Influence of Financial Incentives on Oral Disease Management in Young Children
Phase: NA
Conditions: Toothbrushing, Dental Plaque, Parent-Child Relations, Oral Hygiene, Dental Caries
Sponsor: University of California, San Francisco

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
Protocol 17-084-E 
Version 1.9 
19 October 2020 
 
 
 
Influence of Financial Incentives on Oral 
Disease Management in Young Children 
(BEhavioral EConomics for Oral health 
iNnovation - BEECON) 
 
NIDCR Protocol Number: 17-084-E 
 
NIDCR Grant Number: UH3DE025514 
 
ClinicalTrials.Gov Number: NCT03576326 
 
Principal Investigators: Stuart A. Gansky, DrPH, 
Francisco Ramos-Gomez, DDS, MS, MPH 
 
NIDCR Program Officials: 
Darien Weatherspoon, DDS, MPH 
 
NIDCR Medical Monitor: Kevin McBryde, MD 
 
Draft or Version Number: 1.9 
19 October 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
Protocol 17-084-E 
Version 1.9 
19 October 2020 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
 
 
 
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 NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subjects protection training. 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
Protocol 17-084-E 
Version 1.9 
19 October 2020 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
 
 
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 Investigators or Clinical Site Investigators: 
 
Signed: 
Date: 
 
 
Name: Stuart A. Gansky, DrPH 
Title:  Professor 
Signed: 
 
Date: 
 
 
Name: Francisco Ramos-Gomez, DDS, MS, MPH 
Title: 
Professor 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
Protocol 17-084-E 
Version 1.9 
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Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
 
 
TABLE OF CONTENTS 
PAGE 
INFLUENCE OF FINANCIAL INCENTIVES ON ORAL DISEASE MANAGEMENT IN YOUNG 
CHILDREN .......................................................................................................................... I 
STATEMENT OF COMPLIANCE ................................................................................................ 2 
SIGNATURE PAGE..................................................................................................................... 3 
TABLE OF CONTENTS .............................................................................................................. 4 
LIST OF ABBREVIATIONS ......................................................................................................... 7 
PROTOCOL SUMMARY ............................................................................................................. 9 
1 
KEY ROLES AND CONTACT INFORMATION ................................................................. 13 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ........ 15 
2.1 
Background Information ........................................................................................ 15 
2.2 
Rationale ............................................................................................................... 16 
2.3 
Potential Risks and Benefits .................................................................................. 18 
2.3.1 Potential Risks ........................................................................................... 18 
2.3.2 Potential Benefits ....................................................................................... 19 
3 
OBJECTIVES ................................................................................................................... 19 
3.1 
Study Objectives ................................................................................................... 19 
3.1.1 Primary ...................................................................................................... 19 
3.1.2 Secondary ................................................................................................. 20 
3.2 
Study Outcome Measures ..................................................................................... 20 
3.2.1 Primary ...................................................................................................... 20 
3.2.2 Secondary ................................................................................................. 21 
4 
STUDY DESIGN ............................................................................................................... 22 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................... 23 
5.1 
Subject Inclusion Criteria ....................................................................................... 23 
5.2 
Subject Exclusion Criteria ...................................................................................... 24 
5.3 
Strategies for Recruitment and Retention .............................................................. 25 
5.4 
Treatment Assignment Procedures ....................................................................... 26 
5.4.1 Randomization Procedures ........................................................................ 26 
5.4.2 Masking Procedures .................................................................................. 27 
5.5 
Subject Withdrawal................................................................................................ 27 
5.5.1 Reasons for Withdrawal ............................................................................. 27 
5.5.2 Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ................................................................................................ 28 
5.6 
Premature Termination or Suspension of Study ..................................................... 28 
6 
STUDY INTERVENTION .................................................................................................. 28 
6.1 
Study Behavioral or Social Intervention(s) Description ........................................... 28 
6.2 
Administration of Intervention ................................................................................ 29 
6.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ......... 30 
6.4 
Assessment of Subject Compliance with Study Intervention .................................. 30 
7 
STUDY SCHEDULE ......................................................................................................... 31 
7.1 
Screening .............................................................................................................. 31 
7.1.1 Screening Visit (Visit 1, T = business day -10) ........................................... 31 
7.1.2 Baseline (Post-Run-In/Randomization) Visit (Visit 2, T = 0 [+10/-2]) ........... 32 
7.2 
Intermediate Visits ................................................................................................. 32 
7.2.1 Month 3 Follow-Up Study Visit (Visit 2, T = business day 65 ± 28) ............. 32 

Influence of Financial Incentives on Oral Disease Management in Young Children 
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7.2.2 Month 6 Follow-Up Study Visit (Visit 3, T = business day 130 ± 28) ........... 32 
7.2.3 Month 9 Follow-Up Study Visit (Visit 4, T = business day 195 ± 28) ........... 33 
7.2.4 Month 12 Follow-Up Study Visit (Visit 5, T = business day 260 ± 28) ......... 33 
7.2.5 Month 15 Follow-Up Study Visit (Optional for Control Group Only, Visit 
6, T = business day 325 ± 28) .................................................................... 34 
7.2.6 Month 18 Follow-up Study Visit (Optional for Control Group Only, Visit 
7, T = business day 390 ± 28) .................................................................... 35 
7.3 
Withdrawal Visit..................................................................................................... 36 
7.4 
Unscheduled Visit .................................................................................................. 36 
8 
STUDY PROCEDURES /EVALUATIONS ......................................................................... 36 
8.1 
Oral Examination Procedures ................................................................................ 36 
8.2 
Focus Groups and Interviews ................................................................................ 36 
8.3 
Questionnaires ...................................................................................................... 37 
8.4 
Anticipatory Guidance ........................................................................................... 37 
8.5 
Toothbrushing Performance and Frequency .......................................................... 37 
8.5.1 Smart Toothbrushes .................................................................................. 37 
8.6 
Dental Visit Attendance ......................................................................................... 38 
8.7 
Study Products ...................................................................................................... 38 
8.7.1 Plaque Disclosing Solution ........................................................................ 38 
8.7.2 Fluoride Varnish ........................................................................................ 38 
8.7.3 Fluoride Toothpaste Pump ......................................................................... 38 
8.8 
COVID-19 Modifications ........................................................................................ 39 
9 
ASSESSMENT OF SAFETY ............................................................................................ 39 
9.1 
Specification of Safety Parameters ........................................................................ 39 
9.1.1 Unanticipated Problems (UPs) ................................................................... 39 
9.1.2 Adverse Events ......................................................................................... 40 
9.1.3 Serious Adverse Events (SAEs) ................................................................ 40 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ........................ 40 
9.3 
Characteristics of an Adverse Event ...................................................................... 41 
9.3.1 Relationship to Study Intervention .............................................................. 41 
9.3.2 Expectedness of AEs ................................................................................. 41 
9.3.3 Severity of Event ....................................................................................... 41 
9.4 
Reporting Procedures ........................................................................................... 42 
9.4.1 Unanticipated Problem (UP) Reporting to IRB and NIDCR ......................... 42 
9.4.2 Serious Adverse Event Reporting to IRB and NIDCR ................................. 43 
9.4.3 Reporting of SAEs and AEs to FDA ........................................................... 44 
9.4.4 Events of Special Interest .......................................................................... 44 
10 
STUDY OVERSIGHT ....................................................................................................... 44 
11 
CLINICAL SITE MONITORING ......................................................................................... 45 
12 
STATISTICAL CONSIDERATIONS .................................................................................. 45 
12.1 
Study Hypotheses ................................................................................................. 45 
Primary Null Hypothesis ........................................................................................ 45 
Secondary hypotheses .......................................................................................... 46 
12.2 
Sample Size Considerations .................................................................................. 46 
12.3 
Planned Interim Analyses (if applicable) ................................................................ 47 
12.4 
Final Analysis Plan ................................................................................................ 47 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................... 49 

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14 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................... 50 
15 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 50 
15.1 
Ethical Standard .................................................................................................... 50 
15.2 
Institutional Review Board (IRB) ............................................................................ 51 
15.3 
Informed Consent Process .................................................................................... 51 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) ..................... 51 
15.5 
Subject Confidentiality ........................................................................................... 51 
16 
DATA HANDLING AND RECORD KEEPING ................................................................... 52 
16.1 
Data Management Responsibilities ....................................................................... 52 
16.2 
Data Capture Methods .......................................................................................... 52 
16.3 
Types of Data ........................................................................................................ 53 
16.4 
Schedule and Content of Reports .......................................................................... 53 
16.5 
Study Records Retention....................................................................................... 53 
16.6 
Protocol Deviations ............................................................................................... 53 
16.6.1 Robust Action Plan .................................................................................... 54 
17 
PUBLICATION/DATA SHARING POLICY ........................................................................ 56 
18 
LITERATURE REFERENCES .......................................................................................... 58 
SUPPLEMENTAL MATERIALS ................................................................................................. 64 
APPENDICES ........................................................................................................................... 65 

Influence of Financial Incentives on Oral Disease Management in Young Children 
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LIST OF ABBREVIATIONS 
 
AAP 
American Academy of Pediatrics 
ADA 
American Dental Association 
AE 
Adverse Event/Adverse Experience 
ASTDD BSS 
Association of State and Territorial Dental Directors’ 
Basic Screening Survey 
CAPI 
Computer Assisted Personal Interview 
CC 
Coordinating Center 
CDMP 
Clinical Data Management Plan 
CFR 
Code of Federal Regulations 
CHR 
Committee on Human Research 
CI 
Confidence Interval 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CROMS 
Clinical Research Operations and Management Support 
CTMS 
Clinical Trials Management System 
dmfs 
Number of decayed, missing, and filled tooth surfaces 
DSMB 
Data and Safety Monitoring Board 
ECC 
Early Childhood Caries 
ECOHIS 
Early Childhood Oral Health Impact Scale 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Collection 
EHS 
Early Head Start 
FDA 
Food and Drug Administration 
FFR 
Federal Financial Report 
GIFVT 
Glass Ionomer and Fluoride Varnish Trial 
GLMM 
Generalized Linear Mixed Model 
ICER 
Incremental Cost Effectiveness Ratio 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
ID 
Identification 
IRB 
Institutional Review Board 

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ITT 
Intention-To-Treat 
MICE 
Multiple Imputation using Chained Equations 
N 
Number (typically refers to subjects) 
NIDCR 
National Institute of Dental and Craniofacial Research, NIH 
NIH 
National Institutes of Health 
OCTOM 
Office of Clinical Trials Operations and Management, NIDCR, NIH 
OHDC 
Oral Health Disparities in Children 
OHI-S 
Debris Index of the Simplified Oral Hygiene Index 
OHI-MIS 
Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PII 
Personal Identifying Information 
QALYs 
Quality Adjusted Life Years 
RCT 
Randomized Controlled Trial 
ROI 
Return on Investment 
SAE 
Serious Adverse Event/Serious Adverse Experience 
TB 
Toothbrush 
TP 
Toothpaste 
UP 
Unanticipated Problem 
US 
United States 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
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PROTOCOL SUMMARY 
 
Title: 
Influence of Financial Incentives on Oral Disease Management 
in Young Children (BEhavioral EConomics for Oral health 
iNnovation = BEECON) 
Précis: 
Rewards have facilitated positive changes in health-promoting 
behaviors (e.g. smoking cessation, weight loss, and blood 
glucose and hypertension management). Behavioral economic 
interventions, especially with small incentives, can lead to 
healthy behaviors even after incentives end. The project’s 
overall goal is to assess the efficacy of rewards towards 
promoting early childhood caries (ECC) preventive health 
behaviors (toothbrushing performance) for young children of 
predominantly Latino parents/caregivers in Early Head Start 
(EHS) and day care center programs. In this trial, eligible 
consenting parent-child participant dyads, within strata and 
permuted blocks, will be randomized in equal allocation to one 
of two groups: 1) Monetary Reward or 2) Delayed Monetary 
Reward Control. Strata will be based on site and smartphone 
operating system (iOS or Android). Participants in the 
Monetary Reward group will be eligible to enter into a weekly 
drawing to receive incentives (rewards) during the first 6 
months of the trial. Children will be followed for 12 months to 
determine reward effects on toothbrushing, fluoride toothpaste 
(TP) use, plaque score, and caries screening status. Results 
will inform researchers and public health practitioners on the 
longer-term maintenance of behavioral changes and oral 
health screening status following removal of the rewards. 
Objectives: 
1. The primary objective of this randomized controlled trial 
(RCT) is to compare the impact of Monetary Rewards (weekly 
drawings for those with qualifying toothbrushing sessions) 
versus Delayed Reward Control through 6 months on ECC 
preventive behaviors. The primary outcome measure is 
toothbrushing performance, measured as follows: mean of the 
number of qualifying half-day toothbrushing episodes per 
week, through the Month 6 visit. (A Bluetooth-recorded 
toothbrushing episode qualifies if it lasts at least one minute 
within one of 14 half-day windows in the week.) . 2. Secondary 
objectives are: to assess the impact of the Monetary Rewards 
Intervention versus Delayed Reward Control on toothbrushing 
performance through 12 months to assess sustainability of the 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
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behavior after the drawing incentives cease, through 1 month 
to assess short-term (immediate) impact on the behavior after 
the drawing incentives and powered toothbrush use begin (i.e. 
may include novelty effect of power toothbrushes in all 
participants), and through 3 months to assess mid-term impact 
on the behavior after the drawing incentives and powered 
toothbrush use begin (i.e. after potential novelty effect of power 
toothbrushes ends in all participants); to estimate the short- 
and long-term cost effectiveness and return on investment of 
rewards in improving parent/caregiver behaviors and children’s 
oral health; and to assess potential mediation effects of beliefs 
(behavioral, normative, and control) on intermediate outcomes 
(intentions, salience, and habit) and primary outcome 
(toothbrushing performance). The secondary outcome 
measures are toothbrushing performance, measured as 
follows: mean number of qualifying half-day toothbrushing 
episodes per week, through the Month 12, Month 1, and Month 
3 visits and net costs to calculate incremental cost 
effectiveness ratio. 
Population: 
The study population will be primarily Hispanic/Latino parent- 
child (ages 6 months to <48 months) dyads and other high-risk 
racial/ethnic groups from underserved communities in Los 
Angeles County (N=488 participants, 244 dyads). 
Phase: 
II 
Number of Sites: 
Up to 6 Los Angeles County Early Head Start (EHS) and 
affiliated day care / preschool centers; the study visits will 
occur at Los Angeles Venice Family Clinic locations at 
Simms/Mann, Lou Colen, and Robert Levine centers. 
Description of 
Intervention: 
The Monetary Reward intervention is a drawing reward, in 
which participants are eligible for weekly rewards based on 
toothbrushing performance. 
Study Duration: 
(a) 25 months from opening enrollment to completing data 
collection and (b) 32 months from opening enrollment to final 
data analyses. 
Subject 
Participation 
Duration: 
Each parent/caregiver-child dyad will complete the trial visits in 
approximately 12 months. The Delayed Reward Control group 
participants will have the option to continue for another 6 

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months (i.e., 18 total months) to earn the same monetary 
rewards as the intervention group. 
Estimated Time to 
Complete 
Enrollment: 
Approximately 14 months. 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
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Delayed Reward Control Group only 
Follow-up assessments of outcome measures and safety. Questionnaires, dental screening, 
extraoral photo, TB prophy, standardized anticip guidance. Weigh TP, dispense new TP, and 
new brush head & earned incentives. 
Delayed Reward Control Group only (2 earning windows) 
Questionnaire, dispense new brush head & earned incentives. 
 
Schematic of Study Design: 
Screening 
Day -10 (+10/-2)* 
 
Run-in 
Baseline/Randomization 
Day 0 
 
 
 
 
 
 
Questionnaires & Randomize to Group 
 
Reward 
122 dyads 
Delayed Reward Control 
122 dyads 
 
 
Ongoing 
between visits 
 
Month 3+/-1 
 
 
 
Month 6+/-1 
Month 9+/-1 
Month 12+/-1 
 
 
 
 
 
 
 
 
 
Month 15+/-1 
 
 
 
Month 18+/-1 
 
 
* business days 
12 Month Assessments 
Compare TB app, plaque index, & 
TP weight change data. Questionnaire, dental 
screening, TB prophy, extraoral photo, dispense 
new brush head and TP, standardized anticip 
guidance & earned incentives (Interven Arm). FV 
application (Control Arm). FGDs. 
 
Randomize to earning window 
Questionnaire, and dispense new brush head. 
Follow-up assessments of outcome measures and safety. 
Questionnaire, dental screening, extraoral photo, TB prophy, FV application, standardized 
anticip guidance. FGDs and stakeholder interviews. Weigh TP, dispense new TP, and new 
brush head & earned incentives (Interven Arm). 
Questionnaire, dispense new brush head, & earned incentives (Interven Arm). 
Brushing behavior data collected: smartphone application sync. SMS reminders & reports of 
toothbrushing frequency (both arms) & incentives earned (when applicable). 
Total N=244 dyads: Informed consent. Eligibility screening. Brief questionnaire. Baseline 
assessments: dental screening, extraoral photo, toothbrush (TB) / toothpaste (TP) demo, 
fluoride varnish (FV) application, standardized anticipatory guidance. 

Influence of Financial Incentives on Oral Disease Management in Young Children 
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1 KEY ROLES AND CONTACT INFORMATION 
 
Principal 
Investigators: 
Stuart A. Gansky, DrPH 
University of California, San Francisco 
Box #1361 
San Francisco, CA 94143 
tel: 1-415-502-8094 
fax: 1-415-502-8447 
stuart.gansky@ucsf.edu 
Francisco Ramos-Gomez, DDS, MS, MPH 
University of California, Los Angeles 
10833 Le Conte Ave. 
Box 951668 
Los Angeles, CA 90095-1668 
tel: 1-310-825-9460 
fax: 1-310-206-7597 
frg@dentistry.ucla.edu 
NIDCR Project 
Scientist: 
Darien Weatherspoon, DDS, MPH 
National Institute of Dental and Craniofacial Research (NIDCR) 
6701 Democracy Blvd, MSC 4878 
Bethesda, MD 20892-4878 
tel: 1-301-594-5394 
darien.weatherspoon@nih.gov 
Medical Monitor: 
Kevin McBryde, MD 
National Institute of Dental and Craniofacial Research (NIDCR) 
6701 Democracy Blvd. Room 638 
Bethesda, MD 20892 
tel: 1-301-594-0170 
fax: 1-301-480-8319 
mcbrydekd@nidcr.nih.gov 
Institutions: 
Venice Family Clinic Children First Early Head Start (10 sites) 
2509 Pico Blvd 
Santa Monica, CA 90405-1828 
Volunteers of America LA Head Start & Early Head Start 
3600 Wilshire Blvd, Suite 1500 
Los Angeles, CA 90010 
Westside Children’s Center – Early Head Start & Day Care 
12120 Wagner St 
Culver City, CA 90230 

Influence of Financial Incentives on Oral Disease Management in Young Children 
(BEhavioral EConomics for Oral health iNnovation - BEECON) 
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Other Key 
Personnel: 
James G. Kahn, MD, MPH 
University of California, San Francisco 
Box #0936 
San Francisco, CA 94143 
tel: 1-415-476-6642 
fax: 1-415-476-0705 
JGKahn@ucsf.edu 
Jenny X. Liu, PhD 
University of California, San Francisco 
Box #0646 
San Francisco, CA 94143 
tel: 1-415-502-5200 
fax: 1-415-502-5208 
Jenny.Liu2@ucsf.edu 
Justin S. White, PhD 
University of California, San Francisco 
Box #0936 
San Francisco, CA 94143 
tel: 1-415-476-8045 
fax: 1-415-476-0705 
Justin.White@ucsf.edu 
Bonnie Jue, DDS 
University of California, San Francisco 
Box #1361 
San Francisco, CA 94143 
tel: 1-415-305-9701 
fax: 1-415-502-8447 
bonnie.jue@ucsf.edu 
Tracy L. Finlayson, PhD 
School of Public Health 
San Diego State University 
5500 Campanile Drive 
San Diego CA 92182-4162 
Tel: 1-619-594-0559 
Fax: 1-619-594-6112 
tfinlays@sdsu.edu 

Influence of Financial Incentives on Oral Disease Management in Young Children 
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Tracy K. Lin, PhD 
University of California, San Francisco 
Box #0646 
San Francisco, CA 94143 
tel: 1-425-753-1879 
tracy.lin@ucsf.edu 
 
Nancy Fan Cheng, MS .University of California, San Francisco 
Box #1361 
San Francisco, CA 94143 
 
 
2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
2.1 
Background Information 
Early childhood caries (ECC) remains the most prevalent chronic childhood disease in 
the United States (Vargas et al., 1998; Poland & Hale, 2003; CDC, 2001) and poses a 
serious threat to child welfare, particularly among economically disadvantaged, 
underserved, and migrant children (Ramos-Gomez et al., 2007; DHF, 2006). National 
ECC prevalence (any decayed, extracted, or filled primary teeth (deft)) among 2–5 year 
olds was 23% in 2011-2012 (Dye et al., 2015). Mexican-Americans had double the ECC 
severity of non-Hispanic Whites (Wiener et al., 2015). 
Since dental disease risk increases as a child’s teeth erupt (ADA, 2014), brushing with 
fluoridated toothpaste (TP) (smear for children under 3 years old, pea-sized for those 3- 
6 years old) for 2 minutes twice daily (Creeth et al., 2009) can help prevent ECC. For 1- 
to 2-year old children, professional application of fluoride varnish (FV) over 2 years is 
efficacious (Weintraub et al., 2006; Gansky et al., 2007) and the standard of care for 
prevention. Powered toothbrushes can provide better plaque removal than manual 
toothbrushes (Yacoob et al. 2014), but may also have a short-term novelty effect. 
Research participants using powered toothbrushes may also experience a Hawthorne 
effect from knowing they are in a research study. Both the novelty and Hawthorne 
effects have been reported to abate after 12 weeks among college students in a 
randomized controlled trial (RCT) evaluating plaque levels (McCracken et al. 2000). 
Types of Rewards. Incentives are a common component of health promotion 
programs. Recognizing the important role that incentives can play, NIH has placed the 
evaluation of incentives on health-related behaviors among its highest priority areas for 
health economics research (NIH, NOT-OD-16-025, 2015). 
Lottery prizes (a type of monetary incentive) have been more successful than non- 
monetary incentives for encouraging more physical activity (Wing et al., 1996), smoking 

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cessation, and blood donation (Dey et al., 1999; Goette & Stutzer, 2008), but not for 
encouraging prenatal visit attendance (Laken & Ager, 1995). Non-monetary incentives 
(e.g., social recognition, gifts) have effectively boosted immunization (Banerjee et al., 
2010; Birkhead et al., 1995; Nexoe et al., 1997; Satterthwaite, 1997) and follow-up 
cancer screening visits (Marcus et al., 1992; Mayer & Kellogg, 1989), and non-monetary 
incentives may work as well as material gifts especially if aimed at reducing barriers 
(e.g., transportation) (Melnikow et al., 1997; Smith et al., 1990). 
Large incentives may displace intrinsic motivation for behavior change with the 
expectation of extrinsic rewards to achieve the same health goals, and consequently 
remove motivation to adhere to new behaviors once rewards are withdrawn (Gneezy & 
Rustichini, 2000). Similarly, incentives may alter expectations of interpersonal trust (e.g., 
between patients and doctors) if exchanges with incentives are viewed as monetary 
transactions (Heyman & Ariely, 2003). 
Incentive form and size to motivate sustained behavior change must reflect contextual 
factors, including interpersonal relations and reciprocity. Populations place different 
value on the reward associated with different incentive types (i.e., if the reward is 
viewed simply as a commercial transaction versus as an added symbolic value of 
interpersonal trust (vis-à-vis social exchange theory) (Gneezy & Rustichini, 2000; 
Homans, 1974; Burns, 1973). 
Lastly, incentive payout form and size affect program sustainability. While cash transfer 
programs conditional on children’s school and health visit attendance (conditional cash 
transfers) successfully alleviate poverty and promote social goals, health and nutrition, 
they have high administrative costs (Handa & Davis, 2006). Moreover, policy makers 
may prefer in-kind to cash transfers (Das et al., 2005). For the same cost, differently 
structured incentives may have substantially different effects (Volpp et al., 2009; Haisley 
et al., 2012). Although some studies have included a cost-effectiveness calculation to 
evaluate an incentive’s added value to preventive health behaviors (Kane et al., 2004), 
none have done so for oral health. 
The project’s overall goal is to assess the efficacy of rewards towards promoting ECC 
preventive health behaviors (toothbrushing adherence) for young children of 
predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center 
programs. 
2.2 
Rationale 
Numerous factors may contribute to parents/caregivers’ inability to provide ADA- or 
AAP-recommended oral health prevention for their children (i.e., consume fluoridated 
water, brush with a smear/pea-sized amount of fluoridated TP for 2 minutes twice daily, 
and attend regular oral health appointments by age one or within six months of first 
tooth eruption). Minimal oral health knowledge and/or literacy, financial obstacles, and 

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competing influences, such as daily stress, work, housing priorities, childcare needs, 
transportation, or geographic location, are a few considerations that may result in failure 
to follow these oral health recommendations. Further, cultural influences may lead to 
distrust of fluoride, or believing preventive oral care is unnecessary (Butani et al., 2008). 
Prospect Theory and Present Bias 
The intervention – weekly drawings based on qualifying toothbrushing sessions – draws 
on insights from several theories from the field of behavioral economics. The design of 
the drawing is based on aspects of prospect theory (Kahneman & Tversky, 1979). 
Participants who fail to meet the weekly threshold for earning rewards are informed if 
they would have won the drawing in order to leverage loss aversion and regret aversion, 
a sense that a person does not want to give up something that is hers. The drawing also 
leverages nonlinear probability weighting from prospect theory, in which people have a 
tendency to overweight small probabilities. The reward design also incorporates the 
theoretical construct, present-biased preferences (also known as present bias or 
hyperbolic discounting) (Ainslie, 1992; Laibson, 1997). This is the tendency to 
overweight immediate costs and benefits relative to those in the future. The weekly 
rewards are a way to provide relatively immediate and frequent feedback, both of which 
can help counter present bias. Rewards may have additional theoretical benefits: 
increasing salience of the targeted behavior, offsetting a person’s limited attention, and 
promoting habit formation. The following figure shows where in the decision pathway 
the intervention is hypothesized to affect the preventive behavior, as well as some of the 
covariates affecting behavior. 
 

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Rewards have facilitated positive changes in health-promoting behaviors, such as 
quitting smoking (Marteau et al., 2009; Rogers et al., 2014), weight loss (John et al., 
2011), and managing blood glucose and blood pressure (Sen et al., 2014). Conditional 
rewards are particularly effective in encouraging behavioral changes; in some cases 
small incentives can be equally effective or more effective than larger ones (Marteau et 
al., 2009; Sen et al., 2014). These “behavioral economic” interventions can lead to 
healthy behaviors even after incentives end, particularly with smaller incentives (Sen et 
al., 2014). To date, no study has evaluated such a program for oral health. 
2.3 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
This study poses minimal risk to participants. Study participation is completely 
voluntary, and participants may discontinue participation at any time without 
prejudice. Regarding study questionnaires, parent participants may experience 
psychological discomfort in discussing personal health information or negative 
experiences at a dental or other relevant office (such as enrolling a child in Medicaid). 
As with any study, there is the potential for loss of confidentiality. Appropriate 
precautions will be taken to mitigate this risk. Parents/guardians will be reminded not to 
change the app profile study ID number to any personal identifying information; if they 
do it will be transmitted to Philips Sonicare. These include the use of unique study 
codes for participants and password-protected computers for data storage. Compliance 
with all Institutional Review Board (IRB) regulations concerning data collection, data 
storage, and data destruction will be strictly observed. Data will be accessible to 
research personnel only and will be stored and coded according to guidelines set forth 
by the UCSF IRB. 
The child participant could have potential mechanical trauma to the teeth or gingiva 
from the powered toothbrush. Parents will be carefully instructed on proper brushing 
techniques to reduce possible oral discomfort. 
Additionally, there is a rare chance of tooth brush head disintegration (bristles falling 
out), which is a potential choking hazard. The powered toothbrush should always be 
used with adult supervision, and children should be discouraged from chewing on the 
brush head. 
Even though it is extremely unlikely that a child will get access to and eat the TP, using 
TP pumps will further reduce the chance of toxicity since the pumps require dexterity 
that children in the study age range likely lack, and the pumps limit the amount of TP 
dispensed at any one time. Parents will be advised to keep the TP on a counter and out 
of the reach of all children in the household. 

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There is a possibility that a participant may experience an allergic reaction to the TP, 
FV, and/or plaque disclosing solution; however, the likelihood from TP and FV is 
extremely rare, while the likelihood from disclosing solution is also rare according to the 
package insert. Parents/caregivers will be instructed to contact the study’s Project 
Manager in the unlikely event that an allergic reaction to a study product is suspected. 
Any adverse reactions will be reported as outlined in Section 9. 
All parent/caregiver participants will be asked if they are willing to be contacted again for 
research purposes. For those who agree, personal identifying information (PII), 
including contact information, will be requested for subsequent contact and interviewing, 
creating the risk of a loss of confidentiality of contact information. All participants will be 
informed of this risk and of steps taken to reduce this possibility. 
2.3.2 
Potential Benefits 
Each child participating in this trial, regardless of study group, will have a dental 
screening and FV applied to his/her teeth as the current standard of care, unless the 
parent reports that it has been applied within the past month. Each child participant will 
also receive oral hygiene aids, such as a powered smart toothbrush (TB), brush heads, 
and fluoride TP pumps. As needed, children with early care or urgent care needs 
(treatment class 2 or 3 as documented in the ASTDD BSS form) will be provided with 
referrals for dental visits to providers who agree to take their insurance. In addition, 
parents/caregivers will be provided Anticipatory Guidance in a standardized video 
format in English or Spanish; families participating in this study may benefit from the 
Anticipatory Guidance information. 
Overall, participants in the study may benefit from an increased awareness of oral 
health prevention behaviors. 
 
3 OBJECTIVES 
 
3.1 
Study Objectives 
 
3.1.1 
Primary 
The primary objective of this RCT is to compare the impact of Monetary Rewards 
(weekly drawings for those with qualifying toothbrushing sessions) versus 
Delayed Reward Control through 6 months in predominantly Latino 
parents/caregivers to increase ECC preventive behaviors of their children 
enrolled in or waitlisted for a participating Los Angeles County EHS or affiliated 
day care center program. 

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3.1.2 
Secondary 
The secondary objectives are as follows: 
• To assess the impact of the Monetary Rewards Intervention versus Delayed 
Reward Control on toothbrushing performance: 
o Through 12 months to assess sustainability of the behavior after the 
drawing incentives cease. 
o Through 1 month to assess short-term (immediate) impact on the 
behavior after the drawing incentives and powered toothbrush use 
begin (i.e. may include novelty effect of power toothbrushes in all 
participants). 
o Through 3 months to assess mid-term impact on the behavior after the 
drawing incentives and powered toothbrush use begin (i.e. after 
potential novelty effect of power toothbrushes ends in all participants). 
• To estimate the short- and long-term cost effectiveness and return on 
investment of rewards in improving parent/caregiver behaviors and children’s 
oral health. 
• To assess potential mediation effects of beliefs (behavioral, normative, and 
control) on intermediate outcomes (intentions, salience, and habit) and 
primary outcome (toothbrushing performance). 
3.2 
Study Outcome Measures 
 
3.2.1 
Primary 
The primary outcome is toothbrushing performance through the Month 6 visit, measured 
with a Bluetooth-enabled toothbrush, and expressed as a mean of the number of 
qualifying half-day toothbrushing episodes per week. A toothbrushing session recorded 
with the app qualifies to contribute to the weekly count if it lasts at least one minute and 
occurs within one of the 14 possible half-day windows during a week; only one session 
per half-day window contributes to the weekly count, which can range from 0 to 14. 
A participant qualifies for weekly drawing eligibility as follows: 
• Low threshold - if the child’s teeth were brushed at least once per day for at least 
one minute each day of the week; 
• High threshold - if the child’s teeth were brushed at least once per half-day for at 
least one minute each day of the week. 

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3.2.2 
Secondary 
Intermediate toothbrushing performance measures are as follows: 
• Mean of the number of qualifying half-day toothbrushing episodes per week, 
through 1 month for short-term effects 
• Mean of the number of qualifying half-day toothbrushing episodes per week, 
through the Month 3 visit for mid-term effects after any novelty effect would be 
expected to end, 
• Mean of the number of qualifying half-day toothbrushing episodes per week, from 
Month 6 visit to Month 12 visit for longer-term effects 
For the outcomes listed above, the minimum qualifying length of time is 1 minute. 
Additional secondary oral health measures will be ascertained: 
• Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) 
to measure plaque on primary maxillary incisor facial (labial) tooth surfaces at 
Month 6 and Month 12 visits (mean of 4 ordinal scores) 
• TP pump weight change (grams) at Month 6 and Month 12 visits 
• Binary measure of Association of State and Territorial Dental Directors Basic 
Screening Survey (ASTDD BSS) untreated caries status (dt>0) at Month 6 and 
Month 12 visits 
• Binary measure of ASTDD BSS caries experience status (dmft>0) at Month 6 
and Month 12 visits; m is missing due to caries only 
• Binary measure of ASTDD BSS severe caries (dmft 4+) status at Month 6 and 
Month 12 visits; m is missing due to caries only 
• Binary measure of a dental visit in the past 12 months, obtained through EHS 
ChildPlus database which records annual dental visit and other required health 
screenings 
To assess potential mediation effects of beliefs (behavioral, normative, and control) on 
intermediate outcomes (intentions, salience, and habit) and primary outcome 
(toothbrushing performance), the aforementioned primary and secondary outcome 
measures will be assessed. Behavioral, normative, and control beliefs will be collected 
via the BRFQ at each study visit (see Section 8.3). Intentions, salience, and habit will be 
collected with components of the BRFQ (e.g. intentions to brush child’s teeth in the next 
6 months, preventive habits for one’s self and for one’s child, age started brushing study 
child’s teeth.). 
To estimate the short- and long-term cost effectiveness and return on investment of 
rewards in improving parent/caregiver behaviors and children’s oral health, net costs will 
be ascertained (as detailed in Section 12.4). 
During the qualitative process evaluations at the Month 6 and Month 12 visits, the 
following will be ascertained: oral health behaviors and health habits, dental care 

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motivation behavior, toothbrushing and reactions to the powered toothbrush, toothpaste 
pump use, toothbrush syncing, Sonicare app use, text message reminders, opportunity 
costs, incentives, overall satisfaction, and perspectives on behavior data tracking for 
personal use and outside monitoring purposes. 
 
4 STUDY DESIGN 
 
We will conduct a stratified RCT testing the impact of monetary rewards on ECC 
preventive behaviors and oral health. Eligible child-parent/caregiver participant dyads 
will be consented, enrolled, and, following a 2 week run-in, randomized within strata and 
permuted blocks in equal allocation to one of two groups: 1) Monetary Rewards or 2) 
Delayed Reward Control. Strata will be based on site and smartphone operating 
system. The intervention will be offered for 6 months, and children (ages 6 months 
through <48 months) will be followed for 12 months to determine reward effects on 
dental visit attendance, toothbrushing, fluoride TP use, OHI-MIS plaque score , and 
caries screening status. Results will inform researchers and public health practitioners 
on the longer-term maintenance of behavioral changes and oral health screening status 
following removal of the rewards. 
The study population will be predominantly low income Hispanics/Latinos who are 
parents/caregivers with children enrolled in, or waitlisted for, one of the participating Los 
Angeles County EHS or affiliated day care center programs. After enrollment 
parents/caregivers will use powered toothbrushes for a 2 week run-in to ensure their 
technology works and they are willing to follow study procedures; after the enrollment 
visit and run-in, randomization will occur at a separate visit. Participants who are unable 
to provide data during the run-in period will not be randomized or continue in the study. 
Participants in the Monetary Reward group will be eligible to earn one of two incentive 
amounts every week for the first 6 months of the trial. A participant who meets a low or 
high threshold will earn entry in that week’s drawing for financial incentives (See Section 
6.1 for additional details). 
In the Delayed Monetary Reward Control group, participants will receive feedback on 
their toothbrushing performance during the first 12 months of the trial. After the Month 
12 follow-up visit, the Control group participants will have the option to participate in a 
delayed 6-month extension by being randomized to one of two groups to earn the same 
expected monetary rewards the intervention group was eligible to earn through Month 6; 
both Control groups will have weekly drawings (as in the intervention group though 6 
months), but one Control group will be randomized into drawing results shared weekly 
(as in the intervention group through 6 months), while the other randomized Control 
group will have the 13 weekly drawing results only shared quarterly, with equal reward 
amounts and the same probabilities for high and low thresholds. 

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Toothbrushing performance will be ascertained via Philips Sonicare for Kids (S4K) 
powered toothbrushes and brush heads, which will be synced with a custom BEECON 
study version of their existing S4K smartphone application. Data to be transmitted 
includes toothbrushing start time, toothbrushing duration, application start time, and 
whether toothbrushing was conducted with the application open or without the 
application (offline). 
SMS text message notifications will be sent via Twilio and REDCap to remind 
participants to sync the powered toothbrush to the smartphone app. Further, all study 
participants will be sent weekly SMS text messages with feedback on toothbrushing 
progress, and, if in the intervention group, the incentives earned. 
Additionally, participants will undergo study visits every 3 months. At screening and 
Month 6, 12, and 18visits the participating child will receive an ASTDD BSS dental 
screening after parents/caregivers provide a brief child medical history, and a OHI-MIS 
plaque score will be determined. Participants in each group will be provided a new TP 
pump at the Month 6 and Month 12 visits and 1 new brush head at each study visit 
(every 3 months). Questionnaires will be configured in REDCap. 
 
Four focus group discussions (FGDs) of trial participants will be conducted after the 
Month 6 visit, and two FGDs of intervention arm participants will be conducted after the 
Month 12 visit. Participants will be chosen based on study performance (e.g., above and 
below high and low thresholds of toothbrushing adherence). 
 
Stakeholder interviews (6-12) with EHS and affiliated day care center staff will be 
conducted after the Month 6 visit. 
 
5 STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Subject Inclusion Criteria 
Child 
To be eligible to participate in this study, a child must meet all of the following criteria, to 
be verified during a screening visit: 
• at least 6 months old but less than 4 years (48 months). 
• at least 2 fully erupted teeth. 
• enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or 
affiliated day care center or area clinic programs. 
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To be eligible to participate in this study, a parent/caregiver must meet all of the 
following criteria, to be verified during a screening visit: 
• Provide signed and dated informed consent form in English or Spanish. 
• Agree to comply with all study procedures and be available for the duration of the 
study. 
• Aged 18 and older. 
• Speak either English or Spanish and self-reported ability to read and write either 
English or Spanish. 
• Be a parent or caregiver of a child at least 6 months old but less than 4 years (48 
months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of 
the participating Los Angeles County EHS or affiliated day care center or area 
clinic programs. 
• Not be planning to move residence for the next 18 months outside the greater 
Los Angeles area. 
• Own a smartphone with the Google Play or iTunes store and be willing to 
download and install the smart powered TB app at the Screening visit and keep it 
installed for the duration of the project. [If the app cannot be properly installed by 
the baseline visit, the participant will not be randomized.] 
• Be willing to be contacted via text-messaging (SMS) for study related 
notifications, such as incentives earned or reminders to sync the TB. 
Stakeholder 
To be eligible to participate in the stakeholder interviews, a staff member must meet all 
of the following criteria: 
• Be a staff member at a participating study site (e.g. EHS or affiliated day care 
center). 
• Verbally agree to participate after being provided a study information sheet. 
5.2 
Subject Exclusion Criteria 
Child 
A child who meets any of the following criteria will be excluded from participation in this 
study: 
• Known allergic reaction to components of the study product(s). 

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• Uncooperative or behaviorally unsuited (assessed during a TB prophylaxis, 
ASTDD BSS caries screening, and photograph of maxillary incisors at the 
screening visit). 
• More than 2 crowns on maxillary incisor teeth (#D, E, F, G, or equivalently #52, 
51, 61, 62). 
• Participated in the pilot trial. 
• A sibling of a child enrolled in the study (the family’s oldest child in the eligible 
age range will be the study child). 
• Enrolled in foster care. 
• Anything else that would place him/her at increased health risk or preclude the 
individual’s full compliance with or completion of the study. 
Parent/caregiver 
A parent/caregiver who meets any of the following will be excluded from participation in 
the study: 
• Participated in the pilot trial. 
• Unable or unwilling to install and use the smart powered TB app during the run-in 
period. 
5.3 
Strategies for Recruitment and Retention 
 
Recruitment Plans: Participants will be recruited from Los Angeles County EHS or 
affiliated day care centers; the study visits will occur at Los Angeles Venice Family 
Clinic locations at Simms/Mann, Lou Colen, and Robert Levine centers. The EHS and 
affiliated day care centers had a 2016-2017 enrollment of 661 center-based and 616 
home-based children for 1277 total children; thus, fewer than one in five child-parent 
dyads would need to be enrolled for the RCT. Venice Family Clinic has more than 10 
Early Head Start sites and Volunteers of America – Los Angeles has more than 35 
sites. Should the study team determine that recruitment/enrollment is lagging, 
pediatrician (non-dental) clinics affiliated with or adjacent to EHS and day care centers 
in Los Angeles may be recruited as additional recruitment sites for this trial (with this 
group comprising one stratum). 
 
Using a standardized recruitment script similar to those used in the recently completed 
glass ionomer sealant and fluoride varnish trial (GIFVT) and BEECON pilot trial, 
research study personnel will contact EHS and day care center families to determine 
interest in study participation. Outreach may occur at the EHS center, during EHS 

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monthly parent meetings, at day care center meetings, health fairs, or via telephone 
calls to interested parents/caregivers who contact study staff. Recruitment is estimated 
to continue for 14 months with a goal of enrolling approximately 17 children per month 
(approximately 21 business days per month) to achieve the target sample size. Pilot 
trial enrollment was completed in less time than originally planned: 36 participants in 29 
business days. 
 
Mailings and flyers with study recruitment information may also be sent out or posted in 
the EHS and day care facilities. The monthly EHS newsletter may also include an 
invitation to participate in this trial. 
 
Retention Plan: This trial will utilize a 2-week run-in phase to decrease initial post- 
randomization drop-out and increase retention. Because study participant retention is 
essential, research staff may attempt to contact participating parents/caregivers via 
postcard mailings, SMS text messages, and phone calls between the visits throughout 
the study to update contact information and remind them about follow-up appointments. 
Additionally, parents/ caregivers will receive text message reminders to sync the 
powered TB to their smartphone app. Finally, all study participants will be sent weekly 
SMS text messages with toothbrushing performance status per smart TB data, and the 
incentive earned if assigned to the incentive group. Remuneration for syncing and/or 
rewards will be provided at follow-up visits, and participants will be remunerated for 
attending each follow-up visit, encouraging regular attendance. This trial expects to 
have 85% retention over 1 year, based on the team’s recently completed GIFVT, which 
had 85% retention over 2 years. 
5.4 
Treatment Assignment Procedures 
A randomization schedule will be generated by the Coordinating Center (CC) and stored 
in REDCap to randomize consenting parent/caregiver-child dyads into one of two 
groups. Once eligibility is confirmed, informed consent is documented, the run-in period 
is completed, and a staff member confirms the app has been properly installed and 
maintained, the project manager will click the “randomize” button in REDCap to reveal 
group assignment for the parent/caregiver-child dyad. 
5.4.1 
Randomization Procedures 
 
A custom SAS program using PROC PLAN stratifying on site (facility type) and phone 
type (iPhone or Android) as well as permuted blocks of varying sizes will be utilized with 
a random seed based on the date the program is first modified from the program used 
in the pilot trial. The randomization schedule will be stored on the secure UCSF CC 
server in a restricted permissions folder, as well as, in REDCap. Only staff needing to 
administer the intervention, or the DSMB if needed for safety reasons, will be unblinded 
before completion of the trial. Randomized arm assignment will not be unblinded to 

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other team members until the trial is completed or has been stopped early by NIDCR or 
the DSMB. 
5.4.2 
Masking Procedures 
 
An independent dental examiner and PIs will be blinded to participants’ group 
assignment, and participants will be told that the examiner and PIs cannot answer any 
incentive questions and they should not mention the incentive program to them. Due to 
the nature of the intervention, the staff explaining the study arms after randomization 
and providing the incentive gift cards at Month 3, 6, 9, 12, 15, and 18 visits cannot be 
blinded. At the Month 6 and 12 visits, dental screenings will precede monetary incentive 
payment. 
5.5 
Subject Withdrawal 
 
Participants may withdraw voluntarily from the study at any time. 
5.5.1 
Reasons for Withdrawal 
 
Participants may decide not to answer any Computer Assisted Personal Interview 
(CAPI) item or not to participate in the study at any time without penalty. 
Participants are free to withdraw from participation in the study at any time upon 
request, for any reason, without penalty or loss of benefits as a member of their EHS or 
affiliated day care program or health clinic. This may occur due to discomfort with 
questions or practical concerns that limit the time available (e.g., pressing employment 
schedule or child care needs). 
An investigator may terminate a study participant’s participation in the study if: 
• Any clinical adverse event (AE) or other medical condition or situation occurs 
such that continued participation in the study would not be in his/her best 
interest. 
• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. 
• Participants who are unable to provide app data during the run-in period will be 
withdrawn prior to randomization. 

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5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
If parent/caregiver informs the study staff that he/she does not wish to continue with the 
study any further, the staff member will document the reason(s) and remove the parent 
and child from the study. The participant will be encouraged to continue with regular oral 
health preventive behaviors and dental examinations at the child’s dental home, which 
could detect early signs of disease. A participant’s withdrawal from this study will not 
influence his/her future relations with any of the study’s collaborating institutions, 
including but not limited to LA County EHS and affiliate day care center sites, UCSF, 
UCLA, or the child's medical or dental care provider. Randomized participants who 
withdraw will not be replaced. All study data provided before withdrawing will be used 
for analysis, unless the participant asks that her/his data and her/his child’s data not be 
used. 
5.6 
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 Drs. Stuart Gansky and 
Francisco Ramos-Gomez (PIs). If the study is prematurely terminated or suspended, 
the PIs 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. 
• Insufficient adherence to protocol requirements. 
• Data that are not sufficiently complete and/or evaluable. 
• Determination of futility. 
 
6 STUDY INTERVENTION 
 
6.1 
Study Behavioral or Social Intervention(s) Description 
 
In the Drawing Monetary Reward group, participants will be eligible to earn one of two 
types of entries with different winning probabilities each week during the 6-month 
incentive intervention period. Caregivers in the drawing payment group will be informed 
that the drawing will occur every week through the first 6 months of the trial. Participants 
will be sent a text message about entering into a drawing every week; the participant 
can click the REDCap survey link in the text to select a 2-digit number or let his or her 
number be chosen at random. The amount of winnings possible depends on the 

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participant’s level of toothbrushing performance. A participant who meets the low 
adherence threshold (brushing his/her child’s teeth once per day for 7 days in a week) 
will be eligible for an 18% chance (matching one digit with the winning number) of 
winning $25 and a 1% chance (matching both digits in order) of winning $50 (an 
expected payout of $5; 81%x$0 + 18%x$25 + 1%x$50=$5). A participant who meets the 
high adherence threshold (brushing his/her child’s teeth twice per day for 14 days in a 
week) will be eligible for a 34% chance (matching either digit without regard to order) of 
winning $25 and a 3% chance (matching both digits without regard to order) of winning 
$50 (an expected payout of $10; 63%x$0 + 34%x$25 + 3%x$50). Participants who fail 
to reach either adherence threshold will receive a text message that states what they 
would have won had they brushed more regularly, thereby taking advantage of a 
psychological tendency toward anticipated regret to motivate future brushing. 
In the Delayed Monetary Reward Control group, participants will not be eligible to 
receive any performance-based rewards during the first 12 months, but will receive 
information on their toothbrushing performance. After the 12-month follow-up visit, the 
Control group participants will have the option to participate in a delayed 6-month open 
label extension to earn the same monetary rewards the intervention group was eligible 
to earn until Month 6. This is not a formal part of this trial, but rather a necessary 
condition of the trial design to assure that all participating parents/caregivers have the 
chance to earn the same monetary incentives. Control participants who choose the 6- 
month extension will follow the same procedures (i.e., texting notifications) as the 
Monetary Reward intervention group from the 12-month follow-up to an 18-month 
follow-up; they will be randomized into one of two groups which will convey weekly 
drawing information to participants either weekly or quarterly. At the 18-month follow-up 
visit, they will be able to collect the earned incentives when the child attends the visit 
and the returned TP pump is weighed. 
After the Month 6 visit through the end of the trial (Month 12), participants will continue 
to sync their powered toothbrushes and will receive incentives for syncing, but will not 
be eligible to receive rewards for toothbrushing performance, to assess behavior 
maintenance after the rewards have ended. 
6.2 
Administration of Intervention 
 
All participants will be instructed to sync their smart powered toothbrushing data to the 
app three times per week. Failure to sync three times per week will disqualify the 
participant from receiving any incentives that week for those in an incentive group. All 
participants, regardless of group assignment, will receive a fixed payment of $1 per 
sync for syncing their data up to three times per week (Wednesdays, Fridays, and 
Sundays, specifically). A text message reminder to sync the app will be sent to 
participants before each of these three times every week. 

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First, all participants will enter two initial “practice” (run-in) weeks at the start of the 
intervention, during which participants will sync their toothbrushing data (and be eligible 
for up to $3 of incentives for syncing), but will not be eligible for the performance-based 
toothbrushing reward. Following the two practice weeks, intervention group participants 
are eligible to earn rewards over the first 24 weeks (6 months), while Delayed Monetary 
Reward Control group participants may earn rewards between the 12-month visit and 
18-month visit. 
All participants will be sent text messages of their toothbrushing performance status 
each week, per the powered toothbrushing data. For participants assigned to the 
intervention group, the text message will include the amount earned and the total gift 
card balance accrued to date for the previous 3-month period. Additionally, participants 
will have the option to have text messages sent to other family members who regularly 
brush the child’s teeth and who consent by text message to receiving messages. 
Contact information for all family members will be obtained at the baseline visit. 
Thus, the total expected payout value of attaining the high toothbrushing adherence 
threshold throughout the 6-month intervention period is $240. 
To claim any incentives, including for syncing data, a parent/caregiver and child must 
attend the follow-up visits. Based on developmental stage telephone survey 
preferences, all earned reward payments will be awarded as gift cards at the Month 3 
and Month 6 visits for the Monetary Reward group, and Month 15 and Month 18 visits 
for the Delayed Monetary Reward Control group. Syncing payments will be awarded as 
gift cards at all follow-up appointments. 
6.3 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity 
The Project Manager will train all research staff members on how to explain intervention 
procedures and incentive program details to participants in English or Spanish utilizing a 
communication script. The Project Manager or another supervisor will assess fidelity 
from 100% of audio recordings during the training period and then from a randomly 
selected 10% of recordings every week thereafter during participant accrual. A study- 
specific checklist of intervention procedures and incentive program details will be used 
to evaluate fidelity from the recordings. Checklists with less than 90% fidelity during the 
training period or during baseline visits will be declared inadequate and require staff re- 
training by the Project Manager. A study co-investigator will train the Project Manager to 
code fidelity data from the recordings. 
6.4 
Assessment of Subject Compliance with Study Intervention 
 
Study team staff will document that the information was presented and that the 
parent/caregiver explained the procedures back in his/her own words. Throughout the 

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study intervention, a random selection of 5% of SMS text messages to 
parents/caregivers will ask for a reply to verify receipt. 
 
7 STUDY SCHEDULE 
 
7.1 
Screening 
 
Each child will be scheduled for a screening visit with his/her parent/caregiver. 
7.1.1 
Screening Visit (Visit 1, T = business day -10) 
 
• Explain purpose and procedures of study to prospective parent/caregiver 
participant. Verify inclusion/exclusion criteria. 
• Obtain and document consent from subject on study consent form electronically 
with DocuSign. 
• Study staff download app on parent’s/caregiver’s smartphone and sync the TB to 
his/her smartphone. Walk parent through the app. Explain how to sync. 
• Administer CAPI questionnaire to parent/caregiver. 
• Record medical history and perform ASTDD BSS dental screening on child 
participant’s teeth (by blinded dental provider); record decay and assess 
treatment urgency. Children with urgent treatment needs will be referred with a 
warm handoff to staff at the corresponding dental clinic. 
• Apply plaque disclosing agent to child’s teeth (by blinded dental provider). 
• Take extraoral photograph(s) of the facial surfaces of child’s anterior teeth. 
• Give the family the Oral Hygiene Kit, which includes the smart powered 
toothbrush and fluoride TP pump. Attach label with child’s name. 
• Instruct the parent/caregiver on how to use the TP pump to show the proper 
amount of TP, and how to brush the child’s teeth. Have the parent brush off the 
child’s plaque disclosing solution. 
• Apply FV to the child’s teeth (by dental provider). 
• Have the parent/caregiver watch the standardized Anticipatory Guidance 
presentation on a tablet. 

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7.1.2 
Baseline (Post-Run-In/Randomization) Visit (Visit 2, T = 0 [+10/-2]) 
 
• Administer CAPI questionnaire to parent/caregiver. 
• Click the REDCap “randomize” button to reveal participant’s randomized 
assignment to arm. Explain the intervention procedures and rewards program (if 
assigned to the Intervention Arm) to the parent/caregiver and have her/him 
explain it back in her/his own words. Explain control procedures (if assigned to 
the Control Arm) to the parent/caregiver and have her/him explain it back in 
her/his own words. 
• Schedule the family’s next visit (in approximately 3 months) and give the 
parent/caregiver $30 compensation for attending the baseline visit. 
7.2 
Intermediate Visits 
 
7.2.1 
Month 3 Follow-Up Study Visit (Visit 2, T = business day 65 ± 28) 
 
During this Month 3 follow-up visit, the following procedures will be completed by trained 
staff members. 
• Administer CAPI questionnaire to parent/caregiver. 
• Dispense new brush head. 
• Dispense earned rewards to the parent/caregiver (Intervention Arm). 
• Dispense syncing payments to the parent/caregiver (both groups). 
• Schedule the family’s next visit (in approximately 3 months) and give the 
parent/caregiver $30 compensation for attending the 3-month visit. 
7.2.2 
Month 6 Follow-Up Study Visit (Visit 3, T = business day 130 ± 28) 
 
During the Month 6 follow-up visit, the following procedures will be completed by trained 
staff members. 
• Perform follow-up assessments of outcome measures and safety. 
• Administer CAPI questionnaire to parent/caregiver. 
• Record medical history and perform ASTDD BSS dental screening on child 
participant’s teeth (by blinded dental provider); record decay and assess 
treatment urgency. Children with urgent treatment needs will be referred with a 
warm handoff to staff at the corresponding dental clinic. 

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• Apply plaque disclosing agent to child’s teeth (by blinded dental provider). 
• Take extraoral photograph(s) of the facial surfaces of child’s anterior teeth. 
• Brush off plaque disclosing solution. 
• Apply FV to the child’s teeth (by dental provider). 
• Have the parent/caregiver watch the Anticipatory Guidance presentation on a 
tablet. 
• Record weight of TP pump. 
• Dispense new toothbrush head and TP pump. 
• Dispense earned rewards to the parent/caregiver (Intervention Arm). 
• Dispense syncing payments to the parent/caregiver (both groups). 
• Schedule the family’s next visit (in approximately 3 months) and give the 
parent/caregiver $30 compensation for attending the 6-month visit. 
• After this visit, perform FGDs and stakeholder interviews 
7.2.3 
Month 9 Follow-Up Study Visit (Visit 4, T = business day 195 ± 28) 
 
During the Month 9 follow-up visit, the following procedures will be completed by trained 
staff members. 
• Administer CAPI questionnaire to parent/caregiver. 
• Dispense new toothbrush head. 
• Dispense earned rewards to the parent/caregiver (Intervention Arm.) 
• Dispense syncing payments to the parent/caregiver (both groups). 
• Schedule the family’s next visit (in approximately 3 months) and give the 
parent/caregiver $30 compensation for attending the 9-month visit. 
7.2.4 
Month 12 Follow-Up Study Visit (Visit 5, T = business day 260 ± 28) 
 
The Month 12 visit is the final study visit for participants randomized to the incentive 
group. During this visit, a trained staff member will complete the final questionnaire and 
post-test with the parent/caregiver. 

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• Administer CAPI questionnaire to parent/caregiver. 
• Collect the TP pump. Record weight of TP pump. 
• Record medical history and perform ASTDD BSS dental screening on child 
participant’s teeth (by blinded dental provider); record decay and assess 
treatment urgency. Children with urgent treatment needs will be referred with a 
warm handoff to staff at the corresponding dental clinic. 
• Apply plaque disclosing agent to child’s teeth (by blinded dental provider). 
• Take extraoral photograph(s) of the facial surfaces of child’s anterior teeth. 
• Brush off plaque disclosing solution. 
• Apply FV to the child’s teeth (by dental provider) (Continuing delayed control arm 
only). 
• Give the parent/caregiver an electronic tablet to watch the Anticipatory Guidance 
presentation. 
• Give the parent/caregiver the accumulated rewards (Intervention Group). 
• Distribute 1 new toothbrush head and new TP pump. 
• Dispense syncing payments to the parent/caregiver (both groups). 
• Give the parent/caregiver $30 compensation for attending this 12-month visit. 
• After this visit, perform FGDs. 
• Optional for Control Group only: Randomize Control Group participants who want 
to continue into 1 of 2 groups: weekly or quarterly drawing result communication. 
Explain the intervention procedures and Monetary Rewards program to the 
parent/caregiver and have her/him explain it back in her/his own words 
(teachback). Schedule the family’s next visit (in approximately 3 months). 
7.2.5 
Month 15 Follow-Up Study Visit (Optional for Control Group Only, 
Visit 6, T = business day 325 ± 28) 
During this Month 15 follow-up visit, the following procedures will be completed by 
trained staff members. 
• Administer CAPI questionnaire to parent/caregiver. 

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• Dispense new toothbrush head. 
• Dispense earned rewards to the parent/caregiver. 
• Dispense syncing payments to the parent/caregiver. 
• Schedule the family’s next visit (in approximately 3 months) and give the 
parent/caregiver $30 compensation for attending the 15-month visit. 
7.2.6 
Month 18 Follow-up Study Visit (Optional for Control Group Only, 
Visit 7, T = business day 390 ± 28) 
The Month 18 study visit is the final visit for participants randomized to the Delayed 
Reward Control Group. During this visit, a trained staff member will complete the final 
questionnaire and post-test with the parent/caregiver following the established protocol. 
. 
• Administer CAPI questionnaire to parent/caregiver. 
• Collect the TP pump. Record weight of TP pump. 
• Record medical history and perform ASTDD BSS dental screening on child 
participant’s teeth (by blinded dental provider); record decay and assess 
treatment urgency. Children with urgent treatment needs will be referred with a 
warm handoff to staff at the corresponding dental clinic. 
• Apply plaque disclosing agent to child’s teeth (by blinded dental provider). 
• Take extraoral photograph(s) of the facial surfaces of child’s anterior teeth. 
• Brush off plaque disclosing solution. 
• Give the parent/caregiver an electronic tablet to watch the Anticipatory Guidance 
presentation. 
• Give the parent/caregiver the accumulated rewards. Distribute 1 new toothbrush 
head and new TP pump. 
• Dispense syncing payments to the parent/caregiver. 
• Give the parent/caregiver $30 compensation for attending this final visit. 

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7.3 
Withdrawal Visit 
 
No early termination or withdrawal visits are anticipated, but in the event that this 
occurs, such a visit would follow the same guidelines established for a final study visit 
as long as the parent/caregiver is willing. 
7.4 
Unscheduled Visit 
 
Although no unscheduled visits are anticipated, it is possible a participant may have a 
problem with the smartphone app, or Bluetooth toothbrushes and ask for study staff to 
help. Any such additional visits will be logged into REDCap. All adverse events will be 
reported as outlined in Section 9. 
 
8 STUDY PROCEDURES /EVALUATIONS 
 
8.1 
Oral Examination Procedures 
 
The clinical procedures and evaluations for this study will consist of the following: child’s 
medical history will be evaluated via a self-reported standardized questionnaire 
administered to the parent/caregiver at the enrollment/baseline visit. A trained dental 
provider will perform the ASTDD BSS dental screening examination. Then, after 
applying disclosing solution, a study staff member will take photographs of anterior teeth 
with the study iPhone camera to record plaque levels. A central rater will determine a 
plaque score from an image of the facial (labial) surfaces of anterior teeth, following the 
Debris Index of the Simplified Oral Hygiene Index (OHI-S) modified for only the primary 
maxillary incisors (labeled the Debris Index of the Simplified Oral Hygiene Index for 
Maxillary Incisors and denoted as OHI-MIS). The OHI-MIS evaluator will be trained and 
calibrated as per CC protocol. Annually, the OHI-MIS evaluator will rerate 30 randomly 
selected photos during an intra-rater reliability plaque score calibration. After study staff 
demonstrate and observe parent/caregiver performance of study procedures, the dental 
provider will apply FV. 
8.2 
Focus Groups and Interviews 
 
Four focus group discussions (FGDs) of approximately 10 people per arm will be 
conducted in English and Spanish after the Month 6 visit. Two FGDs of intervention arm 
participants (one in English and one in Spanish) will be conducted after the Month 12 
visit. Participants will be chosen based on study performance (e.g., above and below 
high and low thresholds of toothbrushing performance). Each FGD session will be about 
45-60 minutes in duration. The FGDs will focus on topics related to participants’ 
involvement in the intervention: oral health behaviors and health habits, dental care 
motivation behavior, toothbrushing and reactions to the powered toothbrush, toothpaste 
pump use, toothbrush syncing, Sonicare app use, text message reminders, opportunity 

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costs, incentives, overall satisfaction, and perspectives on behavior data tracking for 
personal use and outside monitoring purposes. Semi-structured discussion guides will 
be developed and refined for comprehension, relevancy, and appropriateness prior to 
conducting all interviews. Participants will receive a $30 grocery store gift card for their 
time and participation. 
In addition, 6 to 12 stakeholder interviews will be conducted with EHS and affiliated day 
care center staff after the Month 6 visit. Semi-structured interview guides will be refined 
for comprehension, relevancy, and appropriateness prior to conducting all interviews. 
Topics include how stakeholders were involved in executing the intervention, 
perceptions of the value the intervention added for the population served, the most 
challenging aspect for their organization, and recommendations for improvements. 
Based on prior feedback, stakeholders (staff) will receive a retailer gift card. 
8.3 
Questionnaires 
 
Research staff will administer CAPI questionnaires to parents/caregivers during each 
study visit, with data entered directly into the EDC; questionnaire data will be analyzed 
for changes in self-reported behaviors and perceptions, including relevant common data 
elements (CDEs) identified by the Oral Health Disparities Consortium Collaborative 
Working Groups. Questionnaire items include demographics, behavioral beliefs (e.g. 
current brushing behaviors, dental visit attendance), normative beliefs (e.g. peer 
comparisons), control beliefs (e.g. motivation, and self-efficacy) from BRFQ (Albino et 
al., 2017), economic module (time preferences, risk preferences, ambiguity aversion, 
numeracy, overconfidence, and limited attention/memory), and Early Childhood Oral 
Health Impact Scale (ECOHIS) (Pahel et al. 2007). Follow-up questionnaires will 
assess satisfaction/acceptance of the incentives and study procedures, as well as 
adherence with study procedures, such as whether others in the household used the 
child’s powered toothbrush or TP pump. 
8.4 
Anticipatory Guidance 
 
A short health education video in English or Spanish will provide parents/caregivers with 
key preventive oral health messages appropriate for the child’s age, such as the 
importance of fluoride supplements, healthy snacking and how to prevent the spread of 
bacteria that causes caries. 
8.5 
Toothbrushing Performance and Frequency 
 
8.5.1 
Smart Toothbrushes 
 
During the baseline visit, all participants will receive a “smart” powered toothbrush (e.g., 
Philips Oral Healthcare). The toothbrush uses Bluetooth technology to transmit data on 
brushing timing, frequency, and duration from the toothbrush to an app installed on the 

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participant’s smartphone. The vendor (i.e., Philips Oral Healthcare) has provided a 
script which the Coordinating Center has scheduled to run weekly to securely transmit 
coded (indirectly identifiable) participants’ brushing data to REDCap. 
8.6 
Dental Visit Attendance 
 
For children enrolled at an EHS, preventive dental visit attendance of participating 
children will be ascertained through dental exam data from Head Start’s ChildPlus 
Management Software health module at baseline and the Month 12 follow-up. In 
addition, for all children, parents will be asked about the date of the last dental visit 
within the baseline and Month 12 follow-up questionnaire. 
8.7 
Study Products 
 
The Project Manager will maintain a log of disclosing solution, FV, and TP shipments, 
including batch numbers and expiration dates. The study products will be stored in the 
Project Manager’s office at UCLA. 
8.7.1 
Plaque Disclosing Solution 
 
At the baseline, Month 6, and Month 12 follow-up visits, the dental provider will apply 
Henry Schein Reveal Liquid plaque disclosing agent to the child’s teeth with a 
microbrush for OHI-MIS plaque assessment. 
8.7.2 
Fluoride Varnish 
 
Vanish Fluoride Varnish (3M) is a varnish that is applied to the teeth and enhances 
enamel acid and boosts salivary fluoride levels. The product contains fluoride, calcium 
and phosphate (but not CPP-ACP), which helps the product remain on the teeth longer 
and provides extra protection. Vanish Fluoride Varnish can be applied quickly without 
color change to the teeth. A dental provider will apply the fluoride varnish with a 
microbrush. 
8.7.3 
Fluoride Toothpaste Pump 
 
Study participants will be instructed to use fluoridated TP based on the recent ADA 
consensus guideline (2014) that recommends all children use fluoride TP to help 
prevent dental disease. The study will use Colgate Maximum Cavity Protection Pump 
Fluoride Toothpaste (Colgate-Palmolive Company) (mild bubble fruit flavored). 
The parents/caregivers will be instructed on how to dispense a smear or pea-sized 
amount (depending on child’s age) of fluoride TP onto the toothbrush for the child, as 
per study guidelines. 

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If a child experiences an adverse reaction to the fluoride TP, he/she will be provided 
clinical guidance (e.g., discontinue use of the product); based on clinical judgment and 
appropriate input from oversight groups, use may be re-started. However, no 
modification of study product dosage will be made. 
8.8 
COVID-19 Modifications 
 
The COVID-19 pandemic resulted in “stay at home” orders in Los Angeles county, 
causing the BEECON study move to remote/telephonic visits starting on 16 March 
2020. Starting 01 October 2020, in accordance with state, county, UCLA, and 
community health center guidance, the Venice Family Clinic allowed BEECON to 
resume in-person visits. BEECON will continue to utilize a hybrid of remote/telephonic 
visits and conducting in-person dental screens as the clinic and public health guidelines 
allow. 
 
9 ASSESSMENT OF SAFETY 
 
9.1 
Specification of Safety Parameters 
 
The Principal Investigator (PI) will report safety events for the study (unanticipated 
problems [UPs], adverse events [AEs], serious adverse events [SAEs]) to the 
Institutional Review Board (IRB) in accordance with the IRB’s requirements. 
The PI will also report UPs involving risks to subjects to NIDCR. This will include UPs 
that meet the definition of a SAE. AEs that are temporally associated with the 
administration by study personnel of FV will be recorded in an adverse event log, and 
this log will be monitored to identify events that meet the definition of a UP. If a UP is 
identified, it must be reported. 
9.1.1 
Unanticipated Problems (UPs) 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
(UPs) 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 

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• 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. 
9.1.2 
Adverse Events 
OHRP defines an adverse event as any untoward or unfavorable medical occurrence in 
a human subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research (modified from the definition of adverse events in the 1996 
International Conference on Harmonization E-6 Guidelines for Good Clinical Practice). 
AEs will be recorded in REDCap, and the PI will monitor these events to grade severity, 
relationship to the study product, and assess whether the nature, severity, frequency is 
unexpected, and thus warrants reporting as a UP. 
9.1.3 
Serious Adverse Events (SAEs) 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
• Results in death. 
• Is life-threatening (places the subject at immediate risk of death from the event 
as it occurred). 
• Results in inpatient hospitalization or prolongation of existing hospitalization. 
• Results in a persistent or significant disability or incapacity. 
• Results in a congenital anomaly or birth defect. 
• An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up 
 
AEs, UPs, and SAEs will be recorded in the data collection system throughout the study. 
Events will be followed for outcome information until resolution or stabilization. 
The Study PI will record all reportable events with start dates occurring any time after 
informed consent is obtained until seven (for non-serious AEs) or 30 days (for SAEs) 
after the last day of study participation. Parents/caregivers will be instructed to report 

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any doctor office or emergency room visits in the three days after the fluoride varnish 
application. At the 6- and 12-month follow-up study visits, the staff will inquire about the 
occurrence of AE/SAEs including FV-related AE/SAEs since the last visit. Events will be 
followed for outcome information until resolution or stabilization. 
9.3 
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 AEs 
 
The study PI will be responsible for determining whether an AE is expected or 
unexpected. An AE 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 
 
Severity of Event: All reportable AEs will be assessed by a clinician study PI or co- 
investigator using the following guidelines to quantify intensity: 
1. Mild: events require minimal or no treatment and do not interfere with the 
participant’s daily activities. 

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2. Moderate: events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with 
functioning. 
3. Severe: events interrupt a participant’s usual daily activity and may require 
systemic drug therapy or other treatment. Severe events are usually 
incapacitating 
9.4 
Reporting Procedures 
 
9.4.1 
Unanticipated Problem (UP) Reporting to IRB and NIDCR 
 
Incidents or events that meet the OHRP criteria for UPs require the creation and 
completion of an UP report form. OHRP recommends that PIs include the following 
information when reporting an AE, or any other incident, experience, or outcome as an 
UP 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 AE, incident, experience, or outcome; 
• An explanation of the basis for determining that the AE, incident, experience, or 
outcome represents an UP; 
• A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline: 
• UPs that are (a) SAEs or (b) definitely, probably, or possibly related to study 
procedures will be reported to the UCSF IRB (CHR) and to NIDCR within 5 
working days of a PI becoming aware of the event, unless life-threatening or 
resulting in death in which case they will be reported within 24 hours (according 
to SAE reporting procedures outlined in 9.4.2). 
• All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or 
designee), and OHRP within one (1) month of the IRB’s receipt of the report of 
the problem from a PI. 
All UPs will be reported to NIDCR’s centralized reporting system via Rho Product 
Safety: 

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• Product Safety Fax Line (US): 1-888-746-3293 
• Product Safety Fax Line (International): 1-919-287-3998 
• Product Safety Email: rho_productsafety@rhoworld.com 
• CC Safety Email: OHDCSAE@ucsf.edu 
• CC Safety Fax Line: 1-415-502-8447 
General questions about UP reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time): 
• US: 1-888-746-7231 
• International: 1-919-595-6486 
9.4.2 
Serious Adverse Event Reporting to IRB and NIDCR 
 
In the unlikely event that an AE or SAE incident occurs during this study, any AE 
meeting the specified SAE criteria will be submitted within 5 work days of a PI’s 
awareness in the UCSF electronic IRB system to the UCSF CHR and on an SAE form 
to NIDCR’s centralized safety system via Rho Product Safety. This report may be sent 
by fax or email. Once submitted, Rho Product Safety will send a confirmation email to 
the PIs within one (1) business day. The investigator should contact Rho Product Safety 
if this confirmation is not received. This process applies to both initial and follow-up SAE 
reports. 
SAE Reporting Contact Information: 
• Product Safety Fax Line (US): 1-888-746-3293 
• Product Safety Fax Line (International): 919-287-3998 
• Product Safety Email: rho_productsafety@rhoworld.com 
• CC Safety Email: OHDCSAE@ucsf.edu 
• CC Safety Fax Line: 1-415-502-8447 
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time): 
• US: 1-888-746-7231 

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• International: 919-595-6486 
The study clinician will complete a SAE form and submit via fax or email within the 
following timelines: 
• All deaths and immediately life-threatening events, whether related or unrelated, 
will be recorded on the SAE form and submitted to Product Safety within 24 
hours of site awareness. 
• SAEs other than death and immediately life-threatening events, regardless of 
relationship, will be reported by fax within 5 work days of site awareness. 
All SAEs will be followed until resolution or stabilization. 
9.4.3 
Reporting of SAEs and AEs to FDA 
 
Any AE meeting the specified SAE criteria and being rated as related (possible, 
probable, definite) to FV administration will be submitted to the FDA using the 
MedWatch voluntary reporting system 
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home). 
9.4.4 
Events of Special Interest 
Suspected child abuse reporting is mandatory because the study participants include 
minors; any incidents will be reported to an EHS or day care center supervisor. 
California law stipulates that a provider seeing a child as a patient is not required to 
report domestic violence or abuse of the parent/caregiver. But the parent/caregiver may 
choose to make his/her own report by contacting police. We do not anticipate any other 
events of special interest during the short duration of this study. 
 
10 STUDY OVERSIGHT 
 
The principal investigators will be responsible for study oversight, including monitoring 
safety, ensuring that the study is conducted according to the protocol and ensuring data 
integrity. The PIs will review the data for safety concerns and data trends at regular 
intervals, and will report Unanticipated Problems (UPs), protocol deviations, or any 
other significant events that arise during the conduct of the study to the IRB, NIDCR, 
and Data and Safety Monitoring Board (DSMB) in accordance with their prescribed 
timelines. 
 
In addition to the PIs’ responsibility for oversight, study oversight will be under the 
direction of a DSMB composed of members with appropriate clinical, statistical, 
scientific, and ethical expertise. The NIDCR will appoint the Board. The DSMB will meet 
annually to assess safety and efficacy data, study progress, and data integrity for the 

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study. If concerns arise, more frequent meetings may be held. The DSMB will operate 
under the rules of an NIDCR-approved charter that will be approved at the 
organizational meeting of the DSMB. The DSMB will provide recommendations to the 
NIDCR. 
 
11 CLINICAL SITE MONITORING 
 
Clinical site monitoring is conducted to ensure that the rights of human subjects are 
protected, that the study is implemented in accordance with the protocol and/or other 
operating procedures, and that the quality and integrity of study data and data collection 
methods are maintained. Monitoring for this study will be performed by NIDCR’s 
Clinical Research Operations and Management Support (CROMS) contractor. The 
monitor will evaluate study processes and documentation based on NIDCR standards 
and the International Conference on Harmonisation (ICH), E6: Good Clinical Practice 
guidelines (GCP). 
Details of clinical site monitoring will be documented in a Clinical Monitoring Plan (CMP) 
developed by the CROMS contractor, in collaboration with the NIDCR Office of Clinical 
Trials and Operations Management (OCTOM) and the NIDCR Program Official/Project 
Scientist. The CMP will specify the frequency of monitoring, monitoring procedures, the 
level of clinical site monitoring activities (e.g., the percentage of subject data to be 
reviewed), and the distribution of monitoring reports. Some monitoring activities may be 
performed remotely, while others will take place at the study site(s). Staff from the 
CROMS contractor will conduct monitoring activities and provide reports of the findings 
and associated action items in accordance with the details described in the CMP. 
Documentation of monitoring activities and findings will be provided to the site study 
team, the study PIs, OCTOM, and the NIDCR. The NIDCR reserves the right to conduct 
independent audits as necessary. 
 
12 STATISTICAL CONSIDERATIONS 
 
Statistical Design, Power, and Statistical Analysis Plan: 
12.1 
Study Hypotheses 
 
Primary Null Hypothesis H0: No difference between intervention and control group 
participants in mean number of qualifying half-day toothbrushing episodes per week, 
through Month 6 visit. 
Primary Alternate Hypothesis HA: Intervention and control group participants differ in 
mean number of qualifying half-day toothbrushing episodes in per week, through the 
Month 6 visit. 

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Secondary hypotheses relate to differences between intervention and control group 
participants in the secondary outcomes. (See Sections 3.1.2 and 3.2.2.) 
Secondary hypotheses also relate to behavioral economic measures mediating the 
relationship between the intervention and toothbrushing. (See Sections 2.2 & 12.4.) 
12.2 
Sample Size Considerations 
With 2 parallel groups, the sample size calculation was conservatively conducted for 
one continuous outcome using short-term pilot data; the mean number of qualifying 
brushing episodes in a half-day window per week through 6 weeks was 5.5 with a 
standard deviation (SD) of 4.8 for a coefficient of variation (CV) of 0.87. To be more 
conservative, a SD 25% larger (i.e. 6.0) was used. The mean percent of qualifying 
brushing episodes (out of 14 half-days per week) was 63% with a SD=32% for a 
CV=0.514. A sample size of 91 in each group is estimated to have 84% power to detect 
a difference in means of 2.65 with a common SD of 6.0 using a two group t-test with 2- 
sided alpha=0.05. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In addition, a sample size of 91 in each group was estimated to have 85% power to 
detect a 1.25-fold change in means (expected ratio) between intervention and control 
with the larger (more conservative) CV=0.525 using a two group 2-sided t-test with 
alpha=0.05. With a CV=0.567 and a 1.25-fold change or a CV=0.695 and a 1.30-fold 
change, n=91 per group is still estimated to have 80% power. 
Assuming 75% retention over 12 months, a total of 244 parent-child dyads (N=488) will 
need to be enrolled. (Retention was 85% over 24 months in the team’s recently 
completed glass ionomer sealant and fluoride varnish trial (GIFVT) in a similar 
Two group t-test of equal means (equal n's) 
90 
80 
70 
60 
50 
40 
30 
20 
10 0 
20 
40 
60 
n per group 
80 
100 
120 
 
 
Power ( %) 

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population. Retention was 75% over 2 months in the BEECON pilot trial, but retention 
procedures have been added including a 2 week run-in to eliminate people enrolling 
only for the powered toothbrush.) 
 
Sample sizes for semi-structured interviews and focus group discussions are based on 
prior experience. Focus group discussions with a total of 40 parent/caregiver 
participants are expected to reach saturation, but it is possible an additional focus group 
discussion will be needed to reach saturation. 
12.3 
Planned Interim Analyses (if applicable) 
 
No interim analyses are planned unless the DSMB recommends interim analyses. 
12.4 
Final Analysis Plan 
 
Intent-to-treat (ITT) analyses standard in incentive based behavioral economics studies 
will be utilized (e.g. Halpern et al. 2015, Patel et al. 2016). Generalized linear mixed 
models (GLMMs) will be used to compare primary and secondary outcomes over time 
between groups. GLMMs make fewer missing data assumptions than other methods, 
which assume missing data are missing completely at random. Identity link will be used 
for numeric (interval) outcomes (e.g., mean number of qualifying half-day toothbrushing 
episodes per week, through Month 6 visit; mean OHI-MIS plaque score; and TP pump 
weight change). The group x time interaction will also be assessed; short-term effects 
will be assessed for 1 month of the intervention, mid-term effects after the novelty effect 
of powered toothbrushing usually ends for the Month 3 Visit, and long-term effects for 
the Month 6 Visit (primary outcome), as well as, maintenance of behavior after removing 
the incentives for the Month 12 Visit. Recent, powerful Precision Medicine methods 
which do not inflate Type I error will be used to detect heterogeneity of treatment effects 
by groups of participants based on baseline characteristics (e.g., Lazar et al. 2013). 
Multiple imputation using chained equations (MICE) for arbitrary missingness patterns 
(Raghunathan et al. 2001; van Buuren 2007) will be used for sensitivity analyses. 
Supplemental analyses will also explore: a) trajectories of mean number of qualifying 
half-day brushing episodes per week over time; as well as b1) variability in morning 
brushing times, b2) variability in evening brushing times, and c) variability in weekday 
versus weekend brushing times associated with mean number of qualifying half-day 
brushing episodes, OHI-MIS plaque scores, and ASTDD BSS caries screening 
measures. 
To examine potential impact of timing of drawing reward communication time, GLMM 
analyses as above will be performed comparing the weekly and quarterly drawing result 
communication arms for primary and secondary outcome data from Month 12 to Month 
18. 

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To investigate the behavioral economics mechanisms through which behavior change 
outcomes may have operated, mediation analyses will be conducted with the 
measures of risk preferences (i.e., for the presence of prospect theory tendencies), time 
preferences (i.e., for the presence of present bias), and forgetfulness (i.e., for attention). 
Each of these factors will be investigated in separate models to assess the extent the 
particular underlying construct lies within the pathway toward toothbrushing behavior 
change (i.e., by reducing the estimate of the ITT main effect). 
 
In addition, because parents and children with different backgrounds (e.g., child’s age, 
parent’s/caregiver’s education) and behavioral, normative, and control beliefs may 
respond differently to the incentives given, heterogeneity of treatment effect analyses 
will be conducted to identify groups influenced by the intervention. For example, the 
UH2 pilot (White et al. 2020) suggested the intervention on toothbrushing frequency 
may vary by child age (<24mo vs >24mo). The results of these analyses will also 
inform the sampling frame for the parent FGDs so that important dimensions of diversity 
can be represented. 
 
We will assess cost-effectiveness and return on investment in three steps. First, we 
will assess the net cost of the intervention and its consequences, using micro-costing 
and modeling techniques. Costs for the intervention itself will include mainly personnel 
to implement the intervention (in particular, training on toothbrush software use), the 
cost of the toothbrush, the value of the financial incentives, and incentive administration. 
This will be assessed through a combination of financial record review (e.g., 
expenditures and human resources) and observation of project activities via staff activity 
logs. We will also cost the change in health care utilization precipitated by the 
intervention: both increased preventive care and decreased restorative care. This will be 
assessed combining utilization with standard values for unit cost, based on payment 
rates by Medi-Cal and other payers. Together, these generate net costs. We will also 
estimate toothbrushing time (including preparation) by caregivers. Second, we will 
quantify the health benefits of the intervention, including dental health events (e.g., 
number of carious lesions) and quality-adjusted life years (QALYs) which translate 
morbidity in the short term (measured in Aim 4) and long term (projected based on 
published longitudinal clinical studies) into a standard metric of health status. Health 
state utility data (for QALYs) will derive from studies in the literature. The analysis of 
expected costs and QALYs in the intermediate and long-term will be structured using a 
spreadsheet-based decision-analysis created for this purpose in consultation with 
clinical experts. Third, we will calculate the economic outcome measures including 
incremental cost-effectiveness ratio (ICER) and return on investment (ROI). The 
ICER is the ratio of net cost to health gain, comparing the intervention and control arms. 
It is indicated if the intervention has a net cost (i.e., does not save money) while 
improving health outcomes (QALYs gained). The ROI calculates annual rate of return 
over a specified time period (e.g., 30 years), by comparing expenditures and savings in 
each year. It is indicated if the intervention generates net savings, i.e., reductions in 
dental care costs exceed implementation costs. We will also calculate ROI using 

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willingness-to-pay for a QALY gained. All analyses will be repeated for 1, 2, 5, 10, & 20 
years, and subjected to extensive sensitivity analyses to test the impact of uncertainty 
on results. 
The FGD and stakeholder interview audio recordings will be transcribed. One research 
assistant will transcribe the English interviews and third party translating services, 
Language Service Solutions (LSS), will translate and transcribe Spanish interviews into 
English. One fluent Spanish and English reading, writing, and speaking research 
assistant will review all LSS English translated transcriptions for cultural language 
accuracy. Two independent coders will use general thematic analysis to code excerpts 
(i.e., parent codes and child sub-codes will be derived from data rather than a priori) 
from interview transcripts using web-based Dedoose qualitative software. To develop 
the final codebook, each coder will iteratively review several transcripts to develop an 
initial list of codes, which will then be merged and reconciled to refine code definitions 
and hierarchies, a process that will be repeated until only minor adjustments to the 
codebook result. Using the agreed-upon codebook, each coder will then individually 
code each transcript and results will be compared and discussed to calibrate intercoder 
reliability. Preliminary themes relating to factors explaining the intervention impact and 
perspectives on behavior change motivation, as well as overall program acceptability 
will be analyzed and discussed to reach theme consensus. 
 
13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
 
Study staff will maintain appropriate medical and research records for this study, in 
compliance with ICH E6, Section 4.9 and regulatory and institutional requirements for 
the protection of confidentiality of subjects. Study staff will permit authorized 
representatives of NIDCR and regulatory agencies to examine (and when required by 
applicable law, to copy) research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity. 
Data collected in this study will take the form of toothbrushing data collected 
electronically via a Bluetooth-enabled toothbrush and a smartphone app, 
parent/caregiver drawing incentive data, parent/caregiver questionnaires administered in 
structured CAPIs, dental examination data, iPhone photographs of anterior teeth for OHI- 
MIS plaque score assessments, audio recordings from focus groups and interviews that 
will be transcribed, and cost data obtained from staff activity logs. FGDs and interviews 
will be digitally audiorecorded. Source documents for this study are: parent/caregiver 
questionnaires collected with electronic case report forms (eCRFs) during structured 
interviews, electronic smart toothbrushing performance data, digital photos of teeth 
saved as electronic image files, and dental examination data which will be collected 
electronically in REDCap. All data and source documents will be stored on password- 
protected computers with full hard drive encryption and secure servers behind a firewall. 

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Any paper informed consent forms administered if the electronic system is offline will be 
stored in locked cabinets. 
 
14 QUALITY CONTROL AND QUALITY ASSURANCE 
 
All staff will be appropriately trained in his/her position’s duties with appropriate Human 
Subjects Research training; they will be provided with full information about the study 
such as background and significance, specific aims, milestones, study designs, 
procedures and analytic plans. All team members will be encouraged to view 
themselves as crucial team members encouraged to comment, ask questions, and make 
suggestions to ensure the highest study quality; robust and rigorous data will be 
gathered and handled according to protocol. Fidelity monitoring using audio recordings 
as described in Section 6.3 will help to ensure consistency when study staff explain 
intervention procedures and incentive program details to participants. 
Working with the CC, we will use the REDCap web-based clinical trials management 
system (CTMS) to manage the trial visit schedule, group assignment, eCRFs, and AE 
and UP reporting. After training from the CC, staff will directly enter participant data into 
the CTMS. 
Conventional EDC data-checking routines will assess data completeness and will 
ensure data are input successfully and within reasonable ranges. Checks will be done 
shortly after data collection. CC quality assessment reports will be provided to the team 
on a routine basis and will be reviewed regularly. After data-cleaning procedures, files 
for specific data collection will be validated and locked. Additionally, reports of electronic 
data collected will be provided to and reviewed with the study team for quality 
management purposes. 
The study PIs will rigorously and periodically monitor study activities and engage in 
study team meetings to ensure that procedures are being performed correctly in the field 
in the proper sequence. If any breach is discovered, the particular activity will be 
undertaken a second time and monitored closely for full compliance with the approved 
procedures. 
 
15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
15.1 Ethical Standard 
 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6. 

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15.2 Institutional Review Board (IRB) 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the 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, study procedures or instruments will require review and approval by the 
IRB before the changes are implemented in the study. UCSF’s Committee on Human 
Research (CHR) will be the reviewing IRB while UCLA’s CHR will be the relying IRB, 
formalized with an official Notice of Intent to Rely through the University of California 
system. 
15.3 Informed Consent Process 
 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Discussion of risks 
and possible benefits of study participation will be provided to potential participants and 
their families. A consent form describing in detail the study procedures and risks will be 
given to the participant. Consent forms will be IRB-approved, and the participant is 
required to read and review the document on a digital tablet in English or Spanish or 
have the document read to him or her. The investigator or designee will explain the 
research study to the participant and answer any questions that may arise. The 
participant will electronically sign (with UCSF IRB-approved DocuSign) the informed 
consent document prior to any study-related assessments or procedures. Participants 
will be given the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. They may withdraw consent at any time throughout the 
course of the study. A copy of the electronic signed informed consent document will be 
emailed to participants along with the Bill of Experimental Subject’s Rights in English or 
Spanish (as per California law) for their records; participants who do not have email will 
be provided a paper copy of each. 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 electronically documented in the clinical research record. 
15.4 Exclusion of Women, Minorities, and Children (Special Populations) 
 
Inclusion and exclusion criteria have been developed, which do not include any 
exclusions based on gender or race/ethnicity. 
15.5 Subject Confidentiality 
 
Subject confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. 

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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. 
Authorized representatives of the sponsor may inspect all study documents and records 
required to be maintained by the investigator for the study subjects. The clinical study 
site will permit access to such records. 
No individual identities will be used in any reports or publications resulting from this 
study. No identifying information will be transmitted from the clinical site or UCSF to 
NIDCR. 
eCRFs, which contain the participants’ personal identifying information will be kept 
separately from other data. 
 
16 DATA HANDLING AND RECORD KEEPING 
 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents will 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 eCRFs, and source 
documentation. 
16.1 
Data Management Responsibilities 
 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the PIs. All source documents must be reviewed by the study 
team and data entry staff, who will ensure that they are accurate and complete. UPs 
and AEs must be reviewed by the PIs or their designees. 
16.2 
Data Capture Methods 
 
Data stored electronically will include informed consent documents. Data will be 
collected electronically through REDCap eCRFs and will include oral health screening 
data, TP pump weights, and questionnaire data. ChildPlus dental attendance visit data 
will be obtained from the EHS computer database and entered into a REDCap eCRF. 
Smart toothbrush toothbrushing data and SMS text message data will be obtained as 
separate databases from the toothbrush vendor and the SMS text messaging provider. 
Photographic images of maxillary incisors will be collected with iPhone camera in 
regular mode or burst mode if needed. FGDs and interviews will be audiorecorded and 
transcribed. 

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16.3 
Types of Data 
 
Types of data will include eCRFs in the REDCap EDC, electronic image files, smart 
toothbrushing data, SMS text message data, FGD and stakeholder interview 
audiorecordings, and safety data. 
16.4 
Schedule and Content of Reports 
The study team will utilize monthly reports and figures to monitor enrollment and 
retention and will provide monthly enrollment/retention reports to NIDCR for review. 
Accrual and data completion will be tabulated at least fortnightly. The analytic database 
will be cleaned and locked as described in the OHDC CC Clinical Data Management 
Plan (CDMP). 
16.5 
Study Records Retention 
 
Study records will be maintained for at least three years after the date that the grant 
federal financial report (FFR) is submitted to the NIH. 
The study will maintain participant records, including data from dental records; 
electronic informed consent records for minors will be retained based on the UC 
Counsel General’s recommendation, which is that records be kept for seven years after 
a child reaches 18 years old (the age of majority), or until the child is 25. This could 
mean that participant records would be retained for up to 25 years after the end of the 
study, depending upon enrollment date in the study. 
Each individual will be assigned a unique study identification (ID) code number to be 
used on all study instruments, documents or files. A coding key containing the basic 
information about participants (e.g., names) and their assigned study ID numbers will be 
securely kept (password protected and encrypted) in the REDCap CTMS. All coded 
(indirectly identifiable) data will be kept indefinitely. 
Master files will be stored on a UCSF secure server (e.g., via password protection and 
encryption) for possible later use in specific analyses, and all other copies erased from 
any portable disk, flash drive, or other media. 
16.6 
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 participant, 
the investigator, or study staff. As a result of deviations, study staff may develop 
corrective actions, which will be implemented promptly. 

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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. 
16.6.1 Robust Action Plan 
 
One type of deviation that has occurred repeatedly throughout the study has been 
names appearing in the brushing data that is sent to Philips. This has been a result of 
an adult in a participating household changing the assigned SID# to a name within the 
profile. As a result, the BEECON staff developed a Robust Action Plan to try to 
prevent any future deviations from occurring: 
Robust Action Plan to prevent recurrence of this type of event: 
 
Currently, members of the BEECON research team are taking multiple measures to prevent 
protocol violation / incidents from occurring: 
1. Verbal explanation during Screening Visits with participants 
o 
Modified Informed Consent PowerPoint - first explanation 
 
Research Assistant #1 first addresses the issue of confidentiality during 
the modified informed consent explanation PowerPoint (version 1.1, 
approved 28Aug2018) which is shown in English/Spanish to participants 
early in the initial screening visit. Slide with language below: 
 
"All efforts will be made to keep your personal information private 
and confidential. The research team will have access to 
information about you and your child, but no names, addresses, 
telephone numbers, or specific date information will be used in 
any reports. However, if you or a member of your household 
change the app profile from the study identification number to the 
child's name, this data will be sent to Philips/Sonicare." 
 
In addition to showing participants this slide, Research Assistant #1 also 
states “One of the ways we protect your child’s identity is by assigning 
them a Study ID #. It is up to you as their parent/guardian to maintain this 
confidentiality by not changing the ID # in the app to your child’s name or 
initials.” 
o 
App download - second explanation 
 
When Research Assistant #2 is downloading the Sonicare For Kids (S4K) 
app onto the participant’s phone, they refer back to the confidentiality 
portion of the modified informed consent explanation PowerPoint (version 
1.1, approved 28Aug2018) that the participant just reviewed and 
emphasize that the Study ID # that they are entering into the S4K app 
should be the only thing entered into the profile. 
 
Participants are asked to give verbal confirmation that they understand 
the Study ID # needs to be the only thing added to the profile in the S4K 
app. 

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o 
Summary of visit - third explanation 
 
Before the participant leaves the Screening Visit, the Research Assistants 
provide a verbal summary of the visit- reiterating again that the profile in 
the S4K app is set up and that they should not change it from the Study 
ID # to the child’s name or initials. 
2. Informed Consent Forms modified (version 1.3, 15Aug2018) 
o 
In August 2018 the informed consent forms were modified so that 
parents/guardians would be aware of the potential risk of lack of privacy if 
personal identifying information was added into the study app profile. The 
specific language that was added was: 
 
“However, if you or a member of your household change the app profile 
from the study identification number to the child’s name, this data will be 
sent to Philips/Sonicare." 
3. Handout 
o 
In April 2019, the study team created a 1/4 page handout on brightly colored 
paper that outlines the importance of participants not to change the Study ID # to 
a first or last name or initial. Participants receive this at their initial screening visit. 
4. Vendor changes to app 
o 
The study team worked with the vendor to develop a system to lock the study ID 
# in the app once it has been entered by the Research Assistant. This 
modification to the app occurred on 7/12/19. 
o 
Since this release of the lock on the app, the study team determined that 
participants were still able to add an additional profile into the app so 
after working with the vendor - they have developed a system to prevent 
participants from being able to add additional profiles. This update was released 
on 5/15/20 but it does not prevent parents from being prompted to enter in the 
child's name if the app is deleted from the phone and then re-downloaded. 
5. Teach-back language 
o 
They study team has developed teach-back language to add at the end of every 
visit which will hopefully improve participant understanding of the consequences 
of adding their child's name to the app and help participants to remember that the 
best thing to do if they have to re-install and set up the app is to contact 
BEECON staff. Language is as follows: 
• 
BEECON RA: “As a reminder- if you get a new phone or the S4K app 
gets deleted and has to be re-downloaded, please reach out to us for 
assistance. It is important that if this happens, a name is not added to the 
app during the re-downloaded process, otherwise Philips Sonicare will 
see the name.” 
• 
“So, what will happen if you enter a name in the profile on the app?” 
• 
PARTICIPANT will hopefully respond: “Philips Sonicare may see the 
name” 
• 
BEECON RA: “So, what will you do if you get a new phone or have to 
delete the app and need to re-download it?” 
• 
PARTICIPANT will hopefully respond: “I will contact the BEECON staff” 

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All deviations from the protocol must be addressed in study subject source documents 
and promptly reported to NIDCR and the local IRB, according to their requirements. 
 
17 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
 
Data from this study will be shared in accordance with the NIH Data Sharing Policy. 
https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm 
Investigators are strongly encouraged to decide on authorship of scientific documents 
prior to writing them. The principles set forth in the International Committee of Medical 
Journal Editors’ (ICMJE) Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals (the “Vancouver Rules”) are to be followed. These standards can 
be reviewed online at http://www.icmje.org. 
In the event of disagreement, an ad hoc Publication Committee appointed by the three 
MPIs will provide resolution. 
The ICMJE member journals have adopted a clinical trials registration policy as a 
condition for publication. The ICMJE defines a clinical trial as any research project that 
prospectively assigns human subjects to intervention or concurrent comparison or 
control groups to study the cause-and-effect relationship between a medical intervention 
and a health outcome. Medical interventions include drugs, surgical procedures, 
devices, behavioral treatments, process-of-care changes, and the like. Health outcomes 
include any biomedical or health-related measures obtained in patients or participants, 
including pharmacokinetic measures and adverse events. The ICMJE policy requires 
that all clinical trials be registered in a public trials registry such as ClinicalTrials.gov, 
which is sponsored by the National Library of Medicine. Other biomedical journals are 
considering adopting similar policies. For interventional clinical trials performed under 
NIDCR grants and cooperative agreements, it is the grantee’s responsibility to register 
the trial in an acceptable registry, so the research results may be considered for 
publication in ICMJE member journals. The ICMJE does not review specific studies to 
determine whether registration is necessary; instead, the committee recommends that 
researchers who have questions about the need to register err on the side of 
registration or consult the editorial office of the journal in which they wish to publish. 
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or 
FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or 

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designated principal investigator) register and report results of certain "applicable 
clinical trials:" 
Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I 
investigations, of a product subject to FDA regulation; 
Trials of Devices: Controlled trials with health outcomes of a product subject to FDA 
regulation (other than small feasibility studies) and pediatric postmarket surveillance 
studies. 
NIH grantees must take specific steps to ensure compliance with NIH implementation of 
FDAAA. 
The National Institutes of Health (NIH) has issued a policy to promote broad and 
responsible dissemination of information from NIH-funded clinical trials through 
ClinicalTrials.gov. The policy establishes the expectation that all investigators 
conducting clinical trials funded in whole or in part by the NIH will ensure that these 
trials are registered at ClinicalTrials.gov, and that results information of these trials is 
submitted to ClinicalTrials.gov. Please see 
https://www.federalregister.gov/documents/2016/09/21/2016-22379/nih-policy-on-the- 
dissemination-of-nih-funded-clinical-trial-information 

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SUPPLEMENTAL MATERIALS 
These separate documents are relevant to the protocol, but they are not considered part 
of the protocol. They are stored and modified separately. As such, modifications to 
these documents do not require protocol amendments. 
• Parent/Caregiver Informed Consent Form 
• Questionnaire (Baseline (first) visit) 
• Questionnaire (3-month follow-up visit) 
• Questionnaire (6-month follow-up visit) 
• Questionnaire (9-month follow-up visit) 
• Questionnaire (12-month follow-up (final for intervention arm) visit) 
• Questionnaire (15-month follow-up visit) 
• Questionnaire (18-month follow-up (final for control arm) visit) 
• Oral Health Screening Form (with ADA Treatment Urgency Classification) 
• Plaque Assessment Form (OHI-MIS) 
• Manual of Procedures 

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APPENDICES