Is Professional Tooth Cleaning Necessary for Managing Gingivitis (Gingival Inflammation) if Subjects Use Intelligent Toothbrushes?

Официальное название

Optimal Oral Care Regimen With or Without Professional Mechanical Plaque Removal in Managing Gingivitis (Gingival Inflammation): A Non-inferiority Randomized Controlled Trial

Обзор

Periodontitis is highly prevalent and develops from plaque-induced gingivitis. Managing gingivitis is key to preventing periodontitis and its complications. Professional mechanical plaque removal (PMPR) with oral hygiene guidance is effective for gingivitis, but large-scale implementation-especially in China-faces challenges such as workforce shortages. Meanwhile, patient compliance with daily oral hygiene remains poor. An optimal oral care regimen featuring an intelligent electric toothbrush (i-Brush) has shown promise in enhancing self-care adherence and efficiency. However, it remains unclear whether PMPR is still necessary when used in conjunction with this optimal oral care regimen. This study aims to verify whether the i-Brush-based regimen is non-inferior to the combination of PMPR and the regimen in improving gingival inflammation in gingivitis and stage I periodontitis.

Подробное описание

Periodontitis is highly prevalent and develops from gingivitis caused by plaque accumulation. Managing gingivitis is the "best-buy" approach for preventing periodontitis and avoiding its local and systemic sequelae. Professional mechanical plaque removal (PMPR), which aims at removing plaque biofilm and dental calculus, is generally considered effective in treating gingivitis when provided in the context of oral hygiene instructions. However, delivering PMPR to large populations such as the Chinese population poses formidable challenges, including the formation of an adequate workforce. Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. However, many studies have shown poor patient compliance with routine oral hygiene instruction. A new technology based on an intelligent electric toothbrush (i-Brush) and the Internet of Things shows good application prospects. A previous study has verified the effectiveness of optimal oral care regimens, which involve the use of an i-brush and the application of standard toothpaste, in enhancing the adherence and performance of self-performed oral hygiene, leading to significant savings and a more effective allocation of healthcare resources. However, it is unclear whether PMPR still plays an important role when combined with such optimal oral care regimens in managing gingivitis and early-stage periodontitis. This study aims to determine whether the effect of the optimal oral care regimen in improving gingival inflammation in gingivitis and stage I periodontitis is not inferior to the effect of the combination with PMPR.

Вмешательства

• Поведенческое Optimal oral care regimen
  Both groups will receive the optimal oral care regimen throughout the entire research period. This regimen comprises using a commercially available intelligent toothbrush connected to the Chinese consumer version of an application, receiving targeted oral health messages, and using dental floss.
• Устройство Periodontal Treatment
  At baseline, the control group will receive standard professional mechanical plaque removal consisting of supra - and subgingival debridement using ultrasonic device.
• Устройство Sham Periodontal Treatment
  At baseline, the test group will receive sham professional mechanical plaque removal consisting of cleaning the teeth with the same ultrasonic device but applied more than 2 mm away from the gingival margin.

Первичные конечные точки

• changes in full mouth bleeding score (FMBS) [Срок оценки: from baseline to 6 months]

Вторичные конечные точки (6)

• changes in probing depth (PD) [Срок оценки: from baseline to 6 months]
• changes in plaque index (PI) [Срок оценки: from baseline to 6 months]
• changes in calculus surface index (CSI) [Срок оценки: from baseline to 6 months]
• changes in oral biomarker concentration [Срок оценки: from baseline to 6 months]
• changes in subgingival plaque taxa [Срок оценки: from baseline to 6 months]
• changes in patient reported outcomes [Срок оценки: from baseline to 6 months]

Критерии участия

Критерии включения

• ≧18 years old and < 65 years old
• Gingivitis, Stage I and Localized Stage II Periodontitis
• With more than 20 teeth
• Agree to use the electronic I-brush with the Oral-B APP

Критерии исключения

• Presence of any systemic disease that can alter the outcome of periodontal treatment
• Pregnancy or lactation during the study
• Having received antibiotics within the previous 3 months
• Having received professional periodontal treatment within the previous 3 months
• With ongoing orthodontic treatment

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Публикации

• Li Y, Wu X, Liu M, Deng K, Tullini A, Zhang X, Shi J, Lai H, Tonetti MS. Enhanced control of periodontitis by an artificial intelligence-enabled multimodal-sensing toothbrush and targeted mHealth micromessages: A randomized trial. J Clin Periodontol. 2024 Dec;51(12):1632-1643. doi: 10.1111/jcpe.13987. Epub 2024 Apr 17. PMID 38631679
• Tonetti MS, Deng K, Christiansen A, Bogetti K, Nicora C, Thurnay S, Cortellini P. Self-reported bleeding on brushing as a predictor of bleeding on probing: Early observations from the deployment of an internet of things network of intelligent power-driven toothbrushes in a supportive periodontal care population. J Clin Periodontol. 2020 Oct;47(10):1219-1226. doi: 10.1111/jcpe.13351. Epub 2020 Aug PMID 32748486
• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290. PMID 32383274
• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945. PMID 29926495

Идентификаторы

NCT: NCT07549347 · ibrush-2026-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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