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Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model

Plaque Induced Gingivitis Clinical Trial

Official title:
Clinical Safety and Efficacy of AutoBrush® 360° U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06122376
Study type Interventional
Source Lander Enterprises, LLC
Contact
Status Completed
Phase N/A
Start date May 31, 2023
Completion date July 14, 2023
View Details
See also
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