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

Primary Purpose

Plaque, Dental

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Battery operated toothbrush
Manual toothbrush
Sponsored by
Church & Dwight Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque, Dental

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • All Sum Research Center Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Battery operated toothbrush

Manual toothbrush

Arm Description

battery operated toothbrush

Manual toothbrush

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2021
Last Updated
March 10, 2021
Sponsor
Church & Dwight Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04794452
Brief Title
Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush
Official Title
Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Church & Dwight Company, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Battery operated toothbrush
Arm Type
Active Comparator
Arm Description
battery operated toothbrush
Arm Title
Manual toothbrush
Arm Type
Active Comparator
Arm Description
Manual toothbrush
Intervention Type
Device
Intervention Name(s)
Battery operated toothbrush
Intervention Description
Device on plaque removal efficacy
Intervention Type
Device
Intervention Name(s)
Manual toothbrush
Intervention Description
Device on plaque removal efficacy
Primary Outcome Measure Information:
Title
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 5 to 8 years Be a regular manual toothbrush user. Exclusion Criteria: Have any physical limitations or restrictions which might preclude normal tooth brushing. Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments. Have fixed or removable orthodontic appliances.
Facility Information:
Facility Name
All Sum Research Center Ltd.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5N 6J2 C
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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