# Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries

> **NIH NIH U01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2021 · $780,601

## Abstract

ABSTRACT/ PROJECT SUMMARY
Longstanding practice has treated early childhood caries (ECC) primarily through surgical dental repair,
reinforced by current payment systems, an approach that does not address the natural history of the disease
or the oral hygiene and dietary behaviors that mediate its occurrence. Professional consensus on the value of
ECC disease management is emerging but behavioral strategies remain largely unstudied among Hispanic
children in the United States. The long-term goal of the proposed study is to reduce oral health disparities and
inform a paradigm shift from a focus on treatment to one that also embraces prevention. It is known that using
fluoridated toothpaste twice daily and consumption of a low cariogenic diet has both preventive and therapeutic
value. What is not known is how to best translate the adoption and maintenance of salutary behaviors to
populations at greatest risk. The proposed randomized controlled trial will evaluate the efficacy of a family
focused behavioral intervention, MySmileBuddy, to reduce ECC progression in high-risk Hispanic
preschoolers. We propose to recruit and enroll 858 two to five year-old children, all with ECC, along with their
caregiver from pediatric medical clinics in northern Manhattan, New York City. Specific Aims are: (1) to assess
MySmileBuddy's efficacy (versus control) to decrease ECC progression (defined as positive change in number
of decayed, missing, or filled teeth (∆dmft>0) or surfaces (∆dfs>0)) measured 12-months post-randomization
(and assessed again 24-months post-randomization); (2) to assess MySmileBuddy's efficacy (versus control)
to enhance adoption of twice daily fluoridated toothpaste use and consumption of a low cariogenic diet; and (3)
to assess causal pathways through which MySmileBuddy influences twice daily fluoridated toothpaste use and
consumption of a low cariogenic diet. The proposed research is innovative and represents a departure from the
status quo by shifting focus from treatment to prevention, shifting education from verbal instructions and written
materials provided by dental professionals to using interactive Health Information Technology delivered by
Community Health Workers, and capitalizing on general pediatrics practices as a conduit for promoting
children's oral health. At the completion of this study, we will know the extent to which MySmileBuddy
promotes parents' acquisition and maintenance of oral hygiene and dietary behaviors that reduce ECC
progression in a high-risk population of Hispanic preschool children. Ultimately, such knowledge has the
potential to reduce the number of children needlessly affected by this preventable disease.

## Key facts

- **NIH application ID:** 10237215
- **Project number:** 5U01DE026739-04
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** CAROL KUNZEL
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $780,601
- **Award type:** 5
- **Project period:** 2018-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10237215

## Citation

> US National Institutes of Health, RePORTER application 10237215, Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries (5U01DE026739-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10237215. Licensed CC0.

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