Efficacy Trial of MySmileBuddy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tooth Decay

Intervention / Treatment
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* Behavioral: MySmileBuddy (MSB)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 71 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MySmileBuddy<br>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. | Behavioral: MySmileBuddy (MSB)<br>* 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).<br>* Other names: MSB;|
| No Intervention: Control<br>Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decay, Oral hygiene, Decay Progression