Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser (NCT06352645) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser
United States165 participantsStarted 2025-03-04
Plain-language summary
The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.