Clinical trial

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

Name

RecepTayyipErdoganUni

Description

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.

Trial arms

Trial start

2021-01-01

Estimated PCD

2023-06-01

Trial end

2024-02-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Methyprednisolon and low level laser theraphy

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.

Arms:

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

Size

Primary endpoint

Electromyographic Analysis

1 month

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Not required.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}

Updated at

2024-01-03

1 organization

1 product

4 indications

Organization

Recep Tayyip Erdogan University

Product

Indication

Indication

Indication

Indication

Facial Nerve Injuries