Does Low-level Laser Therapy Protocol Affect the Efficacy of Treatment of Inferior Alveolar Nerve Injury After Maxillofacial Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- the Visual Analog Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with different sessions, start time and cause of IAN injury were compared.
Low level laser therapy was applied to all patients.
干预措施: Low Level Laser Therapy (Device)
结局指标
主要结局
the Visual Analog Scale (VAS)
时间窗: 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.
次要结局
未报告次要终点
研究者
Halenur Ateş
DDS
Karadeniz Technical University