CompletedNot Applicable

ToothWave Plaque and Gingivitis Study

United States86 participantsStarted 2019-02-28

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:
✓.2. Baseline gingivitis (MGI) score of at least 1.80, 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI Index. 2.4. Total Calculus deposits greater than 7 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.

What they're measuring

Dental plaque

Timeframe: 6 weeks

Gingival inflammation

Timeframe: 6 weeks

Trial details

NCT IDNCT03885323

SponsorHome Skinovations Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-15

View on ClinicalTrials.gov More Gingivitis trials