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Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

November 25, 2019

Overview

The objective of the study is to evaluate the safety and efficacy of the home-use device Silk’n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.

 

Study Information

The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks. Treatment is defined as 2 minutes of teeth brushing in a regular manner, twice a day. Two treatment groups will participate in the study; one will use Silk’n toothbrush – ToothWave and the other will act as the control group and use an ADA approved power toothbrush. The study will have an estimated total enrollment of 90 participants. It began on August 7th 2019 and is predicted to be completed by May 31st 2020. 

 

Inclusion Criteria

 

  • Adult subjects in good health aged 18-70
  • 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.

 

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.

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