Efficacy Trial of MySmileBuddy

Columbia University

Status: Withdrawn

Conditions: Tooth Decay

Treatments: Behavioral: MySmileBuddy (MSB)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04845594

AAAR7549

1U01DE026739-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 24 to 71 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

MySmileBuddy

Experimental group

Description:

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.

Treatment:

Behavioral: MySmileBuddy (MSB)

Control

No Intervention group

Description:

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