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OpenTrials
Completed

NCT Number: NCT04794452

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

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Key information

Conditions

Plaque, Dental Dental Deposits Dental Plaque Stomatognathic Diseases Tooth Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2 C, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Battery operated toothbrush

Device

Device on plaque removal efficacy

Manual toothbrush

Device

Device on plaque removal efficacy

Primary outcomes

  1. Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2021
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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