Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

ConditionPlaque Induced Gingivitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorTufts University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Bixdo Ultra Compact Water Flosser
Device
Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
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.

Treatment groups

165 Participants

are divided into 2 treatment groups

Group A: Interventional GroupExperimental treatment 1 intervention

Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Time frame

8 weeks

Sponsors and contacts

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Tufts University

Lead sponsor

Guang Dong Bixdo Health Technology Co.,Ltd

Collaborator

Source ClinicalTrials.gov

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