AzTrials
AzTrials

ToothbrushingBEECONNCT03576326

BEhavioral EConomics for Oral Health iNnovation Trial

A study testing Drawing Incentive in people with Toothbrushing and Dental Plaque, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 6 to 47 monthsHealthy volunteers can take part
What is being tested?
Drawing Incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
1 siteUnited States
Study dates
9 May 2018to 30 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 47 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Venice Family Clinic Children First Early Head Start

    Santa Monica, California, 90405-1828

Other trials in United States

About this study

Official title: Influence of Financial Incentives on Oral Disease Management in Young Children

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.

Being tested
Drawing Incentive
Keywords
Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics
Medical subject headings
Dental Plaque, Dental Caries, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drawing IncentiveBehavioural

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

Study groups in NCT03576326
Study groupRoleWhat they receive
Incentive DrawingExperimentalEligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Receives: Behavioral: Drawing Incentive
Control - Delayed IncentiveNo interventionNo rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toothbrushing Performance

    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.)

    Measured: Baseline visit through the Month 6 visit

Secondary outcomes (10)

  1. Short-term (Immediate) Toothbrushing Performance

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

    Measured: Baseline visit through the Month 1 visit

  2. Mid-term Toothbrushing Performance

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

    Measured: Baseline visit through the Month 3 visit

  3. Toothbrushing Performance Sustainability

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

    Measured: Month 6 visit through the Month 12 visit

  4. Self-efficacy Scale

    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.)

    Measured: Month 6 visit

  5. Modified Simplified Oral Hygiene Index

    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)

    Measured: Month 6 visit and Month 12 visit

  6. Change From Baseline in Toothpaste Weight

    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.

    Measured: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit

  7. Untreated Caries

    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)

    Measured: Month 6 visit and Month 12 visit

  8. Caries Experience

    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)

    Measured: Month 6 visit and Month 12 visit

  9. Severe Caries

    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)

    Measured: Month 6 visit and Month 12 visit

  10. Past Year Dental 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

    Measured: Month 12 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2018
  2. Study start9 May 2018
  3. Primary completion13 May 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible consenting parent-child participant dyads, within strata and permuted blocks, will be randomized in equal allocation to one of two arms. Strata will be based on site and smartphone operating system (iOS or Android).
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03576326
Sponsor's protocol ID
NIDCR 17-084-E UH3DE025514
Other IDs
UH3DE025514
Acronym
BEECON
Status last verified
Sep 2025
First submitted
23 May 2018
Last updated
19 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be made available.

Publications

  • Ramos-Gomez F, White JS, Lindau HE, Lin TK, Finlayson TL, Liu JX, Gansky SA. Family monetary incentives as a value-based care model for oral hygiene: rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial. J Public Health Dent. 2020 Oct 8:10.1111/jphd.12406. doi: 10.1111/jphd.12406. Online ahead of print.

    PubMed 33090505

Questions about this trial

What is this clinical trial studying?

A study testing Drawing Incentive in people with Toothbrushing and Dental Plaque, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toothbrushing Performance (time frame: Baseline visit through the Month 6 visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03576326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in