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临床试验/NCT07549347
NCT07549347招募中不适用

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2026年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
92
试验地点
1
主要终点
changes in full mouth bleeding score (FMBS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Statistician and laboratory test assessors will also be masked

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ≧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

排除标准

  • 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

研究组 & 干预措施

Test group

Experimental

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 at baseline.

干预措施: Optimal oral care regimen (Behavioral)

Test group

Experimental

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 at baseline.

干预措施: Sham Periodontal Treatment (Device)

Control group

Other

The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline.

干预措施: Optimal oral care regimen (Behavioral)

Control group

Other

The control group will receive standard Professional Mechanical Plaque Removal consisting of supra- and subgingival debridement at baseline.

干预措施: Periodontal Treatment (Device)

结局指标

主要结局

changes in full mouth bleeding score (FMBS)

时间窗: from baseline to 6 months

changes of full mouth bleeding score after periodontal treatment

次要结局

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

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maurizio Tonetti

Professor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

研究点 (1)

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