Safety and effectiveness of an electric flosser with a manual toothbrush for gingivitis and plaque

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.