Personalized Digital Coaching for Oral Hygiene Adherence: Randomized Controlled Trial.

NCT07167875 | Enrolling By Invitation

• 2 other identifiers: IRB-24-0661UH3DE028723
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if a personalized Digital Oral Health Intervention (DOHI) improves how well adults follow recommended tooth brushing routines. Researchers also aim to understand which factors influence the success of the intervention. The main questions this study will answer are: Does using the DOHI lead participants to brush twice daily for two minutes, covering all four quadrants (the 2x2x4 routine) more consistently than traditional oral hygiene instructions alone? Which participant characteristics, such as demographics or baseline oral hygiene habits, affect how well the DOHI helps people improve their brushing? How does engagement with the digital coaching and technology impact adherence to recommended oral hygiene practices? In this study: 230 adults receiving care at community dental clinics in California will participate. Everyone will begin with a 2-week run-in period using traditional oral care instructions. Afterward, participants will be randomly assigned to one of two groups: The control group will continue with traditional oral hygiene instructions. The intervention group will receive traditional oral hygiene instructions plus personalized digital coaching delivered through a mobile app and an electronic toothbrush system. The DOHI provides personalized feedback, educational content, and motivational prompts that adapt over time based on each participant's brushing behavior and engagement. Both groups will use an electronic toothbrush to objectively record when, how long, and how well they brush. Participants will: Follow the assigned oral hygiene instructions for 19 weeks. Use an electronic toothbrush and mobile app as instructed. Have their brushing data automatically collected and analyzed by researchers. The study will look at changes in brushing frequency and duration from before to after the intervention. Researchers will also explore how personal characteristics and engagement with technology influence outcomes. The results of this trial will help community dental clinics know if personalized, digital coaching can help more adults maintain healthy habits and achieve better oral health, and guide future improvements in digital health interventions for oral hygiene.

Conditions

Dental Disease; Behavioral Changes

Keywords

dental disease; digital interventions; behavioral changes

Outcome Measures

Primary Outcomes (2)

• Change in Daily Brushing Sessions as Measured by Electric Toothbrush Data Collection

  Change in number of daily brushing sessions from baseline to 19 weeks, objectively measured through electric toothbrush data collection system. Baseline defined as average daily brushing frequency during 2-week run-in period. Target adherence is twice daily brushing (2 sessions per day).

  19 weeks

• Mean Change in Daily Brushing Duration as Measured by Electric Toothbrush Data Collection

  Change in average brushing duration per session measured in minutes from baseline to 19 weeks using electric toothbrush data collection. Baseline defined as mean brushing duration during 2-week run-in period. Target duration is 2 minutes per session. Data reported as mean change in minutes with standard deviation.

  19 weeks

Secondary Outcomes (2)

• Demographic Predictors of Digital Oral Health Intervention Response as Measured by Multivariable Logistic Regression Analysis

  19 weeks

• Baseline Oral Hygiene Behavior Predictors of Digital Intervention Success as Measured by Electronic Toothbrush Data Collection and Multivariable Regression Analysis

  19 weeks

Study Arms (2)

Digital Intervention

EXPERIMENTAL

Participants randomized to the intervention group will receive a personalized digital coaching promoting adherence to the 2x2x4 brushing routine.

Behavioral: Personalized Digital Oral Health Coaching

traditional oral hygiene instruction

NO INTERVENTION

All participants will use an electronic toothbrush and mobile app to record brushing behavior throughout the study. However, the control arm will use the devices strictly for data collection without access to personalized digital coaching features.

Interventions

Personalized Digital Oral Health Coaching BEHAVIORAL

All participants will use an electronic toothbrush and mobile app to record brushing behavior throughout the study. However, only the intervention arm will receive personalized digital coaching through the Oralytics app, including tailored feedback, educational messages, and motivational prompts.

Digital Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Fluent in English (speaking, reading, writing)
• Dentulous or partially edentulous (minimum 2 teeth per quadrant)
• Own and regularly use a smartphone (iOS or Android) with active data plan
• Receiving dental care at a participating study site
• Willing to use electronic toothbrush and mobile application for 19 weeks
• Able to provide informed consent

You may not qualify if:

• Edentulous (no natural teeth)
• Fewer than 18 teeth or fewer than 2 teeth in any quadrant
• Unable to use mobile devices due to cognitive or physical impairments
• Unwilling to comply with study procedures
• Current participation in another oral health intervention study

Sponsors & Collaborators

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

Study Sites (2)

Petaluma Health Center-Dental, Petaluma, CA

Petaluma, California, 94954, United States

Location

Dientes Community Dental Care

Santa Cruz, California, 95065, United States

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Vivek Shetty, DMD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 12 months after publication of primary results and ending 5 years after article publication
• Access Criteria: Requests for data access require written scientific proposals, institutional oversight documentation, and signed data use agreements. Requests will be reviewed by the Principal Investigator and institutional data sharing committee."

Locations

US (2)