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

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.

Study Overview

• Status: Completed
• Conditions: Plaque, Dental
• Intervention / Treatment: Device: Battery operated toothbrush; Device: Manual toothbrush

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5N 6J2 C
      • All Sum Research Center Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Battery operated toothbrush; battery operated toothbrush	Device: Battery operated toothbrush; Device on plaque removal efficacy
Active Comparator: Manual toothbrush	Device: Manual toothbrush; Device on plaque removal efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: ST-20-U82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No