Abstract
Background: Although largely preventable through diet management and topical fluoride use, early childhood caries (ECC) often progresses to severity that necessitates surgical repair. Yet repair often fails to mitigate caries progression. Needed is an effective behavioral intervention to address underlying behavioral causes. Methods: This randomized controlled trial will evaluate the efficacy of a behaviorally focused, family-centered intervention, the MySmileBuddy Program (MSB Program), to reduce ECC progression in high-risk preschoolers in New York City. Recruitment will target 858 children ages 24–71 months with ECC and their parents from primary care medical and dental clinics. The study aims to assess the MSB Program’s efficacy to: (1) decrease ECC progression measured 12-months post-randomization; and (2) enhance adoption of a low cariogenic diet and twice-daily fluoridated toothpaste use compared to control group. Potential causal pathways (mediators and moderators) will be explored. The MSB Program equips community health workers (CHWs) with an app that facilitates multilevel risk assessment and provides motivational interviewing-based counseling to inform parents about the caries process, develop personalized goals, and create family-level action plans to achieve targeted behaviors. Social support from CHWs (4 interactions during the 6-month intervention, supplemented by up to 4 in-person/remote contacts throughout the 12-month study period, based on need) is bolstered by automated text messages. Participants will be randomized to a Control Group (paper-based educational handout plus toothbrushes and fluoridated toothpaste for the child) or Intervention Group (MSB Program, two tooth-brushing observations with feedback and instruction, and toothbrushes and toothpaste for the entire family). All children will receive visual ICDAS dental examinations and parents will complete study measures at baseline and 12-months. An incentive up to $150 plus round-trip transit cards ($5.50 value) will be provided. Discussion: This study hypothesizes that the MSB Program can reduce ECC progression in a high-risk population. Sufficient incentives and a focus on establishing rapport between participants and CHWs are anticipated to mitigate recruitment and retention challenges. If successful, this study will advance the long-term goal of reducing pediatric oral health disparities by demonstrating the efficacy of an acceptable and feasible intervention that shifts attention from dental repair to behavioral risk mitigation. Trial registration: Trial registration was completed on 4/13/2021 through the U.S. National Library of Medicine ClinicalTrials.gov website (Identifier: NCT04845594).
| Original language | English |
|---|---|
| Article number | 246 |
| Journal | BMC Oral Health |
| Volume | 21 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Dec 2021 |
Bibliographical note
Publisher Copyright:© 2021, The Author(s).
Funding
The research protocol reported in this publication was supported by the National Institute of Dental & Craniofacial Research of the National Institutes of Health under Award Number U01DE026739, which funded development of the protocol but not conduct of the clinical trial it describes. The funder’s role in the study was to provide oversight throughout the protocol development process and conduct a final review and approval of the complete protocol. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Research reported in this publication was supported by the National Institute of Dental & Craniofacial Research of the National Institutes of Health under Award Number U01DE026739. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The MSB Program and App were developed with support from the National Institutes of Health (NIH; UL1TR001873, RC1MD004257), evaluated for validity of its risk components [, ], assessed for feasibility and acceptability when delivered to a low-income primarily Hispanic population [–], and tested through a pragmatic effectiveness trial with families of 1,207 children supported by the federal Center for Medicare and Medicaid Innovation (C1CMS331347). Needed to assess the Program is a randomized controlled trial (RCT) that tests the efficacy of the MSB Program in a high-risk minority population and advances understanding of its mechanisms of action. This report describes the protocol for such an RCT as developed and initiated with support from the NIH National Institute of Dental and Craniofacial Research (R34DE023158, U01DE026739). This RCT was halted in March 2020 by the COVID-19 pandemic just as recruitment began. Since that time, a grant from the Cabrini Foundation of New York City has been secured to refashion the MSB Program for virtual telehealth visits. When and if resumed, this RCT will measure factors shown to influence motivation (perceived threat, ECC contextual knowledge, and positive outcome expectations) and ability to act on motivation (knowledge and skills, self-efficacy, action goal setting, and access to toothbrushes and toothpaste) to initiate and maintain positive oral health behaviors.
| Funders | Funder number |
|---|---|
| Cabrini Foundation of New York City | |
| Center for Medicare and Medicaid Innovation | C1CMS331347 |
| National Institutes of Health | UL1TR001873, RC1MD004257 |
| National Institute of Dental and Craniofacial Research | U01DE026739 |
ASJC Scopus Subject Areas
- General Dentistry