ToothWave Calculus Reduction and Accumulation Prevention Study
Completed · Not applicable · Has a placebo group
Conditions studied: Gingivitis, Plaque, Calculus, Dental
In brief
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.
Key facts
- Study ID
- NCT04596761
- Run by
- Home Skinovations Ltd.
- People needed
- 90
- Starts
- 2020-07-15
- Expected to finish
- 2020-12-10
- Last updated by the study team
- 2021-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Salus Research — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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