Self-selection Study of the Toothwave Toothbrush
Primary Purpose
Gingivitis, Plaque, Calculus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toothwave toothbrush
Sponsored by
About this trial
This is an interventional screening trial for Gingivitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Hellman Dermatology clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Toothwave contraindicated subject
potential users of the Toothwave device
Arm Description
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.
The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04023097
First Posted
July 11, 2019
Last Updated
November 23, 2020
Sponsor
Home Skinovations Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04023097
Brief Title
Self-selection Study of the Toothwave Toothbrush
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2, 2019 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Home Skinovations Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque, Calculus, Tooth Discoloration
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.
Masking
Participant
Masking Description
Before they start their part in the study, participants won't be aware if they can use the brush or not.
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toothwave contraindicated subject
Arm Type
Experimental
Arm Description
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.
Arm Title
potential users of the Toothwave device
Arm Type
Active Comparator
Arm Description
The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users.
Intervention Type
Device
Intervention Name(s)
Toothwave toothbrush
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Hellman, MD
Organizational Affiliation
Hellman Dermatology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hellman Dermatology clinic
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-selection Study of the Toothwave Toothbrush
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