NCT04023097

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Home Skinovations Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis
• Plaque
• Calculus
• Tooth Discoloration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-02
• Primary completion: 2019-07-09
• Completion: 2019-07-09
• First posted: 2019-07-17
• Last updated: 2020-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study