Efficacy Trial of MySmileBuddy

NCT ID: NCT04845594

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2020-12-02

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.

Conditions

Tooth Decay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MySmileBuddy (MSB)

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

MSB

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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Carol Kunzel

Professor of Dental Community Health, Dental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carol Kunzel, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

References

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.

Reference Type: DERIVED

PMID: 33962602 (View on PubMed)

Other Identifiers

1U01DE026739-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR7549

Identifier Type: -

Identifier Source: org_study_id