Self-selection Study of the Toothwave Toothbrush

Gingivitis Clinical Trial

Official title:

Self-selection Study to Confirm the "Toothwave" Labeling and User Manual Are Clear Enough for Contraindicated Users to Self-exclude Themselves From Using the Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023097
• Other study ID #: DO116508
• Status: Completed
• Phase: N/A
• Start date: July 2, 2019
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2019
• Source: Home Skinovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Calculi
• Calculus
• Gingivitis
• Plaque
• Tooth Discoloration

Intervention

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.

Locations

Country	Name	City	State
United States	Hellman Dermatology clinic	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Home Skinovations Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes