Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

NCT06352645 | Recruiting FDA Device

• 1 other identifier: STUDY00004879
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Inflammation Reduction

  At each of the three study visits, the examiners will conduct a periodontal clinical exam, following standard of care procedure, to evaluate the levels of inflammation in the gingiva of subjects in both the intervention and control groups.

  8 weeks

• Bacterial plaque removal

  At each of the three study visits, subjects will be given dental plaque erythrosine disclosing agents (Sunstar GUM® RED-COTE®) to assess the level of plaque on the subjects teeth

  8 weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

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

Device: Bixdo Ultra Compact Water Flosser

Control Group

ACTIVE COMPARATOR

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.

Device: Manual toothbrush

Interventions

Bixdo Ultra Compact Water Flosser DEVICE

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

Interventional Group

Manual toothbrush DEVICE

For those in the control group, they will be asked to use only the study-provided manual toothbrush, twice a day for 8 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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% BOP, 1.75 modified gingival index (MGI), and 0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm.
• Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. 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 may not qualify if:

• Systemic disease self-reported that has an impact on periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
• History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS).
• History of immunosuppressive chemotherapy or history of any disease known to severely compromise immune function (e.g., cytomegalovirus infection) within the last 5 years.
• Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses).
• Patients with visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
• 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.
• Patients with PPD \>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.
• Patients who self-report pregnancy or lactation (hormonal changes that can affect periodontal health and aggravate existing periodontal disease).
• Current smokers.
• Inability or unwillingness to sign informed consent form.
• Patients who do not agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns).
• 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.

Sponsors & Collaborators

• Tufts University: lead
• Guang Dong Bixdo Health Technology Co.,Ltd: collaborator

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

RECRUITING

Related Publications (25)

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Study Officials

• Mabi Singh

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mabi Singh

CONTACT

6176362408; dentalresearchadministration@tufts.edu

Ann-Marie Billig

CONTACT

6176363931; dentalresearchadministration@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)