NCT04092062

Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)

Safety and Efficacy of the ToothWave (Model H7001) Powered Toothbrush Home Use Device for Extrinsic Stain Reduction (Texas)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Home Skinovations Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.

Detailed description

The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks. One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA approved powered toothbrush (PTB)) will participate in the study. For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group. Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA accepted PTB and standard fluoride toothpaste.

Conditions

• Tooth Discoloration

Interventions

Type	Name	Description
DEVICE	ToothWave	RF-utilizing powered toothbrush for teeth whitening
DEVICE	powered toothbrush	regular powered toothbrush with no RF

Timeline

• Start date: 2019-08-07
• Primary completion: 2020-01-28
• Completion: 2020-01-28
• First posted: 2019-09-17
• Last updated: 2020-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study