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

Recep Tayyip Erdogan University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Facial Nerve Injuries; Methylprednisolone; Laser Therapy; Nerve Injury

Treatments: Drug: Methyprednisolon and low level laser theraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT06185426

TSA-2020-1045 (Other Grant/Funding Number)

RecepTayyipErdoganUni

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Male

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

35 participants in 5 patient groups, including a placebo group

Healthy Control Group (HCG)

Placebo Comparator group

Description:

Seven rats will be included randomly in this group. No surgical/medical approach will be applied.

Treatment:

Drug: Methyprednisolon and low level laser theraphy

Damaged Control Group (DCG):

Active Comparator group

Description:

Facial nerve injury will be created on the right facial nerve. No surgical/medical approach will be applied.

Treatment:

Drug: Methyprednisolon and low level laser theraphy

Laser Group (LG)

Experimental group

Description:

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.

Treatment:

Drug: Methyprednisolon and low level laser theraphy

Steroid group (SG)

Experimental group

Description:

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.

Treatment:

Drug: Methyprednisolon and low level laser theraphy

Laser+Steroid Group (LSG):

Experimental group

Description:

Facial nerve injury will be created on the right facial nerve. Laser and steroid treatment will be applied in combination.

Treatment:

Drug: Methyprednisolon and low level laser theraphy