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.
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 when they will brush their teeth twice daily only with a provided soft-bristle, flat-trim manual toothbrush (Oral-B Indicator-35) and an ADA Accepted sodium fluoride toothpaste (Crest Cavity Protection). Approximately 80 generally healthy 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 assessments in the following order: * Dental and medical health history questions, record of concurrent medications. * Oral Soft and Hard Tissue (OSHT) examination. * Gross assessment of gingival health (review of gingival inflammation, probing depth measurements and bleeding on probing) to avoid inclusion of participants with ≥ 30% of teeth with Stages II-IV periodontal disease. Participants will be enrolled into the study with existing mild to moderate gingivitis and there will be no dental prophylaxis performed during the study. At Baseline, Day 15 and Day 30, the following exams will be performed in the following order: * Oral soft and hard tissue exam will be assessed for irritation or other abnormalities. * Gingival inflammation according to MGI (Modified Gingival Index and Bleeding on Probing * Supragingival plaque levels on the facial and lingual surfaces, according to the Rustogi Modified Navy Plaque Index (RMNPI)1: * All evaluable teeth, in relation to the inclusion/exclusion criteria scorable dentition, will be assessed. * At Day 30, a pre- and post-cleaning RMNPI 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: 1. Control Group (Brushing only): Twice daily brushing for two minutes with a standard, flat trim manual soft toothbrush (Oral-B Indicator 35) with Crest Cavity Protection 0.24% sodium fluoride toothpaste. 2. Investigational Group - Electric Flosser + Brushing: Once daily flossing using the electric flosser and twice daily brushing for two minutes with a standard flat trim, soft bristle manual toothbrush with Crest Cavity Protection 0.24% 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 Crest Cavity Protection toothpaste. Participants will 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, 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Electric flosser, interdental cleaning device
Soft manual toothbrush used twice daily for two minutes
Salus Research, Inc.
Fort Wayne, Indiana, United States
RECRUITINGReduction 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 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
Time frame: Baseline and Day 30
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-cleaning
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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 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
Time frame: 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).
Time frame: 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).
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 30