Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
NCT06122376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2023-11-08
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.
Conditions
- Plaque Induced Gingivitis
Interventions
- 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
Sponsors & Collaborators
-
Lander Enterprises, LLC
lead INDUSTRY
Principal Investigators
-
Jeffery L Milleman · Salus Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-31
- Primary Completion
- 2023-07-14
- Completion
- 2023-07-14
Countries
- United States
Study Locations
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