Actively Recruiting

Phase Not Applicable
Age: 3Years - 6Years
All Genders
Healthy Volunteers
NCT07441148

Digital vs. Parent Modeled Toothbrushing

Led by University of Southern California · Updated on 2026-02-27

112

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Digital vs. Parent Modeled Toothbrushing

Who Can Participate

Age: 3Years - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 6 years attending recall dental visits at AltaMed (Sunflower) or USC Advanced Pediatric Dental Clinic
  • ASA physical status classification I or II
  • Must speak English or Spanish
  • Behavior rating of Frankl 3 or 4 (positive or definitely positive behavior)
Not Eligible

You will not qualify if you...

  • Physical limitations preventing adequate oral hygiene
  • Extensive tooth decay preventing accurate plaque index readings
  • Teeth needed for plaque scoring not fully erupted or missing
  • Behavior that prevents cooperation during exam and toothbrushing
  • Inability to brush teeth for a full two minutes

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Southern California

Los Angeles, California, United States, 90089

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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