ToothWave Plaque and Gingivitis Study
NCT03885323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2020-11-25
Summary
The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.
Conditions
- Gingivitis
- Plaque
- Calculus, Dental
Interventions
- DEVICE
-
RF utilizing powered toothbrush
RF utilizing Powered toothbrush
- DEVICE
-
Control placebo with no RF
Placebo control, with no RF
Sponsors & Collaborators
-
Home Skinovations Ltd.
lead INDUSTRY
Principal Investigators
-
Jeffry L. Milleman, DDS, MPA · Salus Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-28
- Primary Completion
- 2019-04-15
- Completion
- 2019-04-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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