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Tests treatment safety and results for Plaque Induced Gingivitis
Official title Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser
ClinicalTrials.gov ID: NCT06352645
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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.
You likely can't join 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)...
- 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...
See the full eligibility criteria
- 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.
- people 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.
- people 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: people 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.
- 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.
- 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.
- 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.
- Those not fluent in English
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.