CompletedNot Applicable

ToothWave Calculus Reduction and Accumulation Prevention Study

United States90 participantsStarted 2020-07-15

Plain-language summary

The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult subjects aged 18 years and older, that are in good health.
✓. Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
✓. 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 procedures and schedule, including the follow up visits.
✓. Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.

Exclusion criteria

✕. Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
✕. Regular users of a chlorhexidine mouthrinse.
✕. Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
✕. 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.
✕. 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

Calculus

Timeframe: 6-12 weeks

Trial details

NCT IDNCT04596761

SponsorHome Skinovations Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-10

View on ClinicalTrials.gov More Gingivitis trials