Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300073
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-02-29
Brief Title:
Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children
Sponsor:
Lander Enterprises LLC
Organization:
Lander Enterprises LLC
Study Overview
Official Title:
Plaque Removal Efficacy of AutoBrush a 360 Degree Sonic Power Toothbrush in Children
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childrens 360 sonic toothbrush compared to a marketed childrens 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 childrens 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 18 according to the Lobene-Soparkar Modified Turesky Modification of the Quigley-Hein Plaque Index PI following 12-16 hours plaque accumulation period Under parents 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None