Trials / Completed
CompletedNCT04092075
Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Home Skinovations Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Detailed description
This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus. The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks. One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study. For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. The average data sets will be calculated for each group. Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RF-utilizing powered toothbrush | RF-utilizing Powered toothbrush |
| DEVICE | Control placebo with no RF | Placebo control, toothbrush with no RF |
Timeline
- Start date
- 2019-08-07
- Primary completion
- 2020-04-30
- Completion
- 2020-04-30
- First posted
- 2019-09-17
- Last updated
- 2020-07-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04092075. Inclusion in this directory is not an endorsement.