Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomized Controlled Trial
Phase: NA
Conditions: Dental Caries
Sponsor: NYU College of Dentistry

CARIEDAWAY NH  
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NCT #03448107 
CT.GOV Submission date: 12/4/24 
 
Statewide Implementation and Evaluation of a Rural, School and Community-Based, 
Caries Prevention Program 
This is a pragmatic, cluster randomized, non-inferiority controlled trial to be conducted in New 
Hampshire (NH) elementary schools and at community-based locations to compare simple vs 
complex caries prevention interventions. Simple is defined as fluoride varnish + silver diamine 
fluoride. Complex is defined as fluoride varnish + traditional sealants + 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 
433 First Avenue, Room 720 
212-998-9719 
rniederman@nyu.edu 
 
 
Funding Support: 
 
National Institute of Minorities and Health Disparities 
National Institutes of Health 
6707 Democracy Boulevard, Suite 800 
Bethesda, MD 20892-5465  
Phone: 301-402-1366 Fax: 301-480-4049 
 
 
Study Intervention: 
The trial compares two caries prevention protocols 
delivered twice yearly in elementary schools or at 
community-based locations: a novel simple intervention of 
fluoride varnish + silver diamine fluoride vs the traditional 
complex intervention of fluoride varnish + traditional 
sealants + temporary fillings. 
 
 
IRB Number: 
 
 
S17-01221 
 
 
 
 
Initial version: 
V1 September 14, 2017 
Amended: 
 
V2 July 30, 2018 
Amended: 
 
V3 September 6, 2018 
Amended: 
 
V4 August 15, 2019 

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Amended: 
 
V5 July 17, 2020 
Amended: 
 
V6 February 8, 2021 

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Table of Contents 
 
1 
INTRODUCTION ........................................................................................................................... 8 
1.1 
BACKGROUND ................................................................................................................................. 8 
1.2 
STUDY RATIONALE ......................................................................................................................... 10 
1.3 
INVESTIGATIONAL DEVICE ............................................................................................................... 11 
1.4 
RESEARCH RISKS & BENEFITS ........................................................................................................... 11 
1.4.1 
Risk of Investigational Device ............................................................................................... 11 
1.4.2 
Other Risks of Study Population ............................................................................................ 11 
1.4.3 
Potential Benefits .................................................................................................................. 19 
2 
STUDY OBJECTIVES .................................................................................................................... 19 
2.1 
PRIMARY OBJECTIVE ...................................................................................................................... 19 
2.2 
SECONDARY OBJECTIVE(S) ............................................................................................................... 19 
3 
STUDY DESIGN ........................................................................................................................... 19 
3.1 
GENERAL DESIGN .......................................................................................................................... 19 
3.1.1 
COVID-19 .............................................................................................................................. 19 
3.2 
PRIMARY STUDY ENDPOINTS ........................................................................................................... 21 
3.3 
SECONDARY STUDY ENDPOINTS ....................................................................................................... 21 
3.4 
PRIMARY SAFETY ENDPOINTS .......................................................................................................... 21 
4 
PARTICIPANT SELECTION, ENROLLMENT, AND WITHDRAWAL .................................................... 21 
4.1 
STUDY POPULATION ....................................................................................................................... 21 
4.2 
INCLUSION CRITERIA ...................................................................................................................... 21 
4.3 
EXCLUSION CRITERIA ...................................................................................................................... 21 
4.4 
PARTICIPANT RECRUITMENT, SCREENING AND ENROLLMENT ................................................................. 22 
4.4.1 
Recruitment. ......................................................................................................................... 22 
4.4.2 
School Solicitation. ................................................................................................................ 22 
4.4.3 
School Randomization .......................................................................................................... 25 
4.4.4 
School Rosters and Informed Consent Preparation .............................................................. 25 
4.4.5 
Informed Consent ................................................................................................................. 26 
4.5 
EARLY WITHDRAWAL OF PARTICIPANTS ............................................................................................. 29 
5 
STUDY DEVICE ........................................................................................................................... 29 
5.1 
DESCRIPTION ................................................................................................................................ 29 
5.2 
TREATMENT REGIMEN .................................................................................................................... 29 
5.3 
METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS ............................................................... 29 
5.4 
IMPLANTATION OF STUDY DEVICE ..................................................................................................... 30 
5.5 
SUBJECT COMPLIANCE MONITORING. ............................................................................................... 30 
5.6 
PRIOR AND CONCOMITANT THERAPY ................................................................................................ 30 
5.7 
PACKAGING .................................................................................................................................. 30 
5.8 
BLINDING OF STUDY ....................................................................................................................... 30 
5.9 
RECEIVING, STORAGE, DISPENSING AND RETURN ................................................................................ 30 
5.9.1 
Receiving ............................................................................................................................... 30 
5.9.2 
Storage ................................................................................................................................. 30 
5.9.3 
Dispensing ............................................................................................................................. 30 
5.9.4 
Return ................................................................................................................................... 31 

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6 
STUDY PROCEDURES .................................................................................................................. 31 
6.1 
DESCRIPTION ................................................................................................................................ 31 
6.1.1 
Scheduling ............................................................................................................................. 31 
6.1.2 
COVID-19 Site Pre-Visit Assessment and Screening Procedures ........................................... 31 
6.1.3 
Clinical Room Set-up ............................................................................................................. 32 
6.1.4 
Waiting Room Area. ............................................................................................................. 34 
6.1.5 
Examination and Diagnosis .................................................................................................. 35 
6.1.6 
Prevention ............................................................................................................................. 35 
6.1.7 
Take Home Messages and Follow-on Care ........................................................................... 35 
6.2 
STUDY ADMINISTRATION AND DURATION .......................................................................................... 35 
6.3 
CONTROL/COMPARISON GROUP AND CONFOUNDING FACTORS ............................................................ 36 
6.4 
RANDOMIZATION AND BLINDING ...................................................................................................... 36 
6.4.1 
Randomization ...................................................................................................................... 36 
6.4.2 
Blinding ................................................................................................................................. 37 
6.5 
COMPLIANCE ASSESSMENT .............................................................................................................. 37 
6.6 
PRIOR AND CONCOMITANT THERAPY ................................................................................................ 37 
7 
STUDY PROCEDURE ................................................................................................................... 37 
7.1 
STUDY PROCEDURES TABLE ............................................................................................................. 37 
8 
STATISTICAL PLAN ..................................................................................................................... 38 
8.1 
SAMPLE SIZE DETERMINATION ......................................................................................................... 38 
8.2 
STATISTICAL METHODS ................................................................................................................... 39 
8.3 
SUBJECT POPULATION FOR ANALYSIS ................................................................................................ 40 
8.4 
INTERIM ANALYSIS ......................................................................................................................... 40 
9 
SAFETY AND ADVERSE EVENTS .................................................................................................. 40 
9.1 
RISKS AND DISCOMFORTS ............................................................................................................... 40 
9.2 
ADVERSE EVENT DEFINITIONS .......................................................................................................... 41 
9.2.1 
Recording of Adverse Events ................................................................................................. 41 
9.3 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ............................................ 42 
9.3.1 
Investigator Reporting: Notifying the IRB ............................................................................. 42 
9.4 
UNBLINDING PROCEDURES .............................................................................................................. 43 
9.5 
STOPPING RULES ........................................................................................................................... 43 
9.6 
MONITORING OF EVENTS ................................................................................................................ 43 
9.6.1 
Data Monitoring Committee ................................................................................................. 43 
10 
DATA HANDLING AND RECORD KEEPING ................................................................................... 44 
10.1 
CONFIDENTIALITY .......................................................................................................................... 44 
10.2 
SOURCE DOCUMENTS ..................................................................................................................... 44 
10.3 
CASE REPORT FORMS ..................................................................................................................... 44 
10.4 
RECORDS RETENTION AND STORAGE ................................................................................................. 44 
10.5 
STUDY/REGULATORY BINDER .......................................................................................................... 44 
11 
STUDY MONITORING, AUDITING, AND INSPECTING ................................................................... 44 
11.1 
STUDY MONITORING PLAN .............................................................................................................. 44 
11.2 
AUDITING AND INSPECTING ............................................................................................................. 45 
12 
ETHICAL CONSIDERATIONS ........................................................................................................ 45 
13 
STUDY FINANCES ....................................................................................................................... 45 

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13.1 
FUNDING SOURCE ......................................................................................................................... 45 
13.2 
CONFLICT OF INTEREST ................................................................................................................... 45 
13.3 
PARTICIPANT STIPENDS OR PAYMENTS .............................................................................................. 45 
14 
PUBLICATION PLAN ................................................................................................................... 45 
15 
ATTACHMENTS .......................................................................................................................... 46 
16 
REFERENCES .............................................................................................................................. 46 
 

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List of Abbreviations 
 
• 
AE = Adverse Event 
• 
ABHS = Alcohol-Based Hand Sanitizer 
• 
ASTM = American Society of Testing Materials 
• 
CDC = Centers for Disease Control and Prevention 
• 
COI = Conflict of Interest 
• 
CPHDH = Certified Public Health Dental Hygienist 
• 
CRF = Case Report Form 
• 
CHW = Community Health Worker 
• 
CTSI = Clinical and Translational Science Institute 
• 
DHCP = Dental Health Care Provider 
• 
DHHS = Department of Health and Human Services 
• 
DSMB = Data and Safety Monitoring Board 
• 
eICF = Electronic Informed Consent Form 
• 
EPA = Environmental Protection Agency 
• 
FDA = Food and Drug Administration 
• 
GEE = Generalized Estimating Equations 
• 
GAM = Generalized Additive Models 
• 
GCP = Good Clinical Practice 
• 
IFU = Instructions For Use  
• 
IRB = Institutional Review Board 
• 
MLM = Multilevel Models 
• 
MOU = Memorandum of Understanding 
• 
NESS = New England Survey Systems 
• 
NH = New Hampshire 
• 
NHANES = National Health and Nutrition Examination Surveys 
• 
NIOSH = National Institute for Occupational Safety and Health 
• 
NYU = New York University 
• 
NYUMC = New York University Medical Center 
• 
OHRP = Office of Human Research Protections 
• 
OSHA = Occupational Safety and Health Administration 
• 
PI = Principal Investigator 
• 
PPE = Personal Protective Equipment 
• 
SAE = Serious Adverse Event 
• 
SDF = Silver Diamine Fluoride 
• 
SOC = Standard of Care 
• 
SSL = Secure Socket Layer 
• 
TF = Temporary Filling 
 
 
 
 
 
 

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Study Summary 
 
Title 
Statewide implementation and evaluation of a rural, school and 
community-based, caries prevention program 
Short Title 
CARIEDAWAY NH 
IRB Number 
 
S17-01221 
 
Study Type 
Human  
Study Design 
Pragmatic, cluster randomized, non-inferiority controlled trial 
Study Intervention 
Simple prevention (fluoride varnish + silver diamine fluoride) vs 
complex prevention (fluoride varnish + traditional sealants + temporary 
fillings) 
Study Duration 
5 years 
Study Location(s) 
New Hampshire Title 1 Elementary Schools and Community-Based 
Locations 
Primary Objective 
To determine if the newer simple caries prevention is not inferior to the 
traditional complex caries prevention in the arrest and prevention of 
dental caries. 
Sample Size 
43 schools (approximately 11,000 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 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 and caries prevention. 
Secondary outcomes include cost effectiveness and quality of life. We 
will assess these using multilevel binomial regression and generalized 
estimating equations. 
 

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1 Introduction 
This study will be conducted in compliance with the protocol approved by the IRB, GCP guidelines, and 
applicable NYUMC and federal regulatory requirements. 
1.1 
Background 
Caries Epidemiology, Current Standards of Care, and Limitations 
Caries is the globe’s and U.S.’s most prevalent, uncontrolled, preventable bacterial infection1.  
More than 50% of U.S. elementary school-age children have experienced caries (tooth decay or 
cavities), and more than 20% have untreated caries. For Hispanic/Latino, low-income children 
caries experience is over 70% and the untreated caries is over 30%2-4. Even more problematic, 
children with untreated caries have an incidence of sepsis ranging from 5% to 10%5. In rare 
instances, untreated decay can lead to serious systemic infections and even death 6.  
Pathophysiology and Diagnosis. Caries is a Gram +, aerophilic bacterial infection. These bacteria 
reside on tooth surfaces and release acid as a result of their metabolic activity. The acids, 
essentially, etch the tooth surface. If left untreated, the bacteria ultimately create a crater or 
cavity in the tooth surface. The primary diagnostic method for caries is visual/tactile. That is, 
visually assessing a tooth surface with a light and mirror, and exploring the tooth surface with a 
blunt probe. 
The Current “Standard of Care” and Limitations. Office-based surgical care, consisting of 
anesthesia, drilling and removal of the infected teeth, and filling with a resin or amalgam is the 
standard of care for caries 10. However, these fillings are not permanent: they have a limited life 
span of ~10 years and then require replacement by a larger restoration11-13. The net result is that 
fillings, once placed, must be repeated with more extensive and expensive restorations14,15. 
Office-based care, and particularly surgical care, presents multiple access barriers for patients 
including, in decreasing order of patient importance: cost, fear, geographic location/travel, time, 
knowledge, culture and literacy 16-19.  
Effective Caries Prevention is Available and Cost Effective. Systematic reviews verify the efficacy 
for numerous caries preventing agents (Table 1)20. The identified systematic reviews examined 
trials of individual agents. Our work demonstrates that, when used in combination, and 
delivered by dental hygienists in schools, complex preventive care can be effective in reducing 
the prevalence/incidence of caries21,22.  
 
 
 
Table 1. Summary of Caries Preventive Systematic Reviews20 
Agent 
Frequency 
Est. % 
Efficacy 
1. Water Fluoridation 
Continuous 
20-401 
2. Fluoride toothpaste 
2X/day 
252 
3. Fluoride varnish 
More than 2X/year 
45 3 
4. Traditional Sealant 
1X /pits & fissures 
80 4 
5. Temporary Filling* 
1x/ caries 
80 5 
6. Silver-diamine-fluoride 
2X/year 
80 6 
References: 1. 23-26; 2. 27,28; 3. 29; 4. 30-32; 5. 30,33-35 ; 6. 36-38. * Seal caries to prevent further tooth destruction. Requires 
no anesthesia or drilling. Also called: Interim Therapeutic Restoration, Atraumatic Restoration, Temporary 
Restorations, or Minimal Intervention Dentistry. ** CHW: Community health worker 

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Further, systematic reviews with economic assessments indicate that:  
1) caries prevention is cost-effective39-41; and 2) Investment in prevention outweighs investment 
in fillings33,41-44. When compared to traditional fillings: 3) temporary fillings require no excision of 
tooth structure and have significantly fewer adverse events such as acute pain and endodontic 
involvement 33,35. 
A New Standard of Care with Limitations45. While effective caries prevention agents are 
available, most dental offices do not provide them. From 2003-2009, fewer than 15% of children 
who accessed office-based dental care received appropriate preventive care (e.g.: topical 
fluoride or sealants46), and in 2013, fewer than 16% of 6-9 year olds received sealants47. Further, 
fewer than 40% of U.S. dentists provide sealants48.  
To overcome the barriers of office-based care, at least 13 reports49, and multiple federal 
agencies recommend prevention, and in particular, school-based caries prevention50-52. These 
same reports also recognize the gap between knowing how to implement prevention in a 
community setting to demonstrate effectiveness14,15,17,53,54. Two national surveys55,56 and 
insurance analysis confirms this57. 
 
Intervention Summary 
We propose comparing the effectiveness of two caries prevention protocols – one a newer, 
simpler protocol and the other an older, more complex protocol that we’ve previously 
demonstrated to be effective in preventing dental caries 58. Both protocols are designed to 
provide care to children in natural settings (e.g., schools and community-based settings) rather 
than requiring participants to visit a traditional dental office, increasing access 59.   
Prevention Summary. As indicated in the table below, both simple and complex prevention 
provide primary and secondary prevention. Based on systematic reviews of human randomized 
controlled trials (see Table 1), fluoride varnish + silver diamine fluoride, when compared to 
fluoride varnish + traditional sealants + temporary fillings provide approximately the same 
efficacy. Further, both preventive arms have fewer adverse events than classical restorative 
care33,35. From these perspectives, the current office-based surgical care model is a clinical 
example of the over-use of ineffective therapy, and the under-use of effective prevention20,57,60-
63.  
However, silver diamine fluoride (SDF) was only approved for U.S. use in 2014. Therefore, based 
on educational training and clinical practice experience, the historical bias is that complex 
prevention (fluoride vanish + traditional sealants + temporary fillings) will be more effective 
than simple prevention (fluoride varnish + silver diamine fluoride). We propose testing this 
hypothesis using a non-inferiority trial design. We therefore propose a definitive study  
examining the effectiveness of community-based prevention.57,59 
 
 

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Table 2. Definitions of Primary and Secondary Prevention: Comparison of Proposed Prevention 
Protocols* 
 
* Percentages are efficacy estimates from systematic reviews of human 
randomized controlled trials. 
SDF = silver-diamine-fluoride.  Sealant = traditional sealant.  TF = temporary 
Filling 
 
1.2 
Study Rationale 
Rationale for Study Population. To most rapidly provide and demonstrate improved health 
equity, in collaboration with the New Hampshire Department of Health and Human Services (NH 
DHHS), New Hampshire Dental Society, and Northeast Delta Dental, we selected schools in 
communities with the highest need and the lowest access to care - schools located in rural 
communities.  
Reduced Care Access Creates an Additional Caries Burden for Rural Children. Rural 
communities have nearly one-third fewer dentists per patient than urban areas (22 vs 30 
dentists per 100,000, respectively)14. Rural communities also have greater travel distances 
to access care, higher rates of poverty, less water fluoridation, and lower insurance 
enrollments14,15. These factors contribute to lower dental care access, higher rates of dental 
caries, and greater use of emergency rooms for primary care. Despite health disparity 
reports over the last decade16-18, only in 2011 was priority placed on delivering caries 
prevention for rural children18. 
 
Children’s Oral Health in Rural New Hampshire. New Hampshire could be the “poster 
child” for children’s caries19-21. Nine of the ten New Hampshire counties are rural22 and 
designated as health professional shortage areas23. Caries prevalence is higher in more 
rural counties, reaching 56% in the most rural county, Coos19. Therefore, this project will 
focus on rural New Hampshire counties with the lowest dentist-to-population ratios 20. 
 
Benefits of Study Results and Relevance to Policies and Priorities. There are three distinct 
benefits. First, simple prevention takes approximately ¼ the time and ¼ the cost of complex 
prevention. Concretely: simple takes ~5 minutes and costs ~$20 (supplies + personnel), while 
complex takes ~20 minutes and costs ~$80 (supplies + personnel).  
Therefore, if simple is not inferior, its use will increase access to effective care. Second, the 
preventive agents are grouped to provide both primary and secondary prevention. Third, the 
 
 
Simple Prevention 
Complex Prevention 
Terminology 
Goal 
F-Varnish 
  SDF 
F-Varnish 
Sealant 
  TF 
Primary Prevention 
Smooth surface 
prevention 
+ (45%) 
 
+ (45%) 
 
 
 
Pits and fissure 
prevention 
 
+ (80%) 
 
+(80%) 
 
Secondary 
Prevention 
Caries arrest 
 
+ (80%) 
 
 
+ (80%) 

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methods to be applied and the outcomes identified both address national Healthy People 2020 
goals. 
Known and Potential Risks and Benefits. Caries prevention using: silver nitrate is more than 100 
years old; fluoride is more than 50 years old; while sealants, temporary fillings and silver 
diamine fluoride are more than 25 years old. The only known risks are misuse of the materials 
(e.g.: patient swallowing). Silver diamine fluoride may discolor any cavities resulting in a brown 
or black color.  If silver diamine accidentally touches the skin or cloths, a temporary light brown 
staining will occur.  For stain removal gently apply with soap and water. The potential risks are 
allergic reaction to either the fluoride or the silver or the glass ionomer sealants or the 
temporary fillings.  Some fluoride varnish products contain pine rosin (colophony) as an 
ingredient in their resin formula.  For children with nut allergies we will use an alternate form of 
fluoride varnish that does not contain pine rosin (colophony) as an ingredient (Elevate Oral 
Care® FluoriMax™ Sodium Fluoride Varnish).   The benefit to all participants is that they will 
receive primary and secondary caries prevention twice yearly. 
1.3 
Investigational Device 
Silver diamine fluoride 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 know 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.  If silver diamine fluoride 
accidentally touches the skin or cloths, a temporary light brown staining will occur.  For 
stain removal gently apply with soap and water. 
 
1.4.2 
Other Risks of Study Population 
1. Fluoride varnish  
Children that have a nut allergy.  Some fluoride varnish products contain pine rosin 
(colophony) as an ingredient in their varnish resin formula.  The fluoride varnish 
being used in this study is called FluoriMax™ Sodium Fluoride Varnish and 
distributed by Elevate Oral Care®.  This product does not contain pine rosin 
(colophony) as an ingredient in its resin formula. 
 
There are no other known risks associated with any of the currently used caries 
preventive agents.  The cavity prevention program, provided in school, is spray and 
spatter free, (i.e., aerosol free). 
 
 

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Enhanced precautions to reduce risks for prevention of transmission of COVID-19 
in school and community-based locations 
 
NH DHCP are required to comply with infection control and safety protocols 
including those required under the Bloodborne Pathogens Standard (US CFR 
1910.1030), the laws and regulations of the state of New Hampshire and program 
specific infection control and safety protocols.   
 
School and community-based programs have unique characteristics that warrant 
specific infection prevention considerations due to risk for exposure to COVID-19.  
The Enhanced precautions listed below have been put in place to avoid 
transmission of SARS Cov-2 in school and community-based settings. 
 
It is incumbent on all New Hampshire Dental Health Care Providers (NH DHCP) 
including supervisory professionals to ensure that care is provided in a way that 
maximizes benefits while avoiding harm to personnel and students from potential 
exposure to SARS-CoV-2 infection.   
 
This can be accomplished by five main strategies: 1. Source control to limit contact 
with infected persons.   2. Appropriate use and handling of Personal Protective 
Equipment (PPE).   3. Proper Hand Hygiene. 4.   Precautions to reduce or eliminate 
droplets or spatter or aerosols generated by dental procedures.  5. Proper use of 
barriers and surface disinfection.  These strategies are detailed below: 
2. Source Control Measures: 
Source control measures include pre-screening site visit assessment, screening and 
evaluation of NH DHCP and students for possible symptoms of COVID-19, recent 
contact with infected persons, and recent travel to high prevalence areas or 
participation in large gatherings.    
Site Pre-Visit Assessment 
• Prior to scheduling any school or community-based activities, the Certified 
Public Health Dental Hygienist (CPHDH) will review school and community-
based location policies for prevention of coronavirus transmission among 
studentss, staff, parents/guardians and faculty using either the COVID-19 
School or Community-based location site pre-visit checklist. 
• If there is any reason to believe that policies would put NH DHCP, studentss or 
parents/guardians at risk, the CPHDH will contact the Supervising Dentist to 
determine the appropriate course of action. NH DHCP Responsibilities in 
School or Community-Based Settings 

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• Social distancing with at least 6 feet of distance between students, school and 
community-based staff members, parents/guardians or faculty and use of face 
coverings will be enforced at all times, except when the student is receiving 
clinical care.  
• NH DHCP who have been told by medical or public health authorities to self-
isolate or quarantine must not participate in any school or community-based 
site activities. 
• Starting 2 days before any school or community-based site activity and 
continuing for 2 days after the activity, NH DHCP must self-assess for signs and 
symptoms of COVID-19 infection using the COVID-19 NH DHCP Self Monitoring 
Checklist and Daily Symptom Tracker.  
o If any signs or symptoms are present, NH DHCP must immediately 
notify the Supervising Dentist and will not report for work. 
o The school or community-based location will then be contacted to 
cancel and re-schedule the activity.     
• If NH DHCP develop signs or symptoms consistent with COVID-19 or other 
respiratory illness during school or community-based activities, they must 
immediately notify the school nurse or other school or community-based 
authority, remove themselves from the school or community-based setting, 
contact the Supervising Dentist and seek medical evaluation as appropriate. 
• If NH DHCP test positive or develop symptoms for COVID-19 within 14 days 
following a school or community-based activity, they must notify the 
Supervising Dentist who will contact public health authorities to determine the 
need for contact tracing.   Records of students treated during the potentially 
infectious period will be made available to public health authorities if 
requested.  
• NH DHCP with a positive test or symptoms of COVID-19 will be cleared to 
return to work by the Supervising Dentist on the most current guidance from 
the New Hampshire Department of Health and Human Services (DHHS) or the 
CDC whichever is more stringent.   
Source Control Screening for Students 
When providing services in schools or community-based setting, NH DHCP will 
conduct source control screenings which will be documented on the COVID-19 
Student Screening Log and in the digital record (NESS).  Copies of the 
screening log will be securely maintained consistent with HIPAA requirements.  
Screening will include:  
• Temperature check using a contactless thermometer.  Care for students with a 
measured temperature ≥100.4° F will be deferred for at least 14 days and a 
notation made on the patient’s chart. 
• A verbal response from the student to questions regarding presence of cough 
or other possible COVID-19 symptoms. 

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•  NH DHCP observation of possible signs or symptoms. 
• If off-site, NH DHCP will obtain a verbal response from the parent/guardian if 
present. 
•  If a student exhibits temperature or other signs or symptoms of COVID-19 
infection, care will be deferred for at least 14 days, or until all symptoms have 
resolved. 
• NH DHCP will immediately notify the school nurse, other school official, or 
staff at the community-based location if treatment is deferred as a result of 
COVID-19 screening.  
3. Enhanced Personal Protective Equipment (PPE) for COVID-19. 
PPE requirements for avoidance of exposure to COVID-19 are similar to those 
required by the bloodborne pathogens standard, but with increased emphasis on 
protecting NH DHCP from droplets or spatter contacting the eyes or mucous 
membranes.  The following enhanced procedures will be applied to supplement 
Standard Precautions.  
• Face Mask and Coverings: 
o Cloth face coverings are a form of source control, are not PPE and 
will not be worn during clinical encounters. They may be worn 
when entering or leaving the school or alternative site when not 
engaged in direct clinical care. 
o Since no aerosols generating procedures are performed and no 
symptomatic students will be seen, ASTM Level 2 or 3 face masks in 
combination with face shields are adequate for respiratory 
protection and use of fit tested respirators is not required. 
• Eye Protection:  
o During clinical encounters NH DHCP must wear safety glasses and 
full face-shields in addition to their face mask to ensure the eyes, 
nose, and mouth are all protected from exposure to respiratory 
secretions and saliva during clinical encounters, including those 
where splashes and sprays are not anticipated. 
o Don eye protection (i.e., safety glasses and a face shield that covers 
the front and sides of the face) upon entry to the care area.  
o Reusable eye protection (e.g., safety glasses and face shields) must 
be cleaned and disinfected according to manufacturer’s 
reprocessing instructions prior to re-use.  Disposable eye protection 
should be discarded after use unless following protocols for 
extended use or re-use. 
• Hand Hygiene 
o NH DHCP will perform hand hygiene before and after all student 
contact, contact with potentially infections material, and before on 

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and after removing PPE, including gloves.  Hand hygiene after 
removing PPE is particularly important to remove pathogens that 
have been transferred to bare hands during the removal process 
o NH DHCP will perform hand hygiene by using alcohol-based hand 
sanitizer (ABHS) with 60-95% alcohol or washing hands with soap 
and water for at least 20 seconds.  If hands are visibly soiled, use 
soap and water before returning to use ABHS. 
o NH DHCP are responsible for ensuring that adequate supplies of 
ABHS are available at the clinical site or that soap and access to a 
water source are readily available. 
4. Control of Spray and Droplets 
• NH DHCP will use care to avoid generating droplets or spray during patient 
encounters.   
• No rotary instrumentation, water spray or other irrigation will be used at any 
time 
• Toothbrushing will be done with soft bristle brushes using gentle movement to 
avoid generating droplets or spatter. 
5. Proper use of barriers and surface disinfection 
Selection of surface disinfectants:  Products selected for use by the NH DHCP will 
be confirmed to be included in the US Environmental Protection Agency (EPA) “List 
N” of products presumed to be effective against the SARS CoV-2 virus.  The list can 
be accessed at:  
 
https://www.epa.gov/pesticide-registration/list-n-disinfectants-coronavirus-
covid-19 
 
Special consideration will be taken to ensure that the clinical environment and 
school and community-based surfaces or items not involved in clinical care be 
protected from contamination by potentially infectious droplets or spatter 
 
• Where possible, place all tables, supply boxes and all other items at least 6 
feet from the chair used for clinical care and cover them with a fluid 
impervious drape. 
 
• Any furniture, books, non-clinical seating, or other school or community-based 
items within six feet of the chair must be removed from the clinical care area 
or be covered with a fluid impervious drape. 
  
• Where distancing is not possible, use of impervious barriers may be required. 
 
 

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6. Environmental Infection Control 
Surfaces contacted by NH DHCP may become contaminated with potentially 
infectious viruses and bacteria.  NH DHCP will assure the following. 
• Clinical contact surfaces:  NH DHCP are responsible for assuring that: 
o Where possible, fluid impervious surface barriers will be used to 
protect clinical contact surfaces. 
o An Environmental Protection Agency (EPA) registered hospital 
grade disinfectant with a tuberculocidal claim will be used to clean 
and disinfect clinical surfaces at the between clinical encounters 
where barriers are not used and if a surface is visibly contaminated 
with blood or other potentially infectious material. A list of 
approved cleaners and disinfectants is maintained in the Safety 
Binder along with Safety Data Sheets (SDS) for these agents. (See 
Section 1.4.2.5 for interim EPA List N requirements) 
o Housekeeping services (tables, seating floors etc.) are generally the 
responsibility of school or the community-based authorities, but the 
NH DHCP must ensure that environmental surfaces are not visibly 
soiled or dusty prior to initiating patient encounters and for 
ensuring that housekeeping surfaces that are visibly soiled with 
blood or other potentially infectious materials are immediately 
cleaned and disinfected. 
o If locations provided by the school or community-based location are 
carpeted, cover and secure with duct tape the area under and 
within six feet of the patient chair with plastic drape material to 
prevent contamination. While wearing gloves, eyewear, and face 
mask, remove the drape at the conclusion of clinical treatment and 
discard as non-biohazardous waste. 
o For hard surface floors, advise personnel of the need for floor 
cleaning prior to use by patients or staff at either school or 
community-based locations. 
• Medical Waste and Management and Sharps disposal. 
o Care provided by NH DHCP is non-invasive and materials meeting 
the definition of regulated medical waste will not be generated. 
o An appropriate color-coded sharps container marked with a 
biohazard label will be used to safely secure all items used in 
patient encounters that may cause a percutaneous injury (i.e. 
disposable explorers). 
o When containers reach the designated fill level, they will be sealed 
and transported to the designated dental office that has agreed to 
accept them for disposal.  The office will provide a receipt 
documenting acceptance of the sharps container which will be 
maintained in the safety folder. 

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o If used, re-usable sharps (explorers) will be placed in a color-coded 
and biohazard labeled rigid leak proof sealed plastic container for 
transport for cleaning, sterilization, packaging, and storage. 
o Food storage and Consumption: Food items will not be stored or 
consumed in the immediate patient care or storage/re-processing 
area for contaminated instruments. 
•  Instrument decontamination, cleaning, sterilization, and storage 
 
o Instruments used for patient evaluation and application of intraoral 
preventive agents may become contaminated with blood or saliva 
and must be properly cleaned, and then disinfected or sterilized 
prior to re-use.  When possible, single use disposable items such as 
mirrors and explorers should be used instead of re-usable items.   
All items used in school and community-based settings are 
considered non-critical or semi-critical and can be either high level 
disinfected or sterilized prior to re-use. 
o Copies of the current manufacturer’s Instructions for Use (IFU) for 
all devices (sterilizer) and instruments including proper 
maintenance, disposal and re-processing will be maintained in the 
Safety Binder. 
• Management of single use disposable items. 
o Single use disposable items will be removed from original packaging 
and handled aseptically using clean gloved hands whether placed in 
unit dose wraps (the “burrito) or used directly for clinical care. 
o Following clinical care, sharp disposable instruments (explorers) will 
be placed in a sharps container for proper disposal as described in 
Medical Waste Management. 
o Non sharp instruments (mirrors, cotton products and single use 
applicators) may be discarded in a dedicated container as non-
biohazardous waste.       
• Management of reusable items. 
o All reusable items (e.g. GC America applicators) will be cleaned 
following the manufacturer’s Instructions for use. 
o Items may be sterilized on site using a portable sterilizer following 
manufacturer instructions for use. 
o Alternatively, contaminated reusable items may be placed in a 
plastic sealed rigid leak proof container marked with a biohazard 
label and transported for re-processing at a designated location 
(private dental office). 

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o When using the sterilizer in the clinical setting, it must be placed on 
a stable surface at least 6 feet away from the clinical treatment area 
and cords must be placed to avoid trip hazards. 
o Place the cleaned applicators unwrapped in the portable sterilizer 
and process 18 minutes at 121°C or as otherwise directed by the 
current IFU. 
o Place a sterilization process indicator in each load. 
o Vent the sterilizer at the end of the cycle and allow the items to 
cool.   
o Check the sterilization process indicator to determine that 
sterilization parameters were met before removing items for use 
o If the indicator does not indicate that the parameters were met, run 
one additional load, and re-evaluate.  If the second load indicator 
indicates sterilization failure, discontinue sterilization procedures. 
Save and date the failed indictors and contact the supervising 
dentist or safety officer to determine next steps. 
o If the process indicator indicates that sterilization parameters were 
met, remove individual applicators aseptically using clean gloves 
and use them for individual patients. Keep the sterilizer top closed 
except when removing the applicators. 
o Place used applicators in a plastic sealed rigid leak proof container 
affixed with a biohazard label until they can be cleaned and re-
sterilized either on site or at another location. 
o At the conclusion of all clinical care, clean all applicators and run a 
final sterilization cycle.  Remove the sterilized applicators and place 
them in a clean plastic sealed rigid leak proof container for 
transport. 
o Seal the container with tape and mark it with the date the 
applicators were sterilized. 
o  Unless within 24 hours after sterilization, applicators stored in the 
sealed leak proof container must be re-sterilized on-site prior to the 
next episode of clinical care.  
• Sterility Assurance and Sterilizer Maintenance 
o A spore test will be performed according to the Instructions For Use 
(IFU) provided by the product manufacturer once for each school 
visit.  A record of the test performance and results will be 
maintained in the Safety Binder that includes the date of the test, 
the name of the person performing the test and the test results. 
• 
In the event of a failed spore test, NH DHCP will 
immediately notify the Supervising Dentist. 

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o NH DHCP will re-test the sterilizer and remove it from service 
pending re-evaluation.  All reusable devices on hand will be 
removed from use pending resolution of the problem. 
o Since the reusable items used by NH DHCP are semi-critical and 
exposure to blood or other potentially infectious materials is not 
reasonably anticipated, patient notification is not required in the 
event of a positive spore test. 
o Periodic sterilizer inspection and maintenance will be performed 
according to manufacturer IFU. 
• 
NH DHCP should check sterilizer gaskets for cracks or 
other deterioration prior to beginning each school visit. 
• 
Concerns about the safety or operability of the sterilizer 
will reported to the Supervising Dentist. 
1.4.3 
Potential Benefits 
The potential benefits are a reduction in untreated caries and all students will receive 
primary and secondary caries prevention either one or two times a year. 
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.  
2.2 
Secondary Objective(s) 
To determine the cost and cost effectiveness, including sensitivity analysis, of the two protocols; 
to assess oral health-related quality of life.  
3 Study Design 
3.1 
General Design 
This is a school and community-based, pragmatic, cluster randomized controlled trial comparing 
the non-inferiority of two caries prevention protocols that both provide primary and secondary 
prevention. The two interventions and the efficacy of each element are provided in Table 2 
above. Care will be provided twice yearly to mirror health care recommendations in private 
practice.  
Children will be enrolled at the beginning of each school year. 
The trial will last 5 years to provide outcome measures of caries arrest at 1 year and caries 
prevention at 3 years. Care will continue to be provided after termination of the trial.  
Starting in year 3, all care will be provided by NH DHCP either in schools or at community-based 
locations. 
3.1.1 
COVID-19 
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 

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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, the 
Supervising Dentist and the CPHDH 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 
organizations to discuss their participation as an alternate site location for participation 
in this research study.  
 
The following Site Pre-Visit Assessments will be performed: 
1. COVID-19 Community-Based Location Site Pre-Visit Assessment. 
Once an alternate community-based location has been identified and is 
interested in participating, the CPHDH will meet with the community organization 
staff to review COVID-19 safety precautions at the community-based location.  
They will review clinical protocols, room size and safe distancing requirements.  
The CPHDH will fill out the COVID-19 Community-Based Site Pre-Visit Checklist.  If 
the community-based location does not meet the requirements listed in the 
checklist, the CPHDH will notify the Supervising Dentist to determine the 
appropriate course of action. 
 
If the community-based location meets the requirements of the COVID-19 
Community-Based Site Pre-Visit Checklist and wishes to participate, the 
Supervising Dentist or the Program Manager will review and sign the necessary 
documents and contract.  For scheduling prevention treatments at an alternate 
community-based location, the CPHDH will work with the administrator at each 
community-based location. 
 
As community-based organizations are identified each year and signed on as an 
alternate location for providing care, that information will be submitted to the 
IRB during the annual continuation review and approval process.   
2. COVID-19 School-Based Site Pre-Visit Assessment: 
Prior to providing care in a school, the CPHDH will meet with the school nurse or 
staff to review COVID-19 safety precautions at the school location.  They will 
review clinical protocols, room size and safe distancing requirements.  The 
CPHDH will fill out the COVID-19 School-Based Site Pre-Visit Checklist.  If the 
school does not meet the requirements listed in the checklist, the CPHDH will 
notify the Supervising Dentist to determine the appropriate course of action. 
 
For preparing to provide preventive care we follow CDC, OSHA, and NIOSH 
guidelines.  NH DHCP will be conducting all study related procedures at all 
locations.  All NH DHCP will wear disposable gowns, gloves, ASTM level 2 or 3 face 
mask, safety glasses and face shields.  Face masks and disposable gloves are 
replaced between patients.  Safety glasses and face shields are disinfected 
between patients.  A new disposable gown will be worn for each new clinical 

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prevention session.  When necessary, to conserve resources, gowns may be worn 
for multiple patient encounters unless visibly soiled.  Gowns must be discarded at 
the end of each clinical prevention session or when leaving the treatment area 
for any reason. Disposable gowns are not considered hazardous waste and may 
be discarded after use in routine waste containers. 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. 
 
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 4 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)67,68. Training and standardization of these 
examiners implement the World Health Organization guidelines69,70.  
3.3 
Secondary Study Endpoints 
Quality of life will be assessed at each visit using the short form version of the Child Oral Health 
Impact Profile. Longitudinal change in quality of life will be assessed after four years. At the end 
of the study (5 years), we will evaluate cost and cost effectiveness. 
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). 
4 Participant Selection, Enrollment, and Withdrawal 
4.1 
Study Population 
The study population are elementary school children attending rural NH elementary schools. 
Rural is defined by the US Department of Agriculture.  
4.2 
Inclusion Criteria 
All children attending a participating school, with informed consent and assent, will receive care, 
independent of race, ethnicity, sex, medical condition, or ability to pay. Children with informed 
consent can join at any time.  
4.3 
Exclusion Criteria 
The only excluded children will be those: (1) not attending participating schools, (2) those 
attending participating schools without informed consent, (3) those attending participating with 
informed consent, but without assent, (4) those who are allergic to silver.  

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4.4 
Participant Recruitment, Screening and Enrollment 
4.4.1 
Recruitment. 
Recruitment will be done in concert with all other yearly school notifications and 
requests for consent via informational packets sent home with the children to their 
parents/guardians and under each school’s protocol. Dental packets will contain care 
details, recruitment flyer, research participant informed consent form template which 
includes information on the Health Insurance Portability Accountability Act (HIPAA), and 
a medical and oral health history form. Parents will be asked to return the forms to the 
child’s school. 
 
Parents/guardians will also receive the above information via eICF sent by each school 
via the following website (also see section 4.4.5 Informed Consent): 
 
NESS eConsent Website: 
https://www.ne4m.com/DentalConsentBETA/Login.aspx 
 
All parents/guardians will receive the NH DHHS parent/guardian COVID-19 letter.  The 
letter explains that the cavity prevention program follows the most current COVID-19 
infection control guidance from the Centers for Disease Control and Prevention. All 
clinicians will follow school and state guidance. These precautions will provide 
protection for the children, the school faculty, and the dental program clinicians.  The 
letter also explains that the program may deliver care at an alternate community-based 
location, is voluntary and they can enroll or withdraw their child at any time. 
 
Parents/guardians will be asked to carefully review the NH DHHS COVID-19 letter, the 
principal recruitment letter and the informed consent.  If they have any questions about 
the study or the consenting process they can contact the principal investigator, the 
Supervising Dentist or the CPHDH prior to signing and returning the forms to the child’s 
school. 
 
The recruitment flyer and principal recruitment letter informs the parent/guardian that 
the care being provided, is spray and spatter free (i.e., aerosol free). 
 
The recruitment flyer will also be place Independently, during community engagement 
events as an FAQ (if possible), as a flyer for posting on school bulletin board, as an 
attachment included and dispersed to parents/guardians via email, at the discretion of 
the school staff. 
4.4.2 
School Solicitation. 
To identify school participants, current school-based caries prevention programs in rural 
NH areas were solicited for their interest in participating. If the programs agreed, the 
programs solicited the principals of the schools they serve. All solicited programs and all 
solicited principals agreed to participate. Table 3 below provides the county, town rural 
classification, school, certified public health dental hygienist, and school based 
programs that have agreed to participate.  Table 4 below provides the school town, 

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school name and address, nurse, principal, and contacts of schools that have agreed to 
participate. Additional schools will be added if needed. 
 
 
 

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Table 3. Participating County/Town/School/Hygienist/Programs 
County 
Town 
*NCES 
Classification School 
*Students 
per School *Grades *FR Lunch CPHDH 
School-Based Program 
Merrimack 
Loudon 
Rural: Distant Loudon Elementary 
293 
K - 5 
23% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Pittsfield 
Rural: Distant Pittsfield Elementary 
293 
PK - 6 
58% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Webster 
Rural: Distant Webster Elementary 
108 
K - 5 
26% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Boscawen 
Rural: Fringe 
Boscawen Elementary 
265 
PK - 5 
34% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Concord 
Town: Fringe 
Abbot-Downing 
428 
K - 5 
34% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Concord 
Town: Fringe 
Beaver Meadow 
388 
PK - 5 
28% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Concord 
Town: Fringe 
Broken Ground 
368 
3 - 5 
47% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Concord 
Town: Fringe 
Christa McAuliffe 
421 
K - 5 
32% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Concord 
Town: Fringe 
Mill Brook 
474 
PK - 2 
27% 
Mary Davis 
Concord Dental Sealant Coalition 
Merrimack 
Penacook 
Town: Fringe 
Penacook Elementary 
411 
PK - 5 
33% 
Mary Davis 
Concord Dental Sealant Coalition 
Rockingham Candia 
Rural: Fringe 
Henry W Moore School 
322 
K - 8 
24% 
Bonnie Greaney 
Lamprey Health Care 
Rockingham Deerfield 
Rural: Distant Deerfield Community School 
517 
PK - 8 
14% 
Bonnie Greaney 
Lamprey Health Care 
Rockingham Epping 
Rural: Fringe 
Epping Elementary School 
353 
PK - 5 
27% 
Bonnie Greaney 
Lamprey Health Care 
Rockingham Freemont 
Rural: Fringe 
Ellis Freemont Elementary School 
432 
PK - 8 
18% 
Bonnie Greaney 
Lamprey Health Care 
Rockingham Raymond 
Suburb: Large Lamprey River Elementary School 
515 
PK - 4 
32% 
Bonnie Greaney 
Lamprey Health Care 
Rockingham Newmarket 
Suburb: Small Newmarket Elementary School 
554 
PK -5 
23% 
Bonnie Greaney 
Lamprey Health Care 
Rockingham Northwood 
Rural: Distant Northwood Elementary School 
374 
K - 8 
23% 
Bonnier Greaney Lamprey Health Care 
Rockingham Nottingham 
Rural: Distant Nottingham School 
525 
K - 8 
1% 
Bonnie Greaney 
Lamprey Health Care 
Sullivan 
Acworth 
Rural: Distant Acworth Center School 
25 
1 - 4 
84% 
Kyle Messier 
Sullivan County Dental Initiative 
Cheshire 
Alstead 
Rural: Distant Alstead Primary School 
84 
PK - 4 
49% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Charlestown 
Rural: Fringe 
Charlestown Primary School 
227 
PK - 5 
46% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Croydon 
Rural: Distant Croydon Village School 
25 
K - 4 
44% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan  
Langdon 
Rural: Distant Sarah Porter School 
18 
1 - 4 
33 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Charlestown 
Rural: Fringe 
North Charlestown Community School 78 
1 - 5 
51% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Claremont 
Town: Remote Bluff School 
226 
K - 5 
62% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Claremont 
Town: Remote Disnard Elementary 
308 
K - 5 
53% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Lempster 
Rural: Distant Lempster Community School 
100 
K - 8 
37% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Claremont 
Town: Remote Maple Avenue 
350 
PK - 5 
49% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Claremont 
Town: Remote Claremont Early Childhood Program 
64 
PK 
58% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Newport 
Town: Remote Richards School 
434 
PK _ 5 
63% 
Kyle Messier 
Sullivan County Dental Initiative 
Sullivan 
Unity 
Rural: Distant Unity Elementary 
125 
1 - 8 
39% 
Kyle Messier 
Sullivan County Dental Initiative 

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Table 4. Participating Town/School/Address/Nurse/Principal/Contacts 
 
Town 
School Name 
Address1 
Nurse F 
Nurse L 
Principal F Principal L Phone 
Email 
Acworth 
Acworth Center School 
1 Turkey Shoot Rd. 
Lisa 
Thierren 
Gail 
Rowe 
603-835-2270 growe@sau60.org 
Alstead 
Alstead Primary School 
58 Mechanic Street 
Lisa 
Therrien 
Gail  
Rowe 
603-835-2482 growe@sau60.org 
Boscawen 
Boscawen Elementary School 
1 Best Ave. 
Karen 
Audet 
Jeffrey 
Drouin 
603-753-6512 jdrouin@mvsdpride.org 
Charlestown 
Charlestown Primary School 
84 E. Street Ext. 
Frithsen 
Emily 
Christopher Young 
603-826-3694 cyoung@sau60.org 
Croydon 
Croydon Village School  
889 Route 10 
Honey 
Vaine 
Christine 
Baker 
603- 863-2080 Sites.google.comsau43.org/Cro
d
/
Charlestown 
N. Charlestown Community 
509 River Rd. 
Lantz 
Robyn 
Aaron 
 Cinquemani 603-826-3986 acinquemani@sau60.org 
Claremont 
Bluff School 
1 Summit Rd. 
Deb 
Spencer 
Dale 
Chenette 
603-543-4273 dchenette@sau6.org 
Claremont 
Disnard Elementary School 
160 Hanover St. 
Nicole 
Yatsevich 
Melissa 
Lewis 
603-543-4260 mlewis@sau6.org 
Claremont 
Maple Avenue School 
210 Maple Ave. 
Kathleen 
Hennessey Kathleen 
Bunnell 
603-543-4270 kbunnell@sau6.org 
Claremont 
Claremont Early Childhood Program 
111 South St. 
Jackie 
Contois 
Page 
Jarvis 
603-542-4294 pjarvis@sau6.org 
Concord 
Abbot-Downing School 
152 South St. 
Janet 
Moffett 
  Anthony 
Blinn 
603-225-0827 ablinn@sau8.org 
Concord 
Beaver Meadow School 
40 Sewalls Fall Rd. 
Mary 
Palm 
Michele 
Vance 
603-225-0853 mvance@sau8.org 
Concord 
Broken Ground School 
51 South Curtisville 
Stuart 
Gesen 
Susan 
Lauze 
603-225-0855 slauze@sau8.org 
Concord 
Christa McAuliffe School 
17 North Spring 
Stephanie 
Celestin 
Kristen 
Gallo 
603-225-0840 kgallo@sau8.org 
Concord 
Mill Brook School 
53 South Curtisville 
Janet 
Corkum 
Katie 
Scarpati 
603-225-0811 kscarpati@sau8.org 
Lempster 
Lempster Community School 
29 School St, 
Donna  
Grant 
Ralph 
Peterson 
603-863-1080 rpeterson@sau71.org 
Loudon 
Loudon Elementary School 
7039 School St. 
Paula 
Gatherum Catherine 
Masterson 
603-783-4400 cmasterson@mvsdpride.or 
Newport 
Unity Elementary 
864 2nd NH Tpke. 
Debbie 
Bedard 
Susan 
Schroeter 
603-542-5888 sschroeter@sau6.org 
Penacook 
Penacook Elementary School 
60 Village St. 
Donna 
Ellis 
Jennifer 
Moore 
603-753-4891 jmoore@mvsdpride.org 
Pittsfield 
Pittsfield Elementary School 
34 Bow St. 
Jessica 
Strohl 
Danielle 
Harvey 
603-435-8432 dharvey@pittsfieldnhschoo 
Webster 
Webster Elementary School 
936 Battle St. 
Kara 
Culpon 
Stephanie 
Wheeler 
603-648-2467 stwheeler@mvsdpride.org 
Candia  
Henry W Moore School 
12 Deerfield Road 
Stacia 
Cardillo 
Becky  
Wing 
603-483-2251 bwing@sau15.net 
Deerfield 
Deerfield Community School 
66 North Road 
Bonnie 
Heisey 
Kristen 
Witheee 
603-463-7422 kwithee@sau53.org 
Epping 
Epping Elementary School 
17 Prospect Street 
Meghan 
Young 
Justin 
Benna 
603-679-8018 jbenna@eppingsd.org 
Freemont 
Ellis Freemont Elementary School 432 Main St 
Karen 
McCusker Sharon 
DeVincent 
603-895-6903 sdevincent@sau83.org 
Lamprey 
Lamprey River Elementary School 33 Old Chester Rd 
Susan 
Kizler 
Laura  
Yacek 
603-895-3117 l.yacek@sau33.com 
Newmarket 
Newmarket Elementary School 
243 South Main St 
Diane 
McCormick Sean  
Pine 
603-659-2192 pines@newmarket.k12.nh.us 
Northwood 
Northwood Elementary School 
511 First NH Tpke 
Colleen 
Krochmal 
Jocelyn 
Young 
603-942-5488 jyoung@northwood.k12.nh.us 
Nottinghamm Nottingham School 
245 Stage Rd 
Lori 
Kilbreth 
Christopher Sousa 
603-679-5632 csousa@nottingham.k12.nh.u
s
Newport 
Richards School 
21 School Street 
Susan 
Strebel 
Phil  
Banios 
603-835-3710 pbanios@sau43.org 
Langdon 
Sarah Porter School 
111 Village Road 
Lisa  
Thierren 
Gail 
Rowe 
603-835-2260 growe@sau60.org 
4.4.3 
School Randomization  
Participating schools will be block randomized to receive either simple or complex 
prevention. Schools will be ordered sequentially in ascending order of student 
population. Individual groups of two schools will then be taken and randomly assigned 
to either simple or complex care. All children in a given school or community-based 
location with informed consent, will receive the same preventive care twice per year 
during the progress of this program. 
4.4.4 
School Rosters and Informed Consent Preparation 
Typically in August each school or school district will provide an electronic roster for 
each school. The rosters include the student’s name, address, phone, date of birth and 
sex, home language, race/ethnicity, free/reduced lunch participation, grade and 
teacher. The rosters are used to help distribute the principal recruitment letter and 

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informed consent template by school, grade, teacher, and student. The informed 
consent is combined with a recruitment letter from the principal explaining the 
program. A single PDF is created for each school. These forms have bar codes and are 
electronically readable. 
4.4.5 
Informed Consent 
This study requires an alteration of informed consent.  The CPHDH is not required to  
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 the CPHDH 
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 either on paper or electronically.  If the parent/guardian has any questions 
regarding the study or the informed consent process, they can contact the school nurse, 
the Supervising Dentist, the CPHDH or the Principal Investigator directly prior to signing 
the informed consent.  In some situations, such as alternate community-based location 
settings, the parent/guardian may bring the signed and dated informed consent to their 
child’s scheduled appointment.  Blank paper forms will also be available to 
parents/guardians at alternate community-based locations.   All in person questions will 
be addressed by the NH DHCP prior to the parents/guardians signing the informed 
consent. 
 
1. Paper Informed Consent: 
 
The NYU team works with each NH program to schedule the printing of all forms 
(COVID-19 letters, recruitment letters and recruitment flyer) and informed consent.  
The CPHDH prepares and works directly with the school administrators to facilitate 
delivery of all forms and informed consent to the parent/guardian. All forms are 
distributed with other school forms at the beginning of the school year by the school 
administrator. Each program obtains written informed consent using a NYU IRB 
approved informed consent template.  This template also includes HIPAA 
information and authorization for parents/guardians to review and sign in a separate 
section within the informed consent template.  This form must be signed and dated 
by the parent/guardian and reviewed for completeness by the CPHDH prior to 
acceptance into the study and beginning any study procedures. 
 
When informed consents are returned back to the schools by the parent/guardian 
they are collected by the school administrator.   The school administrator contacts 
the programs CPHDH.  The CPHDH goes to the school and collects the returned 
informed consents.  The CPHDH is responsible for collecting and reviewing each form 
for completeness. Forms that are incorrectly completed by the parent/guardian are 
separated.  The CPHDH then telephones the parent/guardian to discuss which 
sections(s) were not completed correctly.  The CPHDH then sends a new informed 
consent to the parent/guardian for proper completion.  The informed consent is 
then sent back to the school administrator.  The administrator contacts the CPHDH. 
The CPHDH reviews the form again for completeness and acceptance into the study.   
 

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Parents/guardians will be asked to carefully review the NH DHHS COVID-19 letter, 
the principal recruitment letter and the informed consent.  If they have any 
questions about the study or the consenting process they can contact the school 
nurse, the Supervising Dentist, the CPHDH or the Principal Investigator prior to 
signing and returning the forms to the child’s school. 
 
When a school is closed due to COVID-19 and services are to be performed in an 
alternate community location, parents/guardian will be notified by the school 
principal either by email or via the school’s social media communication page.  
Parents/guardians of currently consented children will be informed of the alternate 
community location, the date when the treatment will be provided and the process 
for scheduling the appointment with the CPHDH.  The CPHDH will contact the 
parent/guardian directly for scheduling the appointment at the alternate location. 
 
Parents/guardians of children that have not yet consented will also be given the 
opportunity to participate.  All other study forms (COVID-19 letters, recruitment 
letters and recruitment flyer) will be provided.   
 
The following eICF website link will be listed in the same email or via the school’s 
social media page as listed above.  Once the eICF is received, reviewed for 
completeness and accepted by the CPHDH they will contact the parent/guardian for 
scheduling the appointment at the alternate community location. 
 
NESS eConsent Website link: 
(https://www.ne4m.com/DentalConsentBETA/Login.aspx) 
  
Completed paper informed consent forms are scanned and saved as a PDF.  They are 
then securely uploaded to New England Survey Systems (NESS), an external medical 
recording company using the following password protected link: 
 
 https://nedental.sharefile.com  
 
NESS then assigns each student a unique identification ID number and then populates 
the master database and the electronic dental record on iPads. This process is repeated 
yearly. Reconciliation of the school roster and informed consent facilitates assessment 
of participation by school, grade, and teacher. Informed consent will be valid for 5 years 
for year 1, 4 years for year 2, 3 years for year 3, 2 years for year 4 and 1 year for year 5. 
We follow each schools protocol for contacting and reminding parents/guardians that 
they have consented to a 5 year informed consent. 
 
2. Dental Consent Website and NEForm eConsent Process Provided by NESS 
The purpose of this Website is to register children to the program and administer 
and sign the eConsent. 
 
Electronic informed consent forms will be distributed to parents/guardians by the 
principal either by email or via the school’s social media communication page. 

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The process is outlined below: 
 
• Dental Account Verification 
o School staff, study personnel, and caregivers will receive an email to 
register for an account on the secure website (SSL) 
• Registering the Schools New Account 
o The invitational email will provide a verification code that will be 
needed to proceed 
o The school can be selected for the specific program site providing 
services 
o The program site will then prompt for a new secure password and 
the user can continue to their school-specific eConsent 
• Register/Consent New Child 
o Parents/guardians are sent the eConsent Website link from the 
school principal. 
o The user will then select the consent option and website will then 
route to the eConsent page 
o The eConsent will display an electronic version of the current IRB-
approved informed consent template, the recruitment letter and 
recruitment flyer 
o During the eConsent viewing process, the parent/guardian will have 
the opportunity to highlight text and enter questions for staff into 
the draw zone directly on the web page.  The user will be able to 
see the instructions again at any time by clicking on the blue 
“I”button 
o The names and telephone numbers for the lead dentist and CPHDH 
are listed for the parent/guardian to contact if they have any 
questions that they need answered. 
o The lead dentist and CPHDH listed will answer any questions the 
parent/guardian may have before indicating their consent and prior 
to signature. 
o The parent/guardian will not be able to progress until they 
indicated that the program staff answered all their questions 
o After reviewing the eConsent, the user will be prompted to enter in 
required contact and demographics information as well as 
insurance information 
o This data is the data collected in the IRB approved ICF 

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29 
o After the parent/guardian fills in any/all required consent options, 
they will be prompted to enter the printed name for the signature 
and submit the form 
• eSign the Form 
o The site then proceeds to the eSign process for signing the form 
o After pressing “Start eSigning” and “Click to Sign”, the IRB approved 
PDF copy of the ICF will be displayed.  This will have the option of 
using eSignature to “Click to Sign” and will be populated with the 
responses entered during the eConsent completion 
o After confirming the signature, the parent/guardian will see the 
signatures, date, and data populated in the PDF.  The completed 
document will appear for them to review and keep a copy. 
o They can then click and download the eSigned PDF. 
4.5 
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 NESS is notified, and the 
record flagged to remove the child from the informed consent list in the data base and the iPad 
electronic record. Students who withdraw are not replaced. 
5 Study Device 
5.1 
Description  
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: 
 
 
5.2 
Treatment Regimen  
One drop of silver diamine fluoride is dispensed into a dappen dish.  After drying the affected 
tooth surface, silver diamine fluoride is applied with an Advantage Arrest Applicator for 
approximately 30 seconds. Fluoride varnish is then applied to all teeth. 
5.3 
Method for Assigning Subjects to Treatment Groups  
This is a cluster randomized controlled design. A computer generated randomization assigns 
schools to simple or complex treatment. 

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5.4 
Implantation of Study Device  
Silver diamine fluoride, along with fluoride varnish is stored in a plastic sealed container, placed 
in a combination locked filing box and locked in the secure location overnight.  As indicated in 
5.2, after drying the affected tooth surface, silver diamine fluoride is applied with Advantage 
Arrest Applicator for approximately 30 seconds. Fluoride varnish is then applied to all teeth. 
5.5 
Subject Compliance Monitoring.  
Not applicable. 
5.6 
Prior and Concomitant Therapy 
Prior therapy is noted on the clinical screening. Both arms have concomitant therapy.  
5.7 
Packaging 
Silver diamine fluoride is available in an 8ml. plastic bottle. One drop of liquid is dispensed into a 
dappen dish for delivery to the affected area using an Advantage Arrest Applicator. 
5.8 
Blinding of Study       
Neither the participants or clinicians are blinded. The analysts, however, are blinded. 
5.9 
Receiving, Storage, Dispensing and Return 
5.9.1 
Receiving 
The products used for this trial are typical standard of care (SOC) dental commodities 
obtained from Henry Schein. They include toothbrushes, toothpaste, fluoride varnish, 
and glass ionomer cement (a dental restorative material used in dentistry for dental 
fillings). Silver diamine fluoride (a topical varnish used to treat and prevent dental caries 
and relieve dentinal hypersensitivity can only be obtained from Elevate Oral Care®. 
They are shipped to the school based oral health programs, fluoride varnish and silver 
diamine fluoride are stored in a plastic sealed leak proof container, placed in a 
combination locked filing box and locked in the secure location overnight with the other 
clinical supplies.  
Upon receipt of the of the silver diamine fluoride, an inventory will be performed 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. 
 
We will track the total number of silver diamine fluoride 8 ml. bottles that are dispensed 
throughout this study.  Each bottle of silver diamine fluoride lists the individual lot 
number on the bottom of each box.  Prior to each box being dispensed, the CPHDH or 
the dental assistant will take a picture using the iPad to identify, track and store that 
information within each programs iPad.  
5.9.2 
Storage 
Silver diamine fluoride is stored in a plastic sealed leak proof container, placed in a 
combination locked filling box and locked in a secure location overnight with other 
school based dental supplies in a locked closet. 
5.9.3 
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. An Advantage Arrest Applicator is used to 

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31 
apply the solution to pits, fissures, and frank caries placed on the back teeth only for 30 
seconds. Following application of the silver diamine fluoride varnish is applied. 
5.9.4 
Return  
Not applicable. 
 
 
6 Study Procedures 
6.1 
Description 
Each program will schedule care delivery in a school or at a community-based location to deliver 
care, and then coordinate care delivery. 
6.1.1 
Scheduling 
1. In School  
For in school scheduling of preventive care the NH DHCP will work with the 
schools. 
2. Community-Based 
For scheduling at alternate community-based locations the Supervising Dentist 
and the CPHDH will work with the administrator at each community-based 
location. 
6.1.2 
COVID-19 Site Pre-Visit Assessment and Screening Procedures  
1. Site Pre-Visit Assessment 
Prior to scheduling any school or community-based activities, the CPHDH will 
review the school and community-based location policies for prevention of 
coronavirus transmission among students, staff, parents/guardians and faculty 
using either the COVID-19 School or Community-based location Site Pre-Visit 
Checklist.  If there is any reason to believe that policies would put the NH DHCP, 
students or parents/guardians at risk, the CPHDH will contact the Supervising 
Dentist to determine the appropriate course of action.  
2. NH DHCP Screening 
• 
The NH DHCP who have been told by medical or public health authorities to 
self-isolate or quarantine must not participate in any school or community-
based site activities. 
• 
Starting 2 days before any school or community-based site activity and 
continuing for 2 days after the activity, the NH DHCP must self-assess for 
signs and symptoms of COVID-19 infection using the COVID-19 NH School or 
Community-Based DHCP Self Monitoring Checklist and Daily Symptom 
Tracker.  
• 
If any signs or symptoms are present, NH DHCP must immediately notify the 
Supervising Dentist and will not report for work. 
• 
The school or community-based location will then be contacted to cancel 
and re-schedule the activity.     

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If a NH DHCP develops signs or symptoms consistent with COVID-19 or other 
respiratory illness during school or community-based activities, they must 
immediately notify the school nurse or other school or community-based 
official, remove themselves for the school or community-based setting, contact 
the Supervising Dentist and seek medical evaluation as appropriate. 
If a NH DHCP tests positive or develops symptoms for COVID-19 within 14 days 
following a school or community-based activity, they must notify the 
Supervising Dentist who will contact public health authorities to determine the 
need for contact tracing.   Records of students treated during the potentially 
infectious period will be made available to public health authorities if requested. 
A NH DHCP with a positive test or symptoms of COVID-19 will be cleared to 
return to work by the Supervising Dentist on the most current guidance from 
the New Hampshire Department of Health and Human Services (DHHS) or the 
CDC whichever is more stringent.   
3. Screening of students.   
When providing services in schools or community-based setting, the NH DHCP 
will conduct screenings which will be documented on the COVID-19 Student 
Screening Log and in the iPad digital electronic dental record (NESS).  Copies of 
the screening log will be securely maintained consistent with HIPAA 
requirements.   
Screening will include:  
• 
Temperature check using a contactless thermometer.  Care for 
students with a measured temperature ≥100.4° F will be deferred for 
at least 14 days and a notation made on the student’s chart. 
• 
A verbal response from the student to questions regarding presence 
of cough or other possible COVID-19 symptoms. 
• 
 NH DHCP observation of possible signs or symptoms. 
• 
If off-site, NH DHCP will obtain a verbal response from the 
parent/guardian if present. 
• 
If a student exhibits temperature or other signs or symptoms of 
COVID-19 infection, care will be deferred for at least 14 days, or until 
all symptoms have resolved. 
NH DHCP will immediately notify the school nurse or other school or 
community-based official if treatment is deferred as a result of COVID-19 
screening.  
6.1.3 
Clinical Room Set-up 
The clinical treatment room is set up with only 1 clinical station to provide care to 1 
child at a time.  Where distancing is not possible, use of impervious barriers may be 
required. 
The following procedures are performed: 
 

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1. The clinical work area is disinfected with a hospital grade EPA registered 
disinfectant (See Section 5.2 for COVID 19 specific interim guidance) before 
supplies needed for the day are removed from suitcases, containers or 
backpack.  The table is covered with a disposable tablecloth.  Supplies needed 
for the day are placed on a clean table at least 6’ away from the dental chair and 
covered with a fluid impervious drape. The supply suitcase is then placed under 
the clean table for storage. 
2. Any furniture, books, non-clinical seating, or other school or community-based 
items within six feet of the chair must be removed from the clinical care area or 
be covered with a fluid impervious drape.  
3. Where distancing is not possible, use of impervious barriers may be required. 
4. A dirty table is set up at least 6’ away from the clean clinical supply table.  The 
dirty table is used for the disposal of used PPE that is required to be changed in 
between patients (gloves and face masks), used disposable clinical supplies, and 
used non-disposable clinical supplies which are placed in a biohazard labeled 
sharps container. 
 
 
 

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Clinical Room Diagram 
 
 
6.1.4 
Waiting Room Area. 
If a waiting room is available, the following procedures will be performed in-school or at 
a community-based location: 
1. Upon arrival the NH DHCP will confirm that the child and individual escorting 
them are wearing face masks or covering.  If not, they will be supplied with a 
face mask. 
2. The NH DHCP will ask the child and escort to apply hand sanitizer. 
3. The NH DHCP will take the temperature of the child Note: If the child 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 has a temperature of less than 100.4 °F the dental NH DHCP 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 face mask on until the child has completed their treatment visit. 
 
 
                 6 ‘ 
 
 
 
 
               SUPPLY SUITCASE PLACED UNDER CLEAN TABLE 
                                                                                             
 
  
 
 
 
 
 
 
 
          6 ‘ 
 
 
 
 
 
        
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                  
Dental 
Chair 
Stool 
Stool 
BI-FOLDABLE TABLE  
CLEAN BULK SUPPLIES 
BI-FOLDABLE 
DIRTY TABLE 
TRASH 
PRINTER AND 
ROUTER 
(Location varies 
based on 
electrical outlet) 
TRASH 
 Small 
Foldable 
Tray Table 
Hand 
Sanitizer 
SHARPS 
CONTAINER 

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The waiting room seats will be spaced 6’ apart and disinfected between seating. 
6.1.5 
Examination and Diagnosis  
Each program will use password-protected iPads with electronic dental records pre-
populated with demographic information of all students with informed consent. 
Student lists on the 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, they will provide a gentle toothbrush prophylaxis, oral 
hygiene instruction, a toothbrush and fluoridated toothpaste. They will also carry out a 
screening and provide preventive care.  The cavity prevention program, provided in 
schools and community-based locations, are spray and spatter free, (i.e., aerosol free).  
 
The screening 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. 
6.1.6 
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 temporary fillings (complex prevention). 
6.1.7 
Take Home Messages and Follow-on Care 
Program’s will provide two take-home messages, one each for parents, school nurses. 
The parents’ message will highlight the care provided, additional care needed, and 
names of a local dentist and community health centers that can provide follow on care. 
The message for the nurses will be an Excel spreadsheet that list the children seen, care 
provided and care needed, and that identify children who need immediate care. For the 
latter, they will follow each school’s protocol. 
6.2 
Study Administration and Duration 
Care is delivered in either a school room (e.g.: class room, nurse office, library, etc.) or a 
community-based location using mobile equipment and disposable supplies. These are set up 
prior to the beginning of the day. Care is delivered only during school or community-based 
location hours. 
The clinical treatment room is set up with only 1 clinical station to provide care to 1 child at a 
time.  Where distancing is not possible, use of impervious barriers may be required. 
 
The room is set up prior to the beginning of treatment.  All clinical staff will wear disposable 
gowns, gloves, ASTM level 2 or 3 face mask against face with, safety glasses and face shields. 
Gloves and face masks are changed 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.  Safety glasses and face shields are also disinfected between patients. 

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Based on informed consents, children will be scheduled and seen 1 at a time in a school or 
community-based location.  Children are escorted to the waiting room (if available) in the school 
by a school staff member.  Children will be brought to the community-based location by their 
parent/guardian and instructed to be seated in the waiting area (if available).  All children, 
school staff member and parents/guardians are required to wear a face mask or face covering.  
After the child passes the COVID-19 screening test, the child will be escorted 1 at a time to the 
clinical treatment room by the NH DHCP at all locations. 
 
Care will be provided by the CPHDH, with when available an assistant will record the 
examination and care delivery.  After the child has completed treatment they will be required to 
put their face mask back on.  The NH DHCP will bring the child to the waiting room area.  The 
child will be escorted back to the classroom by the school staff member or back home by the 
parent/guardian from the community-based location. 
 
Simple prevention (screening and care) due to COVID-19 implications can now take up to 20 
minutes. It consists of a gentle tooth brush cleaning, oral hygiene instruction, a screening, 
delivery of silver diamine fluoride using an Advantage Arrest Applicator to all pits and fissures on 
bicuspids or molar teeth, and to all carious lesions. Fluoride varnish is then applied. Each child is 
given a small bag with a toothbrush, fluoride toothpaste, and a take home form indicating the 
results of the screening, the care provided, and a list of local dentists or community health 
centers for follow on care. 
Complex prevention (screening and care)  due to COVID-19 implications can now take up to 30 
minutes. It consists or a gentle tooth brush cleaning, oral hygiene instruction, a screening, 
delivery of glass ionomer sealants and temporary fillings to all pits and fissures on bicuspids or 
molar teeth, and to all carious lesions. Fluoride varnish is then applied. Each child is given a 
small bag with a toothbrush, fluoride toothpaste, and a take home form indicating the results of 
the screening, the care provided, and a list of local dentists or community health centers for 
follow on care. 
Screening and care is provided twice yearly. 
6.3 
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 expect groups to be similar due to the cluster randomization protocol. However, to control 
for any group differences, 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 screening), age at screening, race/ethnicity, and any school-level indicators.  
6.4 
Randomization and Blinding 
6.4.1 
Randomization 
We will do a block randomization, generating sets of unique numbers to assign the 
experimental condition. Thus, for the 43 schools we will generate 22 sets, each set 

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containing a 1 or a 2 in a given order, representing treatment assignment, in random 
order.  
 
6.4.2 
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, however, work in 
teams that only provide either simple or complex prevention. Prior to statistical 
analysis, data will be masked such that the care provided to students in particular 
schools will not be able to be determined.  
6.5 
Compliance Assessment 
This intervention trial depends on protocol compliance by clinicians, not students. We will train 
and standardize clinicians during the summer before beginning each school year. To assess 
compliance, we will use qualitative and quantitative methods together with audit and feedback. 
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 control71,72. 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 temporary fillings (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 then create a fishbone diagram to identify the potential problem and attempt 
to rectify it. We will continue this process during the school year.  
6.6 
Prior and Concomitant Therapy 
Not applicable 
7 Study Procedure 
7.1 
Study Procedures Table 
Following MOU execution with individual schools, and randomization, care will be provided 
twice yearly in each participating schools or community-based locations for children with 
informed consent. 
 

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8 Statistical Plan 
8.1 
Sample Size Determination 
For standard treatment effect power calculations, we assume a two-group comparison of 
simple prevention and complex prevention for a binary outcome, non-inferiority trial. 
Power estimates were first conducted for a one-year comparison following cluster 
randomization. We assume an initial enrollment of 11,219 students across 43 schools (deff 
=10). From our previous studies of school-based caries prevention, baseline caries 
prevalence typically ranges between 30-40%. Power calculations assume an equal 
proportion of untreated decay () of 20%, a non-inferiority margin () of 10%, and a 
participation rate of 35%. This yields an expected baseline sample size of 3,926; however, 
we note that new participants will be enrolled each year and considered in non-inferiority 
analyses. With power of 80%, a total sample size of 198 participants per arm (N=396) is 
required. Adjusted for the design effect yields a required sample size of 3,960. 
Power for longitudinal analyses was computed for generalized estimating equations 85. For 
power estimates, the following assumptions were made: an initial enrollment 11,219 
students across 43 schools; 35% participation rate for each intervention; 20% attrition rate; 
and a 10% natural increase in annual informed consent rates. Based on these assumptions, 
we anticipate a baseline sample size of approximately 3,926 students. In subsequent years 
of the study, new students will enter the program and existing students will be followed 
longitudinally. For 95% power, alpha of .05, four time points (not including baseline), a high 
correlation of repeated measures (r = .6), and a design effect of 20, a sample size of 1961 
students per arm is required to detect a difference in untreated decay of 15% and 2942 for 
a difference of 10%. We note that in the presence of the nonlinear link function, ME-GLM is 
more powerful than GEE, so power estimates are conservative and the sample size is 
sufficient. We also note that the 35% participation rate is based off of national averages, 
Secure MOU from 
Participating Schools 
or Community-Based 
Locations
School
Randomization
Informed Consent
Simple Prevention
Examination + 
Prevention 
2X per Year
Complex Prevention
Examination + 
Prevention 
2X per Year

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which we expect to increase to 50% based on prior experience conducting caries prevention 
programs. 
8.2 
Statistical Methods 
For the non-inferiority of caries arrest, the per-patient proportion of carious lesions at 
baseline treated with simple versus complex prevention that stayed arrested throughout 
the first two years of observation will be determined. Any deciduous teeth with treated 
carious lesions that are lost due to exfoliation will be considered as arrested throughout the 
lifetime of the tooth, with arrested caries status being carried over throughout. Thus, tooth-
level indicators are able to be present for both primary and permanent dentitions at the 
same time. With this approach, each carious tooth treated with either simple or 
comprehensive prevention is a single trial with outcomes either of arrested (1) or failed to 
arrest (0). The percentage of arrested caries (at the child level) will thus be modeled using 
multilevel binomial regression with a logit link Yj ~ Bin(pj), E(Yj) = pj; where pj is the 
probability of success. The noninferiority margin, d, is set at 10%. While there is no gold 
standard criterion for the selection of this margin, the margin was set based on 
collaborative discussion with clinicians to determine what is considered as clinically 
unimportant. The null hypothesis is that the experimental treatment (simple prevention) is 
inferior to the standard treatment (complex prevention) by at least d: psimple - pcomplex ³ d. 
The alternative hypothesis is that psimple - pcomplex < d.  
Based on results from multilevel binomial models, differences in effect sizes estimated by 
confidence intervals will be used to determine clinical non-inferiority of the two prevention 
methods 28. Confidence intervals will be calculated for the difference between the two 
interventions, with the width of this interval signifying the extent of noninferiority. If the 
difference between the two interventions lies to the right of d, then noninferiority will be 
concluded. Though this is method is preferred by reporting guidelines, p-values will also be 
reported, in keeping with other recommendations 28.  
For the prevention of new caries, longitudinal data will be analyzed using generalized 
estimating equations (GEE) and multilevel mixed effects regression models (ML-MEM) with 
the appropriate error distribution for the prevalence and incidence of untreated caries over 
time. The number of teeth at risk for each child during each follow-up interval will be 
identified and the number of those teeth in which new caries is observed at the 
examination that ends that interval will be determined. Primary teeth lost in each interval 
and new permanent teeth will not contribute to data for that interval. Data from baseline 
visits will be omitted from analyses and used as an indicator of any untreated decay at 
baseline. 
To explore non-linear trends in untreated decay between simple and complex prevention, 
longitudinal data will be analyzed using generalized additive models (GAMs) with non-
parametric smoothers, linking the known known proportion pit = E(yit = 1|xijt, zit) to a 
nonlinear nonparametric predictor using the link function 𝑛!" = 𝑔(𝑢!") = ln(𝑢!" 1 −𝑢!"
⁄
) =
∑
𝑠#.𝑥#!"0 + 𝑧!"
$𝑢!
%
#&'
, where sj are smooth nonparametric functions and ui are random 
effects assumed to be iid ~ N(0, D(ψ)) 29. Heterogeneity and correlation among subjects will 
be accounted for through random effects. 
To compare the cost effectiveness of the two included treatments, empirical results will be 
incorporated into a Markov decision tree and incremental cost-effectiveness ratios and net 
health benefits will be estimated. Data for cost and health outcomes will be harvested from 
trees conducted for short-term (e.g., the follow-up time of the presented clinical trial) and 

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long-term (life course) time horizons. Monte-Carlo simulation based probabilistic sensitivity 
analyses will be used to detect the probabilities with which the two treatments represent 
optimum strategies. Finally, budget impact analysis will be applied to estimate expected 
resource implications on the population level and to determine whether and how potential 
cost savings could be used to increase population well-being. 
Missing data will be adjusted for using multiple imputation and inverse probability 
weighting (IPW). Statistical analysis will be performed following intention-to-treat and 
analyzed using Stata v15.0 (StataCorp LLC, College Station, TX, USA) and R v3.1.1. 
8.3 
Subject Population for Analysis 
 
 
For caries arrest, participants will be analyzed using intent to treat (all randomized). All 
participants will be analyzed as randomized in the original randomization, regardless of whether 
or not they received an intervention. For caries prevention, quality of life, and academic 
outcomes, we will use all-treated. Any participant randomized to the study that received at least 
one treatment of an intervention. 
8.4 
Interim Analysis 
There are no interim analyses in this study. 
9 Safety and Adverse Events 
9.1 
Risks and Discomforts 
All children will receive primary and secondary prevention. All preventive interventions are 
currently used in clinical practice as a SOC procedure. Therefore, potential risks for the children 
receiving preventive care are minimal, and identical to children obtaining care in a dental office. 
In this context, the greatest risk is an allergic reaction to fluoride varnish, silver diamine fluoride, 
or glass ionomer. Some fluoride varnish products contain pine rosin (colophony) in their resin 
formula. For children with nut allergies we will use an alternate form of fluoride varnish that 
does not contain pine rosin (colophony) as an ingredient (Elevate Oral Care® FluoriMax Sodium 
Fluoride Varnish™). 
Silver diamine fluoride will change the color of carious lesions from dark brown to black. Our 
survey of parents in private practice and NYU College of Dentistry found that the majority of 
parents found staining acceptable on the posterior teeth, especially when the alternative was 
anesthetics with drilling and subsequent fillings (Crystal et al. Parental perceptions and 
acceptance of silver diamine fluoride staining. JADA, 2017. In press). In our survey of principals, 
nurses, teachers, and parents in our 2 NYC pilot schools, all were more concerned with lack of 
care access than color change. 
The cavity prevention program, provided in schools and community-based locations, are spray 
and spatter free, (i.e., aerosol free). 
All clinical staff will wear personal protective equipment (PPE) to include: gloves, gown, face 
mask, protective eyewear and face shield. 
 
To guard against untoward consequences of unexpected adverse events, all clinical staff are 
trained in CPR, and the school nurse is notified on our arrival and departure from schools. 

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9.2 
Adverse Event Definitions 
Adverse Event 
An AE is any untoward or unfavorable medical occurrence associated with the participant’s 
involvement in the research, whether or not considered related to the study intervention. 
 
Serious Adverse Event  
A SAE is an AE that meets any of the following criteria: 
 
• Fatal or life-threatening 
• Requires or prolongs inpatient hospitalization* 
• Results in persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect 
• Is a significant and impacting event, which may not be immediately life threatening but is 
clearly of major significance. It may jeopardize the participant and may require intervention 
to prevent one of the other outcomes listed above.  
 
AE that do not meet any of the criteria above should be regarded as non-serious.  
 
Unexpected Adverse Event  
An AE is considered “unexpected” if it is not listed in the or at the specificity/severity that has 
been previously observed and/or specified in the investigational protocol or materials related to 
the study. 
 
Adverse Event Reporting Period 
The study period during which AEs must be reported is normally defined as the period from the 
initiation of any study procedures to the end of the study intervention follow-up.  
 
Preexisting Condition 
A preexisting condition is one that is present at the start of the study. A preexisting condition 
should be recorded as an AE if the frequency, intensity, or the character of the condition 
worsens during the study. 
 
Post-Study Adverse Event 
The investigator should follow all AEs until the events are resolved, the participant is lost to 
follow-up, or the event is otherwise explained. At the last scheduled visit, the investigator 
should instruct each participant to report any subsequent event(s) that the participant or 
his/her physician (if applicable) believes might reasonably be related to participation in this 
study.  
 
Any AE occurring after the study period or after the participant has discontinued or terminated 
study participation that may reasonably be related to the study (e.g. death, cancer, a 
subsequently conceived offspring with a congenital anomaly) should be recorded and reported 
immediately.  
9.2.1 
Recording of Adverse Events 
All adverse events occurring during the study period will be recorded. At each contact 
with the participant, the investigator will seek information on adverse events by specific 

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questioning and screening. Information on all adverse events will be recorded on the 
electronic dental record and any appropriate CRFs immediately. The clinical course of 
each event will be followed until resolution, stabilization, or until it has been 
determined that participation in the study is not the cause. Serious adverse events that 
are still ongoing at the end of the study period will be followed to determine the final 
outcome.  
9.3 
Reporting of Serious Adverse Events and Unanticipated Problems 
The investigator will conform to the AE reporting timelines, formats and requirements of 
NYUMC and any other applicable entities to which they are responsible. At a minimum, events 
that must be reported are those that meet one of the following (Refer to Sections 8.1 and 8.2): 
 
• Related to study participation 
• Unexpected 
• Serious or involve risks to participants or others 
 
For Narrative Reports of Safety Events 
If the report is supplied as a narrative, the minimum necessary information to be provided at the 
time of the initial report will include: 
 
• Study identifier 
• Study center 
• Participant number 
• A description of the event 
• Date of onset 
• Current status 
• Whether study treatment was discontinued 
• The reason why the event is classified as serious 
• Investigator assessment of the association 
between the event and study treatment 
9.3.1 
Investigator Reporting: Notifying the IRB 
Federal regulations require timely reporting by investigators to their local IRB of 
unanticipated problems posing risks to participants or others. The following describes 
the NYUMC IRB reporting requirements: 
 
Report Promptly, but no later than 5 working days: 
Researchers are required to submit reports of the following problems promptly but no 
later than 5 working days from the time the investigator becomes aware of the event: 
• Unanticipated problems, including adverse events that are unexpected 
and related: 
 
- Unexpected: An event is “unexpected” when its specificity and severity are 
not accurately reflected in the protocol-related documents, such as the 
IRB-approved research protocol, any applicable investigator brochure, and 
the current IRB-approved informed consent document and other relevant 
sources of information, such as product labeling and package inserts.  
- Related to the research procedures: An event is related to the research 
procedures if in the opinion of the principal investigator or sponsor; the 
event was more likely than not to be caused by the research procedures.  

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- Harmful: either caused harm to participants or others, or placed them at 
increased risk. 
 
Other reportable events: 
The following events also require prompt reporting to the IRB, though no later than 5 
working days: 
• Complaint of a research participant when the complaint indicates 
unexpected risks or the complaint cannot be resolved by the research team. 
• Protocol deviations or violations (includes intentional and 
accidental/unintentional deviations from the IRB approved protocol) for any 
of the following situations:  
 
- One or more participants were placed at increased risk of harm  
- The event has the potential to occur again 
-  The deviation was necessary to protect a participant from immediate 
harm 
• Breach of confidentiality 
• Incarceration of a participant when the research was not previously 
approved under Subpart C and the investigator believes it is in the best 
interest of the participant to remain on the study. 
• New Information indicating a change to the risks or potential benefits of 
the research, in terms of severity or frequency (e.g. analysis indicates lower-
than-expected response rate or a more severe or frequent side effect; other 
research finds arm of study has no therapeutic value). 
 
Reporting Process 
The reportable events noted above will be reported to the IRB using the form: “Reportable 
Event Form” or as a written report, including a description of the event with information 
regarding the criteria above, a follow-up/resolution plan, and the need for revision of any 
applicable documents. Copies of each report and documentation of IRB notification and 
receipt will be kept in the investigator’s study file. 
9.4 
Unblinding Procedures 
Not applicable. The clinician and participant will be aware of the care provided. 
9.5 
Stopping Rules  
Given that we are implementing preventive interventions used in clinical practice, and that silver 
nitrate has been used for more than 100 years, fluoride for more than 50, and silver diamine 
fluoride for more than 25 without significant adverse events, we have not implemented 
stopping rules. 
9.6 
Monitoring of Events 
9.6.1 
Data Monitoring Committee 
 
We will convene a data monitoring board, if required by NIMHD. 

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10 Data Handling and Record Keeping 
10.1 
Confidentiality 
Information about study participants will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those 
regulations require a signed subject authorization informing the participant of the following:  
 
• What protected health information (PHI) will be collected from participants in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research participant to revoke their authorization for use of their PHI 
 
In the event that a participant revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
authorization. For participants that have revoked authorization to collect or use PHI, attempts 
should be made to obtain permission to collect at least vital status (i.e. that the participant is 
alive) at the end of their scheduled follow-up period. 
10.2 
Source Documents 
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, screening and clinical care records. These are all collected electronically and 
maintained on a secure data base at NESS. 
10.3 
Case Report Forms 
All study forms are electronic and reside on iPads. Forms require completion prior to moving to 
next steps. Out of range entries are flagged immediately for correction, if necessary, and re-
entry. 
10.4 
Records Retention and Storage 
 
 
All records are securely stored electronically on the NESS servers. They will be stored for the 
term of the study. 
10.5 
Study/Regulatory Binder 
 
 
We will use an electronic study/regulatory binder.  The software was purchased through 
medpoint digital. 
 
 
 http://www2.medpt.com/siteservices/#esafeJump. 
11 Study Monitoring, Auditing, and Inspecting 
11.1 
Study Monitoring Plan 
 
This study will be monitored. The principal investigator will ensure that the monitor or other 
compliance or quality assurance reviewer is given access to all the above noted study-related 
documents and study related facilities (e.g. pharmacy, diagnostic laboratory), and has adequate 
space to conduct the monitoring visit. 

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11.2 
Auditing and Inspecting 
 
 
The principal investigator will permit study-related monitoring, audits, and inspections by the 
IRB/EC, the funding sponsor, and University compliance and quality assurance groups of all 
study related documents. The investigator will also ensure the capability for inspections of 
applicable study-related facilities. Participation as an investigator in this study implies 
acceptance of potential inspection by government regulatory authorities and applicable 
University compliance and quality assurance offices. 
12 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 a consent describing the study and 
providing sufficient information for them to make an informed decision about their participation. See 
Attachment [NH Caried Away 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 consent form, must be obtained before that 
participant undergoes any study procedure. The parent/guardian or a legally acceptable surrogate must 
sign the consent form.  
13 Study Finances 
13.1 
Funding Source 
 
This study is financed through a grant from the National Institute of Minorities and Health 
Disparities 
13.2 
Conflict of Interest 
 
None. 
13.3 
Participant Stipends or Payments 
 
      None. 
14 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. 

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15 Attachments 
Informed Consent 
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