Trials / Completed
CompletedNCT06122376
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
Clinical 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
- 75 (actual)
- Sponsor
- Lander Enterprises, LLC · Industry
- Sex
- All
- Age
- 5 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | U-shaped Power Toothbrush | Twice daily brushing for 30 seconds with fluoride toothpaste |
| DEVICE | Soft Manual Toothbrush | Twice daily brushing for two minutes with fluoride toothpaste |
Timeline
- Start date
- 2023-05-31
- Primary completion
- 2023-07-14
- Completion
- 2023-07-14
- First posted
- 2023-11-08
- Last updated
- 2023-11-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06122376. Inclusion in this directory is not an endorsement.