Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser in Addition to Toothbrushing-A 8-week Randomized Controlled Trial
Tufts University
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants between the age of 18 - 70 years old. 2. Having at least 20 natural teeth in their dentition - excluding third molars. 3. In good overall systemic health, in the opinion of the investigator. 4. In good dental health with no visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures. 5. No hard or soft tissue lesions. 6. 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. 7. Subject…
Interventions
- DeviceBixdo Ultra Compact Water Flosser
Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
- DeviceManual toothbrush
For those in the control group, they will be asked to use only the study-provided manual toothbrush, twice a day for 8 weeks.
Location
- Tufts University School of Dental MedicineBoston, Massachusetts