About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASA I or II
children aged 3-6 years presenting for recall dental visit at AltaMed (Sunflower) clinic or USC Advanced Pediatric Dental Clinic
must speak English or Spanish, Frankl 3 or 4.
Disqualifiers
Physical limitations that would prevent adequate oral hygiene
Extensive caries preventing accurate readings on plaque index,
Teeth needed for plaque score have not fully erupted or missing
If behavior prevents them from cooperating for exam and toothbrushing
Trial design
Parallel
Treatments tested in this trial
MoodBrush Digital Application
DeviceMoodBrush 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.
Treatment groups
Trial outcomes
Primary outcomes
Plaque Index Score
The primary outcome of this study is the change in plaque index scores before and after toothbrushing using two different methods. Through the measurements of 12 different tooth surfaces as per the Silness and Loe Plaque Index, the plaque scores recorded will be used to assess the immediate effectiveness of each anticipatory guidance method, both parent modeled instruction versus the MoodBrush digital application. Silness and Loe Plaque Index: dental scoring system that measures the thickness of plaque at the gingival margin, giving a score of 0 (no plaque) to 3 (heavy accumulation).
Sponsors and contacts
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