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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2020-12-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Plaque, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Battery operated toothbrush

battery operated toothbrush

Group Type ACTIVE_COMPARATOR

Battery operated toothbrush

Intervention Type DEVICE

Device on plaque removal efficacy

Manual toothbrush

Group Type ACTIVE_COMPARATOR

Manual toothbrush

Intervention Type DEVICE

Device on plaque removal efficacy

Interventions

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Battery operated toothbrush

Device on plaque removal efficacy

Intervention Type DEVICE

Manual toothbrush

Device on plaque removal efficacy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes