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

NCT06185426 | Unknown Early Phase 1

• 2 other identifiers: RecepTayyipErdoganUniTSA-2020-1045
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Injury; Laser Therapy; Methylprednisolone; Facial Nerve Injuries

Keywords

Facial Nerve Injury; Steroid; Low Level Laser Therapy; Nerve Recovery

Outcome Measures

Primary Outcomes (1)

• Electromyographic Analysis

  Measuring the amplitude and latency of the action potential occurring in the nerve with electromyography(On facial nerve)

  1 month

Secondary Outcomes (1)

• Biochemical Analysis

  1 month

Study Arms (5)

Healthy Control Group (HCG)

PLACEBO COMPARATOR

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

Drug: Methyprednisolon and low level laser theraphy

Damaged Control Group (DCG):

ACTIVE COMPARATOR

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

Drug: Methyprednisolon and low level laser theraphy

Laser Group (LG)

EXPERIMENTAL

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.

Drug: Methyprednisolon and low level laser theraphy

Steroid group (SG)

EXPERIMENTAL

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.

Drug: Methyprednisolon and low level laser theraphy

Laser+Steroid Group (LSG):

EXPERIMENTAL

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

Drug: Methyprednisolon and low level laser theraphy

Interventions

Methyprednisolon and low level laser theraphy DRUG

All rats will be anesthetized with ketamine hydrochloride at a dose of 50 mg/kg (i.p) (Ketalar ®, Eczacıbaşı Parke-Davis, İstanbul, Türkiye) and Xylazine HCl (Alfazyne ®, Alfasan International B.V. Woerden, Hollanda) at a dose of 10 mg/kg (intraperitoneal). A right postauricular incision will made under general anesthesia, and an external trunk of the facial nerve will be found. In the DCG and other experimental groups, the facial nerve was dissected, and it will be clamped with an average force of 150 g for about 1 minute. Afterward, the surgical area will be sutured in all rats in the DCG, L, S, and LSG groups. At the end of the 4 weeks of study, tissue samples will be taken from the facial nerve trunk in the control and experimental groups with a second surgical procedure preserved in formalin solution and sent for histopathological and biochemical examination.

Damaged Control Group (DCG):; Healthy Control Group (HCG); Laser Group (LG); Laser+Steroid Group (LSG):; Steroid group (SG)

Eligibility Criteria

• Age: 4 Months - 6 Months
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

RTEU Faculty of Dentistry

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Facial Nerve Injuries

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• zeynep gümrükçü, Associate Professor

  RTEU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Not required.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 29, 2023
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)