Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFlaus, Inc
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Electric Flosser
DeviceElectric flosser, interdental cleaning device
Manual Toothbrush
DeviceSoft manual toothbrush used twice daily for two minutes
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Manual Toothbrush Control GroupPlacebo comparator 1 intervention
Group B: Test GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Reduction from Baseline in proximal Modified Gingival Index (MGI) 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 302
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 303
Change from pre-cleaning to 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-cleaningSecondary outcomes
1
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 152
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 153
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 154
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
Baseline and Day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Flaus, Inc
Lead sponsor
Salus Research, Inc., 1220 Medical Park Dr. A, Fort Wayne ID 46825
Collaborator
Source ClinicalTrials.gov