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:

1. Adult subjects aged 18-70, that are in good health.

2. 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.

3. 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.

4. 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.

5. 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:

1. Any condition that might make it unsafe for the subject to participate in the study,
at the discretion of the investigator

2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere
in the body.

3. Pregnant or nursing by subject report.

4. Any active condition in the oral cavity at the discretion of the investigator.

5. Any surgery in the treated area within 3 months prior to treatment, or before complete
healing.

6. Subjects that do not brush regularly.