Self-selection Study of the Toothwave Toothbrush

Completed · Not applicable

Conditions studied: Gingivitis, Plaque, Calculus, Tooth Discoloration

In brief

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 and the ability to understand accurately the labeling content (box and user manual).

Key facts

Study ID

NCT04023097

Run by

Home Skinovations Ltd.

People needed

10

Starts

2019-07-02

Expected to finish

2019-07-09

Last updated by the study team

2020-11-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Hellman Dermatology clinic — New York, New York, United States

Full record on ClinicalTrials.gov

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