Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser
NCT ID: NCT06352645
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2025-03-04
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional Group
Those randomized into the interventional group will be asked to use the Bixdo Ultra Compact Water Flosser twice a day for 8 weeks.
Bixdo Ultra Compact Water Flosser
Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
Control Group
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.
Manual toothbrush
For those in the control group, they will be asked to use only the study-provided manual toothbrush, twice a day for 8 weeks.
Interventions
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Bixdo Ultra Compact Water Flosser
Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
Manual toothbrush
For those in the control group, they will be asked to use only the study-provided manual toothbrush, twice a day for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Guang Dong Bixdo Health Technology Co.,Ltd
OTHER
Tufts University
OTHER
Responsible Party
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Principal Investigators
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Mabi Singh
Role: PRINCIPAL_INVESTIGATOR
Tufts University School of Dental Medicine
Locations
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Tufts University School of Dental Medicine
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
Tonetti MS, Claffey N; European Workshop in Periodontology group C. Advances in the progression of periodontitis and proposal of definitions of a periodontitis case and disease progression for use in risk factor research. Group C consensus report of the 5th European Workshop in Periodontology. J Clin Periodontol. 2005;32 Suppl 6:210-3. doi: 10.1111/j.1600-051X.2005.00822.x. No abstract available.
Bashir NZ. Update on the prevalence of untreated caries in the US adult population, 2017-2020. J Am Dent Assoc. 2022 Apr;153(4):300-308. doi: 10.1016/j.adaj.2021.09.004. Epub 2021 Dec 22.
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Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
Eke PI, Borgnakke WS, Genco RJ. Recent epidemiologic trends in periodontitis in the USA. Periodontol 2000. 2020 Feb;82(1):257-267. doi: 10.1111/prd.12323.
Cochran DL. Inflammation and bone loss in periodontal disease. J Periodontol. 2008 Aug;79(8 Suppl):1569-76. doi: 10.1902/jop.2008.080233.
Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.
Linden GJ, Herzberg MC; Working group 4 of joint EFP/AAP workshop. Periodontitis and systemic diseases: a record of discussions of working group 4 of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases. J Clin Periodontol. 2013 Apr;40 Suppl 14:S20-3. doi: 10.1111/jcpe.12091.
Genco RJ, Van Dyke TE. Prevention: Reducing the risk of CVD in patients with periodontitis. Nat Rev Cardiol. 2010 Sep;7(9):479-80. doi: 10.1038/nrcardio.2010.120.
Lalla E, Papapanou PN. Diabetes mellitus and periodontitis: a tale of two common interrelated diseases. Nat Rev Endocrinol. 2011 Jun 28;7(12):738-48. doi: 10.1038/nrendo.2011.106.
Lundberg K, Wegner N, Yucel-Lindberg T, Venables PJ. Periodontitis in RA-the citrullinated enolase connection. Nat Rev Rheumatol. 2010 Dec;6(12):727-30. doi: 10.1038/nrrheum.2010.139. Epub 2010 Sep 7.
Whitmore SE, Lamont RJ. Oral bacteria and cancer. PLoS Pathog. 2014 Mar 27;10(3):e1003933. doi: 10.1371/journal.ppat.1003933. eCollection 2014 Mar. No abstract available.
Madianos PN, Bobetsis YA, Offenbacher S. Adverse pregnancy outcomes (APOs) and periodontal disease: pathogenic mechanisms. J Clin Periodontol. 2013 Apr;40 Suppl 14:S170-80. doi: 10.1111/jcpe.12082.
Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
Chapple IL, Van der Weijden F, Doerfer C, Herrera D, Shapira L, Polak D, Madianos P, Louropoulou A, Machtei E, Donos N, Greenwell H, Van Winkelhoff AJ, Eren Kuru B, Arweiler N, Teughels W, Aimetti M, Molina A, Montero E, Graziani F. Primary prevention of periodontitis: managing gingivitis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S71-6. doi: 10.1111/jcpe.12366.
Edlund P, Bertl K, Pandis N, Stavropoulos A. Efficacy of power-driven interdental cleaning tools: A systematic review and meta-analysis. Clin Exp Dent Res. 2023 Feb;9(1):3-16. doi: 10.1002/cre2.691. Epub 2022 Dec 23.
Xu X, Zhou Y, Liu C, Zhao L, Zhang L, Li H, Li Y, Cheng X. Effects of water flossing on gingival inflammation and supragingival plaque microbiota: a 12-week randomized controlled trial. Clin Oral Investig. 2023 Aug;27(8):4567-4577. doi: 10.1007/s00784-023-05081-4. Epub 2023 May 25.
Lyle DM, Qaqish JG, Goyal CR, Schuller R. Efficacy of the Use of a Water Flosser in Addition to an Electric Toothbrush on Clinical Signs of Inflammation: 4-Week Randomized Controlled Trial. Compend Contin Educ Dent. 2020 Mar 1;41(3):170-177. Epub 2020 Jan 1.
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Tyler D, Kang J, Goh HH. Effectiveness of Waterpik(R) for oral hygiene maintenance in orthodontic fixed appliance patients: A randomised controlled trial. J Orthod. 2023 Dec;50(4):367-377. doi: 10.1177/14653125231173708. Epub 2023 May 19.
Sawan N, Ben Gassem A, Alkhayyal F, Albakri A, Al-Muhareb N, Alsagob E. Effectiveness of Super Floss and Water Flosser in Plaque Removal for Patients Undergoing Orthodontic Treatment: A Randomized Controlled Trial. Int J Dent. 2022 Aug 31;2022:1344258. doi: 10.1155/2022/1344258. eCollection 2022.
Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.
Goyal CR, Lyle DM, Qaqish JG, Schuller R. The addition of a water flosser to power tooth brushing: effect on bleeding, gingivitis, and plaque. J Clin Dent. 2012;23(2):57-63.
Related Links
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Adverse Event Reporting to IRBs - Improving Human Subject Protection
Other Identifiers
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STUDY00004879
Identifier Type: -
Identifier Source: org_study_id
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