Clinical Assessment of the Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush

This single‐center, randomized, controlled, examiner‐blind, 30‐day, parallel study willevaluate the efficacy of Flaus electric flosser in reducing interdental plaque, gingivalinflammation, and bleeding. The electric flosser is currently marketed in the U.S. and isa Class 1 Exempt medical device which has the lowest risk to users. This Class 1 statusmeans 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. Duringthis study, data will be collected at baseline, Day 15, and Day 30. Each qualifiedvolunteer will participate in a 30‐day clinical trial, with a 7 to 14‐day pre‐studyWashout period. During this period, participant will brush their teeth twice daily onlywith a soft‐bristle, flat‐trim manual toothbrush and a sodium fluoride toothpaste (CrestCavity Protection).Up to 80 healthy male and female adult participants will be screened, enrolled andrandomized so that 74 participants complete this 30‐day study. Participants will attend aScreening visit that will include collection of informed consent to participate, dentaland medical health history question, oral examination, assessment for plaque andgingivitis.Participants will be enrolled into the study with existing mild to moderate gingivitis.At Baseline, Day 15 and Day 30, the following exams will be performed in the followingorder: oral soft and hard tissue exam, Gingival inflammation according to MGI (ModifiedGingival Index and Bleeding on Probing (BOP), supragingival plaque levels according tothe Rustogi Modified Navy Plaque Index (RMNPI). At Day 30, a pre‐ and post‐cleaningplaque assessment will be performed to assess plaque removal immediately following theuse of the assigned oral care regimen (brushing only or electric flosser + brushing).Prior to each exam visit, participants will refrain from oral hygiene for 8 to 12 hoursand will not eat or drink 30 minutes before the visit, except for small sips of water.Participants meeting study entrance criteria at the Baseline visit will be randomlyassigned to one of two treatment groups: 1. Control Group (Brushing only): Twice daily brushing for two minutes with a standard,flat trim manual soft toothbrush (Oral‐B Indicator 35) and Crest Cavity Protection0.24% sodium fluoride toothpaste. 2. Investigational Group: Electric Flosser + Brushing: Once daily use of the electricflosser and twice daily brushing for two minutes with the manual toothbrush andsodium fluoride toothpaste.Participants will be provided with verbal and written instructions on the use of theirassigned oral care regimen. The first product use will be performed at the clinical siteunder the supervision of study personnel. Participants assigned to the manual toothbrushwill be instructed to brush in their usual manner for two minutes. Participants willdispense a full ribbon of toothpaste and brush once in the morning after breakfast andonce in the evening before bedtime. Each participant will receive a timer to assist withcompliance with the two‐minute brushing. If assigned to the Flaus electric flosser +toothbrushing regimen, participants will brush twice daily for two minutes in their usualmanner and will use the Flaus electric flosser each evening before brushing to clean allinterdental spaces, including distal of the last tooth in each quadrant. Before brushingeach evening: participants will select the speed mode, hold the handle and guide theflosser between their teeth, moving gently along the gumline in an up‐and‐down motion.Participants will use the time needed to floss all teeth. During the study, participantswill refrain from using any oral care products other than the products provided to themand will avoid the use of chewing gums and mints.All participants will be allowed to perform their home care routine in front of a mirrorto assist with proper placement of the flosser between teeth. Participants will bereminded to maintain the daily diary to document compliance with the use of theirassigned regimen. Following the Baseline exams, participants will return at Day 15 andDay 30 for the same assessments for oral safety, gingival inflammation, bleeding, andsupragingival plaque.