NCT04794452

Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush

Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Plaque, Dental

Interventions

Type	Name	Description
DEVICE	Battery operated toothbrush	Device on plaque removal efficacy
DEVICE	Manual toothbrush	Device on plaque removal efficacy

Timeline

• Start date: 2020-11-23
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2021-03-12
• Last updated: 2021-03-12

Locations

1 site across 1 country: Canada