Plaque ReductionNCT07441148
Digital vs. Parent Modeled Toothbrushing
A study testing MoodBrush Digital Application in people with Plaque Reduction, run by University of Southern California at 1 site in United States.
Trial summary
This prospective randomized controlled trial will aim to evaluate the effectiveness of two methods of delivering oral hygiene instruction to children aged 3 - 6 years: parent-modeled toothbrushing (control) and the MoodBrush digital application (experimental). Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Reduction
- What is being tested?
- MoodBrush Digital Application
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 30 Jun 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I or II
- children aged 3-6 years presenting for recall dental visit at AltaMed (Sunflower) clinic or USC Advanced Pediatric Dental Clinic
- must speak English or Spanish, Frankl 3 or 4.
Who cannot join
- Physical limitations that would prevent adequate oral hygiene
- Extensive caries preventing accurate readings on plaque index,
- Teeth needed for plaque score have not fully erupted or missing
- If behavior prevents them from cooperating for exam and toothbrushing
- Inability to brush for full two minutes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Catherine Pham, DDS, 213-740-0412, cathph@ostrow.usc.edu
About this study
Official title: Plaque Reduction: Digital vs. Parental Toothbrushing Instruction in Pediatric Patients
This prospective randomized controlled trial will aim to evaluate the effectiveness of two methods of delivering oral hygiene instruction to children aged 3 - 6 years: parent-modeled toothbrushing (control) and the MoodBrush digital application (experimental). The primary endpoint is the change in plaque index scores before and after brushing, measured on 12 tooth surfaces using the Silness and Loe Plaque Index. The study rationale is based in the need to identify efficient and engaging strategies to improve pediatric oral hygiene. The expected outcome is that both groups will demonstrate significant reductions in plaque scores, with children using MoodBrush achieving similar, if not greater improvements in plaque index scores. Follow-up includes an immediate post-brushing assessment at the dental visit, with intrarater reliability checks to ensure measurement consistency. Statistical analyses will include paired t-tests to evaluate pre-post changes within groups and two-sample t-tests to compare differences between groups, with significance set at p < 0.05. A sample size of 112 participants provides 80% power to detect a mean difference of 0.30 in plaque index score reduction.
Read the detailed description
This study is a prospective randomized control trial. The study will be conducted at the Altamed Clinic (Sunflower location) and the University of Southern California Advanced Pediatric Dental Clinic. Established patients of record that are 3-6 years old who meet inclusion criteria will qualify. A recruitment script will be used to recruit patients into the study. If parents of patients agree to participate in the study, they will sign all informed consents.
Participants will be randomly assigned to two groups by block randomization and having pre-assigned envelopes in numeric order for each participant. The envelopes will then be stored in a folder; once a participant consents to enroll in the study, the envelope will be drawn in numeric order determining the participants group to ensure it is randomized. The control group will be provided oral hygiene instructions in the form of modeling brushing with a parent or caretaker. The experimental group will be provided oral hygiene instructions in the form of a phone application called "MoodBrush" to teach children how to properly brush.
MoodBrush is a helpful app that aids in teaching children how to brush their teeth. The application uses bright colors and graphics to show children where to brush their teeth and has a timer for each quadrant to ensure equal brushing time for each portion of the teeth (Appendix I). MoodBrush is free to download has no in app purchases that will be made during study and is compatible with Apple devices. Parents will not need to download app for participation in this study.
No intervention monitoring will be needed for this study. Principal investigator will be present during all procedures to ensure study is conducted in appropriate manner. Completion of parent survey will serve as record for study participation.
The study will follow a series of systematic steps within standard of care as well as additional steps as part of the study design.
These steps will include: Parent survey (study design), dental exam (standard of care), initial plaque score recorded through visual examination of teeth using intraoral mirror and dental explorer (study design), brushing intervention either part of control or experimental group (study design), post brushing plaque score recorded through visual examination of teeth using intraoral mirror and dental explorer (study design), dental cleaning (standard of care), nutritional counseling (standard of care), oral hygiene instructions (standard of care), and fluoride varnish (standard of care).
3.1 Control Group: Parent of patient will receive a brief survey to assess their oral health education level including their current oral hygiene practices at home. Documentation of plaque index of patient will be done using the Silness and Loe Plaque Index scoring 0-3 on 12 teeth surfaces. Surfaces of teeth will be evaluated using visual examination using intraoral mirror and dental explorer. The surfaces will include #A buccal and lingual, #E buccal and lingual, #J buccal and lingual, #K buccal and lingual, #O buccal and lingual, #T buccal and lingual. Parent and child will then brush their teeth together for two minutes with observation by dental team. Parent and child will be provided toothbrush and will be asked to model proper brushing technique for their child as they would instruct at home. A timer will be set for two minutes to aid in brushing instruction. New plaque score of the child will be taken and recorded after brushing
In the parent modeled brushing group, parents will be expected to provide brushing instructions along side their child while brushing with them for 2 minutes. No additional data will be collected from their parent. No plaque scores for parent will be recorded. Parents will be required to take parent survey for this group.
3.2 Experimental Group: Parent of patient will receive a brief survey to assess their oral health education level including their current oral hygiene practices at home. Documentation of plaque index of the patient will be done using the Silness and Loe Plaque Index scoring 0-3 on 12 teeth surfaces. Surfaces of teeth will be evaluated using visual examination using intraoral mirror and dental explorer. The surfaces will include #A buccal and lingual, #E buccal and lingual, #J buccal and lingual, #K buccal and lingual, #O buccal and lingual, #T buccal and lingual. Parent and child will be present for the visualization of MoodBrush tooth brushing phone application and participant will brush along with instruction provided by the application for two minutes with visual application instruction of 30 seconds per quadrant. The phone application will be present on a tablet in the dental clinic, the patient does not need to download the phone application on their personal device. New plaque score will be taken and recorded after brushing.
For the phone application modeled brushing, parents will not be expected to participate in the brushing intervention portion. Parents will only be required to take the parent survey for this group.
Plaque index will be obtained by one provider. Intrarater reliability will be evaluated to ensure consistency.
Participants will only have data collected during one recall dental appointment. All information will be collected on that day and patients will not need to return for follow up in regards to this study. No parent log will be needed due to no continued monitoring for the purpose of this study.
- Conditions
- Plaque Reduction
- Being tested
- MoodBrush Digital Application
- Keywords
- toothbrushing, plaque, digital application
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodBrush Digital ApplicationDevice
MoodBrush is a helpful app that aids in teaching children how to brush their teeth. The application uses bright colors and graphics to show children where to brush their teeth and has a timer for each quadrant to ensure equal brushing time for each portion of the teeth (Appendix I). MoodBrush is free to download has no in app purchases that will be made during study and is compatible with Apple devices. Parents will not need to download app for participation in this study.
| Study group | Role | What they receive |
|---|---|---|
| MoodBrush Digital Application | Experimental | Parent and child will be present for the visualization of MoodBrush tooth brushing phone application and participant will brush along with instruction provided by the application for two minutes with visual application instruction of 30 seconds per quadrant. The phone application will be present on a tablet in the dental clinic, the patient does not need to download the phone application on their personal device. New plaque score will be taken and recorded after brushing.
For the phone application modeled brushing, parents will not be expected to participate in the brushing intervention portion. Parents will only be required to take the parent survey for this group. Receives: Device: MoodBrush Digital Application |
| Parent Modeling | No intervention | Parent and child will then brush their teeth together for two minutes with observation by dental team. Parent and child will be provided toothbrush and will be asked to model proper brushing technique for their child as they would instruct at home. A timer will be set for two minutes to aid in brushing instruction. New plaque score of the child will be taken and recorded after brushing In the parent modeled brushing group, parents will be expected to provide brushing instructions along side their child while brushing with them for 2 minutes. No additional data will be collected from their parent. No plaque scores for parent will be recorded. Parents will be required to take parent survey for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index Score
The primary outcome of this study is the change in plaque index scores before and after toothbrushing using two different methods. Through the measurements of 12 different tooth surfaces as per the Silness and Loe Plaque Index, the plaque scores recorded will be used to assess the immediate effectiveness of each anticipatory guidance method, both parent modeled instruction versus the MoodBrush digital application.
Silness and Loe Plaque Index: dental scoring system that measures the thickness of plaque at the gingival margin, giving a score of 0 (no plaque) to 3 (heavy accumulation).
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque ReductionStudies of the same condition, open and under way.
- 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Pham, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441148
- Sponsor's protocol ID
- HS-25-00386
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Reduction: Digital vs. Parental Toothbrushing Instruction in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07441148
- Acronym / sponsor ID
- HS-25-00386
- Conditions
- Plaque Reduction
- Keywords
- toothbrushing, plaque, digital application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
This prospective randomized controlled trial will aim to evaluate the effectiveness of two methods of delivering oral hygiene instruction to children aged 3 - 6 years: parent-modeled toothbrushing (control) and the MoodBrush digital application (experimental). The primary endpoint is the change in plaque index scores before and after brushing, measured on 12 tooth surfaces using the Silness and Loe Plaque Index. The study rationale is based in the need to identify efficient and engaging strategies to improve pediatric oral hygiene. The expected outcome is that both groups will demonstrate significant reductions in plaque scores, with children using MoodBrush achieving similar, if not greater improvements in plaque index scores. Follow-up includes an immediate post-brushing assessment at the dental visit, with intrarater reliability checks to ensure measurement consistency. Statistical analyses will include paired t-tests to evaluate pre-post changes within groups and two-sample t-tests to compare differences between groups, with significance set at p < 0.05. A sample size of 112 participants provides 80% power to detect a mean difference of 0.30 in plaque index score reduction.
Detailed description
This study is a prospective randomized control trial. The study will be conducted at the Altamed Clinic (Sunflower location) and the University of Southern California Advanced Pediatric Dental Clinic. Established patients of record that are 3-6 years old who meet inclusion criteria will qualify. A recruitment script will be used to recruit patients into the study. If parents of patients agree to participate in the study, they will sign all informed consents.
Participants will be randomly assigned to two groups by block randomization and having pre-assigned envelopes in numeric order for each participant. The envelopes will then be stored in a folder; once a participant consents to enroll in the study, the envelope will be drawn in numeric order determining the participants group to ensure it is randomized. The control group will be provided oral hygiene instructions in the form of modeling brushing with a parent or caretaker. The experimental group will be provided oral hygiene instructions in the form of a phone application called "MoodBrush" to teach children how to properly brush.
MoodBrush is a helpful app that aids in teaching children how to brush their teeth. The application uses bright colors and graphics to show children where to brush their teeth and has a timer for each quadrant to ensure equal brushing time for each portion of the teeth (Appendix I). MoodBrush is free to download has no in app purchases that will be made during study and is compatible with Apple devices. Parents will not need to download app for participation in this study.
No intervention monitoring will be needed for this study. Principal investigator will be present during all procedures to ensure study is conducted in appropriate manner. Completion of parent survey will serve as record for study participation.
The study will follow a series of systematic steps within standard of care as well as additional steps as part of the study design.
These steps will include: Parent survey (study design), dental exam (standard of care), initial plaque score recorded through visual examination of teeth using intraoral mirror and dental explorer (study design), brushing intervention either part of control or experimental group (study design), post brushing plaque score recorded through visual examination of teeth using intraoral mirror and dental explorer (study design), dental cleaning (standard of care), nutritional counseling (standard of care), oral hygiene instructions (standard of care), and fluoride varnish (standard of care).
3.1 Control Group: Parent of patient will receive a brief survey to assess their oral health education level including their current oral hygiene practices at home. Documentation of plaque index of patient will be done using the Silness and Loe Plaque Index scoring 0-3 on 12 teeth surfaces. Surfaces of teeth will be evaluated using visual examination using intraoral mirror and dental explorer. The surfaces will include #A buccal and lingual, #E buccal and lingual, #J buccal and lingual, #K buccal and lingual, #O buccal and lingual, #T buccal and lingual. Parent and child will then brush their teeth together for two minutes with observation by dental team. Parent and child will be provided toothbrush and will be asked to model proper brushing technique for their child as they would instruct at home. A timer will be set for two minutes to aid in brushing instruction. New plaque score of the child will be taken and recorded after brushing
In the parent modeled brushing group, parents will be expected to provide brushing instructions along side their child while brushing with them for 2 minutes. No additional data will be collected from their parent. No plaque scores for parent will be recorded. Parents will be required to take parent survey for this group.
3.2 Experimental Group: Parent of patient will receive a brief survey to assess their oral health education level including their current oral hygiene practices at home. Documentation of plaque index of the patient will be done using the Silness and Loe Plaque Index scoring 0-3 on 12 teeth surfaces. Surfaces of teeth will be evaluated using visual examination using intraoral mirror and dental explorer. The surfaces will include #A buccal and lingual, #E buccal and lingual, #J buccal and lingual, #K buccal and lingual, #O buccal and lingual, #T buccal and lingual. Parent and child will be present for the visualization of MoodBrush tooth brushing phone application and participant will brush along with instruction provided by the application for two minutes with visual application instruction of 30 seconds per quadrant. The phone application will be present on a tablet in the dental clinic, the patient does not need to download the phone application on their personal device. New plaque score will be taken and recorded after brushing.
For the phone application modeled brushing, parents will not be expected to participate in the brushing intervention portion. Parents will only be required to take the parent survey for this group.
Plaque index will be obtained by one provider. Intrarater reliability will be evaluated to ensure consistency.
Participants will only have data collected during one recall dental appointment. All information will be collected on that day and patients will not need to return for follow up in regards to this study. No parent log will be needed due to no continued monitoring for the purpose of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoodBrush Digital Application | Experimental | Device: MoodBrush Digital ApplicationParent and child will be present for the visualization of MoodBrush tooth brushing phone application and participant will brush along with instruction provided by the application for two minutes with visual application instruction of 30 seconds per quadrant. The phone application will be present on a tablet in the dental clinic, the patient does not need to download the phone application on their personal device. New plaque score will be taken and recorded after brushing. For the phone application modeled brushing, parents will not be expected to participate in the brushing intervention portion. Parents will only be required to take the parent survey for this group. |
| Parent Modeling | No intervention | –Parent and child will then brush their teeth together for two minutes with observation by dental team. Parent and child will be provided toothbrush and will be asked to model proper brushing technique for their child as they would instruct at home. A timer will be set for two minutes to aid in brushing instruction. New plaque score of the child will be taken and recorded after brushing In the parent modeled brushing group, parents will be expected to provide brushing instructions along side their child while brushing with them for 2 minutes. No additional data will be collected from their parent. No plaque scores for parent will be recorded. Parents will be required to take parent survey for this group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I or II
- children aged 3-6 years presenting for recall dental visit at AltaMed (Sunflower) clinic or USC Advanced Pediatric Dental Clinic
- must speak English or Spanish, Frankl 3 or 4.
Key exclusion criteria (5 listed)
- Physical limitations that would prevent adequate oral hygiene
- Extensive caries preventing accurate readings on plaque index,
- Teeth needed for plaque score have not fully erupted or missing
- If behavior prevents them from cooperating for exam and toothbrushing
- Inability to brush for full two minutes.
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 |
|---|---|---|
| MoodBrush Digital ApplicationMoodBrush is a helpful app that aids in teaching children how to brush their teeth. The application uses bright colors and graphics to show children where to brush their teeth and has a timer for each quadrant to ensure equal brushing time for each portion of the teeth (Appendix I). MoodBrush is free to download has no in app purchases that will be made during study and is compatible with Apple devices. Parents will not need to download app for participation in this study. | Device | MoodBrush Digital Application |
Primary outcome
Plaque Index Score
Time frame: Perioperative
The primary outcome of this study is the change in plaque index scores before and after toothbrushing using two different methods. Through the measurements of 12 different tooth surfaces as per the Silness and Loe Plaque Index, the plaque scores recorded will be used to assess the immediate effectiveness of each anticipatory guidance method, both parent modeled instruction versus the MoodBrush digital application. Silness and Loe Plaque Index: dental scoring system that measures the thickness of plaque at the gingival margin, giving a score of 0 (no plaque) to 3 (heavy accumulation).
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 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Plaque Reduction
Not yet recruiting
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
Autism Disorder, Autism Spectrum Disorder (ASD
RecruitingPhase 3
Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
Plaque, Dental Plaque
RecruitingEarly Phase 1
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort
Atherosclerotic Cardiovascular Disease, Acute Coronary Syndromes
Not yet recruitingPhase 4
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
Coronary Artery Disease, Hypercholesterolemia
Not yet recruiting
Clinical Assessment of the Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush
Gingivitis, Gingival Bleeding
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoodBrush Digital Application in people with Plaque Reduction, run by University of Southern California 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 3 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index Score (time frame: Perioperative). 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 27 Feb 2026.