Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

Inclusion criteria

• Participants between the age of 18 - 70 years old.
• Having at least 20 natural teeth in their dentition - excluding third molars.
• In good overall systemic health, in the opinion of the investigator.
• In good dental health with no visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
• No hard or soft tissue lesions.
• Subjects with moderate or severe plaque-induced gingivitis: a minimum of 50% BOP, 1.75 modified gingival index (MGI), and 0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm.
• Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns) for the duration of the study
• For the main study only: Subjects who agree to refrain from using any non-study dental device or oral care products for the duration of the study, return for scheduled visits, and comply with all study procedures.

Exclusion criteria

• Systemic disease self-reported that has an impact on periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
• History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS).
• History of immunosuppressive chemotherapy or history of any disease known to severely compromise immune function (e.g., cytomegalovirus infection) within the last 5 years.
• Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses).
• Patients with visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
• Patients with mild plaque-induced gingivitis: < 50% BOP, <1.75 modified gingival index (MGI), and <0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm.
• Patients with PPD >5 mm.
• Need for antibiotic premedication for routine dental procedures.
• Use of antibiotics within the last 3 months.
• Daily use of steroids or non-steroid anti-inflammatory therapy within the last 3-months.
• Patients who self-report pregnancy or lactation (hormonal changes that can affect periodontal health and aggravate existing periodontal disease).
• Current smokers.
• Inability or unwillingness to sign informed consent form.
• Patients who do not agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns).
• For the main study only: Patients who do not agree to refrain from using any non-study dental device or oral care products, return for scheduled visits, and comply with all study procedures.
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study at the discretion of the investigators.
• For the main study only: Patients who need assistance from others to perform their daily oral hygiene practices or read the manual of instructions that come with the at-home product.
• Those not fluent in English