Clinical trial NCT04845594: Efficacy Trial of MySmileBuddy
Official title: Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tooth Decay
Keywords: Oral hygiene
Decay
Decay Progression
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2021-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Number of Decayed, Missing, or Filled Teeth or Surfaces
timeFrame: 12 months post-randomization
measure: Proportion of Participants with Early Childhood Caries Progression
timeFrame: 12 months post-randomization
Secondary outcomes:
measure: Change in Twice Daily Fluoridated Toothpaste Use
timeFrame: 12 months post-randomization
measure: Change in Consumption of a Low Cariogenic Diet
timeFrame: 12 months post-randomization
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Carol Kunzel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.