Safety and Efficacy of the ToothWave -12 Weeks Calculus Study (NCT04092075) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
United States87 participantsStarted 2019-08-07
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Adult subjects aged 18-70, that are in good health.
✓. Subject must have:
✓.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).
✓.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.