Clinical trial NCT06185426: Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury
Official title: Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Nerve Injury
Laser Therapy
Methylprednisolone
Facial Nerve Injuries
Keywords: Facial Nerve Injury
Steroid
Low Level Laser Therapy
Nerve Recovery
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 35
Sex: MALE
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Not required.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

-Thirty-five male Sprague-Dawley rats weighing 200-300 g will be included the study

Exclusion Criteria:

-Rats that are older than 6 months and are not healthy and have impaired facial motor functions will be excluded from the study.

Primary outcomes:
measure: Electromyographic Analysis
timeFrame: 1 month
Secondary outcomes:
measure: Biochemical Analysis
timeFrame: 1 month
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: RTEU Faculty of Dentistry
Study officials:
affiliation: RTEU
name: zeynep gümrükçü, Associate Professor
role: STUDY_DIRECTOR
References: