 • https://doi.org/10.3352/jeehp.2020.17.10
21. WHO. Coronavirus Disease (COVID-2019) Situation Reports-48. Available online:
https://www.who.int/docs/ default-source/coronaviruse/situation-reports/20200308-sitrep-48-
covid-19.pdf?sfvrsn=16f7ccef_4 (accessed on 10 March 2020).
22. WHO. Clinical Management of Severe Acute Respiratory Infection When Novel Coronavirus
(nCoV) Infection Is Suspected. Available online: https://www.who.int/publications-detail/clinical-
management-of-severeacute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-
suspected (accessed on 17 March 2020).
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23. Selvan, M.E. Risk factors for death from COVID-19. Nature Reviews Immunology |
https://doi.org/10.1038/s41577-020-0351-0 | Published online: 27 May 2020.
24. Cantrill, JA et al., Indicators of the appropriateness of long term prescribing in general practice in the
United Kingdom: consensus development, face and content validity, feasibility, and reliability.
Quality in Health Care 1998;7:130–135.
25. Tibshirani, R. Regression Shrinkage and Selection via the lasso. J Royal Stat Soc Series B. Wiley
1996, 58: 267-288.
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SUPPLEMENTAL MATERIALS
None
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APPENDICES
Table of Contents
Appendix
Appendix A: Schedule of Events – LAB Patient Subjects
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2 Weeks Prior to
Visit (Day -14 +/- 7
days)
Week Prior to
Day -7 (+/- 5 days)
Day Prior to Visit
Day -2 (+/- 2 days)
Visit
Day 1
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APPENDIX A: SCHEDULE OF EVENTS
LAB Patient Subject
Procedures
Obtain Consent
X
Collect Saliva (LAB) Sample                                              X
Drop of Saliva Sample at Dental Office                              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)
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