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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03885323
Study type Interventional
Source Home Skinovations Ltd.
Contact
Status Completed
Phase N/A
Start date February 28, 2019
Completion date April 15, 2019

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