Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

Официальное название

Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser in Addition to Toothbrushing-A 8-week Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство Bixdo Ultra Compact Water Flosser
  Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks.
• Устройство 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.

Первичные конечные точки

• Inflammation Reduction [Срок оценки: 8 weeks]
• Bacterial plaque removal [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.
• 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.
• Subjects 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: 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Tufts University School of Dental Medicine — Boston

Публикации

• 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. PMID 30496104
• 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. PMID 16128839
• 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. PMID 34952680
• Tarnow DP. Increasing Prevalence of Peri-implantitis: How Will We Manage? J Dent Res. 2016 Jan;95(1):7-8. doi: 10.1177/0022034515616557. No abstract available. PMID 26701918
• 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. PMID 25261053
• 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. PMID 31850640
• Cochran DL. Inflammation and bone loss in periodontal disease. J Periodontol. 2008 Aug;79(8 Suppl):1569-76. doi: 10.1902/jop.2008.080233. PMID 18673012
• Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38. PMID 28805207

Идентификаторы

NCT: NCT06352645 · STUDY00004879

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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