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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04794452

Enrollment

Registered

2021-03-12

Start date

2020-11-23

Completion date

2020-12-11

Last updated

2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque, Dental

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.

Interventions

DEVICEBattery operated toothbrush

Device on plaque removal efficacy

DEVICEManual toothbrush

Device on plaque removal efficacy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 8 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026