跳至主要内容
临床试验/NCT04213144
NCT04213144已完成不适用

Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis

Rambam Health Care Campus2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Change in the implant probing depth (IPD)

研究概览

简要总结

the aim of the study is to compare between two non-surgical methods of treatment of peri-implantitis by using debridement and placing an healing abutment with electomagnetic field (MED-Magdent Miniaturized Device) in the test group and Sham healing abutment in the control group ( Sham MED).

详细描述

Dental Implants are common alternative for replacement at the time of tooth loss. The two common methods for treatment implant with inflammation include surgical and global non-surgical treatment.

The non-surgical treatment includes soft tissue debridement with various tools which including manual, ultrasonic rotators, lasers and delayed release devices.

Using an electromagnetic field to induce bony healing in fractures and around implants is being investigated for studies and was found to be effective and safe. The electric field lowers osteoclasts activity, speeds up osteoid construction and stimulates creation blood vessels development. Forty patients who will attend to the department of periodontology at Rambam health care campus, at the School ofpostgraduate Dentistry, which will meet the research criteria, will be recruited. All patients will exhibit a moderate-onset gum infection around one of the implants.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent.
  • Patients of 20 - 85 years.
  • pocket depth of 5-8 mm and bone loss of 3-5mm Patients with fixed prosthodontics Implant with standart width

排除标准

  • Heavy smokers (more than 10 cigarettes per day).
  • Pregnant women
  • active periodontal disease
  • Consumption of Non Steroidal Anti Inflammatory drugs

结局指标

主要结局

Change in the implant probing depth (IPD)

时间窗: baseline, 4 weeks, 12 weeks

clinical measurement of the depth of the pocket around the implant in 6 sites

次要结局

  • changing in the concentration of the RANKL cytokine(baseline, 2 weeks, 4 weeks, 12 weeks)

研究者

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

Hadar Zigdon MD

Rambam Health Care Campus

Rambam Health Care Campus

研究点 (2)

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