Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Electromyographic Analysis
研究概览
简要总结
The objective of the study will be to investigate the effect of low-level diode laser therapy (LLLT) and steroid on facial nerve injury. Thirty five male Wistar rat will randomly be divided into five groups: healthy control (HCG); damage control (DC); laser (LG); steroid (SG); and combined laser and steroid group (LSG). Right facial nerve electromyography (EMG) data will record after facial nerve damage done and before sacrification at 4th week.The results will be evaluated histopathologically, electrophysiologically and biochemically.
详细描述
The animals will be randomly divided into two control groups, a healthy control group and a damaged control group, and three experimental groups; 7 rats were assigned to each group as follows;
- Healthy Control Group (HCG): Seven rats will be included randomly in this group. No surgical/medical approach will be applied. EMG measurements will betaken over the right facial nerve.
- Damaged Control Group (DCG): Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Laser Group (LG): Facial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) will be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Steroid group (SG): Facial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
- Laser+Steroid Group (LSG): Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination. EMG measurements will be taken over the right facial nerve after the injury and after the four weeks of treatment.
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
- 4 Months 至 6 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Thirty-five male Sprague-Dawley rats weighing 200-300 g will be included the study
排除标准
- •Rats that are older than 6 months and are not healthy and have impaired facial motor functions will be excluded from the study.
研究组 & 干预措施
Healthy Control Group (HCG)
Seven rats will be included randomly in this group. No surgical/medical approach will be applied.
干预措施: Methyprednisolon and low level laser theraphy (Drug)
Damaged Control Group (DCG):
Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied.
干预措施: Methyprednisolon and low level laser theraphy (Drug)
Laser Group (LG)
Facial nerve injury will be created on the right facial nerve. LLLT (Low-Intensity et al.) willl be applied 3 times a week for 4 weeks postoperatively, at 830 nm with an optical power output of 30 mW, an energy density of 4 J/cm2, an irradiation area of 0.116 cm2 and an exposure time of 16 s per spot.
干预措施: Methyprednisolon and low level laser theraphy (Drug)
Steroid group (SG)
Facial nerve injury will be created on the right facial nerve. Intraperitoneal methylprednisolone (1mg/kg/day) will be administered every day for 1 week postoperatively.
干预措施: Methyprednisolon and low level laser theraphy (Drug)
Laser+Steroid Group (LSG):
Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination.
干预措施: Methyprednisolon and low level laser theraphy (Drug)
结局指标
主要结局
Electromyographic Analysis
时间窗: 1 month
Measuring the amplitude and latency of the action potential occurring in the nerve with electromyography(On facial nerve)
次要结局
- Biochemical Analysis(1 month)
研究者
Zeynep Gumrukcu
associate professor
Recep Tayyip Erdogan University