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

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.

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Key information

Conditions

Inferior Alveolar Nerve Injuries Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Facial Nerve Diseases Facial Neuralgia Mandibular Nerve Injuries Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trauma, Nervous System Trigeminal Nerve Diseases Trigeminal Nerve Injuries Wounds and Injuries

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karadeniz Technical University

Trabzon, 61030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with unilateral or bilateral inferior alveolar nerve damage caused by maxillofacial surgery and receiving DESL treatment
Patients with a follow-up period of at least 6 months
Patients whose diagnosis has been confirmed by clinical neurosensory testing
Patients with complete study data and follow-up
Patients who have not previously undergone any microsurgical or conservative treatment in the head and neck region due to nerve damage
Patients without known neurological disease that may affect the study results
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

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

Treatment and study plan

Low Level Laser Therapy

Device

In this study, which had more patients than other studies, different parameters were evaluated to determine the protocol of LLL therapy. These parameters were the cause of IAN injury, number of sessions, time of treatment start and period of follow-up.

Primary outcomes

the Visual Analog Scale (VAS)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2024
First posted: Mar 25, 2025
Registry last updated: Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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