Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis
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
- 是
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
Hadar Zigdon MD
Rambam Health Care Campus
Rambam Health Care Campus
