Does Low-level Laser Therapy Protocol Affect the Efficacy of Treatment of Inferior Alveolar Nerve Injury After Maxillofacial Surgery

Phase 4

Completed

• Conditions: Inferior Alveolar Nerve Injuries

• Registration Number: NCT06893497
• Lead Sponsor: Karadeniz Technical University

Brief Summary

Dear Patient, Dear Parent / Guardian; This consent form has been prepared to enlighten you about the nature of the diagnosis and treatment methods that have been explained to you/patient and will be applied, the expected benefits of the procedures, possible side effects, alternative diagnosis and treatment options and their characteristics, and the consequences that may arise if these procedures are not performed and to obtain your consent. By reading and signing this form, you declare that you have been informed about the procedure and that you freely consent to the procedure. You can ask your doctor about the points you do not understand in the form. Please bring this form with you on the day of your appointment and hand it to your doctor.

WHAT YOU NEED TO KNOW DIAGNOSIS AND PROCEDURE: Low-level laser therapy will be applied for the treatment of sensory impairment resulting from maxillofacial surgery.

WHO WILL PERFORM YOUR PROCEDURE? This procedure will be performed by the physicians working in Karadeniz Technical University Faculty of Dentistry, Oral, Dental and Maxillofacial Surgery. I also accept that KTU Faculty of Dentistry is an educational institution and that my treatment can be used to contribute to the education of interns and that they can participate in my operation.

EXPECTED BENEFITS OF THE PROCEDURE To contribute to the nerve regeneration of the patient whose quality of life has deteriorated due to sensory damage.

PROBLEMS THAT MAY BE ENCOUNTERED IF THE PROCEDURE IS NOT PERFORMED There is no risk associated with low-level laser treatment.

ALTERNATIVES TO THE PROCEDURE, IF ANY: There is no alternative treatment.

possible risks and complications of the procedure Treatment approaches to nerve injuries are divided into two as surgical and non-surgical treatment approaches. Surgical treatment approaches include decompression, resection of neuroma, internal neurolysis, neurorrhaphy, nerve grafts and intubation techniques. However, since there is a risk of complications after surgical treatment, non-surgical treatment approaches are primarily preferred. Non-surgical treatment approaches include pharmacological treatment, acupuncture, moxibustion and low-level laser (DSL) treatment.

ESTIMATED DURATION OF THE PROCEDURE: 15-30 minutes.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Primary Completion: 2023-01-15
• Study Completion: 2024-01-15
• Study First Submitted: 2025-02-08
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Patients with unilateral or bilateral inferior alveolar nerve damage caused by maxillofacial surgery and receiving DESL treatment
2. Patients with a follow-up period of at least 6 months
3. Patients whose diagnosis has been confirmed by clinical neurosensory testing
4. Patients with complete study data and follow-up
5. Patients who have not previously undergone any microsurgical or conservative treatment in the head and neck region due to nerve damage
6. Patients without known neurological disease that may affect the study results
7. Patients without active infection (pain, temperature increase, redness, edema, loss of function, etc.) or pathological findings (tumour, cyst, etc.) in the relevant area were included.

Exclusion Criteria

1. Patients with nerve damage due to other reasons (pathology, infection, etc.) before maxillofacial surgery
2. Patients with lingual nerve damage
3. Patients with known neurological disease that may affect the study results
4. Patients with missing data or patients who cannot be followed up
5. Pregnant patients were not included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the Visual Analog Scale (VAS)	up to 2 years	All patients underwent preoperative and postoperative clinical neurosensory testing (CNT), comprising three levels of evaluation. Level A: two-point discrimination, where the minimum distinguishable distance (15 mm, 10 mm, and 5 mm) was measured using slight skin pressure. Level B: light touch assessment, where a blunt-tipped tool was applied to 10 points on the lower lip, recording detected stimuli. Level C: pin-prick nociception, where forceps compression assessed pain perception at 10 points. A subjective neurosensory deficit assessment was conducted using the Visual Analog Scale (VAS), a 100 mm horizontal line ranging from 0 (no sensation) to 100 (normal sensation), with descriptors at both ends.

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey