Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury

Early Phase 1

Active, not recruiting

• Conditions: Methylprednisolone; Nerve Injury; Facial Nerve Injuries; Laser Therapy
• Interventions: Drug: Methyprednisolon and low level laser theraphy

• Registration Number: NCT06185426
• Lead Sponsor: Recep Tayyip Erdogan University

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-06-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-27
• Study First Posted: 2023-12-29
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-03
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid group (SG)	Methyprednisolon and low level laser theraphy	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.
Laser+Steroid Group (LSG):	Methyprednisolon and low level laser theraphy	Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination.
Healthy Control Group (HCG)	Methyprednisolon and low level laser theraphy	Seven rats will be included randomly in this group. No surgical/medical approach will be applied.
Damaged Control Group (DCG):	Methyprednisolon and low level laser theraphy	Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied.
Laser Group (LG)	Methyprednisolon and low level laser theraphy	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.

Primary Outcome Measures

Name	Time	Method
Electromyographic Analysis	1 month	Measuring the amplitude and latency of the action potential occurring in the nerve with electromyography(On facial nerve)

Secondary Outcome Measures

Name	Time	Method
Biochemical Analysis	1 month	Determination of MDA and GSH levels in blood samples taken

Trial Locations

Locations (1)

RTEU Faculty of Dentistry; 🇹🇷 Rize, Turkey