Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

Last updated: March 4, 2025
Sponsor: Tufts University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Manual toothbrush

Bixdo Ultra Compact Water Flosser

Clinical Study ID

NCT06352645
STUDY00004879
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

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, orthodonticappliances, 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 PlaqueIndex (RMNPI) and PPD ≤5 mm.

  7. Subjects who agree to delay dental prophylaxis, elective dental treatment, andcosmetic 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-studydental device or oral care products for the duration of the study, return forscheduled visits, and comply with all study procedures.

Exclusion

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 toseverely compromise immune function (e.g., cytomegalovirus infection) within thelast 5 years.

  4. Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina,abscesses).

  5. Patients with visible carious lesions, periodontitis, orthodontic appliances, orremovable partial dentures.

  6. Patients with mild plaque-induced gingivitis: < 50% BOP, <1.75 modified gingivalindex (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 affectperiodontal 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 anynon-study dental device or oral care products, return for scheduled visits, andcomply with all study procedures.

  16. Anything that would place the individual at increased risk or preclude theindividual's full compliance with or completion of the study at the discretion ofthe investigators.

  17. For the main study only: Patients who need assistance from others to perform theirdaily oral hygiene practices or read the manual of instructions that come with theat-home product.

  18. Those not fluent in English

Study Design

Total Participants: 165
Treatment Group(s): 2
Primary Treatment: Manual toothbrush
Phase:
Study Start date:
March 04, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Tufts University School of Dental Medicine

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.