An interventional study of Toothwave toothbrush in Gingivitis, Plaque and Calculus, sponsored by Home Skinovations Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by Home Skinovations Ltd. · Not applicable, Interventional, and Screening
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).
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 intended for distribution.
All subjects will sign an informed consent before any study activity. Five (5) potential end users and Additional five (5) contraindicated subjects will be screened for this self-selection study. Subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual).
Once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content.
The study will not include treatment.
Exclusion Criteria:
Modified Inclusion Criteria for contraindicated subjects:
the Toothwave toothbrush is contraindicated for people in certain conditions, e.g. pregnant or nursing women, people with pacemaker and more. This arm is assembled from contraindicated subject, who should exclude themselves from use of the device, based on the user manual and box sleeve.
Device: Toothwave toothbrush
The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users.
Device: Toothwave toothbrush
Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not.
Post-reading questionnaire includes the question: "are you allowed to use this device?". Based on reading the user manual and box labeling, subjects should answer "yes" or "no" according to their condition.
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Home Skinovations Ltd.