Evaluating a new water flosser for treating gingivitis

Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser in Addition to Toothbrushing-A 8-week Randomized Controlled Trial

This study is testing a new water flosser to see if it helps people with gingivitis improve their gum health when used with a regular toothbrush.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tufts University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06352645 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Bixdo A30 Pro Ultra Compact Water Flosser when used alongside a manual toothbrush for individuals with plaque-induced gingivitis. Participants will be randomly assigned to use the water flosser in addition to their regular oral hygiene routine. The study will measure clinical parameters such as inflammation and bacterial plaque removal to determine the flosser's impact on oral health. Eligible participants must meet specific dental health criteria and agree to follow the study's guidelines.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with moderate to severe plaque-induced gingivitis and at least 20 natural teeth.

Not a fit: Patients with significant dental issues, such as periodontitis or removable dentures, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective tool for improving oral hygiene and reducing gingivitis.

How similar studies have performed: While there have been studies on water flossers, this specific evaluation of the Bixdo A30 is novel and untested.

Eligibility criteria

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. Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns) for the duration of the study
8. 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:

1. Systemic disease self-reported that has an impact on periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
2. History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS).
3. History of immunosuppressive chemotherapy or history of any disease known to severely compromise immune function (e.g., cytomegalovirus infection) within the last 5 years.
4. Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses).
5. Patients with visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
6. 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.
7. Patients with PPD \>5 mm.
8. Need for antibiotic premedication for routine dental procedures.
9. Use of antibiotics within the last 3 months.
10. Daily use of steroids or non-steroid anti-inflammatory therapy within the last 3-months.
11. Patients who self-report pregnancy or lactation (hormonal changes that can affect periodontal health and aggravate existing periodontal disease).
12. Current smokers.
13. Inability or unwillingness to sign informed consent form.
14. Patients who do not agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns).
15. 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.
16. 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.
17. 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.
18. Those not fluent in English

Where this trial is running

Boston, Massachusetts

• Tufts University School of Dental Medicine — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Mabi Singh — Tufts University School of Dental Medicine
• Study coordinator: Mabi Singh

Conditions Plaque Induced Gingivitis