Back to resultsEfficacy Trial of MySmileBuddy
Primary Purpose
Tooth Decay
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MySmileBuddy (MSB)
Sponsored by
About this trial
This is an interventional other trial for Tooth Decay focused on measuring Oral hygiene, Decay, Decay Progression
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MySmileBuddy
Control
Arm 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.
Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT04845594
First Posted
April 9, 2021
Last Updated
April 12, 2021
Sponsor
Columbia University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT04845594
Brief Title
Efficacy Trial of MySmileBuddy
Official Title
Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
This study was halted prior to the start of enrollment due to the COVID-19 pandemic. The inability to conduct planned in-person intervention activities during the pandemic related to inherent risks of the virus necessitated withdrawal of the study.
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay
Keywords
Oral hygiene, Decay, Decay Progression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MySmileBuddy
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
MySmileBuddy (MSB)
Other Intervention Name(s)
MSB
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Number of Decayed, Missing, or Filled Teeth or Surfaces
Description
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.
Time Frame
12 months post-randomization
Title
Proportion of Participants with Early Childhood Caries Progression
Description
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.
Time Frame
12 months post-randomization
Secondary Outcome Measure Information:
Title
Change in Twice Daily Fluoridated Toothpaste Use
Description
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).
Time Frame
12 months post-randomization
Title
Change in Consumption of a Low Cariogenic Diet
Description
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.
Time Frame
12 months post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Kunzel, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33962602
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy Trial of MySmileBuddy
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