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

Not Applicable

Completed

• Conditions: Plaque, Dental

• Registration Number: NCT04794452
• Lead Sponsor: Church & Dwight Company, Inc.

Brief 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.

Study Timeline

• Study Start: 2020-11-23
• Primary Completion: 2020-12-11
• Study Completion: 2020-12-11
• Study First Submitted: 2021-02-14
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-12
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 5 to 8 years
2. Be a regular manual toothbrush user.

Exclusion Criteria

1. Have any physical limitations or restrictions which might preclude normal tooth brushing.
2. Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
3. Have fixed or removable orthodontic appliances.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal	up to 2 weeks	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.

Trial Locations

Locations (1)

All Sum Research Center Ltd.; 🇨🇦 Mississauga, Ontario, Canada