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Digital vs. Parent Modeled Toothbrushing

NCT07441148 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Plaque 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.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441148 on ClinicalTrials.gov