Status:
COMPLETED
Self-selection Study of the Toothwave Toothbrush
Lead Sponsor:
Home Skinovations Ltd.
Conditions:
Gingivitis
Plaque
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device...
Detailed Description
The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format inten...
Eligibility Criteria
Inclusion
- Subject is male or female equal to or greater than 18 years of age.
- Subject is a potential candidate for purchasing the Silk'n Toothwave Device.
- Subject is capable of understanding and is willing to sign informed consent.
Exclusion
- Current or history of oral cavity cancer or oropharyngeal cancer.
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Pregnant or nursing.
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
- Modified Inclusion Criteria for contraindicated subjects:
- Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
- Subject is pregnant or nursing (lactating).
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04023097
Start Date
July 2 2019
End Date
July 9 2019
Last Update
November 24 2020
Active Locations (1)
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1
Hellman Dermatology clinic
New York, New York, United States, 10019