NCT07441148 · University of Southern California
Digital vs. Parent Modeled Toothbrushing
What this study is about
This forward-looking randomly assigned controlled trial will aim to evaluate the effectiveness of two methods of delivering taken by mouth hygiene instruction to children aged 3 - 6 years: parent-modeled toothbrushing (control) and the MoodBrush digital application (experimental).
View original scientific description
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.
Interventions
DEVICE
MoodBrush Digital Application
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.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations