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

Plaque, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794452
• Other study ID #: ST-20-U82
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: March 2021
• Source: Church & Dwight Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Plaque, Dental

Intervention

Device:
• Battery operated toothbrush
Device on plaque removal efficacy
• Manual toothbrush
Device on plaque removal efficacy

Locations

Country	Name	City	State
Canada	All Sum Research Center Ltd.	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Church & Dwight Company, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 weeks