Overview

This study is evaluating the safety and efficiency of the Silk’n ToothWave Powered Toothbrush for stain reduction and improvement of teeth shade.

Study Information

The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks. The estimated enrollment for this study is is 90 participants. Participants will be divided into two groups; one will be the treatment group (using Silk’n powered toothbrush – ToothWave) and the other a control group (using an ADA approved powered toothbrush). The study began on August 7th 2019 and is estimated to be completed by May 31st 2020. 

Inclusion Criteria

1. Adult subjects that are in good health and aged 18-70.
2. Subjects should have notable extrinsic dental stains on the 6 maxillary labial front teeth, or on the 6 mandibular front teeth (lingual or labial), with a total extrinsic tooth stain score ≥14 according to the LSI.
3. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 as assessed by the Investigator.
4. Subject front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachedguide 3D-Master or the Vita EasyShade device.
5. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
6. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
7. The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.

Exclusion Criteria

1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
2. Pregnant or nursing by subject report.
3. Any active condition in the oral cavity at the discretion of the investigator.
4. Any surgery in the treated area within 3 months prior to treatment, or before complete healing.
5. Subjects that do not brush regularly.
6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.

Location

This study is taking place at the University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States, 78229-3900. For more information, please contact Liora Levi, PhD, on +970-50-9260334 or at lioral@silkn.com. You may also contact Bennett T Amaechi, BDS, MS, PhD on 210-567-3185 or at amaechi@uthscsa.edu. 

Sponsors/Collaborators

This study is sponsored by Home Skinovations Ltd., with Bennett T Amaechi, BDS, MS, PhD as the Principal Investigator.