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Clinical Trial Summary

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.


Clinical Trial Description

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; 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06185426
Study type Interventional
Source Recep Tayyip Erdogan University
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date January 1, 2021
Completion date February 1, 2024

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