Dental Plaque, Gingival Bleeding, Gingivitis
Conditions
Keywords
randomized controlled clinical trial, Parallel Design, flosser, inflammation, toothbrushing, dental plaque, gingivitis, gingival bleeding
Brief 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.
Detailed description
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.
Interventions
DEVICEElectric Flosser
Electric flosser, interdental cleaning device
DEVICEManual Toothbrush
Soft manual toothbrush used twice daily for two minutes
Sponsors
Flaus, Inc
Salus Research, Inc., 1220 Medical Park Dr. A, Fort Wayne ID 46825
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Examiner-blind, data recorders will not have access to the treatment assignments
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Be generally healthy at least 18 to 70 years of age, at the signing of the informed consent 3. Biological sex at birth was male or female. 4. Be regular manual toothbrush users and able to brush their own teeth daily. 5. Willing and able to comply with scheduled visits, study restrictions, (Lifestyle Considerations) and other study procedures. 6. 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. 7. 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. 8. Be willing and able to refrain from dental treatment during the course of the study, except on an emergency basis. 9. Have sufficient motor skills to perform interdental cleaning. 10. Willing to use only the test products provided during the 30-day study. 11. 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. 12. Participant's oral health meets all of the following: Screening Visit: 13. A participant with good dental health based on medical history and oral soft tissue examination at screening. 14. No significant oral soft tissue pathology based on a visual examination. 15. Have at least 20 natural teeth with scorable facial and lingual proximal surfaces. The following will not be included in the scorable tooth count: third molars, teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth, teeth exhibiting general cervical abrasion and/or enamel abrasion, calculus deposits, and extrinsic tooth stain which, in the opinion of the clinical examiner, would interfere with the assessments. 16. Has mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner, based on a gross assessment of gingival health (review of gingival inflammation, probing measurements and bleeding on probing) to avoid inclusion of participants with ≥ 30% of teeth with Stages II-IV periodontal disease. Baseline Visit: 17. Present with a mean gingival index score ≥ 1.75 according to the Modified Gingival Index and at least 20% interdental bleeding on probing (BOP) sites. 18. Participant presents with a mean proximal plaque index score ≥ 0.6 according to the Rustogi Modified Navy Plaque Index (RMNPI), following an 8 to 12-hour plaque accumulation period.
Exclusion criteria
1. 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. 2. Have participated in any study involving oral care products, concurrently or within the 30 days of baseline exams. 3. Require antibiotic premedication before dental procedures. 4. Self-reported serious medical conditions. 5. If female, pregnant or lactating since these conditions can impact the gingivitis assessments. 6. 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). 7. Have had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 14days of screening exams. 8. Has been diagnosed with xerostomia or is taking any medication that in the view of the investigator is causing xerostomia. 9. 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). 10. Currently using any cannabis product via smoking, vaping or dabbing. 11. Currently active orthodontic treatment (e.g., orthodontic banding, fixed or removable appliances (including Invisalign type appliances). 12. Daily wears a night guard or other such device for bruxism or TMJ disorder. 13. A history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials. 14. 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. 15. 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. 16. Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush or floss product. 17. Presence of supragingival calculus or extrinsic tooth stain that can impede the visual assessment of gingivitis and plaque, at the clinical examiner's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction from Baseline in MGI Proximal, Gumline and Whole Mouth scores at Day 15 | Baseline and 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. |
| Reduction in Bleeding on Probing (BOP) proximal, gumline and whole mouth scores at Day 15 | Baseline and 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 |
| Reduction from Baseline in RMNPI proximal, gumline and whole mouth scores at Day 15 | Baseline and 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). |
| Reduction from Baseline in pre-cleaning proximal, gumline and whole mouth RMNPI scores at Day 30. | Baseline and 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). |
| 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 | 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). |
| Reduction from Baseline in MGI Gumline and Whole Mouth 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 Bleeding on Probing (BOP) gumline and whole mouth scores 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. |
Countries
United States
Contacts
CONTACTJeffery L. Milleman, DDS, MPA
Outcome results
None listed