Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06122376
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2023-11-05
Brief Title:
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
Sponsor:
Lander Enterprises LLC
Organization:
Lander Enterprises LLC
Study Overview
Official Title:
Clinical Safety and Efficacy of AutoBrush 360 U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model
Status:
COMPLETED
Status Verified Date:
2023-11
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 30 day randomized two group parallel examiner-blind clinical trial is to assess the safety and efficacy of AutoBrush 360 U-shaped Sonic Toothbrush on plaque and gingivitis compared to an American Dental Association ADA reference manual soft toothbrush The extent of gingival abrasion and recession and oral safety will be evaluated
Detailed Description:
This single-center randomized controlled examiner-blind 30-day parallel study will consist of Screening and Baseline visits with approximately 80 subjects age 5-65 years who will read and sign an informed consent form and assent form assessed for evidence of gingivitis and plaque according to the Modified Gingival Index MGI and the Lobene-Soparkar Modification of Turesky Modified Quigley-Hein Plaque Index LSPI at Baseline Day 15 and Day 30 Gingival recession and gingival abrasion will be measured at all visits Subjects will be randomly assigned to one of two groups twice daily brushing with ADA accepted fluoride toothpaste and 1 two-minute brushing with ADA reference standard manual toothbrush or 2 30-second brushing with AutoBrush 360 U-shaped Sonic Toothbrush
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?:
False
Is an FDA AA801 Violation?:
None