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临床试验/NCT07308522
NCT07308522尚未招募不适用

Clinical ,Microbiological and Compliance Outcomes of AI-based vs Standard Electric and Manual Toothbrushes in Adults With Plaque-Induced Gingivitis: A 6-Week Randomized Controlled Trial

University of Baghdad2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
33
试验地点
2
主要终点
Plaque index

研究概览

简要总结

Severe periodontitis is widespread and begins with reversible gingivitis, driven by poor oral hygiene and a dysbiotic microbiome. Daily toothbrushing is the simplest prevention, but patients still leave plaque. Electric brushes remove more plaque and reduce gingivitis better than manual ones, and users show better periodontal status. App-connected smart brushes and apps aim to improve adherence. Trials increased plaque reduction and brushing time versus manual brushing, but app layers have not clearly beaten standard power brushes, and microbiological outcomes are rarely reported. Xiaomi's AI-based sonic T501 adds pressure sensing, personalised coaching and coverage tracking, whereas the T302 is a simpler non-connected sonic brush. Streptococcus sanguinis is a health-associated early coloniser; its qPCR-measured relative abundance marks a healthy supragingival profile. It is still unclear whether AI guidance adds extra benefit beyond a standard electric brush in adult gingivitis.

详细描述

Worldwide, 538 million people are reported to have severe periodontitis .The root of this problem lies in its initial stage, gingivitis. Gingivitis typically results from inadequate oral hygiene, which can quickly shift a healthy oral microbiome to a dysbiotic state, leading to gingival inflammation and bleeding. If this early stage is not treated, more advanced periodontal disease can occur with irreversible oral health consequences and systemic implications.

Among the simplest and most cost-effective approaches for preventing periodontal disease is daily self-care. Effective toothbrushing mechanically removes plaque, reverses gingivitis, and prevents its inception.The better plaque is controlled, the more substantial the clinical gains. However, even with their best efforts, patients often leave considerable amounts of plaque behind after toothbrushing .

Various toothbrush designs and technologies have been developed to improve plaque removal. Results of systematic reviews and meta-analyses evaluating these options consistently showed electric toothbrushes provide significantly greater plaque removal and gingivitis control than manual toothbrushes. These benefits have been corroborated by the results of population-based research showing poorer periodontal health status and fewer teeth present for manual toothbrush users than electric toothbrush users. AI in dentistry uses machine-learning tools to assist clinicians detecting disease on radiographs, supporting diagnosis/risk assessment (e.g., caries/periodontitis), optimizing treatment planning/CAD-CAM, and boosting patient adherence via smart, sensor-based brushes and apps. In early app-connected trials, adolescents used a manual brush and an interactive, Bluetooth-enabled oscillating-rotating brush + app. The app-connected brush significantly increased whole-mouth plaque reduction and brushing time in a 2-week single-blind RCT .

Another was a three-arm, eight-week RCT that compared a manual brush to the same power brush with or without app assistance in dental students with gingivitis.

For plaque and bleeding, both powered brushes performed better than the manual; however, in that sample, the app layer did not provide a definite clinical advantage over the non-app powered brush . Recently, a smart sonic toothbrush (Xiaomi T501) has been introduced that combines a magnetic-levitation motor with motion/pressure sensing and app-based coaching. The motor generates high-frequency micro-vibrations that transmit energy to the bristle tips while the built-in pressure sensor limits excessive force.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants should be systemically healthy
  • 18 years old, with the presence of ≥ 20 teeth
  • Diagnosed with generalized plaque-induced gingivitis having >30% bleeding sites, with probing depths ≤3 mm and intact periodontium
  • Participants with at least secondary school education, who are able to read and understand basic English to follow the app-based toothbrush instructions

排除标准

  • Participants who using antibiotics or anti-inflammatory medication throughout the investigation or during the previous 3 months prior to the study.
  • Drug-induced gingival enlargement (phenytoin, cyclosporine, calciumchannel blockers).
  • Individuals with periodontitis and healthy periodontium.
  • Mouth breathers .
  • Individuals with severe dental crowding or malalignment that prevents proper toothbrushing.
  • Individuals with heavy calculus.
  • Individuals who smoke or alcoholism.
  • Pregnant, breastfeeding women or those using contraceptive tablets.
  • Individuals with orthodontic devices or removable dentures

结局指标

主要结局

Plaque index

时间窗: This index will be recorded at baseline, after 2 weeks, and 2 months after enrollment

Turesky-modified Quigley-Hein Plaque Index will be quantified on a scale between 0 to 5: 0 No plaque 1. Isolated areas of plaque at the cervical margin of the tooth. 2. A thin continuous band of plaque (up to 1 mm) at cervical margin of tooth. 3. A band of plaque wider than 1 mm but covering less than one- third of the crown of the tooth. 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth. 5. plaque covering two-thirds or more of the crown of the tooth.

次要结局

  • Modified sulcular bleeding index(The index will be recorded at baseline, 2 weeks, and 2 months after enrolment)
  • Compliance to oral hygiene instructions and level of satisfaction(The compliance will be assessed after 2 week and 2 months. Satisfaction will be assessed at the endpoint of the study (2 months))
  • Microbiological analysis(Plaque samples will be collected for analysis at baseline, 2 weeks, and 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Buthaina Firas Faisal

Researcher

University of Baghdad

研究点 (2)

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