Self-selection Study of the Toothwave Toothbrush

NCT04023097 | Completed FDA Device

• 1 other identifier: DO116508
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Gingivitis; Plaque; Calculus; Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Toothwave contraindicated subject

EXPERIMENTAL

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

potential users of the Toothwave device

ACTIVE COMPARATOR

The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users.

Device: Toothwave toothbrush

Interventions

Toothwave toothbrush DEVICE

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.

Toothwave contraindicated subject; potential users of the Toothwave device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Home Skinovations Ltd.: lead

Study Sites (1)

Hellman Dermatology clinic

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid; Calculi; Tooth Discoloration

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Tooth Diseases

Study Officials

• Judith Hellman, MD

  Hellman Dermatology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Before they start their part in the study, participants won't be aware if they can use the brush or not.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 17, 2019
• Study Start: July 2, 2019
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: November 24, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)