Dental DiseaseNCT07167875
Personalized Digital Coaching for Oral Hygiene Adherence: Randomized Controlled Trial.
A study testing Personalized Digital Oral Health Coaching in people with Dental Disease and Behavioral Changes, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Disease, Behavioral Changes
- What is being tested?
- Personalized Digital Oral Health Coaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Petaluma Health Center-Dental, Petaluma, CA
Petaluma, California, 94954
Dientes Community Dental Care
Santa Cruz, California, 95065
About this study
Official title: Personalized Digital Behavior Change Interventions to Optimize Oral Hygiene Behaviors: Randomized Controlled Trial
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:
Read more
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.
Read the detailed description
This multisite randomized controlled trial is designed to evaluate whether a personalized Digital Oral Health Intervention (DOHI) can improve adherence to recommended oral hygiene behaviors compared to traditional oral hygiene instruction alone. The study addresses the persistent challenge of maintaining long-term oral hygiene habits by utilizing technology-facilitated coaching, adaptive intervention delivery, and reinforcement learning algorithms that respond to each participant's real-time brushing behaviors.
A total of 230 adults (aged 18 years and older) will be recruited from three community dental clinics in California: Dientes Community Dental Care (Santa Cruz County), Petaluma Health Center (Sonoma County), and University of California, Los Angeles (UCLA)Dental Clinics (Los Angeles County). Following baseline education in the recommended 2x2x4 brushing protocol (brushing twice daily for two minutes, covering all four dental quadrants) and a 2-week run-in period to ensure comfort with the electronic toothbrush system and study procedures, eligible participants will be randomized in equal numbers to either the intervention or control group.
Participants in the control group will continue with traditional oral hygiene instruction and receive standard feedback on their brushing patterns over the 19-week intervention period. The intervention group will also receive traditional instruction and standard feedback, but in addition they will be provided with personalized digital coaching through the DOHI platform. The DOHI integrates an electronic toothbrush and the Oralytics mobile application to deliver tailored feedback, educational resources, and motivational strategies such as micro-incentives. The system uses reinforcement learning algorithms to dynamically adjust the timing, frequency, and content of coaching prompts based on each participant's brushing data and engagement patterns, aiming to optimize involvement and support sustainable behavior change.
The primary outcome of the study is the change in participants' adherence to the recommended brushing frequency and duration, objectively measured from baseline through 19 weeks using data collected by the electronic toothbrush system. Secondary outcomes include analyses of individual-level factors-such as demographics, initial oral hygiene behaviors, and patterns of technology use-that may influence the effectiveness of the DOHI for promoting oral self-care.
The results of this trial are expected to provide evidence for the implementation of adaptive digital interventions to support oral health, with the potential for broad application in community dental care settings.
- Conditions
- Dental Disease, Behavioral Changes
- Being tested
- Personalized Digital Oral Health Coaching
- Keywords
- dental disease, digital interventions, behavioral changes
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Digital Oral Health CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Intervention | Experimental | Participants randomized to the intervention group will receive a personalized digital coaching promoting adherence to the 2x2x4 brushing routine. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 19 weeks
Secondary outcomes (2)
Demographic Predictors of Digital Oral Health Intervention Response as Measured by Multivariable Logistic Regression Analysis
Analysis of demographic factors (age, gender, race/ethnicity, education level, income, employment status) that predict differential response to the Digital Oral Health Intervention (DOHI) compared to control group using multivariable logistic regression models. Response defined as binary outcome: achieving ≥75% adherence to recommended 2x2x4 brushing routine (success) versus <75% adherence (failure) measured by electronic toothbrush data collection over 19 weeks. Analysis will examine interaction effects between demographic variables and treatment assignment. Results reported as odds ratios with 95% confidence intervals for each demographic predictor, indicating the strength of association between specific demographic characteristics and likelihood of intervention success. Higher odds ratios indicate greater likelihood of achieving target adherence for participants with that demographic characteristic.
Measured: 19 weeks
Baseline Oral Hygiene Behavior Predictors of Digital Intervention Success as Measured by Electronic Toothbrush Data Collection and Multivariable Regression Analysis
Investigation of baseline oral hygiene behaviors that predict successful adherence to the Digital Oral Health Intervention (DOHI) using multivariable regression analysis. Baseline predictors include: brushing frequency (sessions per day), brushing duration (minutes per session), timing patterns (morning/evening consistency), and oral health knowledge scores assessed via validated questionnaire during 2-week run-in period. Success defined as composite binary outcome: achieving both ≥1 additional brushing session per day AND ≥30 seconds increase in average brushing duration from baseline to 19 weeks, measured objectively by electronic toothbrush data collection system.
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Vivek Shetty, DDS, DMD, University of California, Los Angeles
- Investigators
- Vivek Shetty, DMD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167875
- Sponsor's protocol ID
- IRB-24-0661
- Other IDs
- UH3DE028723
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be made available to the research community 12 months after publication of primary analyses. External data requests require written proposals and institutional oversight documentation, subject to confidentiality agreements and Principal Investigator approval.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Digital Behavior Change Interventions to Optimize Oral Hygiene Behaviors: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07167875
- Acronym / sponsor ID
- IRB-24-0661
- Conditions
- Dental Disease, Behavioral Changes
- Keywords
- dental disease, digital interventions, behavioral changes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multisite randomized controlled trial is designed to evaluate whether a personalized Digital Oral Health Intervention (DOHI) can improve adherence to recommended oral hygiene behaviors compared to traditional oral hygiene instruction alone. The study addresses the persistent challenge of maintaining long-term oral hygiene habits by utilizing technology-facilitated coaching, adaptive intervention delivery, and reinforcement learning algorithms that respond to each participant's real-time brushing behaviors.
A total of 230 adults (aged 18 years and older) will be recruited from three community dental clinics in California: Dientes Community Dental Care (Santa Cruz County), Petaluma Health Center (Sonoma County), and University of California, Los Angeles (UCLA)Dental Clinics (Los Angeles County). Following baseline education in the recommended 2x2x4 brushing protocol (brushing twice daily for two minutes, covering all four dental quadrants) and a 2-week run-in period to ensure comfort with the electronic toothbrush system and study procedures, eligible participants will be randomized in equal numbers to either the intervention or control group.
Participants in the control group will continue with traditional oral hygiene instruction and receive standard feedback on their brushing patterns over the 19-week intervention period. The intervention group will also receive traditional instruction and standard feedback, but in addition they will be provided with personalized digital coaching through the DOHI platform. The DOHI integrates an electronic toothbrush and the Oralytics mobile application to deliver tailored feedback, educational resources, and motivational strategies such as micro-incentives. The system uses reinforcement learning algorithms to dynamically adjust the timing, frequency, and content of coaching prompts based on each participant's brushing data and engagement patterns, aiming to optimize involvement and support sustainable behavior change.
The primary outcome of the study is the change in participants' adherence to the recommended brushing frequency and duration, objectively measured from baseline through 19 weeks using data collected by the electronic toothbrush system. Secondary outcomes include analyses of individual-level factors-such as demographics, initial oral hygiene behaviors, and patterns of technology use-that may influence the effectiveness of the DOHI for promoting oral self-care.
The results of this trial are expected to provide evidence for the implementation of adaptive digital interventions to support oral health, with the potential for broad application in community dental care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intervention | Experimental | Behavioral: Personalized Digital Oral Health CoachingParticipants randomized to the intervention group will receive a personalized digital coaching promoting adherence to the 2x2x4 brushing routine. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Digital Oral Health CoachingAll 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. | Behavioural | Digital Intervention |
Primary outcome
Change in Daily Brushing Sessions as Measured by Electric Toothbrush Data Collection
Time frame: 19 weeks
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).
Mean Change in Daily Brushing Duration as Measured by Electric Toothbrush Data Collection
Time frame: 19 weeks
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.
2 secondary outcomes
Demographic Predictors of Digital Oral Health Intervention Response as Measured by Multivariable Logistic Regression Analysis
Time frame: 19 weeks
Baseline Oral Hygiene Behavior Predictors of Digital Intervention Success as Measured by Electronic Toothbrush Data Collection and Multivariable Regression Analysis
Time frame: 19 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be made available to the research community 12 months after publication of primary analyses. External data requests require written proposals and institutional oversight documentation, subject to confidentiality agreements and Principal Investigator approval.
Related trials for Dental Disease
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Enrolling by invitationObservational study
Knowledge of Vital Pulp Therapy in Permanent Teeth After Educational Programme: A Before and After Study
Pulp Disease, Dental, Knowledge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vivek Shetty, DMD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Digital Oral Health Coaching in people with Dental Disease and Behavioral Changes, run by University of California, Los Angeles at 2 sites 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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Daily Brushing Sessions as Measured by Electric Toothbrush Data Collection (time frame: 19 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.