Efficacy Trial of MySmileBuddy

Tooth Decay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04845594
• Other study ID #: AAAR7549
• Secondary ID: 1U01DE026739-01A
• Status: Withdrawn
• Phase: N/A
• Start date: October 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: April 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 71 Months

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Dental and Craniofacial Research (NIDCR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Twice Daily Fluoridated Toothpaste Use	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).	12 months post-randomization
Secondary	Change in Consumption of a Low Cariogenic Diet	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.	12 months post-randomization