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

NCT06893497 | Completed Phase 4

• 1 other identifier: 2022/8
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Inferior Alveolar Nerve Injuries

Outcome Measures

Primary Outcomes (1)

• the Visual Analog Scale (VAS)

  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.

  up to 2 years

Study Arms (1)

Patients with different sessions, start time and cause of IAN injury were compared.

EXPERIMENTAL

Low level laser therapy was applied to all patients.

Device: Low Level Laser Therapy

Interventions

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.

Patients with different sessions, start time and cause of IAN injury were compared.

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61030, Turkey (Türkiye)

Location

Related Publications (12)

• Guarini D, Gracia B, Ramirez-Lobos V, Noguera-Pantoja A, Sole-Ventura P. Laser Biophotomodulation in Patients with Neurosensory Disturbance of the Inferior Alveolar Nerve After Sagittal Split Ramus Osteotomy: A 2-Year Follow-Up Study. Photomed Laser Surg. 2018 Jan;36(1):3-9. doi: 10.1089/pho.2017.4312. Epub 2017 Oct 12.

  PMID: 29022844 RESULT

• Favaro-Pipi E, Feitosa SM, Ribeiro DA, Bossini P, Oliveira P, Parizotto NA, Renno AC. Comparative study of the effects of low-intensity pulsed ultrasound and low-level laser therapy on bone defects in tibias of rats. Lasers Med Sci. 2010 Sep;25(5):727-32. doi: 10.1007/s10103-010-0772-2. Epub 2010 Jun 3.

  PMID: 20521077 RESULT

• Miloro M, Repasky M. Low-level laser effect on neurosensory recovery after sagittal ramus osteotomy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jan;89(1):12-8. doi: 10.1016/s1079-2104(00)80006-2.

  PMID: 10630935 RESULT

• Moore KC., Hira N., Kumar PS., Jayakumar CS., Ohshiro T. A Double Blind Crossover Trial of low Level Laser Therapy in the Treatment of Postherpetic Neuralgia. Laser Ther 2004;14:61-4. Doi: 10.5978/ISLSM.14.0_61.

  RESULT

• Kahraman SA. Low-level laser therapy in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2004 May;16(2):277-88. doi: 10.1016/j.coms.2004.02.002. No abstract available.

  PMID: 18088730 RESULT

• Sun G, Tuner J. Low-level laser therapy in dentistry. Dent Clin North Am. 2004 Oct;48(4):1061-76, viii. doi: 10.1016/j.cden.2004.05.004.

  PMID: 15464564 RESULT

• Mohajerani SH, Tabeie F, Bemanali M, Tabrizi R. Effect of Low-Level Laser and Light-Emitting Diode on Inferior Alveolar Nerve Recovery After Sagittal Split Osteotomy of the Mandible: A Randomized Clinical Trial Study. J Craniofac Surg. 2017 Jun;28(4):e408-e411. doi: 10.1097/SCS.0000000000002929.

  PMID: 28538060 RESULT

• Ozen T, Orhan K, Gorur I, Ozturk A. Efficacy of low level laser therapy on neurosensory recovery after injury to the inferior alveolar nerve. Head Face Med. 2006 Feb 15;2:3. doi: 10.1186/1746-160X-2-3.

  PMID: 16480503 RESULT

• Robinson PP, Loescher AR, Yates JM, Smith KG. Current management of damage to the inferior alveolar and lingual nerves as a result of removal of third molars. Br J Oral Maxillofac Surg. 2004 Aug;42(4):285-92. doi: 10.1016/j.bjoms.2004.02.024.

  PMID: 15225944 RESULT

• Esteves Pinto Faria P, Temprano A, Piva F, Sant'ana E, Pimenta D. Low-level laser therapy for neurosensory recovery after sagittal ramus osteotomy. Minerva Stomatol. 2020 Jun;69(3):141-147. doi: 10.23736/S0026-4970.20.04289-2. Epub 2020 Mar 16.

  PMID: 32181610 RESULT

• Miloro M, Criddle TR. Does Low-Level Laser Therapy Affect Recovery of Lingual and Inferior Alveolar Nerve Injuries? J Oral Maxillofac Surg. 2018 Dec;76(12):2669-2675. doi: 10.1016/j.joms.2018.06.001. Epub 2018 Jun 11.

  PMID: 30509397 RESULT

• Lomke MA. Clinical applications of dental lasers. Gen Dent. 2009 Jan-Feb;57(1):47-59.

  PMID: 19146143 RESULT

MeSH Terms

Conditions

Mandibular Nerve Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: March 25, 2025
• Study Start: January 15, 2019
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Jan 2019 - Jan 2023

Locations

TU (1)