Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.

The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks.

One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.

For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. The average data sets will be calculated for each group.

Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.

Inclusion criteria

• Adult subjects aged 18-70, that are in good health.
• Subject must have:

2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).

2.4. Total Calculus deposits greater than 9 according to the Volpe-Manhold Index.

• Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
• 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, including the follow up visits.

Exclusion criteria

• Current or history of oral cavity cancer or oropharyngeal cancer.
• 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 oral cavity within 3 months prior to treatment, or before complete healing.
• Subjects that do not brush regularly.
• Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.