Self-selection Study of the Toothwave Toothbrush

Not Applicable

Completed

• Conditions: Plaque; Tooth Discoloration; Gingivitis; Calculus
• Interventions: Device: Toothwave toothbrush

• Registration Number: NCT04023097
• Lead Sponsor: Home Skinovations Ltd.

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

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 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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-02
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Subject is male or female equal to or greater than 18 years of age.
2. Subject is a potential candidate for purchasing the Silk'n Toothwave Device.
3. Subject is capable of understanding and is willing to sign informed consent.

Exclusion Criteria

1. Current or history of oral cavity cancer or oropharyngeal cancer.
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
3. Pregnant or nursing.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.

Modified Inclusion Criteria for contraindicated subjects:

1. Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
2. Subject is pregnant or nursing (lactating).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
potential users of the Toothwave device	Toothwave toothbrush	The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users.
Toothwave contraindicated subject	Toothwave toothbrush	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.

Primary Outcome Measures

Name	Time	Method
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not.	30 minutes	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.

Trial Locations

Locations (1)

Hellman Dermatology clinic; 🇺🇸 New York, New York, United States