Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT06126250
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:
NCT06126250
Study Brief:
Protocol Section:
NCT06126250