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Efficacy Trial of MySmileBuddy

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04845594
Enrollment
0
Registered
2021-04-15
Start date
2019-10-31
Completion date
2020-12-02
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Decay

Keywords

Oral hygiene, Decay, Decay Progression

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.

Interventions

BEHAVIORALMySmileBuddy (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).

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Months to 71 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Number of Decayed, Missing, or Filled Teeth or Surfaces12 months post-randomizationEarly 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.
Proportion of Participants with Early Childhood Caries Progression12 months post-randomizationThe 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.

Secondary

MeasureTime frameDescription
Change in Twice Daily Fluoridated Toothpaste Use12 months post-randomizationTooth 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).
Change in Consumption of a Low Cariogenic Diet12 months post-randomizationCariogenic 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026