Water Flosser for Gum Disease

Overseen By Mabi Singh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Antibiotics, Steroids, NSAIDs

Disqualifiers: Diabetes, HIV/AIDS, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

165 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used antibiotics, steroids, or non-steroid anti-inflammatory drugs in the last 3 months.

What data supports the effectiveness of the treatment Bixdo Ultra Compact Water Flosser for gum disease?

Research shows that water flossers can significantly reduce plaque, bacteria, and signs of gum inflammation like bleeding and gingivitis, making them effective for improving oral health. ^{1 2 3 4 5}

Is the water flosser safe for use in humans?

Water flossers, also known as oral irrigators, have been studied for over 50 years and are generally considered safe for use. Research shows they do not harm the gums or teeth and are safe for long-term use. ^{3 5 6 7 8}

How does the water flosser treatment for gum disease differ from other treatments?

The water flosser is unique because it uses a stream of pulsating water to clean between teeth and below the gumline, which can be more effective at removing plaque and bacteria than traditional string flossing. It also reduces gingivitis and bleeding, making it a valuable tool for maintaining oral health. ^{1 2 4 5 6}

What is the purpose of 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.

Research Team

Mabi Singh

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

This trial is for individuals with gum disease. Participants should be willing to use a manual toothbrush along with the Bixdo Ultra Compact Water Flosser as part of their daily oral hygiene routine.

Inclusion Criteria

I have at least 20 natural teeth, not counting wisdom teeth.

I do not have any bone or soft tissue tumors.

My teeth and gums are healthy, and I don't have braces or removable dentures.

Exclusion Criteria

I need antibiotics before dental work.

I agree not to have dental cleanings, elective dental work, or cosmetic dental procedures.

Those not fluent in English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Bixdo Ultra Compact Water Flosser or manual toothbrush for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bixdo Ultra Compact Water Flosser

Trial Overview The study aims to test if adding the Bixdo A30 Pro Ultra Compact Water Flosser to regular brushing helps reduce inflammation and remove bacterial plaque more effectively than brushing alone.

Participant Groups

Group I: Interventional Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Guangdong Bixdo Health Technology Co., Ltd.

Collaborator

Trials

1

Recruited

170+

Guang Dong Bixdo Health Technology Co.,Ltd

Collaborator

Trials

2

Recruited

240+

Findings from Research

Water flossers have been shown to effectively remove biofilm and bacteria from teeth and gums, outperforming traditional string floss and manual brushing in many studies.

Clinicians are encouraged to recommend water flossers to suitable patients, taking into account the various features of different models to enhance patient compliance and improve oral health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relevance of the water flosser: 50 years of data. Lyle, DM.[2013]

In a study of 105 participants over four weeks, both a standard water flosser and a water flosser infused with air microbubbles effectively reduced clinical signs of gingivitis, such as bleeding on probing and plaque levels.

The standard water flosser showed significantly greater reductions in bleeding on probing and gingival index scores compared to both the microbubble water flosser and dental floss, indicating it may be the more effective option for daily oral care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of water flossing on clinical parameters of inflammation and plaque: A four-week randomized controlled trial. Mancinelli-Lyle, D., Qaqish, JG., Goyal, CR., et al.[2023]

The study involved 52 patients with chronic gingivitis and compared the effectiveness of a new flossing device delivering chlorhexidine to conventional floss, showing a 51.5% reduction in bleeding with chlorhexidine compared to 38.3% with conventional floss.

Both the chlorhexidine and placebo flossing devices significantly improved gingival health over conventional floss, suggesting that the delivery method may enhance the effectiveness of oral hygiene products, potentially due to user satisfaction with the taste and experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of the standard flossing procedure and a new floss applicator in reducing interproximal bleeding: a short-term study. Kinane, DF., Jenkins, WM., Paterson, AJ.[2013]

Water flossers are effective in improving interdental hygiene by significantly reducing plaque biofilm and subgingival pathogenic bacteria, even in deep pockets up to 6 mm.

Using a water flosser can lead to reductions in gingivitis, bleeding, probing pocket depth, and calculus, making it a valuable addition to a patient's oral care routine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a water flosser for interdental cleaning. Lyle, DM.[2013]

In a study involving 24 periodontitis patients, the use of two generations of power-driven water flossers (Sonicare AirFloss and AirFloss Ultra) for 12 weeks each led to high patient satisfaction, with about 80% of participants expressing a preference for these devices over their previous interdental cleaning methods.

Daily use of the water flossers resulted in a significant reduction in interproximal bleeding on probing (BoP), with reductions of 29.1% overall, indicating a notable improvement in gingival inflammation that was maintained for 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' opinion on the use of 2 generations of power-driven water flossers and their impact on gingival inflammation. Bertl, K., Edlund Johansson, P., Stavropoulos, A.[2022]

Water flossers have been proven safe and effective for over 50 years, positively impacting oral health by reducing plaque, bleeding, and gingivitis.

Extensive research has shown that water flossers do not harm the attachment of gum tissue or pocket depth, countering claims of potential negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of a water flosser: a literature review. Jolkovsky, DL., Lyle, DM.[2016]

A systematic review of 94 case reports involving 118 individuals revealed that adverse events from toothbrush use primarily included ingestion (50 cases) and impaction (27 cases), highlighting significant safety concerns.

Children were more likely to experience injuries from toothbrush use compared to adults, leading to recommendations against using toothbrushes to induce vomiting or while walking or running, particularly for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it safe to use a toothbrush? Oliveira, SC., Slot, DE., van der Weijden, F.[2022]

In a study with 28 participants, the Waterpik Water Flosser combined with a manual toothbrush was found to be significantly more effective at removing plaque compared to interdental brushes used with a manual toothbrush.

The Water Flosser removed up to 29% more plaque in certain areas, demonstrating its superior efficacy in maintaining oral hygiene after just one use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Water Flosser and Interdental Brush on Plaque Removal: A Single-Use Pilot Study. Lyle, DM., Goyal, CR., Qaqish, JG., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Relevance of the water flosser: 50 years of data. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of water flossing on clinical parameters of inflammation and plaque: A four-week randomized controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of the standard flossing procedure and a new floss applicator in reducing interproximal bleeding: a short-term study. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Use of a water flosser for interdental cleaning. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Patients' opinion on the use of 2 generations of power-driven water flossers and their impact on gingival inflammation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of a water flosser: a literature review. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Is it safe to use a toothbrush? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of Water Flosser and Interdental Brush on Plaque Removal: A Single-Use Pilot Study. [2018]