NCT03885323

ToothWave Plaque and Gingivitis Study

Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (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 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 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. The average data sets will be calculated for each group. Treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, 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

• Gingivitis
• Plaque
• Calculus, Dental

Interventions

Type	Name	Description
DEVICE	RF utilizing powered toothbrush	RF utilizing Powered toothbrush
DEVICE	Control placebo with no RF	Placebo control, with no RF

Timeline

• Start date: 2019-02-28
• Primary completion: 2019-04-15
• Completion: 2019-04-15
• First posted: 2019-03-21
• Last updated: 2020-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study