Self-selection Study of the Toothwave Toothbrush

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

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).

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque; Tooth Discoloration; Calculus
• Intervention / Treatment: Device: Toothwave toothbrush

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Hellman Dermatology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toothwave contraindicated subject; 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; 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.
Active Comparator: potential users of the Toothwave device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Home Skinovations Ltd.
• Investigators: Principal Investigator: Judith Hellman, MD, Hellman Dermatology clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Gingival Diseases; Tooth Diseases; Gingivitis; Calculi; Tooth Discoloration
• Other Study ID Numbers: DO116508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No