Recruiting

Bixdo Flosser

Sponsor:

Tufts University

Code:

NCT06352645

Conditions

Plaque Induced Gingivitis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Bixdo Ultra Compact Water Flosser

Manual toothbrush

Study Details

Brief 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.

Conditions

Plaque Induced Gingivitis

Study ID

NCT06352645

Start date

Mar 4, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Group

Those randomized into the interventional group will be asked to use the Bixdo Ultra Compact Water Flosser twice a day for 8 weeks.

active comparator: Control Group

Those randomized into the control group will be asked to only use the study provided manual toothbrush and toothpaste twice a day for 8 weeks.

Interventions

Bixdo Ultra Compact Water Flosser

Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.

Manual 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.

Primary outcome measure

  • Inflammation Reduction [ Time Frame: 8 weeks ]
  • Bacterial plaque removal [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Tufts University School of Dental Medicine

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

More Information

Sponsor

Tufts University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts University on 2026-04-08.