N/A
N=488
BEhavioral EConomics for Oral Health iNnovation Trial
Toothbrushing · Dental Plaque · Parent-Child Relations · Oral Hygiene · Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03576326 ↗Enrolled (actual)
488
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Toothbrushing Performance — 4.6; 5.6 qualifying half-day episodes per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Drawing Incentive (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toothbrushing Performance |
4.6; 5.6 | — |
| SECONDARY Short-term (Immediate) Toothbrushing Performance |
5.4; 6.2 | — |
| SECONDARY Mid-term Toothbrushing Performance |
4.9; 5.8 | — |
| SECONDARY Toothbrushing Performance Sustainability |
4.3; 4.8 | — |
| SECONDARY Self-efficacy Scale |
26.4; 25.9 | — |
| SECONDARY Modified Simplified Oral Hygiene Index |
2.2; 2.1; 2.2; 2.1 | — |
| SECONDARY Change From Baseline in Toothpaste Weight |
-44.9; -40.9; -51.4; -48.0 | — |
| SECONDARY Untreated Caries |
14; 13; 9; 14 | — |
| SECONDARY Caries Experience |
16; 17; 12; 18 | — |
| SECONDARY Severe Caries |
3; 5; 3; 5 | — |
| SECONDARY Past Year Dental Visit |
6; 5 | — |
Summary
This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral economic theory-based financial incentive drawing program versus a control regimen to promote early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center programs.
Eligibility Criteria
Inclusion Criteria
- Child
- at least 2 fully erupted teeth
- enrolled in, or waitlisted for, one of the participating Los Angeles County Early Head Start (EHS) or affiliated day care center or area clinic programs
- Parent/caregiver
- provide signed and dated informed consent form in English or Spanish
- agree to comply with all study procedures and be available for the duration of the study
- aged 18 or older
- speak either English or Spanish and self-reported ability to read and write either English or Spanish
- be a parent or caregiver of a child at least 6 months old but less than 4 years (48 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or affiliated day care center or area clinic programs
- not be planning to move residence for the next 18 months outside the greater Los Angeles area
- own a smartphone with Google Play or iTunes store app and be willing to download and install the smart powered toothbrush app at the Screening visit and keep it installed for the duration of the project. [If the app cannot be properly installed by the baseline visit, the participant will not be randomized.]
- be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the toothbrush
- Stakeholder
- be a staff member at a participating study site (e.g. EHS or affiliated day care center)
- verbally agree to participate after being provided a study information sheet
Exclusion Criteria
- Child
- known allergic reaction to components of the study product(s)
- uncooperative or behaviorally unsuited (assessed during a toothbrush prophylaxis, ASTDD Basic Screening Survey caries screening, and photograph of maxillary incisors at the screening visit)
- more than 2 crowns on maxillary incisor teeth (teeth# D, E, F, G, or equivalently #52, 51, 61, 62).
- participated in the BEECON pilot trial
- a sibling of a child enrolled in the study (the family's oldest child in the eligible age range will be the study child)
- enrolled in foster care
- anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study
- Parent/caregiver
- participated in the BEECON pilot trial
- unable or unwilling to install and use the smart powered toothbrush app during the run-in period
Data sourced from ClinicalTrials.gov (NCT03576326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.