MoodBrush App for Gingivitis
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral hygiene instruction through either parent-modeled toothbrushing or the MoodBrush digital application, followed by plaque index scoring.
Follow-up
Participants are monitored for immediate post-brushing plaque index scores to assess the effectiveness of the intervention.
What Are the Treatments Tested in This Trial?
Interventions
- MoodBrush Digital Application
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Parent and child will be present for the visualization of MoodBrush tooth brushing phone application and participant will brush along with instruction provided by the application for two minutes with visual application instruction of 30 seconds per quadrant. The phone application will be present on a tablet in the dental clinic, the patient does not need to download the phone application on their personal device. New plaque score will be taken and recorded after brushing. For the phone application modeled brushing, parents will not be expected to participate in the brushing intervention portion. Parents will only be required to take the parent survey for this group.
Parent and child will then brush their teeth together for two minutes with observation by dental team. Parent and child will be provided toothbrush and will be asked to model proper brushing technique for their child as they would instruct at home. A timer will be set for two minutes to aid in brushing instruction. New plaque score of the child will be taken and recorded after brushing In the parent modeled brushing group, parents will be expected to provide brushing instructions along side their child while brushing with them for 2 minutes. No additional data will be collected from their parent. No plaque scores for parent will be recorded. Parents will be required to take parent survey for this group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
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