Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06352645

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

Led by Tufts University · Updated on 2026-04-08

165

Participants Needed

1

Research Sites

52 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

Researchers are evaluating the safety and effectiveness of the Bixdo A30 Pro Ultra Compact Water Flosser when used along with a manual toothbrush in people with plaque-induced gingivitis. This randomized controlled trial aims to compare inflammation and bacterial plaque removal over an 8-week period. Participants are randomly assigned to one of two groups. The interventional group will use the Bixdo Ultra Compact Water Flosser twice daily for 8 weeks in addition to toothbrushing. The control group will use only a manual toothbrush and toothpaste provided by the study twice daily for the same duration. Throughout the 8-week study, participants will be monitored for changes in gum inflammation and plaque levels. Researchers will assess clinical parameters such as bleeding on probing and gingival indices to measure outcomes. Participants must follow study procedures, attend scheduled visits, and avoid other dental treatments or devices during the trial to ensure accurate results.

CONDITIONS

Brief Title

Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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, 1.75 modified gingival index, and 0.60 Rustogi Modification of the Navy Plaque Index, and probing pocket depth 5 mm or less.
  • Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures for the duration of the study.
  • Subjects who agree to refrain from using any non-study dental device or oral care products, return for scheduled visits, and comply with all study procedures.
Not Eligible

You will not qualify if you...

  • Systemic diseases impacting periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
  • History of any autoimmune disease (e.g., primary Sjogren's 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).
  • Visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
  • Mild plaque-induced gingivitis with less than 50% bleeding on probing or lower gingival and plaque index scores, and probing pocket depth 5 mm or less.
  • Probing pocket depth 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-steroidal anti-inflammatory therapy within the last 3 months.
  • Pregnancy or lactation.
  • Current smokers.
  • Inability or unwillingness to sign informed consent.
  • Those who do not agree to delay dental prophylaxis, elective dental treatment, cosmetic procedures, or refrain from using non-study dental devices or oral care products.
  • Need for assistance with daily oral hygiene or inability to read product instructions.
  • Not fluent in English.
  • Anything placing the individual at increased risk or preventing full compliance with the study per investigator discretion.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants are asked to use either the Bixdo Ultra Compact Water Flosser or a manual toothbrush twice a day for 8 weeks.

Weekly visits for 8 weeks

Trial Site Locations

Total: 1 location

1

Tufts University School of Dental Medicine

Boston, Massachusetts, United States, 02111

Actively Recruiting

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Research Team

M

Mabi Singh

A

Ann-Marie Billig

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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Published Research Related To This Trial

Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators

https://pubmed.ncbi.nlm.nih.gov/30496104

Advances in the progression of periodontitis and proposal of definitions of a periodontitis case and disease progression for use in risk factor research. Group C consensus report of the 5th European Workshop in Periodontology.

M S Tonetti, N Claffey, European Workshop in Periodontology group C

https://pubmed.ncbi.nlm.nih.gov/16128839

Periodontitis and systemic diseases: a record of discussions of working group 4 of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases.

Gerry J Linden, Mark C Herzberg, Working group 4 of joint EFP/AAP workshop

https://pubmed.ncbi.nlm.nih.gov/23627330