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RECRUITING
NCT07441148
NA

Digital vs. Parent Modeled Toothbrushing

Sponsor: University of Southern California

View on ClinicalTrials.gov

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). 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.

Official title: Plaque Reduction: Digital vs. Parental Toothbrushing Instruction in Pediatric Patients

Key Details

Gender

All

Age Range

3 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-01-05

Completion Date

2027-06-30

Last Updated

2026-02-27

Healthy Volunteers

Yes

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.

Locations (1)

University of Southern California

Los Angeles, California, United States