Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction

The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.

One treatment group (Silk'n power toothbrush - ToothWave) and 1 control group (an ADA approved power 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 manufactur-er'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 ac-cepted PTB and the same standard fluoride toothpaste.

Inclusion criteria

• Adult subjects aged 18-70, that are in good health.
• Subjects should have notable extrinsic dental stains on the front teeth with a total extrin-sic facial tooth stain score ≥14 according to the LSI.
• 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.
• The subjects should be willing to comply with the study procedure and schedule, includ-ing the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
• The subject did not perform any procedure for teeth whitening (either at home or in clin-ic) at least 3 years prior to participating in the study

Exclusion criteria

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