Efficacy Trial of MySmileBuddy

• ClinicalTrials.gov Identifier: NCT04845594
• Recruitment Status: Withdrawn
• First Posted: April 15, 2021
• Last Update Posted: April 15, 2021
• Sponsor: Columbia University
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Information provided by (Responsible Party): Carol Kunzel, Columbia University

Study Description

Brief Summary:

This study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. To do so, this study will evaluate whether or not a family focused intervention, MySmileBuddy, is able to reduce tooth decay progression in Hispanic preschoolers at high risk of this disease.

Condition or disease	Intervention/treatment	Phase
Tooth Decay	Behavioral: MySmileBuddy (MSB)	Not Applicable

Detailed Description:

Tooth decay in young children has traditionally been treated through surgical dental repair, an approach that does not address the oral hygiene and dietary behaviors that cause the disease. Professionals agree that behavioral strategies to prevent tooth decay are needed, but they have not been well studied in Hispanic children in the United States that have disproportionately high rates of this disease. Use of fluoridated toothpaste twice a day and consumption of a healthy diet can both prevent tooth decay and stop it from progressing.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
• Estimated Study Start Date: October 2019
• Actual Primary Completion Date: December 2, 2020
• Actual Study Completion Date: December 2, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: MySmileBuddy; Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will receive a family-focused intervention called MySmileBuddy.	Behavioral: MySmileBuddy (MSB); The technology-based MSB program equips community health workers (CHWs) with an iPad-based app that facilitates assessment of a child's early childhood caries (ECC).; Other Name: MSB
No Intervention: Control; Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention.

Outcome Measures

Primary Outcome Measures :

1. Change in Number of Decayed, Missing, or Filled Teeth or Surfaces [ Time Frame: 12 months post-randomization ]
   Early childhood caries status will be determined by visual examination, assisted by an examination light, mirror, and probe with caries experience defined by number of teeth (t) and surfaces (s) that either have decay (d), are missing due to decay (m), or have had a dental filling (f) due to a cavity.
2. Proportion of Participants with Early Childhood Caries Progression [ Time Frame: 12 months post-randomization ]
   The number of decayed, missing, or filled teeth (dmft)/decayed filled surfaces (dfs) as a count variable will be measured to determine the proportion of participants who have a positive change in the number of dmft/dfs post-intervention.

Secondary Outcome Measures :

1. Change in Twice Daily Fluoridated Toothpaste Use [ Time Frame: 12 months post-randomization ]
   Tooth brushing behaviors will be assess by asking parents a series of multiple choice and open-ended questions and direct observation of tooth brushing behavior measured using the Tooth Brushing Observation Scale (Collett, et al., 2016) at baseline (T1) and 12 months post-randomization (T2).
2. Change in Consumption of a Low Cariogenic Diet [ Time Frame: 12 months post-randomization ]
   Cariogenic diet behaviors will be assessed by asking parents a series of multiple choice and open-ended questions using: (1) an age-appropriate modification of the University of Iowa's Diet Assessment of Caries Risk tool (Marshall, 2009); and (2) the MSB-developed modified 24-hour dietary recall widget.

Eligibility Criteria

• Ages Eligible for Study: 24 Months to 71 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Children aged 24 to 71 months of age, have a minimum of 12 teeth present, and have early childhood caries (ECC)
• Will reside in the New York City (NYC) metropolitan for the following 12 months
• Parents must be 18 years or older and must report having a cell phone with texting capabilities

Exclusion Criteria:

• Children with developmental delays or medical conditions that would impede oral dietary intake, at-home oral hygiene practices, or receipt of oral exams
• Children with parents who are under the age of 18 years of age, do not report having a mobile phone, do not plan to reside in the New York City (NYC) metropolitan area for the following 12 months
• Children of parents who do not provide consent to participate.

Contacts and Locations

Sponsors and Collaborators

Columbia University

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: Carol Kunzel, PhD; Columbia University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lumsden CL, Edelstein BL, Basch CE, Wolf RL, Koch PA, McKeague I, Leu CS, Andrews H. Protocol for a family-centered behavioral intervention to reduce early childhood caries: the MySmileBuddy program efficacy trial. BMC Oral Health. 2021 May 7;21(1):246. doi: 10.1186/s12903-021-01582-4.

• Responsible Party: Carol Kunzel, Professor of Dental Community Health, Dental Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT04845594
• Other Study ID Numbers: AAAR7549; 1U01DE026739-01A1 ( U.S. NIH Grant/Contract )
• First Posted: April 15, 2021
• Last Update Posted: April 15, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carol Kunzel, Columbia University:

Oral hygiene; Decay; Decay Progression

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases