NCT06126250

Safety and Efficacy of U-Shaped Sonic Toothbrush on Plaque and Gingivitis

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Lander Enterprises, LLC · Industry
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plaque Induced Gingivitis

Interventions

Type	Name	Description
DEVICE	Power sonic toothbrush	Subjects will brush twice daily for 30 seconds using a fluoride toothpaste.
DEVICE	Manual toothbrush	Subjects will brush twice daily for 2 minutes using a fluoride toothpaste.

Timeline

• Start date: 2023-09-11
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

1 site across 1 country: United States