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

Tooth Discoloration Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04092062
Study type Interventional
Source Home Skinovations Ltd.
Contact
Status Completed
Phase N/A
Start date August 7, 2019
Completion date January 28, 2020
View Details
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