112 Participants NeededMy employer runs this trial

MoodBrush App for Gingivitis

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

My child is 3-6 years old and is coming for a recall dental visit at the specified clinics.
ASA I or II
I speak English or Spanish and can cooperate well during exams.

Exclusion Criteria

Extensive caries preventing accurate readings on plaque index
Teeth needed for plaque score have not fully erupted or missing
Behavior prevents them from cooperating for exam and toothbrushing
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive oral hygiene instruction through either parent-modeled toothbrushing or the MoodBrush digital application, followed by plaque index scoring.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for immediate post-brushing plaque index scores to assess the effectiveness of the intervention.

Immediate post-treatment
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • MoodBrush Digital Application

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MoodBrush Digital ApplicationExperimental Treatment1 Intervention
Group II: Parent ModelingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+