Flaus, Inc
The purpose of this study to evaluate the safety and efficacy of an electric flosser (interproximal cleaning aid), when used with a manual toothbrush and fluoride toothpaste, on gingivitis reduction and dental plaque removal.
This single-center, randomized, controlled, examiner-blind, 30-day, parallel study will evaluate the efficacy of Flaus electric flosser in reducing interdental plaque, gingival inflammation, and bleeding. The electric flosser is currently marketed in the U.S. and is a Class 1 Exempt medical device which has the lowest risk to users. This Class 1 status means that the device is exempt from the U.S. Food and Drug Administration (FDA) requirements for premarket notification or approval (510(k)) for a medical device. During this study, data will be collected at baseline, Day 15, and Day 30. Each q…
Inclusion Criteria: 1. Provide a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. 2. Be generally healthy at least 18 to 70 years of age, at the signing of the informed consent 3. Biological sex at birth was male or female. 4. Be regular manual toothbrush users and able to brush their own teeth daily. 5. Willing and able to comply with scheduled visits, study restrictions, (Lifestyle Considerations) and other study procedures. 6. A participant in good general and mental health…
Electric flosser, interdental cleaning device
Soft manual toothbrush used twice daily for two minutes
Arctuva estimate
Verify or correct the compensation shown for this listing.