GingivitisNCT07805148
Clinical Assessment of the Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush
A study testing Device: Electric Flosser and Manual toothbrush in people with Gingivitis and Gingival Bleeding, run by Flaus, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis, Gingival Bleeding, Dental Plaque
- What is being tested?
- Device: Electric Flosser and Manual toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 22 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Be generally healthy at least 18 to 70 years of age, at the signing of the informed consent
- Biological sex at birth was male or female.
- Be regular manual toothbrush users and able to brush their own teeth daily.
- Willing and able to comply with scheduled visits, study restrictions, (Lifestyle Considerations) and other study procedures.
- A participant in good general and mental health, in the opinion of the investigator or medically qualified designee; no clinically significant and relevant abnormalities in medical history or upon oral examination.
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- Be willing to refrain from all oral hygiene for approximately 8-12 hours before each study visit and discontinue eating and drinking for approximately 30 minutes before each study visit, except for sips of water.
- Be willing and able to refrain from dental treatment during the course of the study, except on an emergency basis.
- Have sufficient motor skills to perform interdental cleaning.
- Willing to use only the test products provided during the 30-day study.
- For the duration of the study, willing to refrain from the use of any non-study-related products, especially dental floss, all interdental cleaning aids, mouthrinses, and anti-plaque/anti-gingivitis products.
- Participant's oral health meets all of the following:
- Screening Visit:
- A participant with good dental health based on medical history and oral soft tissue examination at screening.
- No significant oral soft tissue pathology based on a visual examination.
- 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:
- Present with a mean gingival index score ≥ 1.75 according to the Modified Gingival Index and at least 20% interdental bleeding on probing (BOP) sites.
- Participant presents with a mean proximal plaque index score ≥ 0.6 according to the Rustogi Modified Navy Plaque Index (RMNPI), following an 8 to 12-hour plaque accumulation period.
Who cannot join
- An employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator.
- Have participated in any study involving oral care products, concurrently or within the 30 days of baseline exams.
- Require antibiotic premedication before dental procedures.
- Self-reported serious medical conditions.
- If female, pregnant or lactating since these conditions can impact the gingivitis assessments.
- Currently taking a systemic medication (e.g., anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g., ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
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- Have had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 14days of screening exams.
- Has been diagnosed with xerostomia or is taking any medication that in the view of the investigator is causing xerostomia.
- Currently using any form of tobacco products (such as smoked, smokeless, and electronic nicotine delivery systems, cigarettes, cigars, hookahs, pipe tobacco, snuff, snus, chewing tobacco, nicotine pouch or dissolvable products).
- Currently using any cannabis product via smoking, vaping or dabbing.
- Currently active orthodontic treatment (e.g., orthodontic banding, fixed or removable appliances (including Invisalign type appliances).
- Daily wears a night guard or other such device for bruxism or TMJ disorder.
- A history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials.
- Using an antibacterial dentifrice or mouthwash (e.g., chlorhexidine, Cetylpyridinium chloride, fixed combination of essential oils mouthwash, stannous fluoride) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between the Screening and the Baseline visits.
- Exhibits ≥ 30% of teeth with stage II - IV periodontitis, according to the American Academy of Periodontology revised classification system for periodontal and peri-implant diseases and conditions,21 at screening and/or baseline visit, or being actively treated for periodontal disease, and has more than three teeth with periodontal pocket depths measuring more than 5 mm.
- Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush or floss product.
- Presence of supragingival calculus or extrinsic tooth stain that can impede the visual assessment of gingivitis and plaque, at the clinical examiner's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Therametric Technologies, Inc.
Noblesville, Indiana, 46060
Prerna Gopal, BDS, PhD, 513-377-7095, Pgopal@therametric.com
Eswar Kamisetti, BDS, MS, 317-565-8062, ekamisetti@therametric.com
About this study
Official title: Evaluation of the Safety and Efficacy of Adjunctive Use of Flaus Electric Flosser and a Manual Toothbrush in Reducing Plaque and Gingivitis: A 30-Day Randomized, Parallel, Controlled Clinical Study
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.
Read the detailed description
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:
- 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 Protection 0.24% sodium fluoride toothpaste.
- Investigational Group: Electric Flosser + Brushing: Once daily use of the electric flosser and twice daily brushing for two minutes with the manual toothbrush and sodium fluoride toothpaste.
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.
- Conditions
- Gingivitis, Gingival Bleeding, Dental Plaque
- Being tested
- Device: Electric Flosser, Manual toothbrush
- Keywords
- dental plaque, gingivitis, gingival bleeding, randomized, parallel design, flosser, manual toothbrush
- Medical subject headings
- Gingivitis, Gingival Hemorrhage, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Electric FlosserDevice
Electric flosser, interdental cleaning device
Manual toothbrushDevice
Soft manual toothbrush used twice daily for two minutes
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: Manual Toothbrush Control Group | Placebo comparator | Flat-trim, soft bristle manual toothbrush Receives: Device: Manual toothbrush |
| Active Comparator: Test Group Electric Flosser + Manual Toothbrush | Active comparator | Electric Flosser + Manual Toothbrush, flosser used once each evening before toothbrushing with manual toothbrush for two minutes Receives: Device: Device: Electric Flosser; Device: Manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: Day 30, pre-cleaning and post-cleaning
Secondary outcomes (7)
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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment 30-day safety and efficacy evaluating unsupervised use of an electric flosser used in conjunction with a manual toothbrush to remove plaque and reduce gingivitis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flaus, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therametric Technologies Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805148
- Sponsor's protocol ID
- FL-2026-03
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Adjunctive Use of Flaus Electric Flosser and a Manual Toothbrush in Reducing Plaque and Gingivitis: A 30-Day Randomized, Parallel, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07805148
- Acronym / sponsor ID
- FL-2026-03
- Conditions
- Gingivitis, Gingival Bleeding, Dental Plaque
- Keywords
- dental plaque, gingivitis, gingival bleeding, randomized, parallel design, flosser, manual toothbrush
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Flaus, IncIndustry (pharma, biotech, devices)
- Collaborators
- Therametric Technologies Inc.
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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 Protection 0.24% sodium fluoride toothpaste.
- Investigational Group: Electric Flosser + Brushing: Once daily use of the electric flosser and twice daily brushing for two minutes with the manual toothbrush and sodium fluoride toothpaste.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment 30-day safety and efficacy evaluating unsupervised use of an electric flosser used in conjunction with a manual toothbrush to remove plaque and reduce gingivitis.
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: Manual Toothbrush Control Group | Placebo comparator | Device: Manual toothbrushFlat-trim, soft bristle manual toothbrush |
| Active Comparator: Test Group Electric Flosser + Manual Toothbrush | Active comparator | Device: Device: Electric Flosser, Device: Manual toothbrushElectric Flosser + Manual Toothbrush, flosser used once each evening before toothbrushing with manual toothbrush for two minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
- Be generally healthy at least 18 to 70 years of age, at the signing of the informed consent
- Biological sex at birth was male or female.
- Be regular manual toothbrush users and able to brush their own teeth daily.
- Willing and able to comply with scheduled visits, study restrictions, (Lifestyle Considerations) and other study procedures.
Key exclusion criteria (17 listed)
- An employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator.
- Have participated in any study involving oral care products, concurrently or within the 30 days of baseline exams.
- Require antibiotic premedication before dental procedures.
- Self-reported serious medical conditions.
- If female, pregnant or lactating since these conditions can impact the gingivitis assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Electric FlosserElectric flosser, interdental cleaning device | Device | Active Comparator: Test Group Electric Flosser + Manual Toothbrush |
| Manual toothbrushSoft manual toothbrush used twice daily for two minutes | Device | Active Comparator: Test Group Electric Flosser + Manual Toothbrush, Placebo Comparator: Manual Toothbrush Control Group |
Primary outcome
Reduction from Baseline in proximal Modified Gingival Index (MGI) scores at Day 30
Time frame: Baseline and 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.
Reduction from Baseline in proximal Bleeding on Probing (BOP) at Day 30
Time frame: Baseline and 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
Change from Day 30 pre-cleaning to Day 30 post-cleaning proximal Rustogi Modified Navy Plaque Index (RMNPI) Scores at Day 30
Time frame: Day 30, pre-cleaning and post-cleaning
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).
7 secondary outcomes
Reduction from Baseline in MGI Proximal, Gumline and Whole Mouth scores at Day 15
Time frame: Baseline and Day 15
Reduction in Bleeding on Probing (BOP) proximal, gumline and whole mouth scores at Day 15
Time frame: Baseline and Day 15
Reduction from Baseline in RMNPI proximal, gumline and whole mouth scores at Day 15
Time frame: Baseline and Day 15
Reduction from Baseline in pre-cleaning proximal, gumline and whole mouth RMNPI scores at Day 30.
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
Time frame: Day 30, pre-cleaning and post-cleaning
Reduction from Baseline in MGI Gumline and Whole Mouth scores at Day 30
Time frame: Baseline and Day 30
Reduction from Baseline in Bleeding on Probing (BOP) gumline and whole mouth scores at Day 30
Time frame: Baseline and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Electric Flosser and Manual toothbrush in people with Gingivitis and Gingival Bleeding, run by Flaus, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prerna Gopal, BDS, PhD (513-377-7095, pgopal@therametric.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction from Baseline in proximal Modified Gingival Index (MGI) scores at Day 30 (time frame: Baseline and Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.