To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.
This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. This study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups. After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Device on plaque removal efficacy
Device on plaque removal efficacy
All Sum Research Center Ltd.
Mississauga, Ontario, Canada
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
Time frame: up to 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.