An interventional study of Device: Electric Flosser and Manual toothbrush in Gingivitis, Gingival Bleeding and Dental Plaque, sponsored by Flaus, Inc. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Flaus, Inc · Not applicable, Interventional, and Treatment
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 qualified volunteer will participate in a 30-day clinical trial, with a 7 to 14-day pre-study Washout period. During this period, participant will brush their teeth twice daily only with a soft-bristle, flat-trim manual toothbrush and a sodium fluoride toothpaste (Crest Cavity Protection).
Up to 80 healthy male and female adult participants will be screened, enrolled and randomized so that 74 participants complete this 30-day study. Participants will attend a Screening visit that will include collection of informed consent to participate, dental and medical health history question, oral examination, assessment for plaque and gingivitis.
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 following order: oral soft and hard tissue exam, Gingival inflammation according to MGI (Modified Gingival Index and Bleeding on Probing (BOP), supragingival plaque levels according to the Rustogi Modified Navy Plaque Index (RMNPI). At Day 30, a pre- and post-cleaning plaque assessment will be performed to assess plaque removal immediately following the use 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 hours and 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 randomly assigned to one of two treatment groups:
Participants will be provided with verbal and written instructions on the use of their assigned oral care regimen. The first product use will be performed at the clinical site under the supervision of study personnel. Participants assigned to the manual toothbrush will be instructed to brush in their usual manner for two minutes. Participants will dispense a full ribbon of toothpaste and brush once in the morning after breakfast and once in the evening before bedtime. Each participant will receive a timer to assist with compliance with the two-minute brushing. If assigned to the Flaus electric flosser + toothbrushing regimen, participants will brush twice daily for two minutes in their usual manner and will use the Flaus electric flosser each evening before brushing to clean all interdental spaces, including distal of the last tooth in each quadrant. Before brushing each evening: participants will select the speed mode, hold the handle and guide the flosser 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, participants will refrain from using any oral care products other than the products provided to them and will avoid the use of chewing gums and mints.
All participants will be allowed to perform their home care routine in front of a mirror to assist with proper placement of the flosser between teeth. Participants will be reminded to maintain the daily diary to document compliance with the use of their assigned regimen. Following the Baseline exams, participants will return at Day 15 and Day 30 for the same assessments for oral safety, gingival inflammation, bleeding, and supragingival plaque.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Flaus, Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Participant's oral health meets all of the following:
Screening Visit:
Have at least 20 natural teeth with scorable facial and lingual proximal surfaces.
The following will not be included in the scorable tooth count: third molars, teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth, teeth exhibiting general cervical abrasion and/or enamel abrasion, calculus deposits, and extrinsic tooth stain which, in the opinion of the clinical examiner, would interfere with the assessments.
Has mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner, based on a gross assessment of gingival health (review of gingival inflammation, probing measurements and bleeding on probing) to avoid inclusion of participants with ≥ 30% of teeth with Stages II-IV periodontal disease.
Baseline Visit:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Flat-trim, soft bristle manual toothbrush
Device: Manual toothbrush
Electric Flosser + Manual Toothbrush, flosser used once each evening before toothbrushing with manual toothbrush for two minutes
Device: Device: Electric Flosser · Device: Manual toothbrush
Electric flosser, interdental cleaning device
Soft manual toothbrush used twice daily for two minutes
Reduction from Baseline in proximal Modified Gingival Index (MGI) scores at Day 30
Description: Modified Gingival Index (MGI) is a noninvasive, visual assessment of gingival inflammation. Each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using a scale of 0 - 4: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the marginal or papillary gingival unit, 2 = Mild inflammation of the entire gingival unit, 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Time frame: Baseline and Day 30
Reduction from Baseline in proximal Bleeding on Probing (BOP) at Day 30
Each of six gingival areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of the scorable teeth will be probed in a similar manner, recording the number of gingival units which bleed within 30 seconds, according to the following scale: 0 = absence of bleeding 1 = bleeding observed
Time frame: Baseline and Day 30
Change from Day 30 pre-cleaning to Day 30 post-cleaning proximal Rustogi Modified Navy Plaque Index (RMNPI) Scores at Day 30
A red disclosing solution will be used to make plaque visible and improve scoring accuracy. Plaque will be quantified on nine sites per facial and lingual tooth surface. Each tooth surface will be divided into 9 sites, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites); A to C along gingival margin; D to F directly above A to C (D and F being proximal areas); G to H across middle of tooth; and I covered incisal coverage. Plaque will be scored as 0 = Absent or 1 = Present in each area. A mean plaque index (RMNPI) will be calculated for each participant on a whole-mouth basis (areas A-I) and separately for the gingival margin (areas A, B, C) and proximal regions (areas D, F).
Time frame: Day 30, pre-cleaning and post-cleaning
Reduction from Baseline in MGI Proximal, Gumline and Whole Mouth scores at Day 15
Modified Gingival Index (MGI) is a noninvasive, visual assessment of gingival inflammation. Each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using a scale of 0 - 4: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the marginal or papillary gingival unit, 2 = Mild inflammation of the entire gingival unit, 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Time frame: Baseline and Day 15
Reduction in Bleeding on Probing (BOP) proximal, gumline and whole mouth scores at Day 15
Each of six gingival areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of the scorable teeth will be probed in a similar manner, recording the number of gingival units which bleed within 30 seconds, according to the following scale: 0 = absence of bleeding 1 = bleeding observed
Time frame: Baseline and Day 15
Reduction from Baseline in RMNPI proximal, gumline and whole mouth scores at Day 15
A red disclosing solution will be used to make plaque visible and improve scoring accuracy. Plaque will be quantified on nine sites per facial and lingual tooth surface. Each tooth surface will be divided into 9 sites, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites); A to C along gingival margin; D to F directly above A to C (D and F being proximal areas); G to H across middle of tooth; and I covered incisal coverage. Plaque will be scored as 0 = Absent or 1 = Present in each area. A mean plaque index (RMNPI) will be calculated for each participant on a whole-mouth basis (areas A-I) and separately for the gingival margin (areas A, B, C) and proximal regions (areas D, F).
Time frame: Baseline and Day 15
Reduction from Baseline in pre-cleaning proximal, gumline and whole mouth RMNPI scores at Day 30.
A red disclosing solution will be used to make plaque visible and improve scoring accuracy. Plaque will be quantified on nine sites per facial and lingual tooth surface. Each tooth surface will be divided into 9 sites, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites); A to C along gingival margin; D to F directly above A to C (D and F being proximal areas); G to H across middle of tooth; and I covered incisal coverage. Plaque will be scored as 0 = Absent or 1 = Present in each area. A mean plaque index (RMNPI) will be calculated for each participant on a whole-mouth basis (areas A-I) and separately for the gingival margin (areas A, B, C) and proximal regions (areas D, F).
Time frame: Time Frame: Baseline and Day 30
Change from pre-cleaning to post-cleaning Rustogi Modified Navy Plaque Index (RMNPI) gumline and whole mouth scores at Day 30
A red disclosing solution will be used to make plaque visible and improve scoring accuracy. Plaque will be quantified on nine sites per facial and lingual tooth surface. Each tooth surface will be divided into 9 sites, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites); A to C along gingival margin; D to F directly above A to C (D and F being proximal areas); G to H across middle of tooth; and I covered incisal coverage. Plaque will be scored as 0 = Absent or 1 = Present in each area. A mean plaque index (RMNPI) will be calculated for each participant on a whole-mouth basis (areas A-I) and separately for the gingival margin (areas A, B, C) and proximal regions (areas D, F).
Time frame: Day 30, pre-cleaning and post-cleaning
Reduction from Baseline in MGI Gumline and Whole Mouth scores at Day 30
Modified Gingival Index (MGI) is a noninvasive, visual assessment of gingival inflammation. Each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using a scale of 0 - 4: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the marginal or papillary gingival unit, 2 = Mild inflammation of the entire gingival unit, 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Time frame: Baseline and Day 30
Reduction from Baseline in Bleeding on Probing (BOP) gumline and whole mouth scores at Day 30
Each of six gingival areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of the scorable teeth will be probed in a similar manner, recording the number of gingival units which bleed within 30 seconds, according to the following scale: 0 = absence of bleeding 1 = bleeding observed.
Time frame: Baseline and Day 30
Plan to share: No
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Flaus, Inc