Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush
Condition(s) studied
Investigational drug(s) / intervention(s)
Electric Flosser: Electric flosser, interdental cleaning device
Manual Toothbrush: Soft manual toothbrush used twice daily for two minutes
Study summary
This is a study to evaluate the safety and the efficacy of an electric flosser (interproximal cleaning aid), when used with a manual toothbrush, on gingivitis and dental plaque removal.
Eligibility
Primary outcome measure(s)
- Reduction from Baseline in proximal Modified Gingival Index (MGI) scores at Day 30 — Baseline and 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. - Reduction from Baseline in proximal Bleeding on Probing (BOP) at Day 30 — 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 pre-cleaning to post-cleaning proximal Rustogi Modified Navy Plaque Index (RMNPI) Scores at Day 30 — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | Recruiting |
More Flaus, Inc trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07779564 on ClinicalTrials.gov ↗ ← All trials in the USA