Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
Phase: NA
Conditions: Dental Caries, Quality of Life
Sponsor: NYU College of Dentistry

CariedAway 
 
page 1 
Version 18.0 July 27, 2022 
 
1 
 
Comparative Effectiveness of School and Community-Based Caries Prevention Programs 
for Children in Underserved, Low Income, Hispanic Communities 
 
This is a pragmatic, cluster, randomized controlled, non-inferiority trial which compares simple 
vs complex caries prevention.  The study is being conducted in schools, at community-based 
locations, or at the New York University College of Dentistry.  Simple is defined as fluoride 
varnish + silver diamine fluoride.  Complex is defined as fluoride varnish + traditional sealants + 
interim therapeutic restorations (also referred to as temporary fillings).  All interventions are: 
currently used in clinical practice; have American Dental Association billing codes; and, 
depending on the state and third party administrator, are compensated by Medicaid. 
 
Principal Investigator: 
Richard Niederman 
Department of Epidemiology & Health Promotion 
380 2nd Ave, Suite 301, 3rd Floor, New York, NY 
212-998-9719 
rniederman@nyu.edu 
Funding Support: 
Patient Centered Outcomes Research Institute 
1828 L St., NW, Suite 900 Washington, DC 20036 
Phone: (202) 827-7700  Fax: (202) 355-9558 
Study Intervention: 
The trial compares two caries prevention protocols 
delivered 1 time or 2 times each year in elementary 
schools, at community-based locations, or at the New York 
University College of Dentistry: a novel simple intervention 
of fluoride varnish + silver diamine fluoride vs the traditional 
complex intervention of fluoride varnish + traditional 
sealants + interim therapeutic restorations.  30 elementary 
schools will be randomized to receive simple prevention 
twice per year and 30 elementary schools will be 
randomized to receive complex prevention twice per year. 
The remaining 16 schools will receive simple prevention 
once per year. 
IRB Number: 
S17-00578 
 
Initial version: V2 MAY 25, 2017 
Amended: 
V3 July 27, 2018 
Amended: 
V4 September 6, 2018 
Amended: 
V5 January 14, 2019 
Amended: 
V6 February 27, 2019 
Amended:        V7 August 13, 2019 
Amended: 
V8 August 22, 2019 
Amended: 
V9 September 12, 2019 
Amended: 
V10 February 13, 2020 
Amended: 
V11 October 19, 2020 
Amended:        V12 January 6, 2021 
Amended: 
V13 April 13, 2021 
Amended: 
V14 June 16, 2021 
Amended: 
V15 December 15, 2021 
Amended: 
V16 January 26, 2022 
Amended: 
V17 April 1, 2022 
Amended: 
V18 July 27, 2022 

2 
 
 
 
 
Table of Contents 
 
STUDY SUMMARY ...................................................................................................................... 6 
1 
INTRODUCTION .................................................................................................................. 7 
1.1 
BACKGROUND AND SIGNIFICANCE ................................................................................... 7 
1.1.1 
Oral Health ............................................................................................................ 7 
1.1.2 
Education .............................................................................................................. 7 
1.1.3 
Need ...................................................................................................................... 7 
1.1.4 
Geography ............................................................................................................. 7 
1.2 
STUDY AIMS ................................................................................................................... 7 
1.3 
INVESTIGATIONAL DEVICE ............................................................................................... 9 
1.4 
RESEARCH RISKS & BENEFITS ........................................................................................ 9 
1.4.1 
Risk of Investigational Device ............................................................................... 9 
1.4.2 
Other Risks of Study Population ........................................................................... 9 
1.4.3 
Potential Benefits ................................................................................................ 10 
2 
STUDY OBJECTIVES ........................................................................................................ 11 
2.1 
PRIMARY OBJECTIVE ..................................................................................................... 11 
2.2 
SECONDARY OBJECTIVE(S) ........................................................................................... 12 
3 
STUDY DESIGN ................................................................................................................. 12 
3.1 
GENERAL DESIGN ......................................................................................................... 12 
3.2 
PRIMARY STUDY ENDPOINTS ......................................................................................... 16 
3.3 
SECONDARY STUDY ENDPOINTS ................................................................................... 16 
3.4 
PRIMARY SAFETY ENDPOINTS ....................................................................................... 16 
4 
PARTICIPANT SELECTION, ENROLLMENT, AND WITHDRAWAL ............................... 17 
4.1 
STUDY POPULATION ...................................................................................................... 17 
4.2 
PARTICIPANT RECRUITMENT, SCREENING AND ENROLLMENT ......................................... 17 
4.2.1 
Recruitment ......................................................................................................... 17 
4.2.2 
School Randomization ........................................................................................ 18 
4.2.3 
School Rosters and Informed Consent Preparation ............................................ 18 
4.2.4 
Informed Consent ................................................................................................ 19 
4.3 
EARLY WITHDRAWAL OF PARTICIPANTS ......................................................................... 20 
4.4 
DENTAL PROVIDER REFERRAL ....................................................................................... 20 
4.4.1 
Children without a Dentist ................................................................................... 20 
4.4.2 
Children that require an urgent referral ............................................................... 20 
5 
STUDY DEVICE ................................................................................................................. 21 
5.1 
DESCRIPTION ................................................................................................................ 21 
5.2 
METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS ....................................... 23 
5.3 
IMPLANTATION OF STUDY DEVICE .................................................................................. 23 
5.4 
SUBJECT COMPLIANCE MONITORING ............................................................................. 23 
5.5 
PRIOR AND CONCOMITANT THERAPY ............................................................................. 23 
5.6 
PACKAGING .................................................................................................................. 23 
5.7 
BLINDING OF STUDY ...................................................................................................... 23 
5.8 
RECEIVING, STORAGE, DISPENSING AND RETURN .......................................................... 23 

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5.8.1 
Receipt of Study Device ...................................................................................... 23 
5.8.2 
Storage ................................................................................................................ 24 
5.8.3 
Dispensing ........................................................................................................... 24 
5.8.4 
Return .................................................................................................................. 24 
6 
STUDY PROCEDURES ..................................................................................................... 24 
6.1 
DESCRIPTION ................................................................................................................ 24 
6.1.1 
Informed Consent ................................................................................................ 24 
6.1.2 
Scheduling ........................................................................................................... 26 
6.1.3 
COVID-19 Pre-Screening and Screening Procedures ........................................ 26 
6.1.4 
Clinical Room Set-up ........................................................................................... 27 
6.1.5 
Waiting Area ........................................................................................................ 28 
6.1.6 
Examination and Diagnosis ................................................................................. 29 
6.1.7 
Prevention ........................................................................................................... 29 
6.1.8 
Take Home Messages and Follow-on Care ........................................................ 29 
6.2 
PREVENTIVE CARE ........................................................................................................ 30 
6.2.1 
Simple prevention ................................................................................................ 30 
6.2.2 
Complex prevention ............................................................................................ 30 
6.3 
STUDY ADMINISTRATION AND DURATION ........................................................................ 31 
6.4 
CONTROL/COMPARISON GROUP AND CONFOUNDING FACTORS ...................................... 32 
6.5 
RANDOMIZATION AND BLINDING ..................................................................................... 32 
6.5.1 
Randomization .................................................................................................... 32 
6.5.2 
Blinding ................................................................................................................ 32 
6.6 
COMPLIANCE ASSESSMENT ........................................................................................... 32 
6.7 
PRIOR AND CONCOMITANT THERAPY ............................................................................. 33 
6.8 
RECEIVING, STORAGE, TRANSPORTING, DISPENSING, BREAKDOWN AND DISPOSAL OF 
CLINICAL SUPPLIES ................................................................................................................... 33 
6.8.1 
Receiving ............................................................................................................. 33 
6.8.2 
Storage ................................................................................................................ 33 
6.8.3 
Transporting ........................................................................................................ 33 
6.8.4 
Dispensing ........................................................................................................... 34 
6.8.5 
Breakdown .......................................................................................................... 34 
6.8.6 
Disposal ............................................................................................................... 34 
6.9 
STUDY PROCEDURES TABLE ......................................................................................... 35 
7 
STATISTICAL PLAN .......................................................................................................... 36 
7.1 
SAMPLE SIZE DETERMINATION ...................................................................................... 36 
7.2 
STATISTICAL METHODS ................................................................................................. 36 
7.3 
SUBJECT POPULATION FOR ANALYSIS ........................................................................... 37 
7.4 
INTERIM ANALYSIS ........................................................................................................ 37 
8 
DATA AND SAFETY MONITORING PLAN (DSMP) ......................................................... 37 
8.1 
INFORMED CONSENT ..................................................................................................... 37 
8.2 
RISK ............................................................................................................................. 38 
8.3 
IMPLEMENTATION .......................................................................................................... 38 
8.4 
CONFIDENTIALITY .......................................................................................................... 38 
8.4.1 
Protection of Subject Privacy .............................................................................. 38 
8.4.2 
Confidentiality During Adverse Event (AE) Reporting ......................................... 39 
8.5 
EXPECTED RISKS .......................................................................................................... 39 
8.6 
ADVERSE EVENT/ UNANTICIPATED PROBLEMS ............................................................... 39 
8.6.1 
Definitions ............................................................................................................ 39 
8.7 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP .................... 40 

4 
 
8.8 
CHARACTERISTICS OF AN ADVERSE EVENT .................................................................... 40 
8.8.1 
Relationship to Study Intervention ....................................................................... 40 
8.8.2 
Expectedness of SAEs ........................................................................................ 41 
8.8.3 
Severity of Event ................................................................................................. 41 
8.9 
REPORTING PROCEDURES ............................................................................................ 41 
8.9.1 
Reporting for Multi-Center Trials ......................................................................... 41 
8.9.2 
Unanticipated Problem Reporting ....................................................................... 41 
8.9.3 
Adverse Event Reporting of Non-IND Studies .................................................... 42 
8.9.4 
Adverse Event Reporting of Investigation New Drug (IND) Studies .................... 42 
8.9.5 
Events of Special Interest (if applicable) ............................................................. 42 
8.9.6 
Reporting of Pregnancy ....................................................................................... 42 
8.10 
HALTING RULES ............................................................................................................ 42 
8.11 
QUALITY CONTROL AND QUALITY ASSURANCE ............................................................... 42 
8.12 
SUBJECT ACCRUAL AND COMPLIANCE ........................................................................... 43 
8.12.1 
Measurement and Reporting of Subject Accrual ................................................. 43 
8.12.2 
Measurement and Reporting of Participant Adherence to Treatment Protocol ... 43 
8.13 
STOPPING RULES ......................................................................................................... 43 
8.14 
SAFETY REVIEW PLAN .................................................................................................. 43 
8.15 
SUBMISSION OF ON-SITE MONITORING/AUDIT AND INSPECTION REPORTS ...................... 44 
8.16 
DATA HANDLING AND RECORD KEEPING ........................................................................ 44 
8.17 
DATA MANAGEMENT RESPONSIBILITIES ......................................................................... 44 
8.18 
DATABASE PROTECTION ............................................................................................... 45 
8.19 
SOURCE DOCUMENTS/PROTECTIONS ............................................................................ 45 
8.20 
CASE REPORT FORMS .................................................................................................. 45 
8.21 
RECORDS RETENTION AND STORAGE ............................................................................ 45 
8.22 
STUDY/REGULATORY BINDER ........................................................................................ 45 
8.23 
SCHEDULE AND CONTENT OF REPORTS ......................................................................... 45 
8.24 
INFORMED CONSENT ..................................................................................................... 46 
8.25 
REPORTING CHANGES IN STUDY STATUS ....................................................................... 47 
9 
ETHICAL CONSIDERATIONS ........................................................................................... 48 
10 
STUDY FINANCES ............................................................................................................ 48 
10.1 
FUNDING SOURCE ......................................................................................................... 48 
10.2 
CONFLICT OF INTEREST ................................................................................................. 48 
10.3 
PARTICIPANT STIPENDS OR PAYMENTS .......................................................................... 48 
11 
PUBLICATION PLAN ......................................................................................................... 48 
12 
ATTACHMENTS ................................................................................................................. 48 
13 
REFERENCES ................................................................................................................... 48 
 

5 
 
 
List of Abbreviations 
 
• 
ADL = Activities of Daily Living 
• 
AE = Adverse Event 
• 
BEDAC = Biostatistics and Epidemiology Data Analytics Center 
• 
CDC = Centers for Disease Control 
• 
COI = Conflict of Interest 
• 
CRA = Clinical Research Associate 
• 
CRF = Case Report Form 
• 
CTSI = Clinical and Translational Science Institute 
• 
DCC = Data Coordinating Center 
• 
DSMB = Data and Safety Monitoring Board 
• 
DSMP = Data Safety Monitoring Plan 
• 
eICF = Electronic Informed Consent Form   
• 
FDA = Food and Drug Administration 
• 
GCP = Good Clinical Practice 
• 
GAMs = Generalized Additive Models 
• 
HCP = Health Care Personnel 
• 
HEAL = Health Evaluation and Analytics Lab 
• 
HIPPA = Health Insurance Portability Accountability Act 
• 
IDs = Identifiers 
• 
IND = Investigational New Drug 
• 
IRB = Institutional Review Board 
• 
ML-MEM = Multilevel Mixed Effects Modeling 
• 
MOU = Memorandum of Understanding 
• 
NESS = New England Survey Systems 
• 
NHANES = National Health and Nutrition Examination Surveys 
• 
NYC = New York City  
• 
NYC DOE = Department of Education 
• 
NYSDOH = New York State Department of Health 
• 
NYU = New York University 
• 
NYUCD = New York University College of Dentistry 
• 
NYUMC = New York University Medical Center 
• 
MOU = Memorandum of Understanding 
• 
OHE = Oral Health Education 
• 
OHRP = Office of Human Research Protections 
• 
OSR = Office of Science & Research 
• 
PCORI = Patient Centered Outcomes Research Institute 
• 
PD = Professional Development 
• 
PI = Principal Investigator 
• 
PPE = Personal Protective Equipment 
• 
QR = Quick Response Code 
• 
REDCap = Research Electronic Data Capture   
• 
UP = Unanticipated Problem 
• 
SAE = Serious Adverse Event 
• 
SDF = Silver Diamine Fluoride 
• 
SOC = Standard of Care 
 

6 
 
 
 
Study Summary 
 
Title 
Comparative Effectiveness of School and Community-Based Caries 
Prevention Programs for Children in Underserved, Low Income, 
Hispanic Communities 
Short Title 
CARIEDAWAY NYC 
IRB Number 
S17-00578 
Study Type 
Human  
Study Design 
Pragmatic, cluster, randomized controlled, non-inferiority trial 
Study Intervention 
Simple prevention (fluoride varnish + silver diamine fluoride) vs 
complex prevention (fluoride varnish + traditional sealants + interim 
therapeutic restorations) 
Study Duration 
5 years 
Study Location(s) 
The study will be conducted in New York City Title 1 Elementary 
Schools, community-based locations, or at the New York University 
College of Dentistry 
Primary Objective 
To determine if the newer simple caries prevention is not inferior to the 
traditional complex caries prevention 
Sample Size 
76 schools (approximately 20,000 children) 
Diagnosis and Main 
Inclusion Criteria 
The disease/condition is untreated caries.  All children in the 
participating schools with informed consent will be included.  The only 
exclusion criteria are children not in the participating schools, children 
without informed consent and children that are allergic to silver. 
Study Product and 
Planned Use 
Silver diamine fluoride (Advantage Silver Arrest).  The liquid is 
administered topically to carious lesions, as well as pits and fissures of 
posterior teeth. 
Control / 
Comparison 
The new simple prevention will be compared to the traditional complex 
prevention. 
Statistical 
Methodology 
Primary outcomes include caries arrest, caries prevention, and quality 
of life.  We will assess these using multilevel binomial regression and 
generalized estimating equations. 
 

7 
 
1 Introduction 
This study will be conducted in compliance with the protocol approved by the Institutional 
Review Board (IRB), Good Clinical Practice (GCP) guidelines, and applicable New York 
University Medical Center (NYUMC) and federal regulatory requirements. 
1.1 
Background and Significance 
 
1.1.1 
Oral Health 
More than 50% of U.S. elementary school-age children have experienced caries 
(tooth decay or cavities), and more than 20% have untreated caries1. The oral 
health needs of low-income minority children are almost double U.S. averages – 
current estimates indicate that 70% have experienced caries, 38% have 
untreated caries, 66% do not have sealants, and all have difficulty accessing 
care1.   Even more troubling, children with untreated caries have an incidence of 
sepsis ranging from 5% to 10%2. In rare instances, untreated decay can lead to 
serious systemic infections and even death3.  Currently, only 25% of children in 
New York City (NYC) schools receive school-based oral health care.  
Importantly, these school-based oral health programs all vary in service provision 
and scope, and none have outcome measures to assess health equity. 
 
1.1.2 
 Education 
Oral health has larger connections to general health and child development, such 
as academic performance and quality of life.  Oral health also affects children’s 
education.  Children with untreated caries and associated toothaches have more 
school absences, cannot pay attention in school, do not keep up with their peers 
academically, and have lower standardized test scores4-8. Additionally, children 
who require dental care in a traditional dental office frequently miss school.  
 
1.1.3 
 Need 
Based on 3 years of conversations, surveys, and guidance, parents and 
stakeholder partners in New York City requested school-based caries 
prevention9-10, and tracking the following patient-centered outcomes: untreated 
cavities, quality of life, and school performance.  Further, these parent and 
stakeholder partners participated in planning, designing, and piloting the 
proposed study. These partners are also participating in the proposed study’s 
conduct, dissemination, and implementation. 
 
1.1.4 
Geography 
NYC elementary schools serve over one million children of varying 
socioeconomic and racial/ethnic backgrounds, many of which are from those 
demographic groups with the highest oral health needs. This initiative focuses on 
improving the oral health of NYC children. We will enroll 76 schools across NYC 
to receive alternative caries prevention treatments.  
 
1.2 
Study Aims 
The overall goal of this study is to measurably improve oral health equity.  Towards this goal, we 
will compare “simple” and “complex” prevention, two packages of interventions designed to 
prevent and arrest dental caries.  The study design is a cluster randomized non-inferiority 
pragmatic trial.  Both preventive interventions are expected to be equally effective in improving 
health equity.  The major difference in the two protocols is that “simple” prevention costs 

8 
 
approximately 25% of “complex” prevention.  Simple also takes approximately 25% of the time 
of complex prevention.  Therefore, if simple and complex are found to be equally effective, for 
the same time and cost, simple prevention could improve health and health equity to 
approximately 3 times the number of children as complex prevention.   
 
Our prior work, and data from systematic reviews, indicates that the protocols we propose 
should be similarly effective in both arresting current caries and preventing subsequent caries 
by 50% to 80%.  Thus all children should benefit from the proposed preventions.  We will collect 
data on oral health and child quality of life, and assess student academic performance.  
 
The study consists of three groups: (1) a group receiving simple prevention twice per year; (2) a 
group receiving complex prevention twice per year; and (3) a group receiving simple prevention 
once per year.  
 
We will select 76 elementary schools to participate in the program over a five-year period. 30 
elementary schools will be randomized to receive simple prevention twice per year and 30 
elementary schools will be randomized to receive complex prevention twice per year. The 
remaining 16 schools will receive simple prevention once per year. The care will be provided in 
schools, community-based locations or at the New York University College of Dentistry. 
 
The inclusion criteria for the schools enrolled in groups (1) and (2) include: A Hispanic/Latino 
population of at least 50% and a free and reduced lunch population of at least 80%. The 
remaining racial/ethnic and socioeconomic distribution of these schools will include children 
from any race/ethnicity and economic background. The inclusion criteria for schools in group (3) 
include any elementary school in New York City and will be selected to include representation 
from every major racial/ethnic group and socioeconomic level.  
 
For the purposes of the analysis on dental-related service use and costs among Medicaid 
beneficiaries, all children participating in Medicaid of elementary school age will be included in 
the analysis, except for children in participating schools that do not provide informed consent to 
provide oral health and Medicaid dental service use data. 
 
The Primary Specific Aims are to:  
1. Determine the non-inferiority of simple vs complex caries prevention for 
preventing new caries (primary prevention). 
2. Determine the non-inferiority of simple vs complex caries prevention for arresting 
current caries (secondary prevention). 
3. Determine the impact of simple vs complex prevention on child oral health-
related quality of life 
4. Determine the impact of once per year vs twice per year care on the arrest and 
prevention of caries 
Notably, toothaches or office based dental care reduces in-class learning time.  If the caries 
prevention programs are as effective as predicted, knowing the time/trade-off will be important.  
Thus a secondary outcome of the study will be school performance (school absence and 
student achievement).  To insure accurate assessments, program participants will be compared 
to children in their own schools and to children in NYC “peer schools” not participating in the 
study. No additional data is collected for educational outcomes from participants. 
 
 

9 
 
 
The Secondary Specific Aims are to: 
1. Determine the impact of prevention vs no prevention on school absence   
2. Determine the impact of prevention vs no prevention on standardized test 
performance 
3. Determine the impact of simple vs complex prevention on school absence and 
test performance 
 
The exclusion criteria will be those: (1) not attending participating schools, (2) those attending 
participating schools without informed consent, or (3) those attending participating schools with 
informed consent, but without assent and (4) those allergic to silver. 
 
For the purposes of the analysis on dental-related service use and costs among Medicaid 
beneficiaries, the only excluded groups are (1) children not participating in Medicaid will be 
excluded and (2) children participating in Medicaid in CariedAway schools, but without informed 
consent to provide oral health and Medicaid dental service use data. 
 
1.3 
Investigational Device 
Silver diamine fluoride (SDF) is a Category B low risk device.  It is a clear liquid, used for 
topical oral application on sensitive dentinal lesions to reduce sensitivity; on carious lesions to 
arrest decay; and on pits and fissures to prevent caries.  Application is eligible for Medicaid 
coverage in some states. 
1.4 
Research Risks & Benefits 
 
1.4.1 
Risk of Investigational Device   
The only known risks are allergies to silver and short-term (3-7 day) irritation from 
dripping on gingiva or epithelium. However oral health professionals working in 
this study will be trained on the proper techniques to avoid risks.  All students 
with a silver allergy will be excluded from participating.  The application of silver 
diamine fluoride may discolor any cavities resulting in a brown or black color.  
This color change indicates that the cavity has stopped growing.  If accidental 
skin contact occurs it can cause a temporary light brown staining to the lips, 
cheeks, or permanent staining to clothing.  For stain removal to the skin, soap 
and water are applied immediately.  The same procedure is applied for cleaning 
clothes. 
  
1.4.2 
Other Risks of Study Population   
1.4.2.1 Fluoride varnish 
Children that have a nut allergy.  Some fluoride varnish products contain pine 
nuts as an ingredient in their varnish resin formula.  There are 2 fluouride varnish 
products being used in this study.  The first product is called FluoroDose® and 
will not contain pine nuts as an ingredient. This product will be used for children 
that have a nut allergy.  The second fluoride varnish product is called PreviDent® 
and will be used on children that do not have a nut allergy.  These products are 
listed in section 5 under Study Device. 
1.4.2.2 COVID-19 
Care follows WHO guidance for essential, aerosol-free care. 2. The care is 
standard of care, based on American Dental Association guidelines. 3. Care 

10 
 
delivery follows current CDC guidelines for PPE.  4.  Our subject population does 
not include categories of individuals currently known to be at greater risk of 
serious COVID-19 consequences.  
 
In school and community-based programs have unique characteristics that 
warrant specific infection prevention considerations due to risk for exposure to 
COVID-19.  Enhanced precautions are in place to avoid transmission of SARS 
Cov-2 in school and community-based settings. 
 
All New York University College of Dentistry Health Care Personnel (NYUCD 
HCP) are required to get COVID-19 diagnostic PCR tests within 14 days prior to 
returning to work and submit verification, be tested every 14 days and complete 
the NYU daily screener. Any NYUCD HCP who fails on the “screener pass” will 
automatically be referred to the NYU COVID prevention & response team and 
will not report to work.   
 
All clinical staff will wear personal protective equipment consistent with CDC, 
DOH, FDA and NYU Dentistry guidelines. 
 
NYUCD HCP will be conducting all study related procedures at all locations.  
NYUCD HCP will wear PPE based on current NYU Dentistry guidelines.  PPE is 
listed below: 
 
1. Disposable gowns 
2. Disposable gloves 
3. N95 respirator that have been fit tested for a specific respirator and shall be 
disposed of at the end of each clinical day 
4. Level 3 surgical masks 
5. Goggles 
6. Face Shields 
7. Bonnets 
8. Booties 
 
Gloves are changed between patients.  Goggles and face shields are disinfected 
with an EPA registered intermediate level surface disinfectant between patients. 
All dental chairs, stools and touch surfaces are disinfected with an EPA 
registered intermediate level surface disinfectant at the beginning of each day, 
prior to and after treating patients, and at the end of the day.   
 
All NYUCD HCP including supervisory professionals will ensure that care is 
provided and overseen in a way that maximizes benefits while avoiding harm to 
personnel, students and parents/guardians from potential exposure to COVID-19 
infection. 
   
1.4.3 
Potential Benefits 
There are three distinct benefits. 
 
1. 
The benefit to all participants is that they will receive either primary or primary 
and secondary caries prevention once or twice yearly.  The expectation is 
that both the simple and complex will reduce caries by 50% to 80%. 

11 
 
2. 
If, as we propose, simple prevention is as effective as complex, and simple 
prevention takes approximately ¼ the time and ¼ the cost of complex 
prevention, its use will increase access to effective care.   
3. 
The methods to be applied and the outcomes identified both address national 
Healthy People 2020 goals. 
Ultimately, evidence-based changes in knowledge, attitudes and practice among 
all patient and stakeholder partners will help reduce the continually high burden 
of caries in children, particularly among minority and low-SES children. Improved 
outcomes data should increase support for the sustainability of ongoing and new 
caries prevention programs at both a local and national level. The benefits to 
society include improved oral health for our children that is sustained by a system 
of preventive care that is more clinically and cost effective than the current 
method of care. 
 
Numerous efficacy trials demonstrate the benefits of complex preventive dental 
care, which has far-reaching effects on physical and emotional health, nutrition, 
social interactions and employability. However, numerous barriers still exist to 
improvements in child oral health: an already-existing global and national burden 
of caries; the burden of disease in NYC; the social burden of disease, particularly 
affecting academic performance and psycho-social development; barriers to 
office-based care9; economic incentives to support treatment rather than 
prevention; the reduced efficacy of treatment to prevention; and large variation in 
care without outcome measures of effectiveness.  
 
Without data to support the effectiveness of preventive oral health care, we 
predict that two things will occur (depending on state and local values and 
circumstances): 1) the current helter-skelter implementation of well-meaning but 
ineffective programs will continue; and/or 2) there will be an extinction of those 
public caries prevention programs that are truly effective. 
 
From a national perspective, our preliminary data suggest that a school-based 
caries prevention program may represent the first program that exceeds the 
goals of Healthy People 2000. If this happened, it would be transformative. This 
information would: 1) set the stage for broader dissemination within NYC and 
other metropolitan areas; and 2) stimulate implementation tests of other “place-
based” caries prevention programs for other populations (e.g.: mothers, elderly, 
etc.), in locations where people learn, work, play, and pray.  
 
Long term, we believe that children (and adults) with improved oral health will be 
better prepared to learn, thrive and improve their social and economic 
opportunities.  These important accomplishments would be one step in reducing 
social inequalities.  The proposed school and community-based, cluster, 
randomized controlled trial, comparing two evidence-based caries prevention 
protocols, will address and potentially obviate all of the identified gaps. 
2 Study Objectives 
 
2.1 
Primary Objective   
To determine if simple prevention is non-inferior to complex prevention for caries arrest and 
longitudinal caries prevention. 

12 
 
  
2.2 
Secondary Objective(s) 
To compare the effectiveness of simple prevention when provided twice yearly versus once 
yearly. 
 
To determine if children receiving either simple prevention or complex prevention will have 
reduced school absence and higher academic performance when compared to matched 
students in non-participating schools. 
 
To determine if children receiving simple prevention or complex prevention will have reduced 
dental service use and costs in Medicaid when compared to matched students in non-
participating schools.  
3 Study Design 
 
3.1 
General Design 
This is a pragmatic cluster randomized non-inferiority controlled trial comparing the clinical 
effectiveness of two caries prevention protocols.  The study consists of three groups. Two 
groups will be randomly assigned at the school level to receive either simple or complex 
prevention provided twice yearly. A third group will be selected to receive simple prevention 
only, provided once yearly.  
 
 A total of 76 elementary schools will be selected from interested schools in New York City, 
identified via letters and phone calls to school principals. For groups (1) and (2) 30 elementary 
schools will be randomized to receive simple prevention twice per year and 30 elementary 
schools will be randomized to receive complex prevention twice per year. For group (3), 16 
elementary schools will be selected to receive simple prevention once per year.  
 
Beginning in the first year of the study, a total of 30 schools will be randomized (15 schools 
receiving simple prevention and 15 receiving complex prevention) to receive prevention twice 
per year consenting children will be followed over five years. In Year 2, 30 additional schools will 
be randomized to receive either simple or complex prevention twice per year. Consenting 
children will be followed over four years. Also in Year 2, an additional 16 schools will be 
selected to receive simple prevention once per year, and consenting children will be followed 
over four years.  Starting in year 3, all care will be provided by NYUCD HCP, in school, at 
community-based locations, or at NYUCD.  Starting in year 5, NYUCD licensed dentists, dental 
hygienists, nurses, and/or advanced level dental hygiene students supervised by licensed 
dental professionals will provide care to participating students, in school, at community-based 
locations, or at NYUCD. 
 
The inclusion criteria for the schools enrolled in groups (1) and (2) include: A Hispanic/Latino 
population of at least 50% and a free and reduced lunch population of at least 80%. The 
remaining racial/ethnic and socioeconomic of the schools beyond these criteria can include 
children from any race/ethnicity and economic background. The inclusion criteria for schools in 
group (3) include any elementary school in New York City. Schools in group (3) will be balanced 
to ensure representation from every primary race/ethnic group and from all socioeconomic 
tertiles. 
   

13 
 
The impact of COVID-19 has greatly impacted our in school-based cavity prevention approach.   
Elementary schools have closed, delayed in opening and will either allow students to return to 
schools part-time under a blended learning model or will learn at home remotely full-time.  This 
has impacted our ability to provide preventive services in some or possibly all of our schools.  In 
order to continue to provide these services, our community engagement administrator will reach 
out to those schools where we cannot currently provide in school care, seek their guidance in 
helping to identify and connect with local community-based organizations in their area and then 
telephone these local organizations to discuss participation in the research study.  
 
Once an alternate community-based location has been identified and is interested in 
participating, our HCP will meet with the community organization staff to review COVID-19 
safety precautions at the community-based location, clinical protocols, room size and safe 
distancing requirements.  NYUCD HCP will fill out the CariedAway COVID-19 community-based 
checklist. If the community-based location does not meet the requirements listed in the 
checklist, the NYUCD HCP will notify the Principal Investigator that the site is not an acceptable 
location for providing safe care. 
 
If the community-based location meets the requirements of the CariedAway COVID-19 
community-based checklist and wishes to participate, the NYUCD HCP will review the 
Memorandum of Understanding (MOU).  As community organizations are identified and sign an 
MOU we will submit their name and location to the IRB. 
 
All clinical personnel will wear personal protective equipment consistent with CDC, DOH, FDA 
and NYU Dentistry guidelines. 
 
NYUCD licensed dentists, dental hygienists, nurses, and/or advanced level dental hygiene 
students supervised by licensed dental professionals will provide care to participating students 
at all locations.  All clinical personnel providing care will wear PPE based on current NYU 
Dentistry guidelines.  PPE is listed below: 
 
1. Disposable gowns 
2. Disposable gloves 
3. N95 respirator that have been fit tested for a specific respirator and shall be disposed of at 
the end of each clinical day 
4. Level 3 surgical masks 
5. Goggles 
6. Face Shields 
7. Bonnets 
8. Booties 
 
Gloves are changed between patients. Goggles and face shields are disinfected between 
patients.  All dental chairs, stools and touch surfaces are disinfected at the beginning of each 
day, prior to and after treating patients, and at the end of the day. 
 
CariedAway school COVID-19 Checklist:  The first day of the school visit the NYUCD HCP will 
review the school’s policies for prevention of coronavirus transmission among students, staff 
and faculty using the CariedAway School COVID-19 Checklist.  If there is any reason to believe 
that schools policies would put NYUCD HCP or students at risk, the NYUCD HCP Dental will 
contact the Principal Investigator to determine the appropriate course of action. 
 

14 
 
Consenting students in participating schools will receive care in a school, at a community-based 
location, or at NYUCD. Randomization will be done by computer and remain in effect during the 
duration of the trial. Care will be provided in a school, community-based locations or at NYUCD 
according to the group selection as described above. Participants in their first and second year 
will contribute data to evaluate caries arrest. We will follow them longitudinally to evaluate 
prevention of new caries. The total expected school enrollment for the clinical and community 
components of the study is 76 schools. 
 
Hypotheses and Interventions: We will test the primary hypothesis that school or community-
based “simple” caries arrest and prevention provided twice yearly is equally effective (non-
inferior) as school or community-based “complex” caries arrest and prevention provided twice 
yearly.   
• 
“Simple” prevention is defined as fluoride varnish, silver diamine fluoride, fluoride 
toothpaste and oral hygiene instruction.  
• 
“Complex” prevention is defined as traditional sealants, interim therapeutic restorations, 
fluoride varnish, fluoride toothpaste and oral hygiene instruction.  
 
 

15 
 
 
Table 1. Comparison simple and complex prevention on primary and secondary caries 
reduction*,**. 
 
 
Complex Prevention 
Simple Prevention 
 
Focus: 
Intervention: Toothpaste Fluoride 
Varnish 
Sealant Interim 
Therapeutic 
Restoration 
Toothpaste Fluoride 
Varnish 
Silver 
Diamine 
Fluoride 
1o 
Prevention 
  
Smooth 
surface 
25%1 
40%2 
  
 
25%1 
40%2 
  
Pits and 
fissure 
 
  
80%3 
 
 
  
80%5 
2o 
Prevention 
Arrest 
current 
caries 
 
  
80%4 
 
  
 80%5 
* Efficacy estimates of caries reduction from systematic reviews of human randomized controlled 
trials. 
**References: 1.11-12; 2.13; 3.14-16; 4.14, 17-19; 5. 20-22 
 
Both types of care will be provided to all children with active informed consent in grades PK – 8 
(ages 5 – 14). Participating schools will be randomized or selected at the school level to receive 
either simple or complex prevention. All participants in a given school, community-based 
location, or at NYUCD will receive the same prevention as randomized. At the beginning of each 
school year, all students in grades PK - 8 will be given a personalized pre-populated principal 
recruitment letter, the parent/guardian alternate location recruitment letter, the parent/guardian 
recruitment flyer, a health history, the NYU Langone Health COVID-19 research participation 
information sheet and a blank informed consent form. 
 
Electronic informed consent forms will be distributed to parents/guardians of new students who 
have not previously consented to see if they wish to have their child participate. Electronic 
informed consents can be distributed by the schools using whichever existing method the 
school uses for mobile phone contact, in emails, or on the school’s social media page in the 
following ways: 
 
1. NYU CariedAway Website URL by selecting “registering your child” 
1) English 
• https://dental.nyu.edu/faculty/epidemiology-health-promotion/pcori-grant.html 
• Short URL: https://dental.nyu.edu/pcori 
2) Spanish 
• https://dental.nyu.edu/faculty/epidemiology-health-promotion/pcori-beca.html 
2. Hyperlinks in English and Spanish  
• 
English language eICF: https://is.gd/CariedAwayNYC 
• 
Spanish language eICF: https://is.gd/CariedAwayNYC_SP 
3. CariedAway email toolkit in English and Spanish 
 
The parent or legal guardian fills out the eICF and uses ‘scratch’ method (mouse, stylus, or 
finger) to sign and then returns the completed ICF via REDCap. 
 

16 
 
The study administrator will then cross-reference the OSIS number in the original .csv file which 
was provided to us at the beginning of each school year by the NYC Department of Education, 
and verify that the correct OSIS number was provided correctly by the consenter. 
 
The study administrator then uploads all of the informed consent PDF’s to NESS via the secure 
and password protected ShareFile link listed below: 
 
• https://nedental.sharefile.com 
 
NESS then uploads each student’s eICF to their electronic dental record in the iPad. 
 
Examination, preventive care, and data collection by a proprietary secure electronic health 
record will be provided and collected up to 5 years, and all children in a given school will receive 
the same preventive care at the same frequency either at the school, at a community-based 
location or at NYUCD. Participants in their first and second years will contribute data to evaluate 
caries arrest, and then they will be followed longitudinally within schools.  50% of children > 8 
years old will be assessed with a validated quality of life instrument, and all children will receive 
a comprehensive oral examination at each visit.  We will also test the secondary hypotheses 
that prevention: improves school performance and is equally effective given once per year as 
twice per year. 
3.2 
Primary Study Endpoints 
Caries arrest and prevention will be determined at each visit.  The primary end point for caries 
arrest will be at 2 years, and follow on to termination of trial determine the length of time that 
caries remains arrested.  The primary end point for caries prevention will be at 3 years, and 
follow on to termination of trial to determine stability of prevention. 
 
Presence / absence of caries is assessed by visual/tactile methods.  Sound tooth surfaces 
appear white and smooth.  Active caries appear brown and soft.  Arrested caries appear dark 
brown or black and hard. 
 
For clinical assessment, we will train and standardize clinicians using validated criteria 
implemented by the Centers for Disease Control and Prevention (CDC) in the National Health 
and Nutrition Examination Surveys (NHANES). Training and validation were developed and 
documented by our Colleague, Dr. Beltran, while at the CDC and field tested in the examination 
of special athletes23,24. Training and standardization of these examiners implement the World 
Health Organization guidelines25,26.  
3.3 
Secondary Study Endpoints 
School absence and academic performance data will be provided by the NYC Department of 
Education.  
 
Medicaid claims, encounter, and eligibility data for elementary students in New York City 
enrolled in Medicaid will be provided by New York University’s Wagner School of Public Service 
and New York University’s School of Medicine. 
 
3.4 
Primary Safety Endpoints 
The care provided is usual and customary care, not high-risk. The only risk about which we are 
aware is a toothache.  Our history suggests that this occurs in approximately 1 in 2000 children.  
In our experience, this occurrence is far less than the percentage of children with tooth aches 
prior to initiation of prevention (approximately 5 in 100 children). 

17 
 
4 Participant Selection, Enrollment, and Withdrawal 
4.1 
Study Population 
The study population will be children with informed consent who do not have an allergy to silver 
and are attending New York City elementary schools. 76 elementary schools will be selected to 
participate in the study. 60 of the participating schools will have at least 50% of the student 
population being of Hispanic/Latino origin and 80% from low socio-economic backgrounds. 
Beyond these inclusion criteria, any child in the school of any race/ethnicity or socio-economic 
group is eligible for participation. 16 of the 76 schools have no inclusion criteria but will be 
purposefully selected to represent a majority of students from every major racial/ethnic and 
socioeconomic group. School participation will be finalized with individual principals and we will 
execute a memorandum of understanding (MOU) with each participating school and each 
community-based organization. 
4.2 
Participant Recruitment, Screening and Enrollment 
 
4.2.1 
Recruitment 
Recruitment will be done during CariedAway community engagement events and 
in concert with all other yearly school notifications and requests for consent via 
informational packets sent home with the children to their parents/guardians, 
mailed to the parents or sent electronically by the school’s system of choice.  
Recruitment information will contain care details written in English and Spanish, a 
pre-populated personalized principal recruitment letter, the parent/guardian 
alternate location recruitment letter, the parent/guardian recruitment flyer, a 
health history, the NYU Langone Health COVID-19 research participation 
information sheet and a blank paper informed consent form. Parents will be 
asked to review the forms and contact the principal investigator if they have any 
questions prior to signing and returning the forms to the child’s school.  
 
Paper pre-populated personalized principal recruitment letter and blank informed 
consent will also be distributed and written in Arabic, Bengali Bangla, Chinese, 
French, Haitian Creole, Korean, Russian or Urdu.  
 
Electronic informed consent forms will also be distributed to parents/guardians of 
new students who have not previously consented.  The CariedAway 
parent/guardian communication toolkit emails contain hyperlinks to the NYU 
CariedAway Websites and REDCap eICF’s in English and Spanish and will be 
provided to school administrators to distribute to parents and guardians of 
children enrolled in the school via whichever existing method the school uses for 
mobile phone contact, email or electronic communication systems. 
 
The parent/guardian recruitment flyer (English and Spanish) will also be placed 
Independently during CariedAway community engagement events as an FAQ, as 
a flyer for posting on school bulletin board, as an attachment included in 
orientation documents for dental champions (school administrative staff, ie. 
(Parent coordinators) and dispersed to parent/guardian via whichever existing 
method the school uses for mobile phone contact, email or electronic 
communication systems, at the discretion of the school staff. 
 
The English and Spanish parental/guardian recruitment flyers have the following 
Quick Response Code (QR code) in each flyer: 

18 
 
 
English QR code:  
 
Spanish QR code:  
 
 
The QR code allows the parent/guardian to use their smart phone to take a 
picture of the English or Spanish QR code.  Once they have taken the picture 
they will be asked if they wish to Open “nyumc.org” in Safari.  If they choose 
“open” they are sent directly to the IRB approved REDCap eICF in the English or 
Spanish.  They can then securely fill out, sign and date the eICF.  
 
All parents/guardians of new or previously consented students will be contacted 
via telephone by one of our clinical team members prior to scheduling any 
appointments.  Parents/guardians of previously consented students will be 
reminded that they signed a 5 year informed consent.  The clinical team member 
will use the research participant telephone recruitment script for COVID-19 
updates.  They will ask the parent/guardian a few questions to assess whether it 
makes sense, from a safety perspective due to the COVID-19 pandemic if they 
wish to have their child to participate or continue to participate in this research 
study.  After a clinical team member speaks with the parent/guardian of a new 
participant, the clinical team member will send the parent/guardian the 
CariedAway new enrollee email written in English or Spanish.  The email will also 
contain a link to the REDCap eICF and provide contact information if the 
parent/guardian has further questions. 
 
4.2.2 
School Randomization 
Beginning in the first year of the study, a total of 30 schools will be randomized 
(15 schools receiving simple prevention and 15 receiving complex prevention) to 
receive prevention twice per year. Consenting children will be followed over five 
years. In Year 2, 30 additional schools will be randomized to receive either 
simple or complex prevention twice per year. Consenting children will be followed 
over four years. Also in Year 2, an additional 16 schools will be selected to 
receive simple prevention once per year, and consenting children will be followed 
over four years. 
 
4.2.3 
School Rosters and Informed Consent Preparation   
In August we will request that the NYC Department of Education provide an 
electronic roster for each school. The rosters are used to create the IRB-
approved pre-populated personalized principal recruitment letter from the 
principal to include school name, school address, and principal/assistant principal 
name and date explaining the program. The pre-populated personalized principal 
recruitment letters, the parent/guardian alternate location recruitment letter, the 
parent/guardian recruitment flyer, a health history, the NYU Langone Health 
COVID-19 research participant information sheet and a blank paper informed 
consent are printed at NYUCD and distributed to each teacher or school.  These 
packets are either sent home with the children or mailed to the parent/guardian 
by the school administrator. 
 

19 
 
The REDCap electronic informed consent forms are updated by the study 
administrator annually and each time a new modification of the consent form has 
been approved by the NYU Langone IRB. 
 
4.2.4 
Informed Consent 
Blank IRB-approved paper informed consent will be distributed during 
CariedAway community engagement events and to students at the beginning of 
each school year in concert with all other school notifications.  Parents can also 
choose to sign their child up for the program at their child’s school.  The blank 
paper informed consent will include a pre-populated personalized principal 
recruitment letter from the principal, the parent/guardian alternate location 
recruitment letter, the parent/guardian recruitment flyer, program information, a 
health history, the NYU Langone Health COVID-19 research participant 
information sheet, and the blank informed consent to be filled out for signature by 
the parent/guardian. 
 
Completed parent/guardian signed and dated paper informed consent will be 
returned to the school and collected by the research team.  This protocol aligns 
with other school vision, hearing, and vaccination programs.  Care will be 
provided to all children with informed consent. 
 
Electronic informed consent forms will be distributed in addition to the 
established protocol for the distribution of paper consent forms to participating 
sites (schools). The following protocol will be followed for eICF distribution: 
 
Electronic informed consent can be distributed by a clinical team member using 
the CariedAway new enrollee email written in English or Spanish using the 
following hyperlinks: 
 
• 
English language eICF: https://is.gd/CariedAwayNYC 
• 
Spanish language eICF: https://is.gd/CariedAwayNYC_SP 
 
Electronic informed consent can be distributed by the schools in English or 
Spanish using whichever existing method the school uses for mobile phone 
contact, in emails, or on the school’s social media page in the following ways: 
 
1. NYU CariedAway Website URL by selecting “registering your child” 
1) English 
§ 
https://dental.nyu.edu/faculty/epidemiology-health-
promotion/pcori-grant.html 
§ 
Short URL: https://dental.nyu.edu/pcori 
2) Spanish 
§ 
https://dental.nyu.edu/faculty/epidemiology-health-
promotion/pcori-beca.html 
2. Hyperlinks in English and Spanish  
§ 
English language eICF: https://is.gd/CariedAwayNYC 
§ 
Spanish language eICF: https://is.gd/CariedAwayNYC_SP 
3. CariedAway email toolkit in English and Spanish  
 

20 
 
The parent or legal guardian fills out the eICF and uses ‘scratch’ method (mouse, 
stylus, or finger) to sign and then returns the completed ICF via Redcap. 
 
The study administrator will then cross-reference the OSIS number in the original 
.csv file which was provided to us at the beginning of each school year by the 
NYC Department of Education, and verify that the correct OSIS number was 
provided correctly by the consenter. 
 
The study administrator then uploads all of the informed consent PDF’s to NESS 
via the secure and password protected ShareFile link listed below: 
 
• 
https://nedental.sharefile.com 
 
NESS then uploads each student’s eICF to their electronic dental record in the 
iPad 
 
To facilitate accurate informed consent and student tracking we will request 
student rosters from the NY City Department of Education (NYC DOE). This will 
facilitate tracking students longitudinally. All forms will be translated into the 
major languages of NYC school children’s parents.   Those languages are 
Arabic, Bengali Bangla, Chinese, English, French, Haitian Creole, Korean, 
Russian, Spanish and Urdu.  
  
The consent form is valid for 5 years or as long as the child is in NYC schools.  If 
guardianship of the child changes a new informed consent will need to be signed. 
4.3 
Early Withdrawal of Participants 
A parent may withdraw their child at any time for any reason, with either a written 
request or a phone call (with verification) to the PI, CRA, or school.  Upon 
withdrawal the center is notified, and the record flagged to remove the child from 
the informed consent list in the data base, in the Apple iPad electronic record.   
Students who withdraw are not replaced. 
4.4 
Dental provider referral 
Parents of children without a dentist or children that require an urgent referral will 
be provided information on local dental providers in the following ways: 
4.4.1 
Children without a Dentist 
Parents/guardians of children without a dentist can access the CariedAway 
Website Dentist finder map.  They are instructed to click on the map, type in their 
address and then click on the blue pins to access the name, address and phone 
number for that provider.  All providers listed accept new patients, see children 
and, accept Medicaid and CHIP.  Parents will also be provided with the NYU 
CariedAway- addition to Website Dentist Provider Map Instructions. 
 
4.4.2 
Children that require an urgent referral 
Parents/guardians of children that require an urgent referral will receive the NYU 
CariedAway parent communication urgent referral email sent to them by the 
CariedAway clinical mangers.  This email provides them with the CariedAway-
addition to Website Dentist Provider Map Instructions.  The email also provides 
information for the NYU Department of Pediatric Dentistry. 

21 
 
5 Study Device  
5.1 
Description   
We use three agents, all are off-label.  None are investigational new drugs.: fluoride varnish (2 
agents), and silver-diamine-fluoride.  These agents are in common clinical use and are currently 
being provided by school-based oral health programs in NYC schools, have multiple 
randomized human clinical trials and systematic reviews indicating their efficacy in controlling 
caries, have American Dental Association billing codes, and are reimbursed by Medicaid and 
private insurers.   
Manufacturer’s information on each is provided below. 
 
 
Fluoride Varnish 
Proprietary Name:  PreviDent® Varnish Mint, Grape and Raspberry 
510(K) Number:  K132109 
Classification Name:  Varnish, Cavity 
Device Class: 2 
Manufacturer:  Colgate Oral Pharmaceuticals, 300 Park Avenue, New York, NY  10022 
Indications for Use: PreviDent® Fluoride Varnish is a topical fluoride for the treatment 
of dentinal sensitivity. 
 
Composition: PreviDent® 5% Sodium Fluoride Varnish contains 22,600 ppm fluoride. It 
has a strong desensitizing action when applied to dental surfaces, treating 
hypersensitivity quickly and easily. This product sets rapidly on contact with saliva, 
resulting in patient comfort and acceptance. PreviDent® Varnish will leave a thin film on 
the teeth after application. 
 
Treatment Regimen: 
1. Wash and dry tooth surface 
2. Mix well prior to application 
3. Apply product with supplied brush in the conventional manner 
4. Apply a thin amount of varnish on the tooth's surface until the varnish surface is 
dry 
5. Dispose of package and applicator after use 
 
 
Post Application Instructions: 
1. Hardens on contact with saliva so the patient may leave immediately after 
application of the product 
2. It is recommended that the patient be instructed to eat only soft foods for 2 hours 
after treatment 
 
Fluoride Varnish 
Proprietary Name:  FluoroDose® 
510(K) Number:  K982915 
Classification Name:  Varnish, Cavity 
Device Class: 2 
Manufacturer:  Centrix, Inc., 770 River Road, Shelton, Connecticut, 06484 
Indications for Use: FlouroDose® Fluoride Varnish is a topical fluoride for the treatment 
of dentinal sensitivity  

22 
 
 
Composition: FluoroDose® contains 5% Sodium Fluoride (NaF) or 22,600 ppm 
fluoride. FluoroDose is lactose, gluten free and nut free  
 
Treatment Regimen: 
1. Clean teeth and remove excess moisture from area to be treated 
2. Grip the foil cover and slowly peel back, exposing the brush applicator and 
varnish well 
3. Remove applicator brush and stir material in well 
4. Paint a thin film of varnish onto treatment area 
5. Let the varnish dry for approximately 10 seconds and then instruct the patient to 
close their mouth 
6. Dispose of package and applicator after use 
 
 
Post Application Instructions: 
1. Patients may leave immediately after treatment 
2. Patient should be advised to remain on a soft food diet and only drink cold liquids 
for two hours after treatment 
3. Patients should be instructed not to brush for a minimum of 4 to 6 hrs. 
 
Silver Diamine Fluoride 
 
Proprietary Name:  Diamine Silver Fluoride Dental Hypersensitivity Varnish 
 
510(K) Number:  K102973 
 
Classification Name:  Silver Dental Arrest 
Device Class: 2 
Manufacturer:  Elevate Oral Care, 346 Pike Road, Suite 5, West Palm Beach, Florida 
33411 
Indications for Use: Silver diamine fluoride is a clear liquid.  It is applied to sensitive 
teeth, carious lesions, and pits and fissures using Advantage Arrest Applicators.  The 
concentration of fluoride in SDF and fluoride varnish are indicated in the table below: 
 
 
Composition:  
Desensitizing Ingredient:  Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v 
Inactive Ingredients:  Purified water, FD&C Blue 1 
 
Treatment Regimen: 
1. Isolate the affected area of the tooth with cotton rolls 
2. Clean and dry the affected tooth surface 
3. Dispense 1-2 drops of solution into a dappen dish 
4. Transfer material directly to the tooth surface with an advantage arrest applicator 
brush for approximately 30 seconds 

23 
 
5. Allow to dry, do not rinse 
 
 
Post Application Instructions: 
1. If accidental contact with skin or clothing occurs gently apply immediately with 
soap and water 
 
5.2 
Method for Assigning Subjects to Treatment Groups   
This is a cluster randomized controlled design.  A computer generated randomization sequence 
will assign schools to simple or complex treatment. 
 
5.3 
Implantation of Study Device  
Silver diamine fluoride, along with all fluoride varnish materials are stored in a locked closet at 
NYU Dentistry.  As indicated in 5.1, after drying the affected tooth surface, silver diamine 
fluoride is applied with an Advantage Arrest Applicators for approximately 30 seconds.  The 
appropriate fluoride varnish is then applied to all teeth. 
 
5.4 
Subject Compliance Monitoring 
N/A 
 
5.5 
Prior and Concomitant Therapy 
Prior therapy is noted on the clinical examination.  The only concomitant therapy provided in this 
study is fluoride varnish.  All children are referred to a local dentist or community health center 
for follow on care.  However, our experience is that only approximately 10% of parents follow 
through.  Therefore, we see children once or twice per year.  Using complex prevention, we 
achieve ~50% reduction in untreated caries, and almost complete elimination of toothaches. 
 
5.6 
Packaging 
Silver diamine fluoride is available in an 8 oz. plastic bottle.  One to 2 drops of liquid are 
dispensed into a dappen dish for delivery to the affected area using Advantage Arrest 
Applicators. 
 
5.7 
Blinding of Study 
Neither the participants or clinicians are blinded.  The analysts, however, are blinded. 
 
5.8 
Receiving, Storage, Dispensing and Return 
 
5.8.1 
Receipt of Study Device 
Upon receipt of the of the silver diamine fluoride, an inventory will be performed 
and a device receipt log filled out and signed by the person accepting the 
shipment.  The designated study staff will count and verify that the shipment 
contains all the items noted in the shipment inventory.  Any damaged or 
unusable study devices in a given shipment will be documented in the study files.  
The investigator will notify the study sponsor of any damaged or unusable study 
devices that were supplied to the investigator’s site.  
 

24 
 
5.8.2 
Storage 
Silver diamine fluoride will be stored with other dental supplies in a locked closet 
on the 8th floor at NY.  Do not freeze. 
 
5.8.3 
Dispensing 
A drop of silver diamine fluoride is dispensed from the 8 ml plastic bottle into a 
dappen dish prior to application for each patient. Advantage Arrest Applicators 
are used to apply the solution to pits, fissures, and frank caries for 30 seconds.  
Following application of the silver diamine fluoride varnish is applied. 
 
5.8.4 
Return 
Typically, we completely use all of an 8 ml plastic bottle each day, as a bottle 
provides enough liquid to care for approximately 150 children. We dispose of the 
empty or partially empty bottle each day. 
6 Study Procedures  
6.1 
Description  
 
6.1.1 
 Informed Consent 
All students enrolled in the 76 participating elementary schools, with paper or 
electronic informed consent signed by the parent/guardian, will receive caries 
prevention currently recommended by systematic reviews and national 
guidelines. Care will be provided independently of a family’s ability to pay. 
Informed consent will be active for the entire time the child is in the school. Each 
year any newly enrolled students at the school will have the opportunity to join 
the program and be enrolled in the study if the parent/guardian signs the paper or 
electronic informed consent.   If guardianship of the child changes during this 
time a new paper or electronic informed consent will need to be signed.  The 
consent form is valid for 5 years or as long as the child is in NYC schools. 
 
To facilitate accurate informed consent and student tracking we will request 
student rosters from the NY City Department of Education (NYC DOE). This will 
facilitate tracking students longitudinally. All forms will be translated into the 
major languages of NYC school children’s parents.   Those languages are 
Arabic, Bengali Bangla, Chinese, English, French, Haitian Creole, Korean, 
Russian, Spanish and, Urdu.  
 
Blank IRB-approved paper informed consent will be distributed during 
CariedAway community engagement events and or mailed to students at the 
beginning of each school year in concert with all other school notifications.  
Parents can also choose to sign their child up for the program at their child’s 
school.  The current IRB approved blank informed consent will include a pre-
populated personalized principal recruitment letter from the principal, the 
parent/guardian alternate location recruitment letter, the parent/guardian 
recruitment flyer, program information, a health history, the NYU Langone Health 
COVID-19 research participant information sheet and, the blank informed 
consent to be filled out for signature by the parent/guardian. 
   
Completed parent/guardian signed and dated paper informed consent will be 
returned to the school and collected by the research team.  This protocol aligns 
with other school vision, hearing, and vaccination programs.  Care will be 

25 
 
provided to all children with informed consent.  The information listed on the 
signed paper informed consent is loaded directly into the Apple password 
protected iPad to create the child’s secure electronic dental record. 
 
Electronic informed consent forms will be distributed in addition to the 
established protocol for the distribution of paper consent forms to participating 
sites (schools). The following protocol will be followed for eICF distribution: 
 
Electronic informed consent can be distributed by a clinical team member using 
the CariedAway new enrollee email written in English or Spanish using the 
following hyperlinks: 
 
• 
English language eICF: https://is.gd/CariedAwayNYC 
• 
Spanish language eICF: https://is.gd/CariedAwayNYC_SP 
 
Electronic informed consent can be distributed by the schools in English or 
Spanish using whichever existing method the school uses for mobile phone 
contact, in emails, or on the school’s social media page in the following ways: 
 
1) NYU CariedAway Website URL by selecting “registering your child” 
1. English 
§ 
https://dental.nyu.edu/faculty/epidemiology-health-
promotion/pcori-grant.html 
§ 
Short URL: https://is.gd/CariedAwayNYC 
2. Spanish 
§ 
https://dental.nyu.edu/faculty/epidemiology-health-
promotion/pcori-beca.html 
2) Hyperlinks in English and Spanish  
§ 
English language eICF: https://is.gd/CariedAwayNYC 
§ 
Spanish language eICF: https://is.gd/CariedAwayNYC_SP 
 
 
The parent or legal guardian fills out the eICF and uses ‘scratch’ method (mouse, 
stylus, or finger) to sign and then returns the completed ICF via Redcap. 
 
Only select study investigators will have access to the eICF data, which will be 
stored on REDCap. This includes the principal investigators, the clinical research 
coordinator, the study administrator, the clinical director, the IRB coordinator and 
NESS.  
 
The study administrator will then cross-reference the OSIS number in the original 
.csv file which was provided to us at the beginning of each school year by the 
NYC Department of Education, and verify that the correct OSIS number was 
provided correctly by the consenter. 
 
The study administrator then uploads all of the informed consent PDF’s to NESS 
via the secure and password protected ShareFile link listed below: 
 
• 
https://nedental.sharefile.com 
 

26 
 
NESS then uploads each student’s eICF to their electronic dental record in the 
iPad. 
 
6.1.2 
 Scheduling 
For in school scheduling of preventive care our NYUCD HCP will work with the 
schools.   
 
For scheduling at alternate community-based locations our clinical teams will 
work with the administrator at each community-based location. 
 
Parents/guardians of children who have consented and need to be scheduled at 
a community-based location will be contacted via telephone by the NYUCD HCP 
to schedule an appointment.  They will be provided with the name and address of 
where we will be providing alternate care and a list of dates and times for 
scheduling.  If they are unavailable to schedule based on the dates provided, we 
will contact them when new dates and times become available. 
 
6.1.3 
 COVID-19 Pre-Screening and Screening Procedures 
The following procedures are performed 
6.1.3.1 NYUCD HCP Screening 
All NYUCD HCP are required to complete the COVID-19 NYU daily 
screener. Any NYUCD HCP who fails on the “screener pass” will 
automatically be referred to the NYU COVID prevention & response team 
and will not report to work.   
6.1.3.2 Screening In-school Students and School Staff 
We will follow the school’s protocol for COVID-19 screening of students 
and school staff.   
6.1.3.3 Screening of Community-based Staff 
We will follow the community-based locations protocol for COVID-19 
screening of their staff.   
6.1.3.4 Telephone Pre-screening of Children, Parent/Guardians at the 
Community-based Location 
1. 24 hours prior to the child’s appointment the NYUCD 
HCP will telephone the parent/guardian and ask them 
the following questions: 
a. Have you or your child had close contact with 
anyone who has a confirmed or suspected 
COVID-19 diagnosis in the past 14 days 
b. Have you or your child had any flu-like 
symptoms like fever, coughing, shortness of 
breath or difficulty breathing in the past 14 
days? 
c. Have you or your child had at least two of the 
following symptoms in the past 14 days:  chills, 
repeated shaking with chills, muscle pain, 
headache, diarrhea, sore throat, new loss of 
taste or smell? 

27 
 
d. Have you or your child traveled within a state 
designated by New York State’s Governor’s 
office as a restricted state? 
 
If the parent/guardian answers yes to any of the above questions, 
the child’s appointment will be scheduled for a later date (10 or 
more days later) 
 
6.1.4 
Clinical Room Set-up 
The following procedures will be performed 
 
The clinical treatment room set up will vary based on room size and ability to 
provide care at a safe distance. If the clinical room is small, only 1 station will be 
set up to provide care to 1 child at a time.  If the clinical room is large (eg: 
auditorium stage or large empty room), individual stations (up to 3) will be set up 
and spaced at a minimum of 6’ apart. 
 
The clinical work area is disinfected with an EPA registered intermediate level 
surface disinfectant before supplies needed for the day are removed from 
suitcases or backpack.  Supplies needed for the day are placed on a barrier 
protected clean table at least 6’ away from the dental chair.  The table is covered 
with a vinyl tablecloth. The suitcase is then placed under the clean table for 
storage. 
 
A barrier protected dirty table is set up at least 6’ away from the barrier protected 
clean clinical supply table. 
The dirty table is used for the disposal of used PPE, use disposable clinical 
supplies, and used non-disposable clinical supplies which are placed in a 
biohazard labeled sharps container and placed under the dirty table 
Clinical Room Diagram:  See illustration below: 

28 
 
 
 
6.1.5 
Waiting Area 
The following procedures will be followed in-school or at a community-based 
location: 
 
6.1.5.1 Waiting Area Preparation 
The following procedures are performed: 
1. On entry to the waiting area, a hand sanitation station is 
set up with: 
a. Alcohol-based hand sanitizer with 60-72% alcohol 
b. Disinfectant 
c. Contact free thermometer 
2. CariedAway HCP will set up chairs for the waiting area 
ensuring a 6’ distance. 
3. Any toys, reading material, or any other objects that are 
difficult to clean will be removed. 
4. A designated area will be assigned to perform the quality 
of life questionnaire (if applicable). 
 
 

29 
 
 
6.1.5.1.1 Waiting Room Screening Procedures 
 
1. Upon arrival the dental assistant will confirm that the child 
and individual escorting them are wearing face masks or 
covering.  If not, they will be supplied with a mask. 
2. The dental assistant will ask the child and escort to apply 
hand sanitizer. 
3. The dental assistant will take the temperature of the child 
and escort with a contact free thermometer.  Note: If the 
child or escort has a temperature of 100.4 °F or greater 
they will be deferred to seek primary care evaluation and 
the appointment will be postponed. 
4. If the child and escort has a temperature of less than 100.4 
°F the dental assistant will escort the child to the treatment 
area where they will seat the child in the dental chair. 
 
If appropriate, the person escorting the child will be seated in 
the waiting are with their mask on until the child has 
completed their treatment visit. 
 
The waiting room seats will be spaced 6’ apart and 
disinfected with an EPA registered intermediate level surface 
disinfectant between seating. 
 
6.1.6 
Examination and Diagnosis 
Each program will use password-protected Apple iPads with electronic dental 
records pre-populated with demographic information of all students with informed 
consent.  Student lists on the Apple iPads will be used to: collect students during 
the care delivery days; record clinical findings and care delivered; and generate 
take home forms (see below).  On the scheduled care days, we will provide a 
gentle toothbrush cleaning, oral hygiene instruction, a toothbrush and fluoridated 
toothpaste.  We will also carry out an examination and provide preventive care. 
 
 
The examination will include a soft tissue inspection and an assessment of all 
primary and permanent teeth to determine the presence/ absence of decay 
(active or arrested), missing, filled, or sealed surfaces on all teeth.  
 
 
6.1.7 
 Prevention   
Both simple and complex care regimens provide both primary and secondary 
caries prevention.  The goal of primary prevention is to prevent or delay the initial 
carious lesion using: 1) fluoride varnish for smooth surfaces (simple and complex 
prevention); and 2) either silver diamine fluoride (simple prevention) or sealants 
(complex prevention) for pits and fissures.  The goal of secondary prevention is 
to arrest caries in situ, and prevent disease progression.  This is accomplished 
with silver diamine fluoride (simple prevention) or interim therapeutic restorations 
(complex prevention). 
 
 
 
6.1.8 
 Take Home Messages and Follow-on Care 

30 
 
We will provide two take-home messages, one for parents, and one for school 
nurses. The parents’ message will identify the care provided to the child, note 
any additional care needed. 
 
Parents of children without a dentist or children that require an urgent referral will 
be provided information on local dental providers in the following ways: 
6.1.8.1 Children without a Dentist 
Parents/guardians of children without a dentist can access the CariedAway 
Website Dentist finder map and link (https://dental.nyu.edu/faculty/epidemiology-
health-promotion/pcori-grant.html).  They are instructed to click on the map, type 
in their address and then click on the blue pins to access the name, address and 
phone number for that provider.  All providers listed accept new patients, see 
children and, accept Medicaid and CHIP.  Parents will also be provided with the 
NYU CariedAway- addition to Website Dentist Provider Map Instructions. 
6.1.8.2 Children that require an urgent referral 
Parents/guardians of children that require an urgent referral will receive the NYU 
CariedAway parent communication urgent referral email sent to them by the 
CariedAway clinical mangers.  This email provides them with the CariedAway-
addition to Website Dentist Provider Map Instructions and link 
(https://dental.nyu.edu/faculty/epidemiology-health-promotion/pcori-grant.html).  
The email also provides information for the NYU Department of Pediatric 
Dentistry. 
 
The message for the nurses will be Excel spreadsheets that list the children 
seen, care provided and care needed, and that identify children who need 
immediate care.  For the latter, we will follow each school’s protocol.  
6.2 
Preventive Care 
 
6.2.1 
 Simple prevention 
Consists of a gentle toothbrush cleaning, oral hygiene instruction, an 
examination, delivery of silver diamine fluoride applied to all pits and fissures on 
bicuspids or molar teeth, and to all posterior, asymptomatic carious lesions. 
Fluoride varnish is then applied. Each child is given a small bag with a 
toothbrush, fluoride toothpaste, and a note indicating the results of the 
examination, the care provided, and a list of local dentists or community health 
centers for follow on care.  
 
6.2.2 
 Complex prevention 
Consists of a gentle toothbrush cleaning, oral hygiene instruction, an 
examination, delivery of glass ionomer sealants to all pits and fissures on 
bicuspids or molar teeth, and to all asymptomatic carious lesions. Each child is 
given a small bag with a toothbrush, fluoride toothpaste, and a note indicating the 
results of the examination, the care provided, and a list of local dentists or 
community health centers for follow on care.  
 
 

31 
 
6.3 
Study Administration and Duration 
Examination and care will be provided based in the school, at a community-based location, or 
NYUCD schedule and allow for a 30-minute eating free time following our care.   
Care is delivered in a school room (e.g.: an empty room or class room, auditorium stage, nurse 
office, etc.), at a community-based location, or at NYUCD using mobile dental equipment and 
disposable supplies.   
The clinical treatment room set up will vary based on room size and ability to provide care at a 
safe distance. If the clinical room is small, only 1 station will be set up to provide care to 1 child 
at a time.  If the clinical room is large (eg: auditorium stage or large empty room), individual 
stations (up to 3) will be set up and spaced at a minimum of 6’ apart. 
 
The room is set up prior to the beginning of treatment. 
 
All clinical personnel will wear personal protective equipment consistent with CDC, DOH, FDA 
and NYU Dentistry guidelines. 
 
NYUCD licensed dentists, dental hygienists, nurses, and/or advanced dental hygiene students 
supervised by licensed dental professionals will provide care to participating students at all 
locations.  All clinical personnel providing care will wear PPE based on current NYU Dentistry 
guidelines.  PPE is listed below: 
 
1. Disposable gowns 
2. Disposable gloves 
3. N95 respirator that have been fit tested for a specific respirator and shall be disposed of at 
the end of each clinical day 
4. Level 3 surgical masks 
5. Goggles 
6. Face Shields 
7. Bonnets 
8. Booties 
 
Gloves are changed between patients.  All dental chairs, stools and touch surfaces are 
disinfected with an EPA registered intermediate level surface disinfectant at the beginning of 
each day, prior to and after treating patients, and at the end of the day.  Goggles and face 
shields are also disinfected between patients. 
 
Care is delivered only during school, community-based location, or NYUCD hours.  Based on 
informed consents, children will be scheduled and seen in a school room, a community-based 
location room, or at NYUCD.  Children are escorted to the waiting room in the school by the 
school’s parent coordinator.  Children are brought by the parent/guardian at a community-based 
setting or at NYUCD.  After the child and parent/guardian at the community-based location 
passes the COVID-19 screening test, the child will be escorted to the clinical treatment room by 
the dental assistant at all locations. 
 
Care will be provided by NYUCD licensed dentists, dental hygienists, nurses, and/or advanced 
level dental hygiene students supervised by licensed dental professionals to all participating 
students at all locations.  After the child has completed treatment they will be required to put 
their mask back on and apply an alcohol-based hand sanitizer.  The dental assistant will bring 
the child to the waiting room area.  The child will be escorted back to the classroom by the 
school’s parent coordinator or back home by the parent/guardian from the community-based, or 
NYUCD locations. 

32 
 
      
Simple prevention takes approximately 5 minutes and is aerosol free.  It consists or a gentle 
tooth brush cleaning, oral hygiene instruction, an examination, delivery of silver diamine fluoride 
which takes approximately 1 minute to apply using Advantage Arrest Applicators to all pits and 
fissures on bicuspids or molar teeth, and to all posterior, asymptomatic carious lesions.  
Fluoride varnish is then applied which also takes 1 minute to apply. 
   
Complex prevention takes approximately 20 minutes and is aerosol.  It consists or a gentle 
toothbrush cleaning, oral hygiene instruction, an examination, delivery of glass ionomer sealants 
to all pits and fissures on bicuspids or molar teeth, and to all asymptomatic carious lesions.  
This takes about 5 minutes to provide care to ¼ of the mouth at a time.  Fluoride varnish is then 
applied which takes approximately 1 minute.   
6.4 
Control/Comparison Group and Confounding Factors 
Complex prevention is the “comparison” while simple prevention is the “intervention” group.  
Both groups receive primary and secondary prevention and we expect both protocols to be 
similarly effective in reducing untreated caries. 
 
We will include relevant confounders a priori in our analysis, including: gender, previous (or 
concurrent) dental treatment (identified as new or existing treated dentition at examination), age 
at examination, race/ethnicity, and any school-level indicators. As these data have a multilevel 
structure, we will additionally assess caries incidence and prevalence using multilevel mixed 
effects Poisson and logistic modeling (ML-MEM). We will examine the effects of comprehensive 
prevention at multiple levels (tooth, child, grade, and school). In this analysis, we will be able to 
explore the variation in clinical outcomes across child and school levels. For all GEE and 
multilevel models, we will conduct analysis for outcomes (caries prevalence and incidence) 
measured by all teeth, all adult teeth only, and all deciduous teeth only.  
6.5 
Randomization and Blinding 
 
6.5.1 
 Randomization  
We will do a block randomization, generating sets of unique numbers to assign 
the experimental condition.  Thus, for the first 30 schools we will generate 15 
sets, each set containing a 1 or a 2, representing treatment assignment, in 
random order. We will repeat this in year 2 for the second set of 30 schools. In 
year 2, an additional 16 schools will be selected to receive simple prevention 
once per year. 
 
6.5.2 
 Blinding 
As a pragmatic trial, this is non-blinded for the participants.  Neither schools, nor 
teachers, nor students, nor clinicians will be blinded.  Clinicians will work in 
teams that only provide either simple or complex prevention.  The analysts will be 
blinded as to the care provided to students in a particular school. 
 
6.6 
Compliance Assessment 
This intervention trial depends on protocol compliance by clinicians, not students.  
We will train and calibrate clinicians during the summer before beginning each 
school year.  To assess compliance, we will use qualitative and quantitative 
methods together with audit and feedback. 
 

33 
 
Qualitatively, to ensure that the electronic records reflect actual implementation, 
we will visit each team in the fall and spring of each year for a one-day site visit.  
During the day, we will monitor adherence to protocol, particularly: student flow, 
caries diagnosis, and procedures delivered. 
  
Quantitatively, we will use the elementary methods of statistical process 
control27,28. We will examine four domains: 1) informed consent rates; 2) caries 
prevalence (e.g.: diagnosis); 3) care provision; and 4) outcomes.  We will monitor 
these domains using electronic records and then verify with in-person site visits.  
We will start with national averages and standard deviations for school-based 
informed consent rate (35%), untreated caries prevalence of (21.5%).  All 
children (100%) with permanent bicuspids and molars should receive either silver 
diamine fluoride (simple prevention) or traditional sealants (complex prevention) 
and fluoride varnish.  All children (100%) with caries on their posterior teeth 
should receive either silver diamine fluoride (simple prevention) or interim 
therapeutic restorations (complex prevention). 
   
We will create histograms, Pareto charts, and control charts, at the school, 
grade, and clinician level to identify common cause and special cause variation. 
Control limits will be adjusted yearly based on prior year data. If a clinician, 
school or grade exhibits variation that is out of the control range we will use this 
audit to work with the clinical team and school to provide feedback. We will 
continue this process during the school year.   
6.7 
Prior and Concomitant Therapy 
NA 
 
6.8 
Receiving, Storage, Transporting, Dispensing, Breakdown and Disposal of Clinical 
Supplies 
    
6.8.1 
 Receiving 
The products used for this trial are typical standard of care (SOC) dental 
commodities obtained from Henry Schien and Elevate Oral Care.  They include 
toothbrushes, toothpaste, bibs, gauze, q-tips, floss, fluoride varnish, silver 
diamine fluoride (a topical varnish used to treat and prevent dental caries and 
relieve dentinal hypersensitivity, and glass ionomer cement (a dental restorative 
material used in dentistry for dental fillings) and all personal protective equipment 
(PPE). They are shipped to NYUCD and stored in a locked closet until used on 
the 8th floor with other clinical supplies. The same products will be safely 
transported to the participant schools or the local community-based location for 
study use.  
 
6.8.2 
Storage 
All supplies when not in use are stored in a locked closet on the 8th floor at 
NYUCD. 
 
6.8.3 
 Transporting 
Supplies are transported to and from the schools or community-based location in 
locked roller suitcases or locked backpacks.  Non disposable contaminated 
instruments are placed in a lockable puncture resistant plastic container which is 
labeled with a biohazard sticker.  The outside of the container is wiped down with 
an EPA registered intermediate level surface disinfectant.  Disposable sharp 

34 
 
instruments are then placed in red biohazard bags, with a biohazard label affixed 
to the outside of the bag.  The bag is then transported in a combination locked 
Agnus Bag (suitcase) to NYU for disposal per NYUCD protocol. 
 
6.8.4 
 Dispensing 
All supplies are removed from locked roller suitcases or locked backpacks. 
Using clean gloves clinical supplies are placed on a clean barrier protected table 
at least 6’ apart from the treatment station and barrier protected dirty table. 
 
6.8.5 
Breakdown  
After completing treatment, all non-used clinical supplies from the clean table are 
placed back in the suitcase or backpack. The outside of the suitcase and 
backpack are disinfected with an EPA registered intermediate level surface 
disinfectant and then locked and transported back to NYUCD where they are 
placed in a locked closet on the 8th floor. 
 
6.8.6 
 Disposal  
After each individual procedure is performed disposable items are brought to the 
barrier protected dirty table which is at least 6’ away from the barrier protected 
clean table.  Disposable items are placed in the trash.  All non-disposable sharps 
are placed in the sharps container labeled with a biohazard sticker which is 
located under the barrier protected dirty tale. Solid waste is disposed of into the 
receptacles lined with clear plastic bags.  If any of the materials contain or may 
contain absorbed droplets of blood, they are placed in a red biohazard bag with a 
biohazard label affixed to the outside of the bag.  The bag is then transported in a 
combination locked Agnus Bag (suitcase) to NYU for disposal per NYUCD 
protocol. 

35 
 
Study Procedures 
 
6.9 
Study Procedures Table 
 
 
 
Following stratification and solicitation, execution of MOU with individual schools, community-
based organizations, and randomization, care will be provided in a school, at a community-
based location, or at NYUCD.  In year 1 care will be offered in 30 schools, and in year 2 an 
additional 46 schools.  In year 3 care will also be offered at a community-based location and at 
NYUCD. 
 
 
NYC Elementary 
School / Community  Stratification
Eligible School / Community 
Solicitation
ID Participating Schools / 
Community Locations
School / Community / NYU MOU
School Randomization
Informed Consent
Exam + Prevention 1X or 2X per 
Year
School / 
Community 
Solicitation
Responders with 
NYU MOU
School 
Randomization
Simple   
Prevention
Examination + 
Prevention 
1X or 2X per Year
Complex 
Prevention
Examination + 
Prevention 
2X per Year
Non Responders

36 
 
 
7 Statistical Plan 
 
7.1 
Sample Size Determination 
The study is powered to the primary outcomes of caries arrest and caries prevention between 
twice-yearly simple and complex prevention. We expect to enroll approximately 14,100 students 
across the initial 60 schools over the duration of the study (N=235 per cluster).  The remaining 
16 schools will contribute approximately 3760 participants. From our pilot studies of school-
based caries prevention, baseline caries prevalence is approximately 40%. Our power 
estimates assume an equal proportion of success, p, of 20% caries arrest. With a given non-
inferiority margin (d) of 10%, a total sample size per group of 198 (Ntot = 396) is required for an 
alpha of 5% and a power of 80%29 . However, as we use a cluster randomized design, this 
sample size is inflated to account for clustering (intraclass correlation coefficient = .10) by a 
design effect of 24.4 to a total required sample of 9,662. 
   
For caries prevention, both interim therapeutic restorations and silver diamine fluoride have 
been shown to be 80% efficacious in individual clinical trials. Power for the repeated measures 
design was estimated using the method of Diggle et al (2002) for generalized estimating 
equations 30. For power estimates, we control for the baseline prevalence of untreated decay. 
We assume a conservative average number of visits per child of 6, with a power of .80 and an 
alpha of 5%. We further assume a repeated measures correlation of 0.5 and a per-visit attrition 
rate of 20%. For a given minimally detectable effect size (standardized effect size difference) of 
.25, an attrition and clustering adjusted sample size of 12,874 is required. Thus, our study is 
powered for these conservative assumptions for caries prevention. Further, we note that in the 
presence of the nonlinear link function, ME-GLM is more powerful than GEE, thus our power 
estimates are conservative and the anticipated sample size is sufficient for analysis.  
7.2 
Statistical Methods 
For caries arrest, we will first determine the per-patient proportion of carious lesions treated with 
simple versus complex prevention that stayed arrested throughout the length of the study. The 
percentage of arrested caries (at the child level) will be modeled using multilevel binomial 
regression. Our noninferiority margin, d, is set at 10%. Our null hypothesis is that simple 
prevention is not inferior to the complex prevention by at least d: psimple - pcomplex ³ d. Our 
alternative hypothesis is that psimple - pcomplex < d. We will use differences in effect sizes as 
estimated by confidence intervals to determine clinical non-inferiority of the two prevention 
methods.  For the prevention of new caries, we will use generalized estimating equations (GEE) 
with a logit link (caries prevalence) and a negative binomial link (caries incidence), assuming an 
exchangeable correlation matrix, to evaluate longitudinal effects of comprehensive care 
untreated decay. We will identify the number of teeth at risk for each child during each follow-up 
interval and determine the number of those teeth in which new caries is observed at the 
examination that ends that interval. Primary teeth lost in each interval and new permanent teeth 
will not contribute to data for that interval.  To explore non-linear trends in untreated decay 
between simple and complex prevention, we will use generalized additive models (GAMs) with 
non-parametric smoothers.  Longitudinal effects of simple and complex prevention on academic 
outcomes, compared to untreated children, will be analyzed using propensity score-matching 
and multilevel modeling. First, we will estimate propensity scores for each participant at 
baseline, establishing the probability of treatment assignment conditional on observed 
covariates (e.g., prior academic performance). Propensity scores will be used to match 
treatment students to students not receiving treatment, considering multiple forms of matching 

37 
 
such as nearest neighbor and caliper. Treated students and matched comparators will then be 
analyzed using multilevel mixed effects linear regression (for academic achievement) and 
Poisson regression (for school absences). 
 
Longitudinal effects of simple and complex prevention on dental-related service use and costs 
among Medicaid participants, compared to children in non-participating schools, will be 
analyzed using difference-in-differences analysis and propensity score matching. The 
propensity score weighting will be used to match children in participating schools to children in 
non-participating schools to account for any selection impacting whether a child is at a school 
participating in the CariedAway programs. The propensity score weighting will be used to 
account for student-level and school-level characteristics impacting whether the student is at a 
school participating in the CariedAway programs. 
 
We will then adapt a published Markov model in combination with threshold analysis to compare 
the simple and complex prevention programs relative to non-participating schools in net costs 
and quality-adjusted life-years to determine the cost-effectiveness and budget impact of all three 
options (simple prevention, complex prevention, no prevention).  
7.3 
Subject Population for Analysis 
For study outcomes, participants will be analyzed using intent to treat. All participants will be 
analyzed as randomized in the original randomization, regardless of whether or not they 
received an intervention. 
 
For dental-related service use and costs, all New York City elementary school-age children 
enrolled in Medicaid will be analyzed using intent-to-treat. 
 
7.4 
Interim Analysis 
There are no interim analyses in this study. 
8 DATA AND SAFETY MONITORING PLAN (DSMP) 
All protocol amendments, other than minor administrative changes will be submitted in a 
prospective manner to the NYU School of Medicine IRB for approval and PCORI for notification. 
8.1 
Informed Consent 
Each participating school will obtain consent in accordance with their local circumstances. 
 
The eICF forms were created and are stored using the secure REDCap data management 
system provided by the NYU Clinical and Translational Science Institute. The REDCap system 
is HIPAA compliant.  
 
The study administrator uploads all of the informed consent PDF’s to NESS via the secure and 
password protected ShareFile link listed below: 
 
• 
https://nedental.sharefile.com 
 
NESS then uploads each student’s eICF to their electronic dental record in the iPad. 
 
Only select study investigators will have access to the eICF data, which will be stored on 
REDCap. This includes the principal investigators, the clinical research coordinator, the study 
administrator, the clinical director, the IRB coordinator and NESS.  
 

38 
 
8.2 
Risk 
Risks associated with program participation include potential loss of privacy of the data. The 
strict security and Data Monitoring plan outlined in this proposal will help reduce this potential 
risk. Monitoring will be carried out by the PIs and Program Director. 
 
8.3 
Implementation 
On a daily basis, performance sites will upload data to New England Survey Systems (NESS). 
On a weekly basis, NESS will upload data to the Biostatistics and Epidemiology Data Analytics 
Center (BEDAC) formerly the Boston University Data Coordinating Center (DCC).  The BEDAC 
will maintain records for each performance site that includes patients seen and data. The 
BEDAC will provide weekly reports to the PIs, Program Director, and clinical research associate 
(CRA) for each performance site that includes the daily reports. These reports will be matched 
with the MOPs to ensure timely recruitment and data reporting. If results are out of expected 
range, the CRA will contact the clinical team to determine the cause and develop a plan to 
resolve the problem. Monthly, quarterly, and yearly reports will be generated by the BEDAC and 
provided to the PIs and Program Director. The initial reports will include recruitment data, while 
subsequent reports will include recruitment, retention, and databases for analysis. 
8.4 
Confidentiality 
8.4.1 
 Protection of Subject Privacy 
Subject Confidentiality is strictly held in trust by the investigators, study staff, and 
the sponsor(s) and their agents. 
   
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 
sponsor. 
 
All patient information will be stored on password protected tablet (Apple iPad) 
computers. The iPads are transported by our clinical staff in a locked backpack to 
and from treatment locations.  The iPads are locked each night in a closet on the 
8th floor at NYUCD.  Participant data is uploaded at the end of each day through 
a secure transmitting server at NESS. NESS verifies validity of data and erases 
data from the tablet (Apple iPad). The BEDAC and NESS have additional data 
security protocols in place for data fidelity and security. Finally, NESS provides 
de-identified data to the BEDAC and the BEDAC provides de-identified data to 
the analytic team. Data monitoring, quality assurance, and quality control will be 
performed by the study Principal Investigators, NESS, the BEDAC, and the NYU 
Institutional Review Board. 
   
The study monitor or other authorized representatives of the sponsor may 
inspect all study documents and records required to be maintained by the 
investigator, including but not limited to clinical data for the study subjects.  The 
PI site will permit access to such records. 
 
The Health Evaluation and Analytics Lab at New York University’s Wagner 
School of Public Service and New York University’s School of Medicine will act 
as a third-party to carry out the the linkage between the oral health outcomes 
data collected through CariedAway and New York Medicaid claims, encounter, 
and eligibility data. The linkage will be carried out using the Medicaid billing IDs 
collected through the implementation of the CariedAway program and/or first 

39 
 
name, last name, date of birth, gender and residential zip code of the student. 
The Health Evaluation and Analytics Lab (HEAL) will then remove all “facial” 
identifiers (IDs, addresses, etc.) from the data provided for analysis to construct a 
HIPAA-defined “limited data set”. We will exclude children from the analysis who 
did not consent to providing their oral health outcomes data and Medicaid claims 
data.  
 
The Medicaid claims, encounter, and eligibility data (and any other data with 
personal identifiers) will be maintained on password-protected computers locked 
inside metal cabinets that would in turn be fastened to office infrastructure, inside 
locked offices in limited-access buildings. Additionally, the cage will be bolted 
down to the floor to prevent the physical removal of the hard drive and the data 
from the cage and from the office. These computers would not have any 
connection to the internet except briefly periodically to upgrade software.  All data 
backups would be maintained on password protected encrypted external hard 
drives stored in locked cabinets in locked offices.  These specifications are in 
accordance with the agreement between the Centers of Medicare and Medicaid 
Services, the NYU School of Medicine, and NYU Wagner for the release and 
analysis of the New York Medicaid claims data. The PD/PI will use only indirect 
patient identifiers to minimize the likelihood of identification. No attempts will be 
made to identify patients in the data, and in the case where subgroup analysis 
leads to small sample sizes at risk of identification, data will be aggregated or the 
subgroup enlarged to prevent identification from occurring.   
 
8.4.2 
 Confidentiality During Adverse Event (AE) Reporting 
AE reports and annual summaries will not include subject or group-identifiable 
material. Each report will only include the identification code. 
 
8.5 
Expected Risks 
There are no expected risks associated with the clinical interventions proposed in this study. 
The only risk would be a data breach. The only possibility for a data breach would be the loss or 
theft of the tablet computers (Apple iPads) used for data collection. However, data is typically 
synced with NESS before the data collector leaves the school. 
 
The iPads are transported by our clinical staff in a locked backpack to and from treatment 
locations.  The iPads are locked each night in a closet on the 8th floor at NYUCD.   
 
8.6 
Adverse Event/ Unanticipated Problems 
8.6.1 
Definitions 
8.6.1.1  Adverse Event (AE) 
For the purposes of this study, we know of no adverse events related to 
the clinical interventions in the study. Adverse events would therefore 
include protocol violations and/or breaches of confidentiality. Breaches of 
confidentiality are unlikely given the above procedures in place. Protocol 
violations will be identified using audits and feedback of patient records to 
ensure protocols are being followed and any complaints from patients. 
Any instances of protocol violation or breach of confidentiality will be 
reported to the IRB and to PCORI.  

40 
 
8.6.1.2  Unanticipated Problems (UP) 
Unanticipated problems will be recorded in the data collection system 
throughout the study.  
8.6.1.3  Serious Adverse Event (SAE) 
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. 
8.7 
Time Period and Frequency for Event Assessment and Follow-Up 
The PI will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation.  At each study visit, the investigator will inquire about the occurrence of 
AE/SAEs since the last visit.  Events will be followed for outcome information until resolution or 
stabilization. 
 
8.8 
Characteristics of an Adverse Event 
 
8.8.1 
 Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines 
are used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and 
event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and 
event onset. 

41 
 
b. An alternate etiology has been established. 
 
8.8.2 
 Expectedness of SAEs 
The Study PIs will be responsible for determining whether an SAE is expected or 
unexpected.  An adverse event will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information 
previously described for the intervention.  No SAEs are expected for clinical 
interventions in this study. 
 
8.8.3 
 Severity of Event 
The following scale will be used to grade adverse events: 
 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
 
2. Moderate: minimal, local, or non-invasive intervention indicated; 
moderate impact on ADL 
 
3. Severe: significant symptoms requiring invasive intervention; subject 
seeks medical attention, needs major assistance with ADL  
8.9 
Reporting Procedures 
 
8.9.1 
 Reporting for Multi-Center Trials 
Not applicable. 
 
8.9.2 
 Unanticipated Problem Reporting 
Incidents or events that meet the Office of Human Research Protections (OHRP) 
criteria for unanticipated problems will result in completing an unanticipated 
problem report form. The following information will be reported 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 (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, unanticipated problems will be 
reported using the following timeline: 
   
• Unanticipated problems that are serious adverse events will be reported to 
the IRB and PCORI within 7 days of the investigator becoming aware of 
the event.  

42 
 
Any other unanticipated problem will be reported to the IRB and PCORI within 14 
days of the investigator becoming aware of the problem.  
 
8.9.3 
 Adverse Event Reporting of Non-IND Studies 
SAEs that are unanticipated, serious, and possibly related to the study 
intervention will be reported to the IRB and PCORI in accordance with 
requirements. 
   
• Unexpected fatal or life-threatening AEs related to the intervention will be 
reported to the PCORI Project Manager within 3 days of the investigator 
becoming aware of the event.  Other serious and unexpected AEs related 
to the intervention will be reported within 7 days. 
• Anticipated or unrelated SAEs will be handled in a less urgent manner but 
will be reported to the IRB in accordance with their requirements and will 
be reported to PCORI on an annual basis.    
• All other AEs documented during the course of the trial will be reported to 
PCORI on an annual basis by way of inclusion in the annual report and in 
the annual AE/DSMP summary which will be provided to PCORI. 
 
We note that no clinical adverse events are expected. 
 
8.9.4 
 Adverse Event Reporting of Investigation New Drug (IND) Studies 
Not applicable. 
 
8.9.5 
 Events of Special Interest (if applicable) 
Not applicable. 
 
8.9.6 
 Reporting of Pregnancy 
Not applicable. 
8.10 Halting Rules 
Given the 25-year history of the study PIs, we know of no safety issues that would prompt 
suspension of enrollment or the interventions. However, if we encounter serious, unexpected, 
and related AEs, the PIs, PCORI, and the IRB would confer to determine whether findings might 
trigger a safety review based on the number of overall SAEs, the occurrence frequency of the 
type of SAE, severe AEs/reactions, or increased frequency of events. 
 
8.11 Quality Control and Quality Assurance 
Each year of the study, student rosters in participating schools will be requested from the NYC 
Department of Education, which will include student unique identification numbers, names, 
addresses, and socio-demographic information. 
 
At the end of each clinic day, the clinical lead in each treatment location will synchronize Apple 
iPads, used to collect data, with NESS to securely upload examination and clinical data to 
electronic dental records. Records will then be checked to verify successful transmission, and 
then erased from each Apple iPad. Transmitted data will include unique identifiers of study 
participants, demographic information, and examination and care data. 
  
Congruence of unique identifier with demographics (for returning students), as well as in/out of 
range includes: date of birth with grade, presence/absence and number and type of teeth, 
increasing occurrence of permanent teeth and decreasing occurrence of primary teeth, and 

43 
 
logic errors (e.g.: change from decay to sound).  Records with apparent errors will be set aside 
for hand check.  If errors cannot be rectified, a child’s data for a given visit will be excluded from 
the analysis. 
  
If metrics are beyond established control limits, the CRA will contact the performance site.  We 
will determine if there is special or to determine the cause and see if and how we can assist the 
performance site. 
   
As indicated in the Research Plan, reports will be generated by the BEDAC and provided to the 
Co-PIs and Patient and Stakeholder Partners.  
8.12 Subject Accrual and Compliance 
NESS maintains records for each program, school, grade, and child.  NESS provides weekly 
reports to the CRA (who will share this with the Co-PIs) to assess accrual.  These reports will be 
matched with the manual of procedures for the performance sites to insure timely recruitment 
and data reporting.  
  
As indicated in the Research Plan, reports will be generated by the BEDAC and provided to the 
Co-PIs and Patient and Stakeholder Partners.  
 
8.12.1 Measurement and Reporting of Subject Accrual 
NESS maintains records for each program, school, grade, and child.  NESS 
provides weekly reports to the CRA (who will share this with the Co-PIs) to 
assess accrual.  These reports will be matched with the manual of procedures for 
the performance sites to insure timely recruitment and data reporting.  
  
As indicated in the Research Plan, reports will be generated by the BEDAC and 
provided to the Co-PIs and Patient and Stakeholder Partners. 
 
8.12.2 Measurement and Reporting of Participant Adherence to Treatment 
Protocol 
Not applicable. 
 
8.13 Stopping Rules 
This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; (3) 
any new information becomes available during the trial that necessitates stopping the trial; or (4) 
other situations occur that might warrant stopping the trial.   
 
8.14 Safety Review Plan 
 
Study progress and safety will be reviewed monthly.  Progress reports, including patient 
recruitment, retention/attrition, and AEs will be provided to the community stakeholder groups as 
listed in the study protocol. An Annual Report will be compiled and will include a list and 
summary of AEs.  In addition, the Annual Report will address (1) whether AE rates are 
consistent with pre-study assumptions; (2) reason for dropouts from the study; (3) whether all 
participants met entry criteria; (4) whether continuation of the study is justified on the basis that 
additional data are needed to accomplish the stated aims of the study; and (5) conditions 
whereby the study might be terminated prematurely.  The Annual Report will be sent to IRB and 

44 
 
PCORI.  The IRB and other applicable recipients will review progress of this study on an annual 
basis 
 
Study Report tables will be generated only from aggregate (not by group assignment) baseline 
and aggregate safety data for the study population. 
 
8.15 Submission of On-Site Monitoring/Audit and Inspection Reports 
Any expectation of violations of protocols will result in an audit of data collection and study 
assessors. The IRB will receive copies of all study monitoring/audit reports that are submitted 
quarterly as listed in Table A. 
 
Table A 
 
8.16 Data Handling and Record Keeping 
The 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.  
 
8.17 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff and NESS, 
under the supervision of the investigators.  All source documents and reports must be reviewed 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Monthly 
PI, Internal QA Reviewer 
(BEDAC) 
Quarterly 
Community Stakeholder Groups 
Status of all enrolled subjects, as 
of date of reporting  
Monthly 
PI, Internal QA Reviewer 
(BEDAC) 
Quarterly 
Community Stakeholder Groups 
Data entry quality control checks 
on 100% of charts 
Weekly 
QA Reviewer (BEDAC) 
Adherence data regarding study 
visits and intervention 
Weekly 
PI, Internal QA Reviewer 
Quarterly 
Community Stakeholder Groups 
Protocol violations 
Weekly 
PI, Internal QA Reviewer 
Quarterly 
 
Community Stakeholder Groups 
Annually 
PCORI, IRB 
SAEs (unexpected and related) 
Per occurrence 
PI 
PCORI 
SAEs (expected or unrelated) 
Per Occurrence 
PI, Internal  
Annually 
Community Stakeholder Groups 
PCORI 
Unanticipated Problems 
Monthly 
PI, Internal QA Reviewer 
Per Policy 
IRB 

45 
 
by the study team and data entry staff, who will ensure that they are accurate and complete. 
Unanticipated problems and adverse events must be reviewed by the investigator or designee.   
8.18 Database Protection 
This study will incorporate a Biostatistics and Epidemiology Data Analytics Center located at 
Boston University for data storage and security. Access to the database will be secured with 
password protection.  The informatics manager will receive only coded information that is 
entered into the database under those identification numbers.  Electronic communication with 
outside collaborators will involve only unidentifiable information. The database incorporates an 
electronic audit trail to show change(s) to data after original entry including the date/time and 
user making the change. 
 
8.19 Source Documents/Protections 
Source data is all information, original records of findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are 
contained in source documents.  For this trial the source documents include: informed consent, 
health history, examination and clinical care records.  These are all collected and entered 
electronically on Apple iPads and maintained on a secure data base at NESS. 
 
 
 
The eICF forms were created and are stored using the secure REDCap data management 
system provided by the NYU Clinical and Translational Science Institute. The REDCap system 
is HIPAA compliant. 
 
The tablet computers (Apple iPads) used in this study are password protected for each user 
(with individual usernames and passwords). Data is transmitted over a secure private network. 
Data is transmitted to investigators using a secure 128-bit encryption.   
 
When a staff member employed at NYUCD who has access to the Apple iPads is no longer 
employed by NYUCD, the CRA notifies NESS and that user’s username and password is 
removed. 
 
8.20 Case Report Forms 
All study forms are electronic and reside on Apple iPads.  Forms require completion prior to 
moving to next steps.  Out of range entries are flagged immediately for correction, if necessary, 
and re-entry. 
 
8.21 Records Retention and Storage 
All records are securely stored electronically on the NESS servers.  They will be stored for the 
term of the study. 
 
8.22 Study/Regulatory Binder 
We will use the MedPoint electronic study/regulatory binder:  https://esafe.medpt.com 
 
8.23 Schedule and Content of Reports 
Enrollment reports will be reviewed biannually, as study enrollment will be conducted in the fall 
semester of each school year. Review will thus occur in the spring of the same academic year. 
Enrollment reports and other study reports will be presented to study stakeholder groups on a 
quarterly basis, as will reports of study conduct. All data will be masked to study investigators as 

46 
 
data are de-identified at the BEDAC prior to being sent to investigators for analysis. The study 
PIs and biostatisticians do not have access to the identification code key. Finally, participating 
schools and students will be assigned IDs prior to data collection.  
8.24 Informed Consent 
This study requires an alteration of informed consent.  The CariedAway study team will not meet 
directly with the parent/guardian to discuss and obtain informed consent for their child to 
participate in this study. The consent process itself does not require a study team member to 
sign off on the informed consent. Instead, school administrators send and provide study 
information and informed consent for the parent/guardian to review and sign themselves.  If the 
parent/guardian has any questions regarding the study or the informed consent process, they 
can contact the school administrator or the principal investigator directly. 
 
Principal personalized pre-populated recruitment letters, the parent/guardian alternate location 
recruitment letter, the NYU Langone Health COVID-19 research participation information sheet 
and blank Informed consent forms are IRB-approved.  The parent or guardian is required to 
read and review the documents or have the documents read to him or her.  The parent or 
guardian will also have the opportunity to call the school administrator or the principal 
investigator if they have questions regarding the study.  The investigator or designee will explain 
the research study and billing procedures to the school principal and designated staff at the 
initial recruitment meeting which may be conducted in person or via Zoom.  Upon receiving 
approval from NYSDOH to provide services in schools, NYUCD HCP will meet again with the 
school principal and designated staff either in person or via Zoom to go over the program and 
discuss the next steps. 
 
All parents/guardians of new or previously consented students will be contacted via telephone 
by one of our clinical team members prior to scheduling any appointments.   Parents/guardians 
of previously consented students will be reminded that they signed a 5 year informed consent.  
The clinical team member will use the research participant telephone recruitment script for 
COVID-19 updates.  They will ask them a few questions to assess whether it makes sense, 
from a safety perspective due to the COVID-19 pandemic if they wish to have their child to 
participate or continue to participate in this research study.  After a clinical team member speaks 
with the parent/guardian of a new participant, the clinical team member will send the 
parent/guardian the CariedAway new enrollee email written in English or Spanish.  The email 
will also contain a link to the REDCap eICF and provide contact information if the 
parent/guardian has further questions. 
 
NYUCD CariedAway staff will also conduct the following community engagement events via 
Zoom, if possible.  Actual activity will be guided by the signed MOU between CariedAway and 
the school or community organization. This may be modified on an ad hoc basis depending on 
the impact of, and reaction to, COVID-19 by a school or community location.    
 
a. One professional development (PD) meeting at least per semester: NYUCD 
CariedAway staff will set up a Zoom meeting with each schools PD to educate 
teachers and additional staff about the program and billing procedures. NYUCD 
CariedAway staff will go over the personalized pre-populated principal 
recruitment letter, the parent/guardian alternate location recruitment letter which 
explains billing procedures and informed consent form in detail, discuss the 
process for scheduling students at alternate community-based locations and 
instruct all staff on how to properly fill out the informed consent form, and answer 
any questions they may have. Teachers will receive personalized pre-populated 
principal recruitment letters, the parent/guardian alternate location recruitment 

47 
 
letter, the NYU Langone Health COVID-19 research participation information 
sheet and blank informed consent forms to distribute to all of their students. 
 
b. In-Class or Zoom Oral Health Education (OHE) Presentations at least once per 
semester: NYUCD CariedAway staff will provide in-class or Zoom OHE to each 
class at each school once per semester. This allows NYUCD CariedAway staff to 
engage with all teachers/staff as well as each student.  Additional personalized 
pre-populated principal recruitment letters, the parent/guardian alternate location 
recruitment letter, the NYU Langone Health COVID-19 research participation 
information sheet and blank informed consent forms may be provided at this 
time. 
 
c. Informational tabling at least once per semester: NYUCD CariedAway staff will 
provide parent/guardian informational tabling during student arrival and students 
dismissal time. This allows parents to meet NYUCD CariedAway staff, learn 
about the program, review and receive the personalized pre-populated principal 
recruitment letter, explain billing procedures, receive the informed consent form, 
and ask any questions they may have. 
 
d. Completed signed and dated informed consent forms are returned to the 
designated school staff to be kept and checked for completeness. NYUCD 
CariedAway staff will collect these consents 2 weeks prior to a scheduled 
treatment week and ensure an additional check for completeness. 
  
The parent or guardian will sign the completed paper or electronic informed consent document 
prior to any study-related assessments or procedures. Consent may be withdrawn at any time 
throughout the course of the study.  
 
A separate picture of page 1 and page 2 of the completed, signed and dated paper informed 
consent is taken with the iPad camera and each image is saved and stored in the electronic 
dental record for each child in the manage subject page within the child’s electronic dental 
record on the Apple iPad. 
8.25 Reporting Changes in Study Status 
During the funding of this study, any action by the IRB or one of the study investigators that 
results in a temporary or permanent suspension of the study will be reported to the PCORI 
Program Official within 3 business days of notification. 
 
 

48 
 
9 Ethical Considerations 
 
This study will be conducted in compliance with the protocol approved by the IRB, GCP 
guidelines, and applicable NYUMC and federal regulatory requirements. No deviation from the 
protocol will be implemented without the prior review and approval of the IRB, except where it 
may be necessary to eliminate an immediate risk to a participant. In such case, the deviation will 
be reported to the IRB according to its policies and procedures.  
 
This protocol and any amendments will be submitted to an IRB in agreement with local legal 
prescriptions, for formal approval of the study conduct.  The decision of the IRB concerning the 
conduct of the study will be made in writing to the investigator.  
 
This study involves children. All parents/legal guardian will be provided an assent form 
describing the study and providing sufficient information for them to make an informed decision 
about their participation.  See Attachment [NYC DOE CariedAway Parental ICF] for a copy of 
the Participant Informed Consent Form.  This consent form will be submitted with the protocol 
for review and approval by the IRB for the study.  The formal consent of a participant, using the 
IRB-approved paper or electronic consent form, must be obtained before that participant 
undergoes any study procedure.  The parent or a legally acceptable guardian or surrogate must 
sign the paper or electronic consent form.  
10 Study Finances 
 
10.1 Funding Source 
This study is financed through a grant from the Patient Centered Outcomes Research Institute 
 
10.2 Conflict of Interest 
None. 
 
10.3 Participant Stipends or Payments 
None. 
11 Publication Plan 
Neither the complete nor any part of the results of the study carried out under this protocol will 
be published or passed on to any third party without the consent of the PI or primary responsible 
party. Any investigators involved with this study will be obligated to provide the PI or primary 
responsible party with complete test results and all data derived from the study. 
12 Attachments 
1.  New York University / New York City MOU 
2.  Current New York City IRB approved Informed Consent 
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