Actively Recruiting
Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser
Led by Tufts University · Updated on 2026-04-08
165
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
T
Tufts University
Lead Sponsor
G
Guang Dong Bixdo Health Technology Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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% bleeding on probing (BOP), 1.75 modified gingival index (MGI), 0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and probing pocket depth (PPD) 4 mm.
- Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (e.g., 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.
You will not qualify if you...
- Self-reported systemic diseases affecting periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
- History of autoimmune diseases (e.g., primary Sj�f6gren syndrome, systemic lupus erythematosus, psoriasis, irritable bowel syndrome).
- History of immunosuppressive chemotherapy or diseases severely compromising immune function within the last 5 years.
- Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses).
- Presence of visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
- Mild plaque-induced gingivitis: less than 50% bleeding on probing (BOP), less than 1.75 modified gingival index (MGI), less than 0.60 Rustogi Modification of the Navy Plaque Index (RMNPI), and probing pocket depth (PPD) 4 mm.
- Probing pocket depth (PPD) greater than 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.
- Pregnancy or lactation.
- Current smokers.
- Inability or unwillingness to sign informed consent.
- Patients who do not agree to delay dental prophylaxis, elective treatment, and cosmetic procedures.
- For the main study only: Patients who do not agree to refrain from non-study dental devices or oral care products, return for visits, and follow study procedures.
- Anything increasing risk or preventing full compliance with the study.
- For the main study only: Patients needing assistance with daily oral hygiene or unable to read product instructions.
- Those not fluent in English.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
M
Mabi Singh
CONTACT
A
Ann-Marie Billig
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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