Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-31 @ 8:54 PM
Study NCT ID:
NCT06126250
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of U-Shaped Sonic Toothbrush on Plaque and Gingivitis
Sponsor:
Lander Enterprises, LLC
Organization:
Study Overview
Official Title:
Clinical Evaluation of the 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 goal of this 30 day, randomized, two group, parallel, examiner-blind clinical study is to evaluate the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on supragingival dental 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 designs 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, be 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, and days 15 and 30 post-baseline. Oral safety, 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 a 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:
False
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?: