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Comparison of Effectiveness of Autobrush vs Manual Toothbrush, Children 9-12

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Summary

The NIH National Library of Medicine registered clinical trial NCT07537803, a randomized crossover study comparing the effectiveness of an Autobrush U-shaped toothbrush versus a manual regular toothbrush in children aged 9-12 years. The study will measure Full Mouth Plaque Scores using disclosing tablets and assess both brushing techniques. Participants avoid oral cleaning procedures 12 hours before appointments.

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What changed

NIH registered clinical trial NCT07537803, a randomized crossover study comparing an Autobrush U-shaped toothbrush with a manual regular toothbrush among children aged 9-12 years. The study assesses Full Mouth Plaque Scores using disclosing tablets, with participants serving as their own controls in a two-phase intervention design.

This study registration represents procedural documentation for a dental research project. Compliance teams at healthcare institutions conducting pediatric dental research should note this registry entry for awareness of ongoing comparative effectiveness research in oral hygiene products for children. The findings may inform future clinical practice recommendations but do not create immediate compliance obligations.

Archived snapshot

Apr 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Comparison of The Effectiveness of Autobrush (U-shaped Toothbrush) Versus Manual Regular Toothbrush Among Children Aged From 9-12 Years

N/A NCT07537803 Kind: NA Apr 17, 2026

Abstract

Demographic information were collected from the participants. Assigned the participant to the intervention group. Participants were instructed to avoid all kinds of oral cleaning procedures approximately 12 hours before their appointments.

To assess the Full Mouth Plaque Score using a disclosing tablet.

participants were assigned to the Autobrush (U-shaped toothbrush) (Manual bundle with double-sided nylon brush head U-shaped fits 9-12 Years, San Diego, California).

First: Manual regular toothbrush (R):

Modified Bass Technique for the mixed dentition was used.

Second: Autobrush U-shaped Toothbrush (U) was used.

Subsequently, the examiner conducted a second FMPS examination.

Conditions: Full Mouth Plaque Score (FMPS)

Interventions: Manual regular toothbrush, Autobrush U-shaped Toothbrush

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Last updated

Classification

Agency
NIH
Published
April 17th, 2024
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537803

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial design Oral hygiene assessment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Clinical Operations

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