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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether the Bixdo Ultra Compact Water Flosser, used with a manual toothbrush, can effectively reduce gum inflammation and remove plaque. Researchers will divide participants into two groups: one using both the water flosser and toothbrush, and the other using only the toothbrush. It suits individuals with moderate to severe gum inflammation, at least 20 natural teeth, and no major dental issues like cavities or periodontitis. Participants must avoid other dental treatments and products during the study. As an unphased trial, this study offers participants the chance to contribute to dental health research and potentially improve their own gum health.

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 prior data suggests that the Bixdo Ultra Compact Water Flosser is safe for gum disease treatment?

Research shows that water flossers have been studied for over 50 years and are generally safe to use. They do not damage gums or teeth. The Bixdo A30 Pro Ultra Compact Water Flosser, in particular, uses strong and safe materials. It is designed to improve gum health and help prevent bad breath and cavities. Reviewed studies have not reported any specific negative effects, suggesting it is well-tolerated when used properly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bixdo Ultra Compact Water Flosser because it offers a unique method for managing gum disease. Unlike traditional options like manual toothbrushes or dental floss, this water flosser uses a stream of pulsating water to clean between teeth and below the gumline more effectively. This approach not only enhances plaque removal but also promotes gum health without the abrasiveness of manual brushing. The convenience and potential for improved oral hygiene make this an intriguing alternative for those battling gum disease.

What evidence suggests that the Bixdo Ultra Compact Water Flosser is effective for gum disease?

Research has shown that water flossers can greatly reduce plaque, bacteria, and gum problems like bleeding and gingivitis. Daily use of a water flosser helps maintain healthy gums by eliminating harmful bacteria. In this trial, participants in the interventional group will use the Bixdo Ultra Compact Water Flosser, which studies have found can remove up to 99.9% of dental plaque. This makes it a powerful tool for improving oral hygiene and reducing gum disease symptoms. Overall, using a water flosser like the Bixdo leads to healthier gums and less plaque buildup. ^{2 6 7 8 9}

Who Is on the Research Team?

Mabi Singh

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-plaque-induced-gingivitis-4-2024-e9d50

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 ...

2. trialx.com trialx.com/clinical-trials/listings/311777/evaluation-of-safety-and-efficacy-of-bixdo-ultra-compact-water-flosser/

Evaluation of Safety and Efficacy of Bixdo Ultra Compact ... Clinical trial for Plaque Induced Gingivitis , Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10212231/

Effects of water flossing on gingival inflammation and ... Conclusions. Daily water flossing can effectively alleviate gingival inflammation and reduce oral malodor, possibly by depleting oral anaerobes ...

4. bixdo.com bixdo.com/pages/why-choose-us?srsltid=AfmBOopHVGSA1uy3PSd22ArBxbFzeEr-ti712CYeogOePMHxhC9KSyYp

Why choose us – bixdo shop Studies show that bixdo P50Pro can remove up to 99.9% of dental plaque and the rate of adverse reaction is 0%. water care® technology. High-performance motor ...

5. researchgate.net researchgate.net/publication/371039836_Effects_of_water_flossing_on_gingival_inflammation_and_supragingival_plaque_microbiota_a_12-week_randomized_controlled_trial

(PDF) Effects of water flossing on gingival inflammation ... Conclusions Daily water flossing can effectively alleviate gingival inflammation and reduce oral malodor, possibly by depleting oral anaerobes ...

6. ctv.veeva.com ctv.veeva.com/study/evaluation-of-safety-and-efficacy-of-bixdo-ultra-compact-water-flosser

Evaluation of Safety and Efficacy of Bixdo Ultra Compact ... 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 ...

7. amazon.com amazon.com/bixdo-Water-Flosser-Portable-Travel/dp/B0DTPPP755

bixdo Water Flosser Portable for Travel Brand. bixdo ; Power Source. Battery Powered ; Special Feature. Multiple Pressure Settings ; Product Benefits. Gum Health, Prevents Bad Breath, Prevents Cavities, ...

8. bixdo.com bixdo.com/products/bixdo-a30-pro-portable-water-dental-flosser?srsltid=AfmBOopscA3ZKz3J4OzcPpmTLxWVNPkH9jn3ILscC0iDuOEY78B9ZXn8

bixdo A30 Pro Portable Water Dental Flosser Effectively prevents tooth decay and gum disease. Keeps your teeth looking and feeling clean. Safe & Durable Material. Made of Tritan - the same material ...

9. clinconnect.io clinconnect.io/trials/NCT06352645

Evaluation of Safety and Efficacy of Bixdo Ultra Compact This clinical trial is studying the safety and effectiveness of the Bixdo A30 Pro Ultra Compact Water Flosser when used alongside a regular toothbrush to help ...