Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Visual Analog scale
研究概览
简要总结
This randomized clinical trial was designed to assess the clinical efficacy of Pulsed electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.
The sample included 120 patients undergoing unilateral mandibular third molar extraction. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.
详细描述
Introduction
Pulsed electromagnetic field (PEMF) therapy is a noninvasive method for delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema. This randomized clinical trial was designed to assess the clinical efficacy of PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.
Materials and methods
The sample included 120 patients undergoing unilateral mandibular third molar extraction. At the end of the surgical procedure, patients were randomly assigned to a test (T) or placebo (P) group and fitted with enabled or disabled PEMF devices, respectively, or to a control (C) group not fitted with a PEMF device. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who needs third molar extraction,
- •good oral hygiene,
- •no contraindications to treatment.
排除标准
- •age under 14 years;
- •poor oral hygiene (plaque index less then 20%);
- •contraindications for surgery (or anesthesia);
- •infectious or systemic diseases;
- •immunosuppressant therapy;
- •pregnancy or breastfeeding;
- •mental disorders.
研究组 & 干预措施
Control Group (no device)
No devices were delivered after third molar tooth extraction
Placebo group (Inactivated device)
Inactivated devices were delivered after third molar tooth extraction
干预措施: RecoveryRx™ (Device)
Test (activated device)
Activated devices were delivered after third molar tooth extraction
干预措施: RecoveryRx™ (Device)
结局指标
主要结局
Visual Analog scale
时间窗: up to day 7 post intervention
次要结局
- Quality of healing(day 7 post intervention)
研究者
Stefano Sivolella
Clinical Faculty department of oral surgery
University of Padova, School of Dental Medicine