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

Part of paid clinical trials in Noblesville, Indiana.

Sponsor
Flaus, Inc
Study ID
NCT07805148
Status
Not Yet Recruiting

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Conditions

  • Dental Plaque
  • Gingival Bleeding
  • Gingivitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Device: Electric Flosser — DEVICE
    Electric flosser, interdental cleaning device
  • Manual toothbrush — DEVICE
    Soft manual toothbrush used twice daily for two minutes

Study Details

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.

Key Dates

First listed
Sep 4, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Oct 22, 2026
Completion
Oct 22, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Comparator: Manual Toothbrush Control Group
    Flat-trim, soft bristle manual toothbrush
  • Active Comparator: Active Comparator: Test Group Electric Flosser + Manual Toothbrush
    Electric Flosser + Manual Toothbrush, flosser used once each evening before toothbrushing with manual toothbrush for two minutes

Primary Outcome Measure

Reduction from Baseline in proximal Modified Gingival Index (MGI) scores at Day 30 [ Time Frame: Baseline and Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Therametric Technologies, Inc.NoblesvilleIndiana46060
Prerna Gopal, BDS, PhD
[email protected]
513-377-7095
Eswar Kamisetti, BDS, MS
[email protected]
317-565-8062
Prerna Gopal, BDS, PHD (PRINCIPAL_INVESTIGATOR)

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Therametric Technologies, Inc.· Noblesville, IN

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