ToothWave Plaque and Gingivitis 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 Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.
Key facts
- Study ID
- NCT03885323
- Run by
- Home Skinovations Ltd.
- People needed
- 86
- Starts
- 2019-02-28
- Expected to finish
- 2019-04-15
- Last updated by the study team
- 2020-11-25
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Salus research — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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