Reducing Oral Health Disparities of Older Adults: Comparative Effectiveness of 2 Treatments
Phase: NA
Conditions: Dental Caries
Sponsor: Case Western Reserve University

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
 
 
 
 
Reducing Oral Health Disparities of Older Adults: 
Comparative Effectiveness of 2 Treatments 
Contract #: AD-2018-C1-10590 
Principal Investigator: Suchitra Nelson, PhD 
PCORI Program Official: Tabassum Majid, PhD, MAgS  
 PCORI Contract Administrator: Rhonda Stewart 
Draft or Version Number:  14.0 
11 April, 2023 
 
 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
 
Version Revision History:  

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
 
Version  # 
Version Date 
Summary of Revisions Made: 
0.1 
28 March, 2019 
Initial draft 
1.0 
23 April, 2019 
IRB Approval 
1.1 
3 May, 2019 
Section 13.2.1 Quality Assurance Procedures was updated. 
Section 15.2 Data Collection Methods and Organization of 
the Data was updated. 
2.0 
3 May, 2019 
PCORI Methodology Standards were added 
3.0 
18 October, 2019 
PCORI Program Officer information updated, Key 
Personnel updated (removed Dr. Pinto and added Dr. 
Dubaniewicz). Sections 7.1, 7.2, 7.3, 8.1.1, 9.2 and Figure 
15.3.1 were updated to add the Safety Questionnaire (Pre-
Exam). 
4.0 
28 October, 2019 
Sections 6.2 and 6.10 were updated to indicate that a 
rotary brush will not be used for the ART treatment 
procedure, only a manual brush. Sections 6.10, 7.1 and 7.2 
were updated to outline procedures for addressing 
participant reported issues with the applied treatment. 
5.0 
11 November 2019 
Sections 4.1 and 5 have been revised to add severe 
cognitive impairment as an exclusion criteria at the 
recommendation of the study’s Data and Safety Monitoring 
Board. Revisions have been made to section 5 to clearly 
outline the screening and enrollment process for the study.  
6.0 
3 April 2020 
Section 7 (Study Schedule) has been revised to add 
temporary COVID-19 procedures for obtaining written 
informed consent and collecting survey data at baseline 
and 26-week follow-up.  
7.0 
17 June 2020 
Section 7 (Study Schedule) has been revised to add 
temporary COVID-19 in-person procedures for recruitment, 
data collection and dental screening/treatment. Section 1 
has been updated with the current name and contact 
information for the PCORI Program Official and Key 
Personnel.  
8.0 
10 August 2020 
Section 7 (Study Schedule has been revised to include that 
study exams/treatment during temporary COVID-19 in-
person visits may take place in an outside location at the 
facility if requested by housing site personnel.  

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
 
9.0 
9 October 2020 
Section 7 (Study Schedule) has been revised to be 
consistent with current screening guidelines indicating that 
individuals with a self-reported or on-site screening 
temperature > 100.0, will not be scheduled nor seen for a 
study visit or exam/treatment. Previously, the cut-off 
temperature was 100.4. Section 7.2 and 7.3 have been 
revised to correct the window timeframes. 
10.0 
13 November 2020 
Section 7 (Study Schedule) has been revised to include 
remote data collection for questionnaires at the 52-week 
follow-up visit rather than in-person during the COVID-19 
pandemic. Section 7.3 has been updated to include 
administration of the COVID-19 dental visit questionnaire at 
the 52-week follow-up visit, and section 6.11 has been 
corrected to indicate the proper arms.  
11.0 
29 September 2021 Updates have been made to the PCORI program official 
name and contact information. The Protocol Summary and 
sections 4, 5, 7.3 and 8.1.2 have been updated to reflect 
PCORI approved modifications to the study timeline (+18 
months), # to be enrolled (+40) and # of facilities (+4) to 
address COVID-19 challenges. Section 8.1.2 has also been 
updated to indicate that focus groups may be conducted at 
a housing site or virtually based on housing site 
circumstances at the time of scheduling.  
12.0 
16 June 2022 
Section 1: Study Sites was updated to add Educator Senior 
Housing. 
13.0 
4 Oct 2022 
Section 1: Study Sites was updated to add Lorain Square 
and Beachcrest. 
14.0 
11 April 2023 
The Protocol Summary was updated to reflect the correct # 
of added sites. Section 1: Study Sites and Section 4.1: 
Facility Table were updated to add all sites where 
recruitment/enrollment was completed. Key Roles and 
Contact Info. was updated to add Gloria Bales as the 
Research Associate. Sections 6.8 and 6.11 were updated 
to reflect that the study dentist may not be present at 52 
week follow-up visits where treatment is not delivered. 
Section 7.3 was updated to reflect that the dentist or 
hygienist will administer the Safety Questionnaire (pre-
exam) at the 52-week follow-up visit. 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
i 
 
 
STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and the PCORI Contract for funded research 
project. All personnel involved in the conduct of this study have completed human subjects 
protection training. 
 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
ii 
 
SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
Principal Investigator: 
Signed: 
 
Date: 
 
 
Name: Suchitra Nelson, PhD 
 
Title: Assistant Dean of Clinical and Translational Research 
          Professor and Interim Chair, Department of Community Dentistry 
 
 
 
 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
iii 
 
TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE ................................................................................................. I 
SIGNATURE PAGE .................................................................................................................... II 
TABLE OF CONTENTS ............................................................................................................. III 
LIST OF ABBREVIATIONS ....................................................................................................... VI 
PROTOCOL SUMMARY ......................................................................................................... VIII 
1 
KEY ROLES AND CONTACT INFORMATION ................................................................. 11 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....... 19 
2.1 
Background Information ........................................................................................ 19 
2.2 
Rationale .............................................................................................................. 20 
2.3 
Potential Risks and Benefits ................................................................................. 21 
2.3.1 
Potential Risks .......................................................................................... 21 
2.3.2 
Potential Benefits ...................................................................................... 22 
3 
OBJECTIVES ................................................................................................................... 23 
3.1 
Study Objectives ................................................................................................... 23 
3.2 
Study Outcome Measures .................................................................................... 23 
3.2.1 
Primary Outcome Measures ...................................................................... 23 
3.2.2 
Secondary Outcome Measures ................................................................. 23 
3.2.3 
Mediators, Process Outcomes .................................................................. 23 
4 
STUDY DESIGN .............................................................................................................. 24 
4.1 
Study Participants ................................................................................................. 24 
4.2 
Model and Design ................................................................................................. 27 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................. 30 
5.1 
Subject Inclusion Criteria ...................................................................................... 30 
5.2 
Subject Exclusion Criteria ..................................................................................... 30 
5.3 
Strategies for Recruitment and Retention ............................................................. 31 
5.4 
Treatment Assignment Procedures ....................................................................... 32 
5.4.1 
Randomization Procedures ....................................................................... 32 
5.4.2 
Masking Procedures.................................................................................. 32 
5.5 
Subject Withdrawal ............................................................................................... 32 
5.5.1 
Reasons for Withdrawal ............................................................................ 32 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ............................................................................................... 33 
5.6 
Premature Termination or Suspension of Study .................................................... 33 
6 
STUDY INTERVENTION .................................................................................................. 35 
6.1 
Study Product Description .................................................................................... 35 
6.1.1 
Formulation, Packaging, and Labeling....................................................... 35 
6.1.2 
Product Storage and Stability .................................................................... 35 
6.2 
Dosage, Preparation and Administration of Study Product .................................... 36 
6.3 
Modification of Study Product Administration for a Subject ................................... 37 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
iv 
 
6.4 
Accountability Procedures for the Study Product .................................................. 37 
6.5 
Assessment of Subject Compliance with Study Product Administration ................ 37 
6.6 
Concomitant Medications/Treatments ................................................................... 37 
6.7 
Administration of Intervention................................................................................ 37 
6.8 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ........ 37 
6.9 
Assessment of Subject Compliance with Study Intervention ................................. 38 
6.10 
Study Procedural Intervention(s) Description ........................................................ 38 
6.11 
Administration of Procedural Intervention.............................................................. 39 
7 
STUDY SCHEDULE ......................................................................................................... 40 
7.1 
Baseline Visit (T0) (Day -30 to 14) ......................................................................... 44 
7.2 
26-Week Visit (T26) (Day 168 to Day 196) ............................................................. 45 
7.3 
52-Week Visit (T52) (Day 365 to 379) .................................................................... 46 
7.4 
Withdrawal Visit .................................................................................................... 47 
7.5 
Unscheduled Visit ................................................................................................. 47 
8 
STUDY PROCEDURES /EVALUATIONS ........................................................................ 48 
8.1 
Study Procedures/Evaluations .............................................................................. 48 
8.1.1 
Quantitative outcomes of interventions ...................................................... 50 
8.1.2 
Focus Group Study Procedures / Evaluations ........................................... 53 
9 
ASSESSMENT OF SAFETY ............................................................................................ 55 
9.1 
Specification of Safety Parameters ....................................................................... 55 
9.1.1 
Unanticipated Problems ............................................................................ 55 
9.1.2 
Adverse Events ......................................................................................... 55 
9.1.3 
Serious Adverse Events ............................................................................ 55 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 56 
9.3 
Characteristics of an Adverse Event ..................................................................... 57 
9.3.1 
Relationship to Study Intervention ............................................................. 57 
9.3.2 
Expectedness of SAEs .............................................................................. 57 
9.3.3 
Severity of Event ....................................................................................... 57 
9.4 
Reporting Procedures ........................................................................................... 58 
9.4.1 
Unanticipated Problem Reporting to IRB and PCORI ................................ 58 
9.4.2 
Serious Adverse Event Reporting to PCORI.............................................. 59 
9.5 
Halting Rules ........................................................................................................ 59 
10 
STUDY OVERSIGHT ....................................................................................................... 60 
11 
STATISTICAL CONSIDERATIONS .................................................................................. 61 
11.1 
Study Hypotheses ................................................................................................. 61 
11.2 
Sample Size Considerations ................................................................................. 61 
11.3 
Planned Interim Analyses ..................................................................................... 61 
11.3.1 Efficacy Review ......................................................................................... 61 
11.4 
Final Analysis Plan ............................................................................................... 62 
12 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 65 
13 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................ 66 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
v 
 
13.1 
Definitions ............................................................................................................. 66 
13.2 
Study Intervention and Study Questionnaires ....................................................... 66 
13.2.1 Quality Assurance Procedures .................................................................. 66 
13.2.2 Quality Control Procedures ....................................................................... 67 
14 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 68 
14.1 
Ethical Standard ................................................................................................... 68 
14.2 
Institutional Review Board .................................................................................... 68 
14.3 
Informed Consent Process ................................................................................... 68 
14.4 
Subject Confidentiality .......................................................................................... 68 
15 
DATA MANAGEMENT PLAN ........................................................................................... 70 
15.1 
Data Management Responsibilities ....................................................................... 70 
15.1.1 Data Collection Methods ........................................................................... 70 
15.1.2 Setting up the EDC.................................................................................... 70 
15.1.3 Changes to a Production EDC System ...................................................... 71 
15.1.4 Version Control for Study Forms ............................................................... 72 
15.1.5 Organization of Paper Form ...................................................................... 72 
15.2 
Types of Data Collected ........................................................................................ 73 
15.3 
Methods to Prevent and Monitor Missing Data. ..................................................... 74 
15.3.1 Univariate Alerts ........................................................................................ 74 
15.3.2 Multivariate and Cross-module Alerts ........................................................ 75 
15.4 
Schedule and Content of Reports ......................................................................... 75 
15.5 
Data Storage and Preservation plan ..................................................................... 76 
15.6 
Study Records Retention ...................................................................................... 77 
16 
PROTOCOL DEVIATIONS ............................................................................................... 78 
17 
PUBLICATION ................................................................................................................. 79 
17.1 
Policy on Public Access ........................................................................................ 79 
18 
DATA SHARING PLAN .................................................................................................... 80 
18.1 
Data Deposition and Data Availability ................................................................... 80 
19 
LITERATURE REFERENCES .......................................................................................... 81 
APPENDICES ........................................................................................................................... 87 
APPENDIX A: SCHEDULE OF EVENTS .................................................................................. 88 
 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
vi 
 
LIST OF ABBREVIATIONS 
AE 
Adverse Event/Adverse Experience 
ACA 
Affordable Care Act 
ADA 
American Dental Association 
ART 
Atraumatic Restorative Treatment 
CRF 
Case Report Form 
CWRU  
Case Western Reserve University 
CHAID 
Chi-Squared Automatic Interaction Detection 
CART 
Classification And Regression Trees 
CONSORT 
Consolidated Standards Of Reporting Trials 
DSMB 
Data Safety And Monitoring Board 
DHHS 
Department of Health and Human Services 
EQUATOR 
Enhancing the QUAlity and Transparency Of health Research 
FV 
Fluoride Varnish 
GEE 
Generalized Estimating Equations 
GOHRQoL 
Geriatric Oral Health Quality Of Life 
GIC 
Glass Ionomer Cement 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HUD 
Housing And Urban Development 
IRB 
Institutional Review Board 
ICDAS 
International Caries Detection And Assessment System  
ICMJE 
International Committee of Medical Journal Editors 
ICH 
International Conference On Harmonisation 
ICC 
Intraclass Correlation 
IDE 
Investigational Device Exemption 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug  
IND  
Investigational New Drug Application 
MCAR 
Missing Completely At Random  
NCOA 
National Council On Aging 
NHANES 
National Health And Nutrition Examination Survey 
NIH 
National Institutes Of Health 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
vii 
 
NIH 
National Institutes of Health 
NDA 
New Drug Application 
PCORI 
Patient-Centered Outcomes Research Institute 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
PI 
Principal Investigator 
PHI 
Protected Health Information 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomized Clinical Trail 
REDCap 
Research Electronic Data Capture 
SAE  
Serious Adverse Event/Serious Adverse Experience 
SDF 
Silver Diammine Fluoride 
SOP 
Standard Operating Procedure 
SPIRIT  
Standard Protocol Items: Recommendations For Interventional Trials 
TSQM 
Treatment Satisfaction Questionnaire For Medication 
UP 
Unanticipated Problem 
US 
United States 
VAS 
Visual Analogue Pain Scale  
WHO 
World Health Organization 
WHO 
World Health Organization  
ZINB 
Zero-Inflated Negative Binomial 
ZIP 
Zero-Inflated Poisson 
 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
 ____________________________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
viii 
 
PROTOCOL SUMMARY 
 
Title: 
Reducing Oral Health Disparities of Older Adults: Comparative 
Effectiveness of 2 Treatments 
Précis: 
The study is a cluster randomized clinical trial (RCT) to be conducted 
in 22 publicly subsidized housing facilities/sites (HUD Section 202) 
and other low-income housing voucher programs in NE Ohio. The 
facilities will be randomized to 2 arms: Arm 1 (11 sites) – Participants 
will receive biannual silver diamine fluoride (SDF) versus Arm 2 (11 
sites):  Participants will receive atraumatic restorative treatment 
(ART) with glass ionomer cement (GIC) + biannual fluoride varnish 
(FV) application. A total of 550 participants (Arm 1: 275, Arm 2: 275) 
will be followed for one year.  
 
Objectives: 
 
Primary:  To compare the effectiveness of two evidence-based 
strategies, a “simple medical” strategy of topical application of SDF 
versus a “typical dental” strategy consisting of ART + FV given to 
older adults 62 and older to address (1) participant reported 
outcomes including tooth pain and hypersensitivity; and (2) clinical 
outcomes (caries arrest).  
 
Secondary: To assess (1) participant reported outcomes (oral health 
quality of life, safety, and patient satisfaction); and (2) clinical 
outcomes (prevention of new decay).  
 
Population: 
Population information: sample size = 550 older adults to be 
randomized; participants aged ≥ 62 years will be recruited from 22 
subsidized housing facilities in NE Ohio, and will be randomized if 
they have at least one untreated active root or coronal carious 
lesion, and are willing to be in the study for 1 year. The socio-
demographics of this population is expected to be a mean age of 74 
years, 76% female, 51% Caucasian, 45% African-American, 2% 
Hispanic, and 2% other groups, 83% with two or more medical 
conditions.  
Due to COVID-19 restrictions which prevented outside 
visitors/providers at the housing sites, approximately 40 enrolled 
individuals did not complete the 26 week visit/second dose of 
treatment. We will therefore increase the total number of enrolled 
participants by 40.  

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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Phase: 
III 
Number of Sites: 
22 independent  living facilities for older adults, plus an additional 11 
housing facilities to address some delays in recruitment due to the 
COVID-19 pandemic.  
Description of  
Intervention: 
The interventions for this study are in current clinical use. Two 
evidence-based strategies in older adults will be compared as 
follows: (Arm 1) a “simple medical strategy” consisting of SDF versus 
(Arm 2) a “typical dental strategy” consisting of ART + FV. We will 
attempt blinding of participants to the study group, but may not be 
possible due to SDF color change.  
The protocol for each arm will address both coronal and root surface 
tooth decay lesions: Arm 1: The treatment will be bi-annual topical 
38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care 
LLC., West Palm Beach, FL) following manufacturer’s instructions 
and guidelines published by UCSF;1 Arm 2: Atraumatic Restorative 
Treatment (ART) will be a modification of the approach used by Lo 
and colleagues (2006),2 and the cavity restored with high viscosity 
glass-ionomer cement (GIC) (GC Fuji Automix LC Resin Reinforced 
Glass Ionomer Restorative, Japan)). Patients will also receive 
biannual topical fluoride varnish treatments (FluoriMax, Elevate) 
according to manufacturer’s instructions.  
Study Duration: 
48 months 
Subject Participation 
Duration: 
12 months 
Estimated Time to 
Complete 
Enrollment: 
26 months 
 
 
 
 
 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
Version 14.0 
Request ID #: 10590 
 
11 April, 2023 
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 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
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Schematic of Study Design: 

Reducing Oral Health Disparities of Older Adults:  
Comparative Effectiveness of 2 Treatments 
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1 
KEY ROLES AND CONTACT INFORMATION 
Principal 
Investigator:   
Suchitra S. Nelson, PhD 
Professor and Interim Chair, Department of Community Dentistry  
Case Western Reserve University School of Dental Medicine 
2124 Cornell Road 
Cleveland, OH 44106-4905 
Telephone: (216) 368-3469 
Fax: (216) 368-3204 
Email: sxn15@case.edu   
PCORI Program 
Official:   
Tabassum Majid, PhD, MAgS 
Healthcare Delivery and Disparities Research 
Patient-Centered Outcomes Research Institute (PCORI) 
1828 L St., NW, Suite 900  
Washington, DC 20036 
Telephone: (202) 827-7700  
Email: tmajid@pcori.org 
Institutions: 
Case Western Reserve University School of Dental Medicine 
2124 Cornell Rd 
Cleveland, OH 44106-4905 
Contact: Suchitra Nelson, PhD 
Telephone: (216) 368-3469 
Fax: (216) 368-3204  
Other Key 
Personnel: 
Jeff Albert, PhD 
Professor, Department of Epidemiology and Biostatistics  
Case Western Reserve University 
10900 Euclid Ave. 
Cleveland, OH 44106 
Phone: 216-368-1968 
Email: jma13@case.edu 
Amelia Dubaniewicz, DDS  
Department of Community Dentistry 
Case Western Reserve University 
10900 Euclid Ave. 
Cleveland, OH 44106 
Phone: 216-368-0746 
Email: amelia.debaniewicz@case.edu 

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Jason Chao, MD, MS 
Professor and Director, Family Medicine Clerkship  
Case Western Reserve University 
10900 Euclid Ave. 
Cleveland, OH 44106 
Phone: 216-368-5867 
Email: jxc19@case.edu 
Gloria Bales, PhD 
Research Associate, Community Dentistry  
Case Western Reserve University 
10900 Euclid Ave. 
Cleveland, OH 44106 
Phone: 216-368-2833 
Email:  
Other Study 
Personnel: 
Shelley Curtan, MEd 
Project Manager, Community Dentistry 
Case Western Reserve University 
10900 Euclid Ave. 
Cleveland, OH 44106 
Phone: 216-368-3968 
Email: sgc36@case.edu 
David Selvaraj, MS 
Data Manager, Community Dentistry  
Case Western Reserve University 
10900 Euclid Ave. 
Cleveland, OH 44106 
Phone: 216-368-4721 
Email: dms256@case.edu 
Peter Milgrom, DDS 
Professor Emeritus, Oral Health Sciences  
University of Washington 
1959 NE Pacific St. 
Seatlle, WA 98195 
Phone: 206-251-6831 
Email: dfrc@uw.edu 
Hafsteinn Eggertsson, DDS, MSD, PhD 
General Dentist  
Willamette Dental Group 

Reducing Oral Health Disparities of Older Adults:  
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2703 Delta Oaks Drive 
Eugene, OR 97408 
Phone: 1-855-433-6825 
Email: heggerts@yahoo.com 
 
Study Sites: 
 
Westerly Apartments 
Debbie Magda-Vukmanic 
14300 Detroit Ave 
Lakewood, OH 44107 
Phone (work): 216-521-0053, ext. 142 
 
St. Timothy Manor 
Susan Fine 
4335 E 131st St 
Garfield Heights, OH 44105 
Phone (work): 216-475-4460 
 
St. Timothy Park 
Susan Fine 
4350 E 136th St 
Cleveland, OH 44105 
Phone (work): 216-662-8449 
 
Villa at Marion Park 
Sr. Mary Slattery 
320 Guys Run Rd. 
Akron, OH 44107 
Phone (work): 330-773-2833 
 
St. Patrick Manor 
Juanita Arnett 
120 Maple St 
Wellington, OH 44090 
Phone (work): 440-647-0406 
 
Jennings 
Manor 
Lena Rhodes 
10614 Granger Rd 
Garfield Heights, OH 44125 
Phone (work): 216-581-2900 

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Comparative Effectiveness of 2 Treatments 
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Library Court 
Lena Rhodes 
16301 Chagrin Blvd 
Shaker Heights, OH 44120 
Phone (work): 216-581-2900 
 
St. Rita 
Lena Rhodes 
10614 Granger Rd 
Garfield Heights, OH 44125 
Phone (work): 216-581-2900 
 
St. Agnes 
Lena Rhodes 
10300 Granger Rd 
Cleveland, OH 44125 
Phone (work): 216-581-2900 
 
Margaret Wagner 
Leila Washington 
2375 Euclid Heights Blvd 
Cleveland, OH 44106 
Phone (work): 216-373-1985 
 
Willowood Manor 
Sandra Milos 
20665 Lorain Rd. 
Fairview Park, OH 44126 
Phone (work): 440-331-0670 
 
Knickerbocker 
Carryeanne Smitley 
27100 Knickerbocker Road 
Bay Village, OH 44140 
Phone (work): 440-871-3234 ext 3 
 
Abington Arms 
Susan Persing 
11501 Mayfield Rd 
Cleveland, OH 44106 

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Phone (work): 216-791-5025 
 
Fedor Manor 
Dan Taylor 
11501 Mayfield Rd 
Cleveland, OH 44107 
Phone (work): 216-226-7575 
 
Ambleside Tower 
Valerie James 
2190 Ambleside Dr 
Cleveland, OH 44106 
Phone (work): 216-476-4172 ext. 15 
 
Severance Tower Apartments 
Valerie James 
25 Severance Circle 
Cleveland Heights, OH 44118 
Phone (work): 216-476-4172 ext. 15 
 
Cedar Extension Hi-Rise Apartments 
Valerie James 
2320 E 30th St 
Cleveland, OH 44115 
Phone (work): 216-476-4172 ext. 15 
 
Addison Square Apartments 
Valerie James 
7400 Wade Park Ave 
Cleveland, OH 44103 
Phone (work): 216-476-4172 ext. 15 
 
Apthorp Tower Apartments 
Valerie James 
12900 Superior Ave 
East Cleveland, OH 44112 
Phone (work): 216-476-4172 ext. 15 
 
Euclid Beach Gardens 
Valerie James 
16001 Euclid Beach Blvd. 

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Cleveland, OH 44110 
Phone (work): 216-476-4172 ext. 15 
 
Bohn Tower 
Valerie James 
1300 Superior Ave 
Cleveland, OH 44114 
Phone (work): 216-476-4172 ext. 15 
 
Riverview Tower Apartments 
Valerie James 
1795 W 25th St 
Cleveland, OH 44113 
Phone (work): 216-476-4172 ext. 15 
 
King Kennedy 
Valerie James 
2501 East 59th Street 
Cleveland, OH 44104 
Phone (work): 216-476-4172 ext. 15 
 
Quarrytown 
Valerie James 
55 W Bagley Rd 
Berea, OH 44017 
Phone (work): 216-476-4172 ext. 15 
 
Franciscan Village 
Lori Stadalsky 
3648 Rocky River Dr 
Cleveland, OH 44111 
Phone (work): 216- 941-3330 
 
 
Carnegie Tower at Fairfax 
Tara Wenger 
8920 Carnegie Ave 
Cleveland, OH 44106 
Phone: 614-233-2138 
 
 

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Mother Teresa Manor/Commons 
Tara Wenger 
5700 Perkins Rd 
Bedford Heights, OH 44146 
Phone: 614-233-2138 
 
 
Educator Senior Housing 
Linda Sack 
9275 North Church Dr. 
Parma Heights, OH 44130 
Phone: 440-845-5666 
 
Lorain Square 
Valerie James 
16800 Lakeshore Dr 
Cleveland, OH 44110 
Phone (work): 216-476-4172 ext. 15 
 
Beachcrest 
Valerie James 
16800 Lakeshore Dr  
Cleveland, OH 44110 
Phone (work): 216-476-4172 ext. 15 
 
Villa Serena 
Keith Berry 
6800 Mayfield Rd 
Mayfield Heights, OH 44124 
Phone (work): 440-449-3977 
 
Helen S. Brown 
Valerie James 
1821 Noble Rd 
Cleveland, OH 44112 
Phone (work): 216-476-4172 ext. 15 
 
Greater Abyssinia Tower 
Valerie James 

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10401 Superior Ave 
Cleveland, OH 44106 
Phone (work): 216-476-4172 ext. 15 
 
Mt. Auburn Manor 
Valerie James 
3061 East 93rd Street 
Cleveland, Ohio 44104 
Phone (work): 216-476-4172 ext. 15 
 
Mildred Brewer Place 
Valerie James 
14028 Euclid Ave 
East Cleveland, OH 44112 
Phone (work): 216-476-4172 ext. 15 
 
La Ronde 
Valerie James 
12024 Shaker Blvd. 
Cleveland, OH 44120 
Phone (work): 216-476-4172 ext. 15 

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2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
 
Background Information 
The current U.S. health care system does not treat comprehensive dental care for adults as an 
essential health benefit under the ACA (RQ-1).3 Medicare excludes dental care and particularly 
for low-income individuals it leaves them with high out-of-pocket costs: 74% of the beneficiaries 
do not receive dental care annually.4 The Institute of Medicine (IOM) recognizes that preventive 
oral care can reduce medical costs.5 
Over 96% of all U.S. older adults aged ≥ 65 years have had caries experience in the permanent 
teeth. 6 Untreated tooth decay is disproportionately found in non-Hispanic Black (41%) and 
Hispanic (27%) compared to non-Hispanic white older adults (16%).7 Consequently, tooth loss 
is also significantly higher in non-Hispanic blacks compared to other groups.7 About 37% of 
adults ≥ 65 years have tooth decay in exposed root surfaces .6 Caries is the primary cause of 
tooth loss in older adults, and tooth loss is inversely related to oral health related quality of life.8 
The progression of oral diseases adversely affects general health.9 A recent 2018 oral health 
screening and survey of older adults highlights that many are living with significant untreated 
dental disease especially low-income seniors impacting their chewing, nutrition, and overall 
wellbeing that requires immediate attention and focus (RQ-1). 10 
Our 2016-17 data on 202 older adults from 16 publicly subsidized housing units indicates 
untreated caries (58%) is two times higher than the national average (28%).11 All had at least 
one medical condition, while 83% had two or more medical conditions (RQ-4). Nationally, 92% 
of U.S. older adults have at least one medical condition, and 77% have ≥ 2 conditions.12  Low-
income U.S. older adults have disparately increased medical conditions compared to their more 
affluent counterparts13 as shown by our NE Ohio data. Recent studies indicates that poor dental 
health (caries, periodontitis) was related to worsening glucose tolerance and an increased risk 
of diabetes,14 and having fewer teeth/tooth loss and other patient reported oral health problems 
was associated with greater physical frailty in older adults.15 Medical conditions lead to less 
frequent dental visits among older adults with cognitive impairment16 and those with diabetes, 
with significant disparities among low-income groups. 17 Moreover, systemic conditions such as 
cardiovascular and respiratory disease, diabetes etc. have been associated with oral 
infections.18   Untreated oral infection leads to pain, overuse of emergency visits, and even 
death (RQ-1).19   
Despite the profound impact of oral health status on quality of life,9many older adults accept 
their oral health problems as an inevitable process of aging and do not seek dental care.20 In 
fact, ADA Health Policy Institute survey indicates that low perceived need (i.e. not needing 
dental care) was the top reason that older adults do not intend to visit a dentist.21 This belief, 
further impacted by limited dental insurance options results in oral health becoming a low 
priority among older adults. The National Health Interview Survey 2014 data indicate that most 
older adults reported financial barriers to receiving dental care compared to any other type of 
health care.22 A further challenge is that older adults have increased medical problems, physical 
frailty, and cognitive issues that challenge dental care access in this group.23 Testing 
interventions provided outside of traditional dental offices will address barriers to seeking care 
among this population (RQ-1, RQ-3).  

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Conventional restorative treatments do not work for older adults. The dental treatment needs of 
older adults differ from those of younger adults and thus makes diagnosis and treatment 
planning more complex due to age related changes to the enamel, dentine, and pulp 
chamber.24For this reason, results of work conducted in children cannot be extrapolated to older 
adults (RQ-1). The majority of tooth decay in older adults is failure of restorations at the gum 
line and in exposed roots.25 These lesions are difficult to diagnose or restore, even for 
experienced dentists.23 A randomized trial in older adults with root caries treated the decayed 
tooth surfaces with either ART or conventional treatment (using a dental drill) and found that 
ART had a similar restoration survival rate (87% vs. 91%).2 Fluoride varnish and SDF are also 
both effective in arresting and preventing new tooth lesions.26  
Silver Diamine Fluoride (SDF) has been long used to arrest caries in other countries and is now 
widely available in the United States.1 The liquid agent is painted on the decayed tooth or root 
and the treated lesion hardens, while the lesion depth decreases 27,28 and becomes resistant to 
caries bacteria.29 SDF inhibits the decay process by restricting the bacterial metabolic and 
reproductive functions leading to bacterial killing. 30 Thus, silver is an antimicrobial that kills 
cariogenic bacteria far superior to other antimicrobial medicaments.31 Annual 38% SDF has 
been effective in arresting and preventing root caries lesions among older adults in clinical 
trials.32–34 Recently, the American Dental Association evidence-based clinical practice guidelines 
recommends bi-annual application of SDF on permanent teeth.35 
Despite the greater dental caries burden, there are no community-based public health 
interventions that exist for low-income older adults like those for children, and the current clinic-
based dental care delivery system is expensive and ill adapted (RQ-1).36 For any caries 
preventive/treatment intervention to be useful on a population level, 5 presumed attributes are 
necessary: pain and infection control, simplicity of use, cost affordability, minimal personnel time 
and training, and non-invasive.37  Our proposed non-surgical interventions can meet this criteria 
and provide evidence (RQ-5). 
Therefore, we propose a cluster RCT to compare two non-surgical evidence-based strategies to 
address disparities in untreated tooth decay and dental care access (RQ-2). The conventional 
surgical care using the “drill” and “fill” paradigm is not the best nor the most effective option for 
low-income older adults. Nationally, if only 26% of Medicare beneficiaries are seeking dental 
care annually in dental offices, our proposed interventions has the potential to reach a lot more 
older adults where they live in order to reduce oral health disparities. 
 
Rationale 
Comparative effectiveness studies of the proposed interventions are needed to inform the most 
effective community-based treatment strategy for older adults and to establish a standard of 
care (RQ-1, SR-1). A systematic review and meta-analysis supports the use of SDF, 38,39 the 
use of ART with high viscosity glass ionomer cements (GIC),40 and the use of fluoride varnish 
(FV)41 for tooth decay management in older adults (RQ-5). Thus, the proposed research 
compares commonly used evidence-based treatments.  
Therefore, this study will determine the effectiveness of two relatively inexpensive, accepted 
non-surgical treatments that can be provided by dental hygienists (dental paraprofessionals) in 

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most states outside of traditional dental clinics to address the unique oral health needs of low-
income older adults (RQ-1) i.e. a “simple medical” strategy using bi-annual application of SDF 
and a “typical dental” more complex strategy consisting of ART and biannual application of FV. 
The rationale is that providing conventional (surgical with a drill) treatment actually exacerbates 
disparities because such treatment is resource intensive and is relatively ineffective. Our 
hypothesis tests that the “medical” strategy is not less effective as the “dental” strategy in caries 
arrest and prevention.  
Further, our focus is on low-income older adults residing independently in Housing and Urban 
Development (HUD) and other publicly subsidized housing facilities with limited access to dental 
care. In particular, we will focus on subgroups of older adults with co-existing medical conditions 
as these individuals are most likely to experience disparities (RQ-4). The non-surgical treatment 
strategies were selected based on scientific evidence and the feasibility of application by 
licensed paraprofessionals in community-based settings as this can address multiple barriers to 
dental care and subsequently increase access for low-income older adults (RQ-5). Both 
approaches are now used in traditional dental clinics along with conventional intensive dental 
care. Our outcomes address the concerns of older adults (based on surveys, interviews, and 
prior studies of this population) that include: tooth decay, and participant reported tooth pain, 
hypersensitivity, and decreased quality of life (RQ-3, RQ-6, PC-1).  
 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
Study Interventions: SDF was introduced in the US in 2015 and approved by the FDA as a 
medical device; the high viscosity glass ionomer cements (GIC) used in ART were introduced in 
the 1970s. All of the interventions are in current clinical use for package inserts for SDF, ART 
with GIC, FV). The study interventions are non-invasive and does not require the use of 
conventional drilling procedures. There is risk of hypersensitivity to silver or fluoride from the 
38% SDF. SDF can stain the gums or oral mucosa or tooth colored fillings. There is minimal risk 
with the ART and FV applications (RQ-5). 
Dental exams: The project will involve clinical dental exams for the participants. The dental 
exams do not pose any additional risks to participants beyond those encountered in daily living. 
Dental examinations will be visual/tactile using a probe and non-invasive. No x-rays will be 
taken. 
Interviews: Some people are uncomfortable answering questions about themselves for 
research. We will try to make participants feel as comfortable as possible. There is also a 
chance that confidential information can be lost but we will use every precaution to protect the 
information. To protect the privacy of participants, a unique ID number will be used. The 
connection between this code number and participant’s identity will be confidential and will be 
required to link the contact form, questionnaires and dental data. Only project staff members will 
have access to these codes and identifying information. Once the study data collection is 
completed, the link between the individual and their data will be destroyed. 

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Focus groups: There is little risk to participants during the focus group discussions. While it is 
unlikely, some participants may feel shy or embarrassed by some of the questions asked during 
the meetings or interviews. The facilitator and moderator will make every effort to put 
participants at ease and to communicate to them that any information shared during the 
discussions and interviews would not be relayed to others. Further, any names or other 
identifying information will be removed during the transcription process and will not appear in 
the final transcripts of the discussion groups. All audio files will be deleted after they are 
transcribed. 
2.3.2 
Potential Benefits 
Participants may benefit from the SDF and ART + FV treatment applications in the arrest of 
caries and in patient-reported pain and oral health quality of life symptoms Society may benefit 
from the knowledge gained about the comparative effectiveness of a simple topical medical 
treatment (SDF) versus a typical dental treatment. The findings from the proposed study will be 
useful for patients and providers. Patients can make informed decisions regarding the evidence-
based non-surgical options that are available for treating decay, reducing tooth pain, and 
improving quality of life. 
Providers will use the findings to establish standard of care for older adults with unique dental 
issues, co-morbid conditions, frailty, and dementia. Long-term having an effective standard of 
care will reduce oral health disparities for older adults with limited resources. Further, delivering 
dental care in community-based settings will be instrumental in treating far more older adults 
than the current dental office-based care. This will address the national disparity gap and the 
limited dental insurance options for older adults. 
There will be no direct benefit to the participants in the focus groups, but taking part in group 
discussions could have indirect or incidental benefits for respondents. These might include the 
social stimulation of the discussion process, or the knowledge that their participation could help 
in disseminating the findings to other populations. 
Older adult respondents will receive a tooth care kit (free toothbrushes, toothpaste, floss) to 
facilitate good oral hygiene. On balance, we believe any potential risks are reasonable in 
relation to the anticipated benefits to research participants and others. 
 

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3 
OBJECTIVES 
 
Study Objectives 
Primary objective:  
1) To investigate the comparative effectiveness of two evidence-based strategies in low-income 
older adults ≥62 years old followed for one year: (Arm 1) a “simple medical” strategy of bi-
annual topical application of silver diamine fluoride (SDF) versus (Arm 2) a “typical dental” 
strategy consisting of atraumatic restorative treatment (ART) + bi-annual application of fluoride 
varnish (FV). 
2) To examine the narratives of subgroups of publicly subsidized housing participants to 
understand their experiences with non-surgical regimens and identify ways to improve and 
disseminate in other community-based settings nationally. 
 
Study Outcome Measures  
3.2.1 
Primary Outcome Measures 
Primary outcomes are: (1) participant reported outcomes including tooth pain and 
hypersensitivity, and (2) clinical outcomes (caries arrest). Clinical outcomes will be assessed 
through dental exams conducted by calibrated examiners. Participant questionnaire will assess 
patient-reported outcomes using validated instruments. All primary outcomes will be measured 
at baseline, 26 & 52 weeks. 
3.2.2 
Secondary Outcome Measures 
Secondary outcomes are: participant reported outcomes (oral health quality of life); and clinical 
(prevention of new decay). All secondary outcomes will be measured at baseline, 26 & 52 
weeks. 
3.2.3 
Mediators, Process Outcomes 
Moderator variables are: socio-demographics, medical/physical conditions, oral health behavior 
that will be collected at baseline (prior to treatment).  
Process outcomes are: Safety measure that  will be collected at 2, 26 & 54 weeks, and 
satisfaction survey with the treatment will be assessed at 54 weeks. 

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4 
STUDY DESIGN 
This study is a cluster randomized clinical trial to assess the comparative effectiveness of two 
caries treatment interventions for individuals residing in 22 publicly subsidized housing 
facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio 
(RQ-2). Each facility will be randomized to 2 arms:  
Arm 1 (11 facilities) – A total of 275 participants from these facilities will receive biannual SDF.  
Primary Hypothesis: Simple medical treatment (Arm 1) is non-inferior to typical dental treatment 
(Arm 2) for clinical (caries arrest) and patient-reported (tooth pain/hypersensitivity) at 12-months 
post treatment.  
Arm 2 (11 facilities): A total of 275 participants from these facilities will receive ART + biannual 
FV application. 
Secondary Hypothesis: Simple medical treatment (Arm 1) is non-inferior to typical dental 
treatment (Arm 2) for clinical (new decay) and patient-reported (oral health quality of life) 
outcomes at 12-months post treatment. 
The participants will be recruited over a three-year period, and each participant will be followed 
for one year (total of 3 visits -baseline, 26 weeks, 52 weeks). All participants will receive a 
dental screening and prophylactic cleaning at all visits. The proposed interventions will address 
the high burden of untreated tooth decay in community dwelling low-income older adults and 
thus reduce disparities (RQ-5). The non-surgical interventions can be provided by 
paraprofessionals. We have previously worked in these housing facilities and understand the 
logistics of recruiting and conducting clinical dental exams on-site (PC-1).  
The randomization is at the level of the cluster (housing facility) for logistical efficiency. This will 
greatly reduce the potential for error that could otherwise occur with people at the same site 
assigned to different treatments. Furthermore, keeping the same treatment at each site reduces 
chances of ‘contamination’ (i.e. participant discussing their treatment with others). Additionally, 
stratified cluster randomization will be used, i.e. a block (constrained) randomization approach 
in which balance over treatments is assured for 2 key cluster-level (stratification) variables, 
namely facility size (>100 versus ≤100 residents), and geographic location (Cuyahoga County 
vs other (RQ-5, RC-2, RC-5). 
 
Study Participants (RQ-3, RQ-4, PC-2) 
Subjects will be low socioeconomic status (SES) adults ≥ 62 years of age in NE Ohio counties 
(Cuyahoga, Lorain, Summit, Ashtabula, Geauga, and Lake) residing in 22 participating HUD 
Section 202 and other publicly subsidized housing facilities (see table 1). The population is 
diverse: African American/Black, Caucasian/White including Hispanic/Latino, and Asian. 
Medicaid participation among the tenants is 76% among facilities. From our prior study in these 
facilities, mean age is 74 years, 76% female, 51% Caucasian, 45% African-American, 2% 
Hispanic, and 2% other racial/ethnic groups; 60% of HUD older adults had none/rare dental 
visits in over 3 years. The study will be offered to all older adults if they are aged ≥ 62 years, 
reside in the 22 housing facilities, have at least one natural tooth and be willing to stay in the 

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study for 1 year. Only those with severe medical, cognitive or motor impairments will be 
excluded. To be eligible for enrollment in the clinical trial phase of the study, at the baseline 
dental exam, subject must have at least one untreated active root or coronal carious lesion with 
ICDAS-II lesion severity code of 3 or greater.  
Table 1. Facilities Enrolled in the Clinical Trial 
Facility Name* 
# of 
tenants 
Name of Individual Providing Letter of 
Support (Agency) 
Type of 
Community 
County 
Westerly 
Apartments 
455 
Linda Sack (Westerly Apartments) 
suburban 
Cuyahoga 
St. Timothy Manor 
40 
Susan Fine (Humility of Mary Housing) 
suburban 
Cuyahoga 
St. Timothy Park 
40 
Susan Fine (Humility of Mary Housing) 
suburban 
Cuyahoga 
Villa at Marion Park 
40 
Sr. Mary Slattery (Humility of Mary Housing) 
urban 
Summit 
St. Patrick Manor 
50 
Juanita Arnett (Humility of Mary Housing) 
suburban 
Lorain 
Jennings Manor, 
Library Court, St. 
Rita, St. Agnes 
220 
Jim Patena (Jennings) 
suburban 
Cuyahoga 
Margaret Wagner  
60 
Rosalind Mitchell (Benjamin Rose Institute) 
urban 
Cuyahoga 
Willowood Manor 
74 
Sandra Milos (Willowood Manor) 
suburban 
Cuyahoga 
Knickerbocker 
168 
Carryeanne Smitley (Knickerbocker) 
suburban 
Cuyahoga 
Abington Arms 
157 
Susan Persing (Abington Arms) 
urban 
Cuyahoga 
Fedor Manor 
145 
Sandra Rodriguez (Fedor Manor) 
suburban 
Cuyahoga 
Ambleside Tower 
201 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
Severance Tower 
188 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
Cedar Highrise 
155 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
Addison Square 
225 
Kristie Groves (CMHA) 
urban 
Cuyahoga 

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Apthorp Tower 
166 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
Euclid Beach 
Gardens 
149 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
Bohn Tower 
267 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
Riverview Tower 
498 
Kristie Groves (CMHA) 
urban 
Cuyahoga 
King Kennedy 
91 
Kristie Groves (CMHA) 
suburban 
Cuyahoga 
Quarrytown 
180 
Kristie Groves (CMHA) 
suburban 
Cuyahoga 
Franciscan Village 
180 
Catherine Sabolik (Franciscan Village) 
urban 
Cuyahoga 
Total # of Tenants 
3749 
 
 
 
*Average Medicaid:               76% 
Additional 11 sites added with modification 
Carnegie Tower at 
Fairfax 
171 
Tara Wenger 
Urban 
Cuyahoga 
Mother Teresa 
Manor/Commons 
99 
Tara Wenger 
Suburban 
Cuyahoga 
Educator Senior 
Housing 
112 
Linda Sack 
Urban 
Cuyahoga 
Lorain Square 
110 
Kristie Groves (CMHA) 
Urban 
Cuyahoga 
Beachcrest 
235 
Kristie Groves (CMHA) 
Urban 
Cuyahoga 
Villa Serena 
242 
Vesta Corp MOU 
Suburban 
Cuyahoga 
Helen S. Brown 
64 
Chase Pesina 
Urban 
Cuyahoga 
Greater Abyssinia 
Tower 
69 
Angela Jackson 
Urban 
Cuyahoga 
Mt. Auburn Manor 
107 
Kristie Groves (CMHA) 
Urban 
Cuyahoga 

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Mildred Brewer 
39 
Kristie Groves (CMHA) 
Urban 
Cuyahoga 
La Ronde 
57 
Kristie Groves (CMHA) 
Urban 
Cuyahoga 
 
 
The 22 housing facilities for this study are located in Northeast Ohio counties. We have formed 
relationships with administration of HUD and Regional Housing Authorities to ensure these sites 
are available. All 22 facilities were carefully chosen to ensure accurate representation of the 
northeast Ohio region. Twelve facilities are located in large metropolitan areas, while 6 are in 
inner ring and 4 are in outer ring suburbs or rural areas.42  All facilities are publicly subsidized 
through United States Department of Housing and Urban Development (HUD) programs geared 
toward seniors with limited financial resources. Several public and private housing authorities 
and management agencies oversee the facilities in our sample, each with multiple housing units 
located throughout the northeast Ohio region. This network of agencies will be of value when 
communicating results and for possible further implementation.  
 
Model and Design 
Figure 4.2.1 shows the study model for the intervention. The comparative effectiveness of 
“simple medical”, i.e. SDF versus “typical dental”, i.e. atraumatic restorative treatment (ART) + 
fluoride varnish (FV) intervention in this study is focused on the person level to address the 
unique oral health needs of low-income older adults. Figure 1 indicates that the proposed 
intervention is hypothesized to arrest caries in older adults with untreated caries and prevent 
tooth pain/hypersensitivity (primary outcomes); prevent new decay and improve oral health-
related quality of life (secondary outcomes) over a 12-month follow-up period. Safety and 
satisfaction measures are process outcomes that are critical to assess for sustainability and 
dissemination of the interventions. Factors likely to moderate the effectiveness of interventions 
are socio-demographics, chronic medical conditions, and oral health behavior. These baseline 
(pre-treatment) variables are also considered as prognostic variables (related to outcomes). 
Additionally, 3 focus groups (≈ 8 to 10/group) of study participants in years 2, 3, and 4 will be 
conducted to understand experience with treatment and find ways of improvement. 
 

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Interventions to be tested: 
The interventions proposed for this study are in current clinical use. Both coronal and root 
surface tooth decay lesions will be treated. The two evidence-based strategies in older adults 
will be compared as follows:  
Arm 1 (N=275 participants): A “simple medical strategy” consisting of SDF  
The treatment will be bi-annual application (at baseline and 26 weeks) of topical 38% silver 
diamine fluoride (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following 
manufacturer’s instructions and guidelines published by UCSF.43 
Arm 2 (N=275 participants): A “typical dental strategy” consisting of ART + FV 
Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and 
colleagues (2006),2 and the cavity restored at baseline with resin reinforced glass-ionomer 
cement (GIC) (GC Corporation, Japan).  
Participants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, 
Elevate) according to manufacturer’s instructions.  
Modifications Made Due to COVID-19 
Due to COVID-19 restrictions which prevented outside visitors/providers at the housing sites, 
recruitment will take longer than the anticipated 24 months. Additionally, approximately 40 
enrolled individuals did not complete the 26 week visit/second dose of treatment. We will 
therefore increase the total number of enrolled participants by 40. We are also adding four 
additional housing facilities to the study to address some delays in recruitment due to the 
COVID-19 pandemic. These four sites are managed by National Church Residences. 

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The additional 4 sites will also be randomized to Arm 1 and Arm 2 for a total of 13 sites in each 
arm. 
 

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5 
STUDY ENROLLMENT AND WITHDRAWAL 
The original 22 housing facilities have a total of 3749 tenants 62 years and older, therefore, we 
will approach 1368 participants, out of whom 958 will be screened for cavities to obtain the 
target sample of 550 older adults (approx. 25/housing facility) who have at least one natural 
tooth. Only individuals with severe medical, cognitive or motor impairments will be excluded. 
Individuals living independently (our study population) will likely not have severe impairments.  
Severe medical and motor impairments preventing enrollment will be those which would prevent 
the individual from completing the dental screening. Severe cognitive impairment will be 
determined through the consent process. If an individual is unable to explain back to the person 
obtaining consent what the study involves and what they will do, they will not be consented.  
Recruitment efforts for the main trial will take place over a two-year period. The study staff will 
approach tenants at various venues and inquire if they are completely edentulous to check 
study inclusion/exclusion criteria. Following are the estimates based on our prior study: 73% 
had at least one tooth; 70% providing consent; 58% with untreated caries. We expect a target of 
550 participants to be randomized to the two arms. 
The recruitment for all housing sites will follow a 2-stage process: (1) all participants consented 
will participate in the dental screening; (2) participants found to have non-urgent cavities at the 
screening and who fulfill the inclusion criteria will be enrolled into the clinical trial.  
 
Subject Initial Inclusion Criteria 
In the first stage of the enrollment process, an individual must meet all of the following criteria: 
• 
Provide signed and dated informed consent form 
• 
Willing to comply with all study procedures and be available for the duration of the study 
(1 year) 
• 
Male or female, aged 62 years or older 
• 
Live in a participating older adult housing facility  
In the second stage of enrollment process, additional inclusion criteria for continuation and 
participation in the RCT is based on the dental screening: 
• 
Have at least one untreated root or coronal caries lesion on any permanent tooth with an 
International Caries Detection and Assessment System (ICDAS) II44 active lesion score 
of 3 or greater (localized enamel cavity to extensive cavity). 
  
 
Subject Exclusion Criteria 
Following the dental screening, further exclusion criteria for non-eligibility to participate in 
the RCT include:  

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• 
Sensitivity to silver or other heavy-metal ions 
• 
Those with ulcerative gingivitis or stomatitis which prevents them from receiving study 
treatment 
• 
Serious life-threatening medical disease 
 
Strategies for Recruitment and Retention 
We will use prior successful strategies in recruiting and also solicit input from our stakeholders. 
Strategies that will be used are as follows: Service coordinators at all 22 facilities will serve as 
site liaisons. The study PI/project manager will provide the service coordinators with an 
introductory letter/flyer containing study information to be given to tenants and to be posted in 
public areas of the facility. Service coordinators will first arrange an informational meeting (study 
dentist will give a talk on the interventions as suggested by our stakeholders), and will arrange a 
second recruitment meeting for study staff to present information regarding the study at 
scheduled group events (e.g. tenant meetings, health fairs). For planning purposes, service 
coordinators will have a sign-up sheet for those interested in the sessions. Study staff will 
schedule those who are interested and meet the inclusion criteria for one-on-one sessions at 
the housing facility to obtain informed consent and collect baseline survey data. Baseline dental 
exam and treatment appointments will then be scheduled at each facility according to a 
designated exam day(s) for each facility, which will occur approximately 1-2 weeks following 
consent and baseline data collection. Six and twelve month dental exams/treatment and one-
on-one interviews for follow-up survey completion for each time point will also occur at the 
housing facility where participants reside  
Retention strategies for participants will include: 
• 
Participants will be given promotional items (i.e. pens, magnets) with the study logo and 
contact phone number at recruitment. 
• 
Alternate contact information for family/friends that may be able to reach the participant if 
primary contact information becomes invalid will be obtained at recruitment. 
• 
Annual birthday/holiday cards will be sent to participants to maintain contact. 
• 
Newsletters will be sent twice a year with updates on the study’s progress (i.e. 
recruitment), and a reminder to update their contact information (by phone or mail). 
• 
Assistance from service coordinators or other facility staff will also be solicited for hard to 
reach/contact participants. 
• 
Due to COVID-19 delays, an additional 4 housing sites are being added to the study to 
accelerate recruitment. 

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Treatment Assignment Procedures 
5.4.1 
Randomization Procedures (RQ-2) 
Randomization is at the level of the cluster (housing facility) for logistical efficiency. This will 
greatly reduce the potential for error that could otherwise occur with people at the same site 
assigned to different treatments. Furthermore, keeping the same treatment at each site reduces 
chances of ‘contamination’ (i.e. participant discussing their treatment with others). Additionally, 
stratified cluster randomization will be used, i.e. a block (constrained) randomization approach 
in which balance over treatments is assured for 2 key cluster-level (stratification) variables, 
namely facility size (>100 versus ≤100 residents), and geographic location (Cuyahoga County 
vs other). The project statistician, Dr. Albert will generate the randomization scheme for the 22 + 
4 additional housing facilities. While the randomization is at the housing level, the study 
objectives, interventions and primary outcomes all pertain to the individual level (RC-1). 
5.4.2 
Masking Procedures (IR-6) 
We will attempt blinding of participants to the study group, but this may not be possible due to 
SDF color change.  
The hygienists will be unaware of the treatment assignment when they go to their respective 
housing facilities. For all treatment visits, assessments will be conducted prior to the intervention 
delivery. 
Two hygienists will go to the housing facility randomized to the SDF arm and the other two will 
go to the ART + FV arm. The baseline treatment to be applied will be revealed only after the 
baseline caries exam has been completed. At the 6 month follow-up visit, the two hygienists that 
applied SDF will now go to the facilities randomized to the ART + FV facilities and vice-versa to 
conduct the 6-month follow up caries assessment exam and treatment. We will follow similarly 
for the 12-moth follow-up visit. By this strategy, we will make sure that potential bias of the 
hygienist evaluating their own work is minimized. Additionally, periodically we will check for the 
quality of the assessment data by Dr. Pinto randomly examining 20% of the participants.   
 
Subject Withdrawal 
5.5.1 
Reasons for Withdrawal 
Subjects are free to withdraw from participation in the study at any time upon request, as 
outlined in the consent form documents. 
Participants who drop out (or withdraw) from the study by their own choice will be considered 
dropouts/withdrawals.  Participants who are discontinued from the study by one of the study 
personnel will be also be considered a dropout/withdrawal.   
An investigator may terminate a study subject’s participation in the study if: 

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• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the subject. 
• 
The subject meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation.  
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
All reasons for dropout/withdrawal or discontinuation of the study intervention will be 
documented in the tracking database and reviewed by the study team and reported to the 
DSMB.  For gathering information on discontinuation, study staff will be contacting participants 
at several time points. Study staff will contact participants by phone 2-3 days before all exam 
and treatment visits to remind participants of the appointment, 2-3 days before all one-on-one 
interview appointments for survey completion, and 24 hours after all dental exam and treatment 
visits to complete the safety questionnaire. Participants will also be seen in person for all exam 
and treatment appointments and one-on-one interview appointments for survey completion.  
In the event of a subject telling study staff that he/she is dropping out of the study, the study 
staff should gather the following information as much as the participant allows. 
● Record the reason for dropping out of the study. 
● Record any adverse event reported by the subject. 
● Complete the appropriate questionnaire nearest the drop out time point. 
If it is determined by study staff that a participant should be discontinued from the study, the 
decision to withdraw a participant must be discussed and confirmed by the PI. 
Participants that withdraw during the baseline data collection window will be replaced by 
recruitment of additional participant to reach enrollment goals. Participants that withdraw or that 
are lost to follow-up any time after the baseline data collection window will not be replaced, but 
data collected up to the point of withdrawal will be used for analysis.  
 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable cause.  
Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to investigator, funding agency, the 
Investigational New Drug (IND) /Investigational Device Exemption (IDE) sponsor and regulatory 
authorities>.  If the study is prematurely terminated or suspended, the principal investigator will 
promptly inform the IRB and will provide the reason(s) for the termination or suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects. 

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• 
Insufficient adherence to protocol requirements. 
• 
Data that are not sufficiently complete and/or evaluable.  
• 
Determination of futility. 

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6 
STUDY INTERVENTION 
 
Study Product Description 
None of the materials used in this study are experimental. All materials are cleared by the FDA 
as Class II medical devices. All of the study materials will be donated by the manufacturers. 
Study Arm 1: 
• 
Advantage Arrest. This is an aqueous solution of 38% silver diamine fluoride, tinted blue.  
Study Arm 2: 
• 
GC Fuji Automix LC. This is a radiopaque light cured resin reinforced glass ionomer 
restorative.   
• 
Cavity Conditioner. Mild aqueous polyacrylic acid solution 
• 
GC Fuji COAT LC.  This is a light cured protective coating. 
• 
FluoriMax Varnish. This is sodium fluoride in an alcohol solution of natural resins. 
6.1.1 
Formulation, Packaging, and Labeling 
Study Arm 1: 
 
• 
Advantage Arrest. This is an aqueous solution of 38% silver diamine fluoride, tinted blue. 
Packaging and labeling are not modified from the commercial product. This product is 
packaged in individual dosettes, with one dosette used per patient. 
 
Study Arm 2: 
 
• 
GC Fuji Automix LC. This is a paste/paste formulation that is packaged in the original 
automix syringe.  Packaging and labeling are not modified from the commercial product. 
Each syringe is expected to provide about 10 restorations. 
• 
Cavity Conditioner. Dispensed in a 5.7 ml multi-use vial. Packaging and labeling are not 
modified from the commercial product. 
• 
GC Fuji COAT LC.  This is a light cured protective coating. Packaging and labeling are 
not modified from the commercial product. Each bottle holds 5.2 ml of product. 
• 
FluoriMax Varnish. This is sodium fluoride in an alcohol solution of natural resins. 
Packaging and labeling are not modified from the commercial product. This varnish is 
packaged in individual dosettes, with one dosette used per patient. 
6.1.2 
Product Storage and Stability 
Study Arm 1: 
 
• 
Advantage Arrest. Product is to be stored in a cool, dark place (4-25 C). It has a shelf life 
of 3 years from the date of manufacture. Individual dosettes should be discarded after 
use. 
 
Study Arm 2: 

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• 
GC Fuji Automix LC. Product is to be stored in a cool, dark place (4-25 C). It has a shelf 
life of 2 years from the date of manufacture.  
• 
GC Fuji COAT LC.  Product is to be stored in a cool, dark place (4-25 C). It has a shelf 
life of 2 years from the date of manufacture. 
• 
Cavity Conditioner (GC). Product is to be stored in a cool, dark place (4-25 C). It has a 
shelf life of 3 years from the date of manufacture. 
• 
FluoriMax Varnish. Product is to be stored in a cool, dark place (4-25 C). It has a shelf 
life of 3 years from the date of manufacture. Individual dosettes should be discarded 
after use. 
 
Dosage, Preparation and Administration of Study Product 
Study Arm 1: 
Advantage Arrest.  The application procedure is below: 
 
1. The cavity will be cleaned with a dry manual tooth brush to remove debris. 
2. The area will be isolated with cotton rolls. If the lesion is at the gumline, the gingiva will 
be coated with a thin layer of petroleum jelly per manufacturer’s instructions. 
3. The single use SDF vial (Advantage Arrest, Elevate Oral Care) will be opened and the 
manufacturer’s supplied brush will be dipped into the reservoir. The SDF will be applied 
with the brush until the lesion is coated fully. 
4. Allow to air dry. The patient can resume normal activity with no restriction. 
 
Study Arm 2: 
GC Fuji and Advantage Arrest. The application procedure is below: 
1. The cavity will be isolated and dried  
2. Any debris and soft, demineralized tooth structure from cavitated lesions will be removed 
with spoon excavators as necessary and protecting the pulp. No local anesthesia will be 
used. 
3. The cavity will be cleaned next with a manual brush and pumice or a toothbrush or 
cotton roll. 
4. Application of polyacrylic acid conditioner to the cavity and rinsing (Cavity Conditioner 
(GC)). 
5. The area will be moisture controlled before placement of resin reinforced glass ionomer 
restoration (GC Fuji Automix LC) with an applicator gun. Next the finger will be used to 
compress the material into the cavity. 
6. After the GIC material is placed, GC Fuji COAT LC will be used.   
7. The occlusion will be checked and cleared using articulating paper. 
8. The GIC application will be light cured. 
More details about the step by step procedure is given in Section 6.10. 

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Modification of Study Product Administration for a Subject 
The study products’ administration are not being modified. 
 
Accountability Procedures for the Study Product 
The study products will be stored in a locked storage area. The principal investigator (or her 
delegate) will maintain an inventory system to account for study products. The products will be 
distributed before each clinic session and unused product will be maintained in the field units. 
The materials will only be used by licensed personnel. 
 
Assessment of Subject Compliance with Study Product Administration 
The principal investigator (or her delegate) will check the inventory against the inventory records 
once per month. Any deviation will be documented. 
 
Concomitant Medications/Treatments 
The study will collect information on concomitant medications by patient self-report at exam and 
again at the final clinical examination. Of particular concern to the validity of study results will be 
use of fluoridated toothpaste, over the counter fluoride rinses or gels, professionally 
administered fluorides, antibiotics, and medications used to counter dry mouth conditions. There 
are no medication exclusion criteria. 
 
Administration of Intervention 
Arm 1: Topical application of 38% silver diamine solution to ICDAS lesions code 3-6. 
Arm 2: Atraumatic Restoration Treatment (ART) to ICDAS lesions code 3-6, followed by topical 
fluoride varnish (FV) to all teeth. 
 
Procedures for Training Interventionists and Monitoring Intervention Fidelity 
The study interventionists (dental hygienists) will receive didactic and clinical instruction on 
administration of the clinical interventions. The hygienists will undergo a two-day training and 
calibration exercise with extracted teeth and applying the intervention on patients. The didactic 
instruction will include required reading, viewing of technique videos, and laboratory and clinical 
practice. The supervised laboratory practice will use extracted teeth in which there are natural or 
instructor created cavities. The clinical application will be practiced on at least one patient.  
To be certified, the study interventionist must demonstrate mastery. For ART and FV application 
the trainee will complete a written or oral exam on procedures (from set up to cleanup); 
Complete no less than 8 ART on the lab bench on extracted teeth; Complete no less than 3 
ART on an older adult patient with cavities; Complete at least one FV treatment on the same 
patient. For SDF the trainee will complete a written or oral exam on procedures; complete at 
least 1 treatment on an extracted tooth; complete at least 1 treatment on an older adult patient.  
During the actual intervention visits to the housing facility, the study dentist will be present to 
supervise the hygienists to make sure that the study treatment were delivered per protocol. If 
there is a problem with the delivery of the treatment or adherence to protocol then the 

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interventionists will be given corrective training. For 52 week follow-up visits, where treatment 
will not be delivered, the study dentist may not be present. 
 
Assessment of Subject Compliance with Study Intervention 
In addition to direct supervision, the interventionist will use clinical photographs to capture 
random images of ART restorations. These will be reviewed on a quarterly basis by the clinical 
dentist supervisor/gold standard trainer and corrective training will be provided if there is a 
problem with clinician compliance. All deviations of protocol will be documented. 
The clinical dentist supervisor will observe the application of the various study materials for each 
of the interventionists. Corrective training will be provided if there is a problem with clinician 
compliance. All deviations of protocol will be documented. 
 ____________________________________________________________________  
 
Study Procedural Intervention(s) Description 
There is no product masking in this study. 
 
Study Arm 1: 
 
Advantage Arrest.  The application procedure is below: 
1. The cavity will be cleaned with a dry manual tooth brush to remove debris. 
2. The area will be isolated with cotton rolls. If the lesion is at the gumline, the gingiva will 
be coated with a thin layer of petroleum jelly per manufacturer’s instructions. 
3. The single use SDF vial (Advantage Arrest, Elevate Oral Care) will be opened and the 
manufacturer’s supplied brush will be dipped into the reservoir. The SDF will be applied 
with the brush until the lesion is coated fully. 
4. Allow to air dry. The patient can resume normal activity with no restriction. 
Study Arm 2: 
Application procedure for the atraumatic restorative treatment is as follows:: 
1. When the lesion is on the occlusal surface, the occlusion will be checked with blue 
articulating paper prior to other clinical procedures. 
2. The field will be isolated with cotton rolls. Soft debris will be removed with moistened 
cotton pellets. Then soft demineralized tooth structure will be removed with a spoon 
excavator at the periphery of the lesion, where there is access. A manual brush and 
pumice will be used to remove any further loose material. The cavity will be washed well 
with water.  
3. The cavity will be conditioned with the liquid of the glass ionomer (polyacrylic acid) for 
10-15 seconds and then rinsed, maintaining moisture control throughout.  

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4. The resin reinforced glass ionomer restorative (Fuji II LC Automix, GC America) will be 
inserted into the cavity using the manufacturer’s delivery device and then coated with 
Fuji Coat (GC America). The restoration will then be light cured for 20 seconds. 
Following the restorative treatment, the patient will be treated with fluoride varnish, as below. 
FluoriMax Varnish. By quadrant or arch, all of the teeth will be coated with fluoride varnish 
(FluoriMax, Elevate Oral Care) using the manufacturer’s brush system. The varnish container 
will be shaken for a few seconds before application. A single application from posterior to 
anterior will be used and then the occlusal surfaces will be coated, with no reapplication. The 
material will be allowed to dry 3-5 seconds and the patient instructed to avoid eating or dental 
hygiene for 4 hours. 
If a participant reports any issue with the applied treatment within one week of the treatment 
date, the study team will return to the housing facility to examine and correct the treated tooth 
as needed. Within 48 hours, the study team will call the participant to ask the participant if the 
issue has been resolved and will administer a paper safety questionnaire. The completed paper 
safety questionnaire will be stored in the CRF folder and documentation of the return 
visit/treatment will be added to the participant’s electronic record. 
 
Administration of Procedural Intervention 
Arm 1(SDF): SDF will be administered by a licensed dental hygienist  at the baseline 
visit, and the 26-week visit.  
Arm 2(ART +FV): ART will be administered by a licensed dental hygienist at the baseline visit + 
Fluoride Varnish application at baseline and the 26-week visit. If ART requires scooping out the 
decay then a licensed dentist will scoop the decay and then have the hygienist complete the 
ART intervention. For 52 week follow-up visits, where treatment will not be delivered, the study 
dentist may not be present. 
 
 

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7 
STUDY SCHEDULE 
Prior to any of the following actions, facilities will be randomized into one of two treatment 
intervention arms. 
Refer to Appendix A for the Schedule of Events. 
Temporary COVID-19 pandemic procedures:  
Recruitment/Enrollment 
• 
Study staff will receive contact information from Service Coordinators/Housing Managers for 
those who are interested in the study.  
• 
Study staff will contact interested individuals by phone or video-conference and send them 
paper consent forms. They will review the consent form with the individual by phone or 
video-conference and answer any questions they may have and ensure the individual 
understands the study and all study procedures.  
• 
Individuals will then be asked to sign the consent form and mail it back to the study staff in a 
stamped, self-addressed envelope provided to them. Study staff will sign the form and send 
a copy of the signed form back to the individual, along with a paper copy of the surveys.  
• 
Study staff will then contact the individual by phone or video-conference to complete the 
surveys. Individuals will be asked to follow along on the paper survey while study staff reads 
the questions to them over the phone or video conference. Participant responses will be 
entered into REDCap by study staff during the phone call or video-conference.  
• 
Exam/treatment appointments will be scheduled once the housing sites, funding agencies, 
IRB and CWRU have approved study personnel returning to being on-site at the housing 
sites.   
26 and 52-week Follow-Up Data Collection 
• 
Study staff will contact individuals due for the 26 and 52-week follow-up survey, to arrange a 
time to complete the survey by phone. Study staff will mail the survey to the individual prior 
to the survey completion phone call.  
• 
Study staff will then contact the individual by phone at the scheduled time to complete the 
surveys. Individuals will be asked to follow along on the paper survey while study staff reads 
the questions to them over the phone. Participant responses will be entered into REDCap by 
study staff during the phone call. 
• 
26-week and 52-week exam/treatment appointments will be scheduled once the housing 
sites, IRB and CWRU have approved study personnel returning to being on-site at the 
housing sites 
Once the COVID-19 pandemic ends, we will follow the original proposed plan. 

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Temporary COVID-19 pandemic procedures for returning to in-person visits: 
During this time, housing sites will determine the best location for study activities, 
including exams/treatment, for their facility. This location may be located in areas 
indoors and/or outdoors at the facility.  
The number of research staff attending on-site recruitment/data collection and dental 
screening/treatment appointments will be kept to a minimum. Only personnel essential for 
completion of the appointments will attend. 
Research staff will complete a screening questionnaire on a daily basis using the CWRU Daily 
Health Assessment (if they are reporting to campus at any time during the day) or the ADA 
COVID-19 Employee Screening Log (if they are reporting only to a study site) to determine work 
readiness. Research staff will wear appropriate PPE as determined by their work function 
(mask, gloves, face shields, gowns, and head covering). All research staff will wear masks at all 
times and will perform proper hand hygiene while on-site at the housing facilities. 
Scheduling Procedures for Recruitment, Data Collection and/or Dental Exam/Treatment 
appointments at the housing sites:  
• 
For recruitment of new participants, research staff will obtain interested individual’s 
contact information so they may contact them by phone to explain the study and 
administer the COVID-19 Screening Questionnaire prior to setting up a one-on-one 
meeting.  
• 
All participants will be called by a research staff member and interviewed using the 
COVID-19 Screening Questionnaire. 
• 
If the COVID-19 Screening Questionnaire is NOT passed (temperature >100.0, 
participant experienced any of the symptoms assessed, an/or participant has tested 
positive for COVID-19 or been in contact with someone who has tested positive for 
COVID-19), the participant will NOT be scheduled at this time.  
• 
If the COVID-19 Screening Questionnaire is passed (no temperature >100.0, no 
reported symptoms, and no positive COVID-19 test or contact with a positive COVID-19 
patient), participants will be scheduled for an individual appointment and will be 
instructed to stay in their apartments on the day of the appointment until called by project 
staff. 
• 
Participants will also be instructed during this call of all procedural changes which will 
take place on the day of their scheduled appointment. 
Appointment Day Procedures for Recruitment, Data Collection and/or Dental Exam/Treatment: 
Prior to the appointment: 
• 
Research staff will call participants to be reassessed using the COVID-19 Screening 
Questionnaire. 
• 
If the COVID-19 Screening Questionnaire is NOT passed (temperature >100.0, 
participant experienced any of the symptoms assessed, an/or participant has tested 
positive for COVID-19 or been in contact with someone who has tested positive for 

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COVID-19), the participant will NOT be seen for their appointment at this time.  They 
may be reassessed after 14 days.  
• 
If the COVID-19 Screening Questionnaire is passed (no temperature >100.0, no 
reported symptoms assessed, and no positive COVID-19 test or contact with a positive 
COVID-19 patient), participants will be asked to come to the facility designated area for 
their individual appointment. 
• 
If scheduled for a dental exam, participants will be asked to brush their teeth thoroughly 
and to use a mouth rinse if possible. 
• 
All participants will be asked to wear a mask of their own into the facility designated 
meeting/exam area.  If a participant does not have a mask, one will be provided to them.     
 
At the appointment: 
• 
Research staff will take and record participant’s temperatures when they arrive for their 
appointment to determine if he/she may participate.  If the recorded temperature is  
> 100.0, the participant will NOT be examined/interviewed.  They may be reassessed in 
14 days.  
• 
If the participant’s temperature is < 100.0, he or she may be interviewed/examined as 
scheduled. 
Clinical Protocol for Dental Exams and Treatment: 
1. Research staff will arrive at assigned site wearing face mask/covering. Staff will 
perform proper hand hygiene upon arrival.  
2. Equipment will be set up in work areas. Once equipment is set up, it will be 
disinfected and appropriate barriers will be placed 
a. Equipment includes dental chair, operator chair, compression unit, tray/light, 
assistant tray, sharps container, equipment supply locker 
b. Disinfection procedure includes spraying equipment with Cavicide and allow 
to sit for three(3) minutes, then wipe with Caviwipes and allow to dry 
3. Once research staff has taken the participant’s temperature and determined that they 
passed the COVID-19 Screening Questionnaire, the dentist will review the health 
history before the participant is moved to the exam/treatment area 
4. The participant will wear their mask until seated in the dental chair and the clinical 
team is ready to perform the dental exam. There will be no physical contact 
permitted, such as shaking hands, etc. Access to the treatment area should be 
limited to appropriate staff and the participant only, when possible.  
5. Paperwork in the treatment area should be limited as much as possible, placing new 
paperwork away from patient contact area when possible and stored on a clipboard, 
under a plastic sheet protector, which may be wiped with a disinfectant wipe. Pens 
are not to be shared among the research staff 
6. Hygienists and dentist will don proper PPE 
a. Dentist/hygienist perform proper hand hygiene 

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b. Put on disposable gown, typing all ties or snapping all snaps, this may require 
help from another provider 
c. Put on surgical mask 
d. Put on face shield 
e. Perform proper hand hygiene again 
f. 
Put on gloves, pulling down over wrists of gown 
7. Participant will be seated in dental chair and will remove mask when instructed. 
Hygienist will place patient napkin on participant. The hygienists will perform exam 
while the recorder charts. The dentist will check charting, confirming areas for 
treatment as trained. 
 If no active decay is detected, participant will be dismissed from treatment 
area to complete exit paperwork with research staff. 
8. The hygienists perform treatment using all necessary precautions to reduce aerosols 
and contamination, such as high volume evacuation and cotton rolls 
 The treatment will be SDF or ART as determined by the treatment 
assignment of the housing site. 
9. . Once treatment is complete, the dentist will check the areas of treatment 
 Photos may be taken of treatment area by research assistant  
10. The hygienist will remove and dispose of the patient napkin and the participant will 
then don their personal mask and leave the treatment area 
11. The examining hygienist and dentist will remove gloves, perform proper hand 
hygiene and sign necessary paperwork 
 Pens are not to be shared between staff 
12. If gloves have been removed, hygienists will then perform proper hand hygiene and 
put on gloves. Hygienists will remove and dispose of all barriers in garbage, all 
instruments will be disposed of in red sharps container.  
13. Hygienists will disinfect treatment area while wearing proper PPE 
a. Spray dental chair, operator chair, compression unit, tray/light, assistant tray, 
sharps container, equipment supply locker with cavicide 
b. allow to sit for three (3) minutes 
c. wipe with Caviwipes and allow to dry 
14. Hygienists will remove gloves, perform proper hand hygiene and apply new barriers 
as trained, to prepare for next participant. Hygienists will spray face shield with 
soap/water solution and wipe dry with paper towel or clean face shield with alcohol 
pad 
15. After completing treatment for the day, equipment will be disinfected and 
disassembled 
a. Spray dental chair, operator chair, compression unit, tray/light, assistant tray, 
sharps container, equipment supply locker with Cavicide 
b. allow to sit for three (3) minutes 
c. wipe with Caviwipes and allow to dry 

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d. Spray and wipe floors with prepared Lysol solution and allow to dry 
16. Dentist/hygienists will then remove PPE 
a. Properly remove and discard gloves 
b. Remove and dispose of gown 
c. Perform hand hygiene 
d. Remove face shield and clean with soap/water solution and a paper towel or 
alcohol pads 
e. Remove surgical mask 
f. 
Perform hand hygiene 
g. All staff should don personal mask to exit the facility 
***ALL PARTICIPANTS AND PROJECT STAFF WILL BE INSTRUCTED TO CONTACT 
RESEARCH PERSONNEL IF THEY EXPERINCE ANY OF THE SYMPTOMS AS ASSESSED 
BY THE COVID-19 SCREENING QUESTIONNAIRE/ADA COVID-19 EMPLOYEE SCREENING 
LOG/CWRU DAILY HEALTH ASSESSMENT, RECORD A TEMPERATURE >100.0, TEST 
POSTIVE FOR COVID-19 AND/OR LEARN THEY HAVE BEEN IN CONTACT WITH A 
PERSON WHO HAS TESTED POSTIVE FOR COVID-19 WITHIN 2 WEEKS OR 14 DAYS OF 
THEIR DENTAL EXAM/RECRUITMENT INTERVIEW OR WORK DAY. 
 
Once the COVID-19 pandemic ends, we will follow the original proposed plan for all visits. 
 
Baseline Visit (T0) (Day -30 to 14) 
Recruitment/Enrollment  
Study staff will recruit potential participants at the 22 participating housing facilities in 
coordination with the housing service coordinators and by using an in person approach at 
venues scheduled at the housing facility.  
• 
Service coordinators will be provided with an introductory letter/flyer containing study 
information to be given to tenants and to be posted in public areas of the facility and will 
arrange an informational meeting for tenants (study dentist will give a talk on the 
interventions as suggested by our stakeholders).  
• 
Service coordinators will arrange in-person recruitment meetings for study staff to present 
information regarding the study at scheduled group events (e.g. tenant meetings, health 
fairs, study informational presentations). For planning purposes, service coordinators will 
have a sign-up sheet for those interested in the sessions. At the conclusion of the session, 
study staff will meet individually with those interested to: 
o 
Review inclusion/exclusion criteria to determine eligibility (Refer to Sections 5.1, 
5.2) utilizing the Screening and Eligibility Form  
o 
Obtain informed consent by reviewing the written consent form (Refer to Section 
15.3) with the potential participant; ensuring comprehension of the study and 

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procedures, answering any questions, signing the consent form acknowledging that 
informed consent was reviewed and obtaining subject signature acknowledging 
consent was obtained. Consent will be obtained one time prior to the initiation of any 
study activities and will remain in effect for the duration of the study. 
 One-On-One Data Collection Interview 
Study staff will interview participants at the housing facility to obtain contact and socio-
demographic information and enter participant responses to the Participant Questionnaire which 
includes medical history, oral health behavior, oral health symptoms, tooth pain/sensitivity, and 
oral health quality of life.  
Baseline Dental Exam 
• 
Dentists will administer the Safety Questionnaire (Pre-Exam). 
• 
Hygienists will perform initial dental exam examination at participant’s respective 
housing facility to determine eligibility to continue in the clinical trial based on caries 
status. 
• 
Study staff will record results of dental exam examination. 
• 
Hygienists, under the direction of the study dentist, will proceed as follows:  
• 
If the participant has an urgent cavity or another serious dental problem, they will be 
instructed to go for dental care immediately and their participation will end. 
• 
If the participant has no cavities or other urgent problems, they will be instructed to 
continue regular visits with their dentist and their participation will end. 
• 
If the participant has cavities that require treatment but no urgent problems, they will 
receive one of two treatments at this visit and will continue to participate in the research. 
Hygienists will administer the intervention treatment (based on study arm) to all 
untreated active root or coronal carious lesion with ICDAS-II lesion severity code of 3 or 
greater. 
• 
If a participant reports any issue with the applied treatment within one week of the 
treatment date, the study team will return to the housing facility to examine and correct 
the treated tooth as needed. Within 48 hours, the study team will call the participant to 
ask the participant if the issue has been resolved and will administer a paper safety 
questionnaire. The completed paper safety questionnaire will be stored in the CRF folder 
and documentation of the return visit/treatment will be added to the participant’s 
electronic record.  
Follow-Up Data Collection 
• 
Study staff will contact participants who received treatment by phone (within 48 hours of 
treatment) to complete the safety survey. 
 
26-Week Visit (T26) (Day 168 to Day 196) 
Dental Exam and Treatment 
• 
Dentists will administer the Safety Questionnaire (Pre-Exam). 

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• 
Hygienists will perform dental examination at participant’s respective housing facility to 
evaluate caries arrest and identify new decay.  
• 
Study staff will record results of dental examination. 
• 
Hygienists, under the direction of the study dentist, will administer the intervention 
treatment (based on study arm) for all previously treated lesions and newly identified 
active root or coronal carious lesion with ICDAS-II lesion severity code of 3 or greater. 
• 
Study staff will give participants referral sheets with exam results and direction to follow 
up with their personal dentist for routine dental care.  
• 
If a participant reports any issue with the applied treatment within one week of the 
treatment date, the study team will return to the housing facility to examine and correct 
the treated tooth as needed. Within 48 hours, the study team will call the participant to 
ask the participant if the issue has been resolved and will administer a paper safety 
questionnaire. The completed paper safety questionnaire will be stored in the CRF folder 
and documentation of the return visit/treatment will be added to the participant’s 
electronic record.  
Follow-Up Data Collection 
• 
Study staff will contact participants by phone (within 48 hours of treatment) to complete 
the safety survey. 
• 
Study staff will interview participants one-on-one at the housing facility to update contact 
information and enter participant responses to the oral health symptoms, tooth 
pain/sensitivity, and oral health quality of life and satisfaction surveys.  
• 
Study staff will randomly select 24-30 participants who have completed treatment for 
three focus group sessions to be held at a housing facility during years two and three. 
Participants will be selected from those who have completed treatment and is geared to 
understanding participant experiences with non-surgical regimens and to identify ways to 
improve and disseminate in other community-based settings nationally. 
 
52-Week Visit (T52) (Day 365 to 379) 
Dental Exam and Treatment 
• 
Dentists or hygienists will administer the Safety Questionnaire (Pre-Exam). 
• 
Hygienists will perform dental examination at participant’s respective housing facility to 
evaluate caries arrest and new decay.  
• 
Study staff will record results of dental examination. 
• 
Study staff will give participants referral sheets with exam results and direction to follow 
up with their personal dentist for further treatment or routine dental care.  

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Follow-Up Data Collection 
• 
Study staff will contact participants by phone (within 48 hours of treatment) to complete 
the safety survey. 
• 
Study staff will interview participants one-on-one at the housing facility to update contact 
information and enter participant responses to the oral health symptoms, tooth 
pain/sensitivity, oral health quality of life, COVID-19 dental visit and the satisfaction 
survey.  
• 
Study staff will randomly select 24-30 participants who have completed treatment for 
three focus group sessions to be held at a housing facility during years two, three and 
four. Participants will be selected from those who have completed treatment and is 
geared to understanding participant experiences with non-surgical regimens and to 
identify ways to improve and disseminate in other community-based settings nationally. 
 
Withdrawal Visit 
The following procedures will be followed for participants who choose to withdraw early or 
whose participation is terminated by the PI: 
• 
Personal contact (by phone or in-person) by study staff will be made to confirm 
withdrawal. 
• 
Record any adverse event reported by participant. 
• 
Debrief about the interventions. 
• 
Obtain responses to the study questionnaires (if applicable)  
• 
If a participant withdraws or moves from the housing facility, visits and data collection will 
end with these participants being considered lost to follow-up. Data collected up to the 
point of withdrawal will be used for analysis. 
 
Unscheduled Visit 
Unscheduled visits for participants may occur if an enrolled individual could not complete a 
scheduled study procedure during the timeframe study staff is scheduled to be on-site at the 
housing facility. In these cases, every attempt will be made by study staff to complete the dental 
screening/exam/treatment and/or data collection interview as near to the visit window as 
possible. Study data would be collected per protocol guidelines, but the time length between 
visits will be accounted for in the analysis stage if necessary.  

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8 
STUDY PROCEDURES /EVALUATIONS 
 
Study Procedures/Evaluations (IR-4) 
Study procedures include interventions and survey/questionnaire performed to assess the 
primary outcome, secondary outcomes, and moderators. The intervention is based on study 
arm. Study Participants in Arm 1 receive silver diamine fluoride (SDF) while Arm 2 participants 
receive atraumatic restorative treatment (ART) and fluoride varnish (FV). There will also be a 
process evaluations (Safety, Satisfaction) at each of the interventions applied. See Table 8.1.1 
for more details on the measure, sources, and timeline. The study timeline is as follows: 
Baseline visit (T0) (visual / tactile dental screening exam / 1st intervention), 26-week visit (T26) 
(visual / tactile dental screening exam / 2nd intervention), and 52-week visit (T26) (visual/tactile 
dental screening exam). 
Table 8.1.1 Quantitative Summary of measures, sources, and timeline (IR-4) 
Variable 
Type 
Measure 
Scale 
Source 
Timeline 
Intervention 
by Study 
Arms 
● Biannual SDF  
(Arm 1) 
 
 
● ART + biannual 
FV(Arm 2) 
 
 
 
 
T0, T26 
Primary 
Outcome 
 
 
Clinical dental 
exam 
● Caries arrest  
 
 
 
 
 
 
● % freq of 
arrested 
surface/teeth  
 
 
 
 
 
 
● overall score 
 
 
 
● ICDAS Coronal and Root 
[Dikmen 2015]44 
 
 
 
 
 
 
 
 
 
T0, T26, T52 
 
 
 
 
 
 

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Self-reported 
evaluation 
● Tooth 
pain/sensitivity 
 
 
● overall score 
 
● PROMIS v.1.0 - Pain Intensity 3a 
[Modified for Dental]45 
 
● Dental Discomfort Questionnaire 
[Modified for Adults from Versloot et 
al. 2006]46 
 
T0, T26, T52 
Secondary 
Outcomes  
Clinical dental 
exam 
● New decay 
 
 
Self-reported 
evaluation 
● OH-quality of 
life  
 
 
● # freq of new 
decay teeth 
  
 
 
● GOHRQoL 
overall score 
 
 
 
● ICDAS Coronal and Root 
[Dikmen 2015]44 
 
 
 
● Geriatric Oral Health Quality of Life 
(GOHRQoL) [Atchison and Dolan, 
1990]47 
 
 
 
T0, T26, T52 
 
 
 
 
T0, T26, T52 
 
Process 
Outcome 
● Safety 
 
 
● Satisfaction 
●  % freq. 
adverse event 
 
● overall score 
 
 
● overall score 
 
● Safety Questionnaire (Pre- and 
Post-Exam/Treatment [Adapted for 
Adults from Milgrom et al. 2018]48 
 
● Treatment Satisfaction 
Questionnaire for Medication 
(TSQM) [Modified for Dental]49  
 
● Satisfaction with New Treatment 
for cavities [Modified for Adults 
from Crystal et al. 2017]50 
 
T0, T26, T52 
 
 
 
T52 
 
 
T52 
Moderators  
● Socio-
demographic 
 
● % freq. 
 
 
● NHANES III [CDC, 1988]51 
 
 
T0  

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● Medical 
Condition 
 
 
● Oral Health 
Behavior 
 
 
 
● Oral Health 
Symptoms 
 
● % freq. 
 
 
 
● overall score 
 
 
 
● overall score 
  
● Common Chronic Heath Condition 
for Adults 65+ [Adapted from 
NCOA 2017]52 
 
● Oral Hygiene [Adapted from 
Kuusela 1997, WHO survey 
1997]53,54 
  
● Self-Reported Measures of Current 
Oral Disease/Tissue Damage 
[Adapted from Gilbert et. al 1997]55 
    
 
 
 
T0  
 
 
T0  
 
 
 
 
T0  
Pre-T0 = Prior to baseline 
T0 = 0-week / Baseline visit / Baseline visual / tactile dental exam (Arm 1: SDF, Arm 2: ART + FV) 
T26 = 26-week follow-up visit / Visual / tactile dental exam (Arm 1, Arm 2)  
T52 = 52-week final visit / Visual / tactile dental exam (Final) 
8.1.1 
Quantitative outcomes of interventions  
The primary (i.e., carries arrest, tooth pain / sensitivity) and secondary outcomes (i.e., presence 
of new decay, oral health-related quality of life) measure the effectiveness of the study 
interventions. The process outcome are to access the safety of the interventions and to 
ascertain patient satisfaction with the treatment 1 year after the initial treatment.   
Primary outcome: Older adults caries arrest and tooth pain / sensitivity (Arm 1: SDF vs. 
Arm 2: ART + FV) will be assessed through: 
● Clinical dental exam: will be performed at the two intervention time points (T0, T26) and final 
time point (T52) by a trained and calibrated dental hygienist according to the International 
Caries Detection and Assessment System II (ICDAS-II).44 The exam will be used to identify 
a change in oral health status between the Baseline visit and the 26-week visit (T0 and T26) 
as well as the 26-week visit and the 52-week visit (T26 and T52).  
● Self-reported evaluation: Scales on tooth pain / sensitivity (PROMIS v.1.0, Health 
Organization56; Dental Discomfort Questionnaire (DDQ)46) will be used to measure levels of 
change in oral pain / sensitivity improvement. Higher scores on the PROMIS and DDQ 

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indicate increased  tooth pain / sensitivity. These measures will be conducted during the 
baseline visit, 26-week visit, and 52-week visit (T0, T26, and T52). 
Secondary outcomes: Older adults’ new decay and GOHRQoL (Arm 1: SDF vs. Arm 2: 
ART +FV) will be assessed through: 
● Clinical dental exam: A newly carious tooth is defined as any tooth receiving an ICDAS 
lesion code ≥3 that received a sound code on the previous dental exam or any tooth surface 
with an ICDAS filling code ≥3 that previously did not have one. The number of teeth with 
new decay or filling will be assessed through clinical dental exams (T0, T26, and T52) and 
recorded on the ICDAS Assessment form. 
● Self-reported evaluation: The Geriatric Oral Health-related Quality of Life (GOHRQoL) 47 
consist of 12 questions and will be used to assess the impact of the intervention on 
participants overall oral health quality of life. The overall score will be calculated with higher 
scores indicating that the participant has greater oral health Quality of Life. The measures 
will be collected within two week of the baseline visit, the 26-week visit (T0, T26), and 52-
week visit exam (T52). 
Process outcome: Safety and satisfaction and moderating variables (Arm 1: SDF vs. Arm 
2: ART +FV) will be assessed through: 
● The Safety Questionnaire-Revised for Adults48 consists of 15 main adverse events (i.e., 
existence of dental insurance, severity of adverse symptoms after receiving the dental 
treatment) and will be used to identify adverse events. Participants will complete this survey 
pre- and post-exam/treatment at the baseline visit, 26-week visit, and the 52-week visit, 
respectively. The treatment satisfaction will be assessed through the treatment satisfaction 
questionnaire for medication49 (TSQM) modified for Dental  and satisfaction with new 
treatment for cavities, 50 comprised of six questions. The overall average score will be 
assessed from these two scales with higher mean score indicating  better satisfaction with 
the study treatment. The measures will be conducted during the baseline visit, follow-up 
visit, and final exam (T0, T26, and T52). 
Moderating Variables will be assessed only at Baseline (T0) through: 
Moderating variables will be collected using the following instruments: a 9-item socio-
demographic questionnaire (NHANES III, CDC)51, a 10-item common chronic health condition 
for adults 65+ questionnaire (adapted from the Nation Council on Aging(NCOA)12, a 12-item 
self-reported measures of current oral disease / tissue damage questionnaire (Gilbert et al., 
1997)55, and a 5-item oral hygiene (adapted from Kuusela, 1997 and WHO) 53,54 These 
measures will be considered as potential moderators and will be collected at the baseline visit 
only. 
Table 8.1.2. Qualitative Focus Study Procedures / Evaluations (to be conducted in year 2,  
year 3, and year 4 either virtually or at a convenient housing facility, based on housing 
site circumstances at the time of focus group scheduling) 
 

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Subject 
Planning / Design 
At the Focus Group 
Process   
Data Collection 
Group 
Participants 
 
Recruitment  
● Participants who will 
complete the clinical trial 
randomly invited to one of the 
three focus group interviews 
 
Comfortable environment  
● Provide signed and dated  
   consent form at the  
   beginning of interview  
   protocol 
 
 
 
Activities 
● Generate ideas / efforts to 
contribution 
● Engagement and input on focus 
group activity  
Moderator 
Design for group interview 
● Develop an agenda  
   and discussion guide 
● Review participants'  
   demographics and  
   characteristics 
● Finalize / review a protocol    
   design with the study staff 
  
 
Probing with Semi-
structured questionnaire  
● Opening  
● Introduction 
● Transition 
● Key questions 
● Conclude (Breen, 2007)57 
 
 
 
Data collection  
● Audio recording 
● Summary notes 
 Key topics 
● Inquire as to participants’ levels 
of satisfaction in accessibility and 
practices of a received 
intervention (Robinson et al., 
2005)58 
● Dissemination of the treatment 
of SDF or ART+FV to other older 
populations  
● Barriers experienced in getting 
treatment of SDF or ART + FV 
(Newton et al., 2001)59 
● Resources and challenges in 
seeking dental care (adapted from 
Gussy et al., 2006)60 
Study Staff  
Define methodologies  
● Define a purpose and goal 
Process 
● Observational notes 
Data Analysis  
● Transcription of audio tapes  

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● Scheduling meeting 
● Guidelines for recruiting  
  (non-proportional approach)   
● Book a room for an interview 
● Arrange materials (name  
   tags, chairs, and table) 
● Capture of non-verbal      
    activities 
Acknowledgment 
● Refreshments 
● Gift card ($25) / travel cost 
 
● Data coding / organizing 
information by using Atlas.ti 
software 
8.1.2 
Focus Group Study Procedures / Evaluations  
Focus groups will be led by an experienced moderator trained in qualitative interviewing 
techniques. The moderator will use a semi-structured interview guide to gather a large number 
of opinions and engage in a collective brainstorming of ideas and solutions.  
Focus group discussions are a part of qualitative technique wherein a researcher assembles a 
group of individuals to discuss a specific topic that can provide a deeper understanding of or 
insight into a particular issue.61 We will use the phenomenological approach and ground theory 
to focus group research for the current study.  
Recruitment, planning and development of the discussion guide 
• 
Participant recruitment will occur prior to the focus group meeting. The research team 
will contact individual participants to promote participation for the focus group study via 
phone, e-mail, and in-person. We will randomly invite participants that have successfully 
completed the clinical trial until 30 participants from the 22 housing facilities agree to 
participate in one three focus group discussion (non-proportional sampling).  
• 
The moderator will prepare a focus group guide for each discussion. The moderator will 
outline the flow of questions and topics to be covered. This discussion strategy will 
encourage participants to pursue topics of interest and to reveal experiences regarding 
the treatment.  
• 
The research staff will develop and agree on standard practice for focus group 
discussion. In collaboration with the moderator, the research team will establish 
management guidelines for the focus group meeting that enable the moderator to 
effectively capture key phrase and understand group dynamics. The staff will reserve a 
convenient and accessible venue and prepare necessary materials for interview. 
Arrangements will be made for name tags, food, and drinks for participants. An 
honorarium ($25) will be given to each participant in appreciation of their time as well as 
any travel costs.  
Focus group procedures and data collection 

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The focus groups will be conducted either virtually or at a convenient housing facility, based on 
housing site circumstances at the time of focus group. Each focus group participant will have 
provided a signed and dated consent form prior to the beginning of the group discussion. The 
moderator will encourage active participation in interviews to gain valuable inputs and ideas. 
• 
The moderator will be responsible for initiating the discussion and keeping the group on 
task as well as creating a comfortable, relaxed atmosphere. Focus group sessions will 
be approximately 90 minutes and an audio recording will be also made so as to ensure a 
complete record of what was discussed. 
• 
The moderator will conduct each focus group using a semi-structured interview guide 
based on five categories of questions (opening, introduction, transition, key, and ending). 
The interview guide for participants will focus on levels of satisfaction of the treatment 
(SDF or ART + FV) in terms of accessibility and convenient practices; barriers and 
facilitators experienced while receiving treatment procedures of SDF or ART +FV; 
resources and challenges of the treatment of SDF or ART + FV; a potential in 
dissemination of the treatment of SDF or ART + FV to other populations of older adults. 
The interview discussion will be audio-recorded, and this data will foster an in-depth 
understanding of participants’ perceptions and attitudes toward the conducted 
interventions. 
• 
One or two staff members who have been trained in focus group interviews will attend 
the discussion to record non-verbal cues, signals, and facial expressions. Observational 
notes during the interview and summary notes after the interview will also be recorded 
by the study staff. After each focus group, in discussion with the moderator, the study 
staff will debrief on key concepts and identify any new questions that should be added to 
the next focus group, if needed. Focus group data collected with two approaches of a 
group interview and observational approaches will be transcribed into data coding steps. 
The coded data will be analyzed using Atlas.ti software, which helps to integrate 
interview findings into coherent qualitative study results.  

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9 
ASSESSMENT OF SAFETY 
 
Specification of Safety Parameters 
This study involves administration of two FDA approved devices, which are applied using 
approved standardized protocols for administration (SDF, ART+FV). 
9.1.1 
Unanticipated Problems 
Unanticipated problems involving risks to subjects or others to include, in general, any 
incident, experience, or outcome that meets all of the following criteria: 
• 
unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• 
related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
• 
suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
The primary responsibility for the evaluation of unanticipated problems lies with the PI of the 
protocol.  This includes the documentation, investigation, and follow-up of these events.  
Consistent with CWRU IRB policy, the PI will report these events to the IRB within three (3) 
business days of discovery of the problem or event.   
The PI must complete the Unanticipated Problems, Deviations, Adverse Events Form and 
submit it to the IRB. If the Unanticipated Problem does not meet these criteria, then the 
event does not meet reporting criteria and should be retained in the investigator’s file for 
reference. 
9.1.2 
Adverse Events 
An adverse event (AE) is any unintended negative experience associated with the study 
materials or research procedures. Adverse events include both physical and psychological 
harms. 
9.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is any adverse event that results in one or more of the 
following outcomes: 
 

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• 
Death 
• 
A life-threatening event 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
A persistent or significant disability/incapacity 
• 
A congenital anomaly or birth defect 
• 
An important medical event based upon appropriate medical judgment 
 
Time Period and Frequency for Event Assessment and Follow-Up 
The primary responsibility for the evaluation of these events lies with the PI of the protocol.  This 
includes the documentation, investigation, and follow-up of these events.  For those events that 
require reports to the IRB, it is the PI’s responsibility to submit the reports in a timely manner.  If 
new risks to the participants are identified they must be included in a revised consent form.   
Multiple factors determine if an Unanticipated Problems, Deviations, Adverse Events Form is 
required.  One of the most important distinctions is whether the event is expected or unexpected.  
To make this determination, it is necessary to know the underlying condition of the subject 
including co-morbidities, and the severity and frequency of events in participants who qualify for 
the study.  An expected adverse event meets one or more of the following criteria: 
• 
Attributed to the underlying condition of the participant being studied. 
• 
Attributed to the subject population being studied. 
• 
Identified in the literature, investigator brochure, other risk documentation or informed 
consent. 
An unexpected adverse event meets one or more of the following criteria: 
• 
Not listed in the informed consent, protocol, or other study documents. 
• 
Not attributed to the underlying condition of the subject taking into account co-morbid 
conditions. 
• 
Not attributed to the subject population 
• 
Severity and/or frequency of the event are beyond the range previously known. 
Unanticipated problems will be recorded in the data collection system throughout the study.  
Study staff will administer the Safety Questionnaire (Pre-exam) prior to the dental exam and 
treatment and then contact each participant by phone 24-72 hours following treatment receipt to 
administer the Safety Questionnaire by phone. The PI, and co-investigator, Dr. Chao, will review 

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all records of participants who indicate they needed medical care or experienced symptoms 
since the treatment on a weekly basis to determine the severity and its relation to the treatment. 
Proper notifications will then be made to the IRB, PCORI and the DSMB based on their 
evaluation. Events will be followed for outcome information until resolution or stabilization. The 
PI will record all reportable events though the duration of the study. 
The PI must complete the Unanticipated Problems, Deviations, Adverse Events Form and 
submit it to the IRB. If the Unanticipated Problem does not meet these criteria, then the event 
does not meet reporting criteria and should be retained in the investigator’ 
 
Characteristics of an Adverse Event 
9.3.1 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset. 
b. An alternate etiology has been established. 
9.3.2 
Expectedness of SAEs 
We do not anticipate any serious adverse events related to the study intervention.  The Study PI 
and co-investigator Dr. Chao will be responsible for determining whether an SAE is expected or 
unexpected.  An adverse event will be considered unexpected if the nature, severity, or 
frequency of the event is not consistent with the risk information previously described for the 
intervention.   
9.3.3 
Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on 
ADL 

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3. Severe: significant symptoms requiring invasive intervention; subject seeks medical 
attention, needs major assistance with ADL 
 
Reporting Procedures 
9.4.1 
Unanticipated Problem Reporting to IRB and PCORI 
Incidents or events that meet the criteria listed above for unanticipated problems require the 
creation and completion of an unanticipated problem report form.  The following information will 
be included when reporting an adverse event, or any other incident, experience, or outcome as 
an unanticipated problem to the IRB: 
• 
appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• 
a detailed description of the adverse event, incident, experience, or outcome;  
• 
an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem;  
• 
a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported using 
the following timeline:   
• 
All unexpected problems involving risks to subject or others must be reported to the 
Case Western Reserve IRB within three (3) calendar days of discovery of the 
problem or event. The only exception to the above timeframe is for the reporting of 
deaths. All internal, unexpected, study-related deaths must be reported to the IRB as 
soon as the investigator learns of the event. Reporting to PCORI must also occur 
within 7 calendar days if death or a life-threatening event occurs or within 14 
calendar days for all other SAEs. 
For all reporting periods “days” refers to business days after the PI learned of the event.  All 
reportable events need to be reported to the IRB within the timeline even if the information 
about the event is incomplete.  Further information can be added with a follow-up report. All 
adverse events, including those reported to the study team must be promptly reviewed by the PI 
and any event that changes the risk/benefit ratio of the study, or requires a change in the 
protocol or the consent form, must be reported to the IRB within 3 business days. 
• 
The PI and the study team must make the protocol changes as soon as possible and 
submit the revised documents to the IRB via the Amendment form 
• 
Other events reported to CWRU IRB are as follows: 
• 
All fatal events must be reported to the IRB as soon as the PI learns of the event, if 
the PI believes the event to be related to the study.  If the death is determined to be 
unrelated to the study, it must be reported at the time of next Continuing Review. 
• 
Deaths which occur after the subject’s research participation has ended do not need 
to be reported to the IRB unless the death is related to study participation. 
• 
All serious adverse events must be reported as soon as the PI learns of the event. 

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• 
All non-serious events and summary reports are kept in the PI’s files and do not 
need to be reported to the IRB. The IRB does not require the PI to report adverse 
events that occur to subjects enrolled in an observational study or non-interventional 
study unless the event is related to study participation, causes a change in study 
design or increases risk for other participants. 
• 
If a CWRU PI is notified about an event that occurred at another site in a study 
related to, but not the same as, the CWRU protocol, and the event results in a 
change in the protocol, consent form, or the risk/benefit ratio, the adverse event must 
be reported within 3 business days of learning of the event.   
• 
If the change in the CWRU protocol is due to publication of results from another 
study which has an adverse impact on the CWRU protocol, it should be reported as 
soon as the PI learns of the valid publication. 
• 
The PI who conducts research projects funded by a federal agency is obligated to 
report adverse events that are serious and unanticipated simultaneously to both the 
federal agency and to the IRB.  The IRB has a separate and distinct obligation to 
report the adverse events to government authorities  
• 
If the event changes the risk for other study participants and requires changes in the 
consent documents, report as soon as the PI learns of the event (but within 3 
business days). 
• 
Adverse events which occur in another study (including fatal events) and which do 
not result in a change in the protocol, consent form, or the risk/benefit ratio for the 
study, do not need to be reported to the IRB but should be kept on file by the PI.  
9.4.2 
Serious Adverse Event Reporting to PCORI 
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an SAE form 
to PCORI within 7 days. This report may be sent by fax or email. This process applies to both 
initial and follow-up SAE reports. 
The PI will complete a Serious Adverse Event Form and submit via fax or email within the 
following timelines:   
• 
All study-related deaths and immediately life-threatening events will be recorded on the 
Serious Adverse Event Form and submitted to Product Safety within 7 calendar days of 
site awareness.  
• 
Study-related serious adverse events other than death and immediately life-threatening 
events, will be reported by fax within 14 calendar days of site awareness.  
All SAEs will be followed until resolution or stabilization. 
 
Halting Rules 
It is not anticipated that there is a necessity for halting rules as the proposed study treatments 
are considered safe and approved by the FDA.  But, all safety and adverse events data will be 
reviewed by the DSMB members. DSMB will review the interim analysis of the safety data and 
will give their recommendations every year.  

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10 STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of a 
Data and Safety Monitoring Board (DSMB) composed of members with appropriate clinical, 
statistical, scientific, and ethical expertise. PCORI will not appoint the Board as per their 
guidelines. But the study investigators would be responsible for the appointment of the DSMB. 
The DSMB will meet at least annually to assess safety and effectiveness data, study progress, 
and data integrity for the study. If concerns arise, more frequent meetings may be held. The 
DSMB will operate under the general rules of a NIH -approved charter that will be approved at 
the organizational meeting of the DSMB. The DSMB will provide recommendations to the study 
investigators and PCORI.   
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of 
PCORI. The PI will submit a report every 6 months to the PCORI  for review. This report will 
include data regarding enrollment and retention, unanticipated problems and protocol 
deviations, outcome measures, quality management findings and other relevant parameters. If 
necessary, additional steps may be taken to ensure data integrity and protocol compliance. 
 

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11 STATISTICAL CONSIDERATIONS 
 
Study Hypotheses 
This study tests the hypothesis that simple medical treatment (Arm 1) is non-inferior to typical 
dental treatment (Arm 2) for primary outcomes (caries arrest, tooth pain/hypersensitivity) and 
secondary outcomes (new decay, oral health quality of life) at 12-months post treatment.  
 
Sample Size Considerations (RC-3) 
For continuous outcomes we computed power using a variance correction (i.e., variance inflation 
factor) to take into account possible correlations of outcomes within cluster. All computations of 
required effective samples sizes (or corresponding power) were done using the PASS 2005 
software. For binary outcomes, we used a specialized program for cluster randomization (a non-
inferiority test comparing two proportions). 
The primary outcome tooth pain was defined as change in pain (based on a 100-mm visual 
analogue pain scale (VAS), where higher is worse pain) from baseline to 1 year. We assume a 
mean difference of 0 between SDF and ART+FV, and consider non-inferiority to be within a 
margin (mean difference) of 8 between SDF and ART+FV arms; and based on prior literature also 
assume a common standard deviation of 25.62 Further, we  assumed an average of 25 subjects 
recruited per site, an intraclass correlation (ICC) of 0.01 (based on prior studies and literature),63,64 
and a 15% dropout rate (based on prior studies). The use of a 0.025 alpha-level one-sided t-test 
to test the null hypothesis of inferiority versus the alternative hypothesis of non-inferiority (as 
defined above), 11 sites per treatment group (corresponding to 275 subjects per treatment group 
or 550 total) will provide an estimated 89% power to conclude non-inferiority. Even if the ICC is 
higher (0.02), there will still be 83% power to detect non-inferiority. 
A second primary outcome is arrest rate. Previous data2,65 show a high arrest rate (of around 
90%) for ART + FV. We expect a similar arrest rate for SDF.34 For the power calculation we 
suppose the unit of analysis to be the person, and consider the binary outcome of ‘arrest’ defined 
as all lesions for an individual being arrested. We assume equal (person-level) arrest rates of 
90% for the ART+FV and SDF groups, and consider non-inferiority to be within a margin 
(difference in arrest proportions for ART+FV versus SDF) of 0.09. With the same assumptions as 
before using a 0.025 alpha level one-sided z test, the targeted sample size of 275 subjects in 11 
sites per treatment group will provide an estimated 85% power to conclude non-inferiority. For a 
higher ICC of 0.02, there will still about 80% power to detect non-inferiority. 
 
Planned Interim Analyses  
The safety data will be analyzed periodically for review by the DSMB. Safety Review 
11.3.1 
Efficacy Review 
N/A  

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Final Analysis Plan (IR-1, RC-4) 
Each primary outcome will be compared between the SDF and ART+FV groups. For tooth pain, 
a 95% confidence interval (CI) based on a t-test for the difference in mean responses (SDF minus 
ART+FV) will be computed. If this confidence interval lies within the interval (-∞, 8) we may 
conclude ‘non-inferiority’ of SDF relative to ART+FV treatment. The confidence interval may 
secondarily be examined to assess possible superiority of one intervention over the other.  For 
arrest rate, a 95% CI for the difference in rates (based on a z statistic) will be computed. If this 
confidence interval lies within the interval (-0.09, 1) we may conclude ‘non-inferiority’ of the SDF 
relative to ART+FV treatment. As above, possible superiority of one intervention over the other 
may also be assessed. For other outcomes, we will also compute 95% CI for differences in means 
(or proportions for binary outcomes). These secondary outcomes will be assessed in an 
exploratory manner for possibly superiority or inferiority based on appropriate margins. 
We will seek to corroborate initial results using a generalized estimating equations (GEE) 
approach. For each outcome we will fit a GEE (marginal) model that includes a treatment indicator 
and prognostic variables (including sociodemographic variables, medical conditions, and oral 
health behaviors). Appropriate link functions (e.g., logit link for binary outcomes and identity link 
for continuous outcomes) will be specified and an exchangeable working correlation matrix used 
to allow for correlations within site. The arrest outcome will be analyzed as a binary outcome (as 
described in the sample size section), and secondarily as the number of arrested lesions 
assuming an appropriate distribution (e.g., negative binomial) and link function (e.g., log link). 
Robust t tests with correction for a small number of clusters66 will be used to test for treatment 
effects and corresponding 95% confidence intervals computed.  
Secondarily, we will extend the above GEE approach to analyze the repeated (baseline, 26 and 
52-week) measures for each outcome. The models for each outcome will include the same 
prognostic variables as before, as well as time and a time by treatment interaction. We will allow 
for correlations among the repeated measures, e.g., using a first-order autocorrelation structure. 
If a substantial within-facility correlation is found we may need to incorporate facility as a second 
cluster levels (within which person – the first cluster level – is nested). We will estimate and test 
(via a robust t-test) the interaction term to compare trends over time for the two interventions. If 
the use of two cluster levels is not found to be feasible in the GEE approach, we will consider a 
generalized mixed effects model approach. 
Causal Inference standards (CI-1, Cl-2, Cl-3, Cl-4): Our use of randomization and adjustment in 
regression models should be sufficient to provide causally interpretable intervention effect 
estimates; special causal inference techniques such as propensity score or instrumental variable 
methods often indicated for observational studies, will therefore not be necessary for our data 
analysis. We will avoid biases in causal inferences about the intended interventions by using an 
intent-to-treat approach, in which individuals are analyzed according to randomized groups 
without regard to (extent of) treatment actually received. 
Sensitivity Analyses IR-5): We will check sensitivity of conclusions to model assumptions as well 
as methodological decisions such as outcome definition. In particular, for the arrest outcome, our 
primary analysis is based on a binary indicator of ‘complete’ arrest of all lesions for an individual. 
We will seek to corroborate results from this approach with an alternative approach analyzing 

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number of lesions arrested. For the GEE analyses, planned for all outcomes, sensitivity will be 
assessed in part by using alternative working covariance structures and alternative sets of 
predictors. For some outcomes, alternative distributions will be considered; for example, for 
number of arrested lesions, possible distributions include Poisson, negative binomial, zero-
inflated Poisson (ZIP), and zero-inflated negative binomial (ZINB). Sensitivity to assumptions 
regarding missing data will also be investigated as described further below. 
Missing Data.  (a) Methods to prevent and monitor missing data (MD-1, IR-7): All questionnaires 
(using tablets) and dental assessment forms (using paper), will be managed in an electronic 
database (REDCap) by study staff. Weekly quality control checks will be run for outliers, entry 
errors, missing data, and potential data anomalies. Statistical analyses, summary and missing 
data reports will be generated by the study biostatistician (Dr. Albert) monthly during the study. 
(b) Statistical Methods to Handle Missing Data and Account for Statistical Uncertainty Due to 
Missingness (MD-2):  The primary analyses, which use GEE based on all available observations, 
assume outcomes are missing completely at random (MCAR). As an initial assessment of missing 
data patterns, intervention groups (including by relevant subgroups and time point) will be 
compared with regard to missing outcome rates. We wlll test for a relationship between 
missingness and outcomes at early time points to evaluate the plausibility of the MCAR 
assumption. We will use multiple imputation methods (an established method) to help assure valid 
inferences. (d) Plans to Record and Report Dropout and Missing Data (MD-3, IR-7): The trial data 
will be managed using REDCap software, currently running at Case Western Reserve University 
(CWRU). REDCap67 is a secure web-based application providing an intuitive interface for 
validated data entry, audit trails for tracking data manipulation and export procedures, and 
automated export procedures for seamless data downloads to common statistical packages. 
Missing data reports will be generated weekly from REDCap for timely resolution and reporting 
purposes. (e) Plans to Examine Sensitivity of Inferences to Missing Data Methods (MD-4):  As 
noted above, multiple imputation will be used to obtain valid inferences in the presence of data 
that are not missing completely at random. We will use predictive mean matching with an 
appropriate prediction model depending on the outcome (e.g. logistic regression for binary 
outcomes, linear regression for continuous and count outcomes). Alternative imputation models 
will be used as part of sensitivity analyses. 
Heterogeneity of Treatment Effects (HTE: HT-1, HT-2, HT-3).  Our primary hypothesis addresses 
the effect of interventions at 12 months, as well as the longitudinal effect of the interventions. 
There is no empiric data on comparative effectiveness of these interventions, but individually they 
have similar effectiveness from prior literature. In particular, we will assess the possible 
moderators indicated in Figure 1; specific examples include age (e.g., dichotomized as age < 75 
versus age >= 75), presence of two or more medical conditions, gender, and race. Heterogeneity 
of treatment effect will be assessed by adding to the GEE models each potential moderator, along 
with the corresponding interaction with treatment. We will test moderator by treatment interactions 
to determine evidence for subgroup differences in the treatment effect. Corresponding 95% 
confidence intervals for the treatment effect for each subgroup will be computed. Secondarily, we 
will conduct an interaction tree approach such as CHAID (Chi-squared automatic interaction 
detection) an extension of CART (Classification and Regression Trees)68 to simultaneously 
assess the set of potential moderators, and determine subgroups that have significant intervention 
effects.  

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Reporting Plan (IR-5): To allow for assessment of study’s internal and external validity, we will 
adhere to standard reporting guidelines for randomized clinical trials as specified by: EQUATOR 
network;69 SPIRIT 2013 statement;70 and CONSORT 2010 statement.71  
 

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12 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate research records for this study, in compliance with ICH E6, 
Section 4.9 and regulatory and institutional requirements for the protection of confidentiality of 
subjects. CWRU will permit authorized representatives of PCORI, and regulatory agencies to 
examine (and when required by applicable law, to copy) research records for the purposes of 
quality assurance reviews, audits, and evaluation of the study safety, progress, and data 
validity. 
All records with identifiable information will be kept in secured locked storage units or stored in 
secure online databases. Only local (i.e. study staff) at CWRU and PCORI staff appointed to the 
trial will have access to the records.  Access by the PCORI staff is for the purposes of quality 
assurance reviews, audits, and evaluation of the study safety and progress. 
Specific original documents and data records include, but are not limited to: 
▪ 
Participant Consent chart contains all participant-identifying information. The chart 
includes the signed consent form, Consent Documentation form, the Contact Info form, 
Unanticipated Problem or Serious Adverse Event forms, Telephone Contact log and 
Reimbursement form. These documents will contain the participant’s name and other 
confidential information (i.e. names of family members). (Electronic and Paper Based) 
▪ 
Participant Research chart includes Case Report Forms (CRFs) and the Progress 
Notes Checklist. Examples are: ICDAS caries dental assessment form ; and Participant 
Questionnaire (Electronic and Paper Based). Medical information for chronic illnesses 
will be from participant self-report.  
▪ 
Tracking logs (in RedCap) (Electronic) 
▪ 
Memoranda (paper-based) 
Some case report forms will be completed by study staff (Research Assistants, the Research 
Associate, or Project Coordinator, depending on the event).  Exceptions will be the Participant 
Questionnaires, Contact information and Consent form(s) that will be completed by the 
Participant. The study staff will complete all provider audit forms. Data will be handled in 
accordance with GCP, U.S. federal regulations, local regulations (if applicable), and instructions 
from PCORI.  All essential documents should be filled out completely and signed by the study 
staff collecting or recording the data.  When necessary, essential documents (like 
consent/assent forms) will be reviewed, signed and dated by the principal investigators or study 
staff designated by the principal investigators.  

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13 QUALITY CONTROL AND QUALITY ASSURANCE 
 
Definitions 
Quality Assurance (QA) 
The process to ensure the quality of the intervention meets the study design expectations. 
Quality Control (QC)  
A set of routine technical activities to measure and control the quality of the intervention and 
accuracy of data acquisition as the intervention is being implemented.   
 
Study Intervention and Study Questionnaires 
13.2.1 
Quality Assurance Procedures 
Study Staff: 
Study staff who will recruit and interact with participants at the facilities, and document study 
activities will attend in-person training which will incorporate the topics of human subject 
protection, Good Clinical Practice (GCP), and adherence to the study protocol. As part of 
tracking and managing study records, staff members will learn how to document activities that 
occur with subjects, update study documentation and use the tracking and audit logs. To assess 
proficiency, the study staff will be certified in the topics presented to ensure their comprehension 
of the expectations.  
In addition, all study staff will be trained to make calls during the dedicated staff training. A script 
for each type of call will be created in REDCap and study staff will practice during training until 
they are proficient in utilizing the script and recording the call details.   
Additionally, the dental hygienists will undergo calibration exercises prior to the main study to 
become proficient in exam related study procedures and to maintain intra- and inter-examiner 
agreement. Dentist experts in the application of SDF, ART, and FV will train and calibrate the 
dental hygienist and study dentist in the clinical protocol during a two day training session. 
Additionally, a gold standard examiner will calibrate/train the examiners in the ICDAS protocol in 
a separate 4-day training session. Detailed clinical and caries assessment training, calibration 
and reproducibility protocols are in the attached training protocol. Hygienists will not utilize 
dental radiographs. At the 26-week and 52-week exams, the hygienists will not have access to 
the results of the baseline examination to avoid detection bias.  
Data Manager: 
Before formal data entry begins, appropriate study staff will be trained on a custom-configured, 
study-specific Electronic Data Capture (EDC) test system by the data manager. This procedure 
is for data entry training and user acceptance testing, concurrently. After completing didactic 
training, staff trainees will enter pre-specified test data into the test EDC system, including 
invalid data, to provide additional training and familiarity with the data entry process. Their 

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entered data will be compared against the pre-specified test data. After completion of training, 
staff members will be granted permission to use the EDC production environment for collection 
of project data. 
13.2.2 
Quality Control Procedures 
Study Staff: 
Data quality control is primarily conducted at the study team level through internal processes of 
data review/data monitoring as the data is collected and through periodic custom reports (See 
Table 16.4.1). Dental exam data will be reviewed for accuracy and completeness after each 
study visit by the Dental Hygienist.  The Study Staff will review the questionnaires after the 
participants have completed them. Each paper form and questionnaire will be entered and 
verified by two separate individuals.  Forms completed electronically via tablets will be checked 
by study staff prior to leaving the facility. Any field that is unclear will be clarified with the 
participant who completed the document.  
All study forms and questionnaires collected and entered into the database will be checked for 
inconsistencies and range and assessed for missing data.  Any inconsistencies, outliers, or 
missing data observed will be compared to the paper document and appropriate corrective 
actions carried out. REDCap’s native data resolution workflow will be used to document and fix 
any data anomalies. The Data Manager will also respond to data queries generated by the PI, 
Study Coordinator, or other study staff. 
Data Manager: 
The Data Manager will design custom reports. Utilization of an EDC system, such as REDCap, 
means that automated data checks can be implemented within the data entry system. This 
helps to prevent most errors immediately. The automated checks are also supported by an 
extensive system of custom reports and manual validation procedures that help to assist in the 
resolution of any additional errors.   
The Data Manager will create a standalone Data Validation Plan (DVP). The DVP will describe 
in more specific detail the edit-checks that will be performed within the EDC system and the 
SOPs for data entry and quality management. The Data Manager  together with the study team, 
will be responsible for the creation, testing, and finalization of the DVP for the project. 
Following collection of all data from a project, additional data processing will be required by the 
Data manager, e.g., longitudinal coding of dental examination data, creation of psychosocial 
scale scores.  In conjunction with that data processing, The Data Manager will run regular 
validation reports to detect data anomalies and will work with the project staff to resolve any 
data anomalies that arise during data entry. Following PI concurrence, the database will be 
locked. 

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14 ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 
46 and/or the ICH E6.  
 
Institutional Review Board 
 The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the Case Western Reserve University (FWA#: 00004428) IRB for review and 
approval.  Approval of both the protocol and the consent form must be obtained before any 
subject is enrolled.  Any amendment to the protocol will require review and approval by the IRB 
before the changes are implemented in the study.   
 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the 
study and continues throughout study participation.  Extensive discussion of risks and possible 
benefits of study participation will be provided to subjects and their families, if applicable.  A 
consent form describing in detail the study procedures and risks will be given to the subject.  
Consent forms will be IRB-approved, and the subject is required to read and review the 
document or have the document read to him or her.  The investigator or designee will explain 
the research study to the subject and answer any questions that may arise.  The subject will 
sign the informed consent document prior to any study-related assessments or procedures.  
Subjects will be given the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate.  They may withdraw consent at any time throughout the course 
of the study.  A copy of the signed informed consent document will be given to subjects for their 
records.  The rights and welfare of the subjects will be protected by emphasizing to them that 
the quality of their clinical care will not be adversely affected if they decline to participate in this 
study. The consent process will be documented in the research record.   
 
Subject Confidentiality 
Subject confidentiality is strictly held in trust by the investigators, study staff, representatives for 
Case Western Reserve University, and the representatives of the study sponsor (PCORI).   
The study protocol, documentation, data, and all other information generated will be held in 
strict confidence.  No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. 
An authorized PCORI member may inspect all study documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) for the study subjects.  The clinical study site will permit access to such records. 

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All information about the participant will be kept strictly confidential and be used only for study 
purposes. When study results are published or presented, all information will be presented in 
group form, without identifiable information. 

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15 DATA MANAGEMENT PLAN 
The investigators are responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported.  All source documents should be completed in a neat, legible 
manner to ensure accurate interpretation of data.  The investigators will maintain adequate case 
histories of study subjects, including accurate case report forms (CRFs), and source 
documentation. 
 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the Study Staff, Data 
Manager and Study Coordinator under the supervision of the PI. All source documents must be 
reviewed by the study team and data entry staff, who will ensure that they are accurate and 
complete. Unanticipated problems and adverse events must be reviewed by the PI.   
 
Data Collection Methods and Organization of the Data 
15.2.1 
Data Collection Methods 
Data for this study will be captured using dental exams, forms, questionnaires, and audio 
recordings.  Study data will be collected and stored using the REDCap Electronic Data Capture 
(EDC) platform hosted by Case Western Reserve University. REDCap is a secure, web-based 
application designed to support remote data capture for research studies, providing: 1) an 
intuitive interface for validated data entry, 2) audit trails for tracking data manipulation and 
export procedures, 3) automated export procedures for seamless data downloads to common 
statistical packages, and 4) procedures for importing data from external sources. 
15.2.2 
Setting up the EDC 
Electronic data capture forms will be created to match paper CRFs. Before the project begins 
recruitment a test/non-production environment will be created where the study form will be 
created and tested. Once the forms have been approved by either the PI and/or the study 
coordinator they will be moved to the production environment. Real study data will only be 
entered in the production environment.   
Prior to being released for data collection, CRFs are configured by the Data Manager in non-
Production REDCap test environments for user acceptance testing. Each form and the overall 
database will be tested by the Project Coordinator and Study Staff. The user acceptance test 
includes exercises involving data entry for a complete mock subject from start to finish, including 
interviews conducted with interruptions (terminated early and restarted). Items that have been 
tested and approved by the PI and/or Study Coordinator are then migrated to the Production 
environment. Items that will be configured in the non-production environment and then migrated 
to the production environment are as follows: 
Study Forms: Confirms that they have been properly translated from the paper CFRs and are 
free from errors in content, design and formatting. 
 

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Univariate and valid value checks: Confirm that checks have been properly imported from 
specifications document. Manually test each check.  
Multivariate and cross-checks: Confirm each check via test data designed to trigger a query. 
Custom functions: e.g. custom reports. Confirm that each custom report is functioning with 
test data designed to trigger an event. Second programmer code review, if possible.  
Generation of subject numbers: Confirm that participant IDs are generated according to 
specifications. 
Customized form or variable delivery (e.g. dynamic fields): Confirm against schedule of 
events and against other specifications. We will use standard operating procedures (SOPs).  
Data completion guidelines: Confirm that the completion guidelines are properly associated 
with each form/field. This will be achieved using SOPs and training manuals for specific roles 
such as Data Manager, Study Staff, etc.  
Derived variable computation: Confirm against specifications using test data. 
Role assignment: Review system. Confirm using list of role functionality. Have testers 
assigned to each role and ensure that they are only able to do/see what they are entitled to, per 
their assigned role.  
Data Extracts: Review extracted data and ensure that it matches specifications (e.g., annotated 
CRF)  
System Reports: Review EDC reports and ensure they are functioning according to 
expectations. Run reports on test data. 
REDCap automatically outputs both a data dictionary and metadata on the data structure once 
the forms are designed. If the forms are modified REDCap automatically updates the data 
dictionary and metadata to reflect the changes. The data dictionary and metadata will reside in 
Redcap. 
15.2.3 
Changes to a Production EDC System 
The goal is to minimize changes made to the data management plan once the protocol-specific 
configuration is loaded into the Production server and is 'live.' Absolutely necessary changes will 
be required to go through the same process as in the initial EDC system. The changes will first 
be entered into the EDC system test environment and tested by the Data Manager. The new 
changes will then go through user training and acceptance testing in the Test environment prior 
to implementation in the REDCap Production environment. Finally, when the Study Coordinator 
and/or PI deems the changes are ready to be implemented in the Production environment, the 
changes will be implemented in the REDCap Production environment. 
 

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When the changes have been implemented in the REDCap Production environment, all 
appropriate training will be conducted to ensure the Project Staff understands the changes in 
their work going forward. Documentation of all changes and testing will be stored in on the 
CWRU local network drive and will be versioned using the version control scheme outlined 
below.  
15.2.4 Version Control for Study Forms 
Study Forms will be versioned and named in the file according to the following file naming 
convention. Each change in version will be tracked on a version tracking log, which will be 
stored on the School of Dental Medicines local network drive and will be accessible to all study 
personnel. 
The rules for file naming are below… 
1. The first element of the file name should be the date. Use YYMMDD format for date. This 
format makes sure all of your files stay in chronological order, even over the span of many 
years.  
2. Special characters such as  ~ ! @ # $ % ^ & * ( ) ` ; < > ? , [ ] { } ' " and | should be avoided. 
3. When using a sequential numbering system, using leading zeros for clarity and to make 
sure files sort in sequential order. 
4. For example, use "001, 002, ...010, 011 ... 100, 101, etc." instead of "1, 2, ...10, 11 ... 100, 
101, etc." 
5. Do not use spaces. Some software will not recognize file names with spaces, and file names 
with spaces must be enclosed in quotes when using the command line. Other options 
include 
- Underscores, e.g. file_name.xxx 
- Dashes, e.g. file-name.xxx 
- No separation, e.g. filename.xxx 
-Camel case, where the first letter of each section of text is capitalized, e.g. FileName.xxx 
 
6. Version number should be the last element in the name and should start with 0.1 for the first 
draft of a document. The first IRB approved version of a document should be version 1.0. 
15.2.5 
Organization of Paper Form 
Study forms may be completed by participants on paper, and subsequently entered into 
REDCap by study staff, or on a tablet directly into REDCap. Paper forms will be securely stored 
in a locked file cabinet. Recorded audio will be deleted from the digital recording device 
immediately after being stored on a secure CWRU School of Dental Medicine network drive. 
 

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Types of Data Collected 
Participant data for this study will include: (1) dental exam data, (2) study questionnaires and (3) 
intervention tracking data.  Additionally, audio recordings will be used for fidelity monitoring. A 
summary of the types of data collected, the storage location and the methods of completion can 
be seen in Figure 15.3.1. 
 
Figure 15.3.1 
Mail Clinical Trial 
Storage Location 
Form/ 
Questionnaire 
 
Type 
Method of Completion 
Consent Folder and 
REDCap 
Consent Form 
Consent 
▪ 
Direct Entry by Participant and 
study staff into RedCap via Tablet 
▪ 
Paper Form 
Consent Folder and 
REDCap 
Consent 
Documentation 
Consent 
▪ 
Direct Entry by study Staff into 
RedCap  
▪ 
Paper Form 
Consent Folder and 
REDCap 
Participant Contact 
Form 
Contact 
▪ 
Direct Entry by Participant into 
RedCap  
▪ 
Paper Form 
CRF Folder and 
REDCap 
Screening and 
Eligibility Form 
Screening and 
Eligibility 
▪ 
Direct Entry by study Staff into 
RedCap  
▪ 
Paper Form 
CRF Folder and 
REDCap 
Participant 
Questionnaire A 
Demographics, 
Medical History, Oral 
Behavior and Oral 
Health Symptoms 
▪ 
Direct Entry by Participant and 
study staff into RedCap  
▪ 
Paper Form 
CRF Folder and 
REDCap 
Participant 
Questionnaire B 
Tooth Pain/Sensitivity 
and Oral Health 
Quality of Life  
▪ 
Direct Entry by Participant and 
study staff into RedCap 
▪ 
Paper Form 
CRF Folder and 
REDCap 
Safety 
Questionnaire (Pre-
Exam) and 
Participant 
Questionnaire C 
Safety 
▪ 
Direct Entry by study staff into 
RedCap  
▪ 
Paper Form 
CRF Folder and 
REDCap 
Participant 
Questionnaire D 
Satisfaction 
▪ 
Direct Entry by study staff into 
RedCap  
▪ 
Paper Form 
CRF Folder and 
REDCap 
Intervention 
Delivery Tracking 
Treatment Log 
▪ 
Direct Entry by study staff into 
RedCap  
▪ 
Paper Form 

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CRF Folder and 
REDCap 
Dental Exam Forms 
Oral Health Screening 
and Carries Arrest and 
New Decay 
▪ 
Direct Entry by study staff into 
RedCap  
▪ 
Paper Form 
Focus Groups 
CWRU Dental 
School Network 
Drive 
Focus Group 
Transcriptions and 
Recordings 
Treatment Satisfaction 
▪ 
Digital Recording and Electronic 
Transcription Files 
 
Methods to Prevent and Monitor Missing Data. 
Utilization of an EDC system, such as REDCap, means that automated data checks can be 
implemented within the data entry system. This helps to prevent most errors, immediately. The 
automated checks are also supported by an extensive system of custom reports and manual 
validation procedures that assist in the resolution of any additional errors. 
At the data collection stage, study staff will also make sure at the visit that all forms are checked 
for completeness of paper and electronic data. 
15.4.1 
Univariate Alerts 
Value Alerts for Multiple-choice Fields (allowing selection of only 1 option) 
• The user is required to choose only one out of a series that represents different response 
option choices. Such multiple-choice fields are defined as radio buttons or are displayed in a 
dropdown menu of choices. 
Valid Value Alerts for Multiple-choice Fields (allowing selection of more than 1) 
• The user is required to choose at least one and is allowed to choose all options from a series 
that represents different data choices. This type of multiple-choice field is defined as a 
checkbox. 
Valid Value Alerts for Number Fields 
• The user is required to enter a number in a format as indicated in the completion guideline and 
notes provided by the system or the system will not allow data entry. 
• The system does not allow entering any character that fails the specification (e.g., letters in a 
number field). 
Valid Value Alerts for Missing Data 
• To ensure completeness, even in the case that data are not available, options of refused, don’t 
know or not-applicable may be made available. 

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15.4.2 
Multivariate and Cross-module Alerts 
• 
Confirming that “Other, specify:” is completed when “Other’ is marked. 
• 
Confirming that only valid options are selected in a “choose all that apply” multiple choice 
field, where the range of options deemed valid depends on some other parameter. 
• 
Confirming data of part-fields which are references for system-based calculations when 
calculated values are out of indicated range (e.g., BMI calculation based on weight and 
height). 
• 
Comparing the dates and times of all assessment time points to confirm that they occur in 
an appropriate sequence. For example, a Study Week 1 assessment should occur before a 
Study week 3 assessment. 
 
Schedule and Content of Reports 
Quality control is primarily conducted at the study team level through internal processes of data 
review/data monitoring using periodic custom reports. See Table 16.4.1 for the project-specific 
custom reports for the main trial. 
Table 15.4.1 Project-specific custom reports 
Responsible 
for Addressing  
Name of Report 
Frequency 
CWRU 
Weekly Enrollment  
Weekly during recruitment 
CWRU 
Cumulative Enrollment  
Weekly during recruitment 
CWRU 
Informed Consent & Documentation Errors 
Weekly during recruitment 
CWRU 
Participant Questionnaire Completion 
As Required by CWRU 
CWRU 
Dental Exam Completion 
As Required by CWRU 
CWRU 
Intervention Completion Log 
As Required by CWRU 
CWRU 
Safety Data 
Weekly during intervention 
delivery 
CWRU 
26-week and 52-week to  be scheduled 
As Required by CWRU 
The Data Manager will run regular validation reports to detect data anomalies and will work with 
the project staff to resolve any data anomalies that arise during data entry. REDCap’s native 

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data resolution workflow will be used to document and fix any data anomalies. The Data 
Manager will also respond to data queries generated by the PI, Study Coordinator, or other 
study staff. 
At the completion of the study, the study Biostatistician will conduct analyses of the data and 
assist in preparation of study publications and presentations. The Data Manager will provide 
technical and data support for the Biostatistician throughout the study. 
The Data Manager will generate regular reports showing enrollment and potential data 
anomalies, which will be sent to PIs, Project Coordinators, and other relevant study staff Data 
Manager will generate a monthly enrollment report (or as requested by the DSMB or PCORI 
Program Official) for sharing progress of the study (see table 15.4 above). 
 
Data Storage and Preservation plan 
Overview of Data Storage and Security in REDCap 
REDCap servers are hosted at CWRU and are guarded by multiple firewall and intrusion 
detection systems. All electronic connections to the REDCap environment are encrypted. The 
REDCap production system is comprised of a web server front-end and a MySQL database 
server back-end. The MySQL server back-end resides in the protected CWRU server subnet 
that is protected by CWRU-maintained firewalls. Only CWRU Information Technology system 
administrators are authorized to access the back-end database server directly. 
Processes of sanitization, filtering, data type checking, and escaping all help to protect against 
methods of attack, such as Cross-Site Scripting (XSS) and SQL Injection. To specifically protect 
against Cross-Site Request Forgery (CSRF), which is another method of attack, REDCap 
utilizes a “nonce” (a secret, user-specific token) on every web form used in the application. The 
nonce is generated as a unique value for each new REDCap session. Additionally, REDCap 
employs “rate limiting” on its web pages, in which there is a set maximum number of web 
requests per minute that are allowed from a single IP address, and after that maximum is hit, 
the IP address of that user is permanently banned from REDCap. 
REDCap implements authentication to validate the identity of end-users that log in to the 
system. For security reasons, the password in the database table is not stored as plain text but 
as an encrypted one-way hash of the password. 
Disaster Recovery Plan 
REDCap databases are backed up on a regularly scheduled basis. 
• The backup cycle consists of daily incremental backups and full back up each week. The 
backups are stored on a local storage disk environment. The local backup files are stored for 14 
days and then automatically aged off of the system. 
• Additionally, all of the backup files are copied, using dedicated network connections, to a 
remote storage disk environment. Remote backup files are kept for 30 days and then aged off of 
the system. 

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• System and file restorations are conducted daily as a part of routine daily operations. Test 
restores are conducted at the request of the application owner and are based on the specific 
application requirements. 
Overview of Data Storage and Security for Paper File 
Paper files with be stored at CWRU in locked offices inside of locked cabinets. Only the Data 
Manager and the PI will have access to the keys for the locked cabinets. The consent charts 
and the CRF charts will be stored in different rooms to help separate data from identifying 
information. A linking file will be keep electronically in REDCap and on a secured network drive 
at CWRU School of dental medicine. This network drive has been specifically designated to 
store PHI. Furthermore, access to each folder is restricted by the owner and will be update to 
limit access to only current study personnel.  
 
Study Records Retention 
Study documents should be retained for 7 years after the final report is submitted to PCORI in 
accordance with PCORI’s policy on data management and sharing. These documents may be 
retained for a longer period, however, if required by local regulations or CWRU IRB.    

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16 PROTOCOL DEVIATIONS 
A protocol deviation is any noncompliance with the clinical study protocol or Good Clinical 
Practice requirements.  The noncompliance may be on the part of the subject, the investigator, 
or study staff (e.g., Project Coordinators, Study Staff).  As a result of deviations, corrective 
actions are to be developed by the PI and/or Project Coordinator, and implemented promptly. 
These practices are consistent with investigator and sponsor obligations in ICH E6: 
● Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
● Quality Assurance and Quality Control, Section 5.1.1 
● Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents and 
promptly reported to PCORI and the Case Western Reserve IRB, according to their 
requirements as outlined below 
According to CWRUIRB, Major Deviations are reported to the IRB within 14 calendar days of 
discovery. Minor Deviations are kept in the investigator’s file to be reported at the time of 
continuing review. 
Examples of Major Deviations: 
• 
Failure to obtain informed consent, i.e., there is not documentation of informed consent  
or informed consent was obtained  after initiation of study procedures; 
• 
Informed consent obtained by someone not approved to obtain consent for the protocol; 
• 
Use of invalid consent form, i.e. consent form without IRB approval; or outdated/expired 
consent form; 
• 
Enrollment of a participant who was ineligible for the study; 
• 
Performing a research procedure not in the approved protocol; 
• 
Failure to report serious adverse event to IRB; sponsor; and/or regulatory agencies; 
• 
Failure to follow the approved study protocol that affect participant safety or data 
integrity (e.g., study visit missed or conducted outside of required timeframe, or failure to 
perform a laboratory test); 
• 
Failure to follow safety monitoring plan; 
• 
Continuing research activities after IRB approval has expired; 
• 
Use of recruitment procedures that have not been approved by the IRB; 
• 
Enrolling significantly more subjects than proposed in the IRB protocol; 
Examples of Minor Deviations 
• 
Missing original signed and dated consent form (only a photocopy available); 
• 
Missing pages of executed consent form; 
• 
Failure to follow the approved study protocol that does not affect participant safety (e.g., 
study procedure conducted out of sequence, failure to perform a required test, missing 
laboratory results, study visit conducted outside of required timeframe.). 

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17 PUBLICATION 
 
Policy on Public Access 
This study will comply with the PCORI’s Policy on Public Access, which ensures that the public 
has access to the published results of PCORI funded research. It requires scientists to submit 
final peer-reviewed journal manuscripts that arise from PCORI funds to the digital archive 
PubMed Central upon acceptance for publication. 
Awardees with published, peer-reviewed articles resulting from PCORI-funded research must 
ensure that the articles are made available in PubMed Central in accordance with the following 
conditions: 
• 
Awardees are to ensure that an electronic copy of their final peer-reviewed manuscript is 
deposited in PubMed Central within four weeks of its acceptance for journal publication. 
(Instructions for posting are available here.) 
• 
The manuscript is to be made publicly available in PubMed Central no later than 12 
months after the official date of journal publication. 
In addition, PCORI support must be acknowledged in every article reporting findings from 
research funded in whole or part by PCORI, consistent with PCORI Guidelines. The 
acknowledgement statement must include the applicable PCORI contract number, which will 
enable PCORI to link the published outputs of PCORI-funded research to the support PCORI 
has provided.  
PCORI will expect all awardees to comply with this Policy on Public Access. 
 
 

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18 DATA SHARING PLAN 
 
Data Deposition and Data Availability 
The Full Data Package will be maintained at CWRU for a period of at least seven (7) years 
following acceptance by PCORI of the Final Research Report. During this period, PCORI may 
notify PI of PCORI’s intent to provide funds for the deposition of the Full Data Package to a 
PCORI-designated repository. Reasons for such notification may include PCORI’s estimation of 
high importance of and interest in research project findings, request(s) from external 
researchers for data access, or the PI’s expressed interest in sharing the data. 
Regarding the data sharing plan, we endorse and will follow the NIH guidelines available at 
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm. We will work in a 
collaborative manner with PCORI in all aspects of the proposed project including sharing all 
materials (protocol, questionnaire/survey etc.), data, and results that will be developed and 
produced through this proposed project. All research resources including the Manual of 
Procedures (MOP), study manuals, questionnaire/survey will be made available to the public.  
Sharing Data and Research Materials  
For any external investigators requesting data, user agreements need to be executed as per 
Institutional guidance and in accordance with IRB regulation. These agreements also forbid the 
external investigator from passing along the data to a third party.  Investigator requests should 
clearly state the goals of their study and what specific data is requested. 

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19 LITERATURE REFERENCES 
 
1. 
Horst JAA, Ellenikiotis H, Milgrom PLM. UCSF Protocol for Caries Arrest Using Silver 
Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016;44(1):16-
28. doi:10.1007/978-1-4614-5915-6 
2. 
Lo ECM, Luo Y, Tan HP, Dyson JE, Corbet EF. ART and Conventional Root Restorations 
in Elders after 12 Months. J Dent Res. 2006;85(10):929-932. 
doi:10.1177/154405910608501011 
3. 
Vujicic M. Our dental care system is stuck: And here is what to do about it. J Am Dent 
Assoc. 2018;149(3):167-169. doi:10.1016/j.adaj.2018.01.006 
4. 
Davis KD, Schoen CS, Willink AW. Medicare Beneficiaries’ High Out-of-Pocket Costs: Cost 
Burdens by Income and Health Status.; 2017. doi:10.15868/socialsector.27426 
5. 
In Focus: Integrating Oral Health into Primary Care - The Commonwealth Fund. 
http://www.commonwealthfund.org/publications/newsletters/quality-matters/2015/february-
march/in-focus 
6. 
Dye BA, Tan S, Smith V, et al. Trends in oral health status: United States, 1988-1994 and 
1999-2004. Vital Health Stat 11. 2007;(248):1-92. 
https://www.ncbi.nlm.nih.gov/pubmed/17633507 
7. 
Dye BA, Thornton-Evans G, Li X, Iafolla TJ. Dental Caries and Tooth Loss in Adults in the 
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APPENDICES 
APPENDIX A: SCHEDULE OF EVENTS 
 

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APPENDIX A: SCHEDULE OF EVENTS 
 
Measure/Process 
 
Type 
 
Instrument/Evaluation/Procedure 
Timeline (Study Week) 
-2 
0 
2 
26 
28 
52 
54 
Screening and 
Eligibility Form 
Screening 
and Eligibility 
Screening and Eligibility Form 
X 
 
 
 
 
 
 
Consent Form 
Consent 
Case IRB Template 
X 
 
 
 
 
 
 
Consent Doc. 
Consent 
Case IRB Template 
X 
 
 
 
 
 
 
Contact Form 
Contact 
Contact Information Form 
X 
 
 
X 
 
 
 
Participant 
Questionnaire A 
Demographi
cs 
Demographics [Adapted from NHANES 
III]72 
X 
 
 
 
 
 
 
Participant 
Questionnaire A 
Medical 
History 
Common Chronic Heath Condition for 
Adults 65+ [Adapted from NCOA 2017]52 
X 
 
 
 
 
 
 
Participant 
Questionnaire A 
Oral 
Behavior 
Oral Hygiene [Adapted from Kuusela 
1997, WHO survey 1997]53,54 
X 
 
 
 
 
 
 
Participant 
Questionnaire A 
Oral Health 
Symptoms 
Self-Reported Measures of Current Oral 
Disease/Tissue Damage [Adapted from 
Gilbert et. al 1997]55 
X 
 
 
 
 
 
 
Participant 
Questionnaire B 
Tooth 
Pain/Sensitiv
ity  
PROMIS v.1.0 - Pain Intensity 3a 
[Modified for Dental]45 
X 
 
 
 
X 
 
X 
Participant 
Questionnaire B 
Tooth 
Pain/Sensitiv
ity  
Dental Discomfort Questionnaire [Modified 
for Adults from Versloot et al. 2006]46 
X 
 
 
 
X 
 
X 
Participant 
Questionnaire B 
Oral Health 
Quality of 
Life 
Geriatric Oral Health Quality of Life 
[Atchison and Dolan, 1990]47 
X 
 
 
 
X 
 
X 
Participant 
Questionnaire C 
Safety 
Safety Questionnaire [Adapted for Adults 
from Milgrom et al. 2018]48 
 
 
X 
 
X 
 
X 
Participant 
Questionnaire D 
Satisfaction 
Treatment Satisfaction Questionnaire for 
Medication (TSQM) [Modified for Dental]49 
 
 
 
 
 
 
X 
Participant 
Questionnaire D 
Satisfaction 
Satisfaction with New Treatment for 
cavities [Modified for Adults from Crystal 
et al. 2017]50 
 
 
 
 
 
 
X 

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Measure/Process 
 
Type 
 
Instrument/Evaluation/Procedure 
Timeline (Study Week) 
-2 
0 
2 
26 
28 
52 
54 
Intervention 
Delivery 
Treatment 
SDF or Art + FV Based on Study Arm 
 
X 
 
X 
 
 
 
Intervention and 
Visit Tracking  
 
 
X 
X 
X 
X 
X 
X 
X 
Safety 
Questionnaire (Pre-
Exam) 
Safety 
Safety Questionnaire [Adapted for Adults 
from Milgrom et al. 2018]48 
 
X 
 
X 
 
X 
 
Dental Exam Form 
Oral Health 
Screening 
Oral Health Screening and Referral Form 
 
X 
 
X 
 
X 
 
Dental Exam Form 
Oral Health 
Screening 
Visual Examination to Detect Gingival or 
Soft Tissue Stomatitis or Ulcerative 
Lesions [Adapted from Milgrom et al. 
2018]48 
 
 
 
X 
 
X 
X 
 
Dental Exam Form 
Carries 
Arrest and 
New Decay 
ICDAS Coronal and Root 
[Dikmen 2015]44 
 
X 
 
X 
 
X