NCT06300073

Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children

Plaque Removal Efficacy of AutoBrush®, a 360 Degree Sonic Power Toothbrush in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Lander Enterprises, LLC · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush.

Detailed description

Up to 22 healthy children (5-8 years old) will be enrolled in a single-center, single-use, randomized, two-period, IRB approved cross-over study. Subjects will be randomly assigned to one of two treatment sequences: 1) brush two minutes with marketed children's manual toothbrush (MTB) or 2) brush 30 seconds with AutoBrush® 360° Sonic Toothbrush (AB) and fluoride toothpaste. Qualified subjects will have pre-brushing supragingival plaque levels ≥ 1.8 according to the Lobene-Soparkar Modified Turesky Modification of the Quigley-Hein Plaque Index (PI), following 12-16 hours plaque accumulation period. Under parent's supervision, subjects brushed at home with their assigned toothbrush, twice daily during a 2-day familiarization period. After refraining (12-16 hours) from oral hygiene, subjects returned for plaque assessment, supervised use of their assigned toothbrush and a post-brushing plaque evaluation. Subjects were given the second toothbrush to begin the next 2-day familiarization period and second period evaluation procedures. Analysis of covariance (ANCOVA) will be used for single-use brushing PI models to assess whole mouth and 8 other hard-to-reach tooth sites.

Conditions

• Dental Plaque

Interventions

Type	Name	Description
DEVICE	Experimental: U-shaped Power Toothbrush	Twice daily brushing for 30 seconds with fluoride toothpaste
DEVICE	Placebo Comparator: Soft Manual Toothbrush	Twice daily brushing for 2 minutes with fluoride toothpaste

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States