Tooth Decay Clinical Trial
Official title:
Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
Verified date | April 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Columbia University | National Institute of Dental and Craniofacial Research (NIDCR) |
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 |
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