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

NCT ID: NCT06185426

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-02-01

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.

Conditions

Nerve Injury; Laser Therapy; Methylprednisolone; Facial Nerve Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Healthy Control Group (HCG)

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

Group Type: PLACEBO_COMPARATOR

Methyprednisolon and low level laser theraphy

Intervention Type: 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):

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

Group Type: ACTIVE_COMPARATOR

Methyprednisolon and low level laser theraphy

Intervention Type: 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.

Laser Group (LG)

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.

Group Type: EXPERIMENTAL

Methyprednisolon and low level laser theraphy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Methyprednisolon and low level laser theraphy

Intervention Type: 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.

Laser+Steroid Group (LSG):

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

Group Type: EXPERIMENTAL

Methyprednisolon and low level laser theraphy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Recep Tayyip Erdogan University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Gumrukcu

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zeynep gümrükçü, Associate Professor

Role: STUDY_DIRECTOR

RTEU

Locations

RTEU Faculty of Dentistry

Rize, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TSA-2020-1045

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RecepTayyipErdoganUni

Identifier Type: -

Identifier Source: org_study_id