跳至主要内容
临床试验/NCT05137392
NCT05137392已完成不适用

Impact of Intensive Oral Hygiene Regimen Based on Individualized Messages and an Intelligent Power-driven Toothbrush on Non-surgical Treatment of Stage II and III Periodontitis: A Randomized, Standard of Care-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 100 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
changes in proportion of periodontal pocket closure

研究概览

简要总结

Achievement of adequate oral hygiene standards is critical to the successful treatment of gum disease. The improvement of the patient's adherence to good oral hygiene is of great importance to obtain the satisfactory treatment outcomes. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. This study evaluates whether a novel oral hygiene instruction regimen can provide some additional benefit for periodontal treatment compared with routine oral hygiene instructions.

详细描述

Dental plaque is causally linked to gingival inflammation and essential for the onset of periodontitis. The main goal of periodontal treatment is the establishment of adequate infection control to reduce the bacterial load below individual threshold levels of inflammation. Achievement of adequate oral hygiene standards is critical to effective periodontal therapy. Classical studies have shown that professional tooth cleaning during healing of subgingival debridement provides superior outcomes. Regrettably, costs do not allow routine implementation of these regimens. By far, patient-centred homecare is the most cost-effective approach to maintaining good oral hygiene. Therefore, improving the adherence with self-performed oral hygiene is a priority in periodontal practice.

Conventionally, clinicians provide oral hygiene instructions to the patients based on the results of their clinical examinations, sometimes supplemented with written information in brochure and disclosing agents to show the location of the biofilm. However, patients' adherence to a proper daily oral hygiene regimen generally remains poor. New technology based on an internet of things network of intelligent toothbrushes (i-Brush) has shown excellent adherence of use in a pilot study in a maintenance population. Other studies have shown that electronic messaging and mobile health (mHealth) supported by smartphones and applications improve oral hygiene performance, particularly in younger individuals undergoing orthodontic treatment. New electric artificial intelligence powered toothbrushes are able to precisely sense the location of the brushing being performed by the patient and transmit information to the clinician who is able to analyze the data and provide targeted instructions, if needed. Remote sensing of oral hygiene practices through the connected intelligent powered toothbrush allows more specific and targeted messages, thereby promoting personalized oral health care and eventually improving the healing outcomes of periodontal therapy through a two-way communication between patients and clinicians. This study aims to investigate the clinical efficacy of a novel regimen consisting of a new generation of power-driven internet connected i-Brush and targeted m-Health messages in improving periodontal treatment outcomes in comparison with routine oral hygiene instructions.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Aged 18 and above
  • Generalized Stage II and Stage III periodontitis
  • Subjects willing to receive NSPT necessary for the management of periodontitis and to comply with research appointments/schedule
  • Use of a compatible Android cell phone with Oral-B 8.5.1 Application

排除标准

  • Edentulism
  • Presence of any systemic disease that can alter the manifestation/outcome of periodontal treatment
  • Pregnancy or intention to become pregnant at any point during the study duration
  • Having received antibiotics within the previous 3 months
  • Need for antibiotic prophylaxis in the context of dental treatment
  • Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
  • Presence of xerostomia interfering with saliva sampling
  • Participation in another intervention trial
  • Inability or unwillingness of individual to give written informed consent.

结局指标

主要结局

changes in proportion of periodontal pocket closure

时间窗: from baseline to 6 months

changes in proportion of periodontal pocket closure defined by probing pocket depth (PPD) ≤4mm without bleeding on probing (BOP) after non-surgical periodontal treatment (NSPT)

changes in probing pocket depth (PPD)

时间窗: from baseline to 6 months

changes in probing pocket depth (PPD) after non-surgical periodontal treatment (NSPT)

次要结局

  • changes in clinical attachment level (CAL)(from baseline to 6 months)
  • changes in oral biomarker concentration(from baseline to 6 months)
  • changes in probing pocket depth (PPD)(from baseline to 3 months)
  • changes in bleeding on probing (BOP)(from baseline to 6 months)
  • changes in periodontal soft tissue volumes(from baseline to 6 months)
  • changes in proportion of periodontal pocket closure(from baseline to 3 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)

Loading locations...

相似试验

Effect of Novel Oral Hygiene Regimen on Non-surgical... | 临床试验