Efficacy Trial of MySmileBuddy

NCT04845594 | Withdrawn DMC

• 2 other identifiers: AAAR75491U01DE026739-01A1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Decay

Keywords

Oral hygiene; Decay; Decay Progression

Outcome Measures

Primary Outcomes (2)

• Change in Number of Decayed, Missing, or Filled Teeth or Surfaces

  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.

  12 months post-randomization

• Proportion of Participants with Early Childhood Caries Progression

  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.

  12 months post-randomization

Secondary Outcomes (2)

• Change in Twice Daily Fluoridated Toothpaste Use

  12 months post-randomization

• Change in Consumption of a Low Cariogenic Diet

  12 months post-randomization

Study Arms (2)

MySmileBuddy

EXPERIMENTAL

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)

Control

NO INTERVENTION

Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention.

Interventions

MySmileBuddy (MSB) BEHAVIORAL

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).

Also known as: MSB

MySmileBuddy

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Related Publications (1)

• 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.

  PMID: 33962602 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Carol Kunzel, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dental Community Health, Dental Medicine

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 15, 2021
• Study Start: October 1, 2019
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share