Clinical trial NCT06352645: Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser
Official title: Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser in Addition to Toothbrushing-A 8-week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plaque Induced Gingivitis
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Guang Dong Bixdo Health Technology Co.,Ltd
First posted: 2024-04-08
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Inflammation Reduction
timeFrame: 8 weeks
measure: Bacterial plaque removal
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Mabi Singh
role: PRINCIPAL_INVESTIGATOR
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