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

NCT07805148 | Not Yet Recruiting

• 1 other identifier: FL-2026-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Gingival Bleeding; Dental Plaque

Keywords

dental plaque; gingivitis; gingival bleeding; randomized, parallel design; flosser; manual toothbrush

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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).

  Day 30, pre-cleaning and post-cleaning

Secondary Outcomes (7)

• Reduction from Baseline in MGI Proximal, Gumline and Whole Mouth scores at Day 15

  Baseline and Day 15

• Reduction in Bleeding on Probing (BOP) proximal, gumline and whole mouth scores at Day 15

  Baseline and Day 15

• Reduction from Baseline in RMNPI proximal, gumline and whole mouth scores at Day 15

  Baseline and Day 15

• Reduction from Baseline in pre-cleaning proximal, gumline and whole mouth RMNPI scores at Day 30.

  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

  Day 30, pre-cleaning and post-cleaning

Study Arms (2)

Placebo Comparator: Manual Toothbrush Control Group

PLACEBO COMPARATOR

Flat-trim, soft bristle manual toothbrush

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

Device: Device: Electric Flosser; Device: Manual toothbrush

Interventions

Device: Electric Flosser DEVICE

Electric flosser, interdental cleaning device

Active Comparator: Test Group Electric Flosser + Manual Toothbrush

Manual toothbrush DEVICE

Soft manual toothbrush used twice daily for two minutes

Active Comparator: Test Group Electric Flosser + Manual Toothbrush; Placebo Comparator: Manual Toothbrush Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Flaus, Inc: lead
• Therametric Technologies Inc.: collaborator

Study Sites (1)

Therametric Technologies, Inc.

Noblesville, Indiana, 46060, United States

Location

MeSH Terms

Conditions

Gingivitis; Gingival Hemorrhage; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases

Central Study Contacts

Prerna Gopal, BDS, PhD

CONTACT

513-377-7095; pgopal@therametric.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiner-blind, data recorders will not have access to the treatment assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 4, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): October 22, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)