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Completed

NCT Number: NCT03576326

BEhavioral EConomics for Oral Health iNnovation Trial

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.

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Key information

Conditions

Toothbrushing Behavior Dental Caries Dental Deposits Dental Plaque Health Behavior Oral Hygiene Parent-Child Relations Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Venice Family Clinic Children First Early Head Start

Santa Monica, California, 90405-1828, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drawing Incentive

Behavioral

The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.

Primary outcomes

  1. Toothbrushing Performance

    Time frame: Baseline visit through the Month 6 visit

    Mean of the number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)

Secondary outcomes

  1. Short-term (Immediate) Toothbrushing Performance

    Time frame: Baseline visit through the Month 1 visit

    Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

  2. Mid-term Toothbrushing Performance

    Time frame: Baseline visit through the Month 3 visit

    Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

  3. Toothbrushing Performance Sustainability

    Time frame: Month 6 visit through the Month 12 visit

    Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

  4. Self-efficacy Scale

    Time frame: Month 6 visit

    Caregiver (parent) oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.)

  5. Modified Simplified Oral Hygiene Index

    Time frame: Month 6 visit and Month 12 visit

    Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure child's plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores each with values ranging from no plaque (1) - which is best - to abundant plaque (4) - which is worst)

  6. Change From Baseline in Toothpaste Weight

    Time frame: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit

    Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time.

  7. Untreated Caries

    Time frame: Month 6 visit and Month 12 visit

    Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt>0)

  8. Caries Experience

    Time frame: Month 6 visit and Month 12 visit

    Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft>0)

  9. Severe Caries

    Time frame: Month 6 visit and Month 12 visit

    Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft>=4)

  10. Past Year Dental Visit

    Time frame: Month 12 visit

    Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of California, Los Angeles

Registry information

Official study title

Influence of Financial Incentives on Oral Disease Management in Young Children

Acronym: BEECON

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2018
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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