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临床试验/NCT02889432
NCT02889432Unknown2 期

Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies - A Randomised, Controlled Clinical Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
40
试验地点
1
主要终点
Subjective neurosensory disturbance

研究概览

简要总结

Orthognathic surgery is commonly performed for the treatment of dentofacial deformities. Yet, one of the most prevalent and long-term complication encountered is neurosensory disturbance thus impairing sensation to parts of the face. In Hong Kong, it has been reported that in patients receiving orthognathic surgery, 5.9% experience long-term neurosensory disturbance post-surgery.

Melatonin is a neurohormone that is produced and secreted by the pineal gland in the brain. Its main physiological role in humans is to regulate sleep. Oral Melatonin supplements is also used in the management of jetlag and other sleep disorders. Recently, animal and human studies have shown Melatonin to improve tolerance to pain and to have a neuroprotective and neuroregenerative effect after nerve injuries.

Hence, it is hypothesized that peri-surgical oral Melatonin supplement can improve neurosensory recovery after orthognathic surgery

详细描述

Background:

Orthognathic surgery is a commonly accepted treatment modality for the management of dentofacial deformities. Although in many cases, satisfying, if not excellent, aesthetic and functional results can be obtained with orthognathic surgeries, this is not without risks; and one of the most prevalent and long-term complication encountered is neurosensory disturbance either in the inferior alveolar nerve or the infraorbital nerve depending on the jaw receiving the osteotomy. A systematic review by Jędrzejewski et al. in 2015 reported cranial nerve injury/sensitivity alteration to be the most common complication after orthognathic surgery and is seen in 50% of cases, and almost all patients will report altered sensation in the immediate post-operative period. Although this will decrease over time, Henzelka et al. have reported a 3% incidence of paresthesia in the inferior alveolar nerve 1 year post-surgery, and Thygesen et al. reported sensory changes in the infraorbital nerve in 7 to 60% of patients depending on site of measurement 1 year post-surgery. In Hong Kong, a 10-year retrospective study of 581 patients by Lee et al. in 2013 reported a 5.9% rate of neurosensory disturbance 1-year post-orthognathic surgery. Of these cases, the majority affected the inferior alveolar nerve, and the combination of ramus osteotomies together with anterior mandibular osteotomies significantly increased the chances of permanent neurosensory disturbance.

Biosynthesis of Melatonin:

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is endogenously produced and secreted by the pineal gland in the brain in a circadian rhythm, with a plasma concentration highest at night and lowest during the day. Its normal physiological roles in humans are to regulate diurnal rhythm, sleep, mood, immunity, reproduction, intestinal motility, and metabolism. Oral exogenous melatonin has been used in the management of jetlag and other sleep disorders. Recently, animal and human studies have shown melatonin to improve tolerance to tourniquet pain in patients receiving hand surgery performed under regional anaesthesia, to improve dyspnea in patients with chronic obstructive pulmonary disease, and to have a neuroprotective and neuroregenerative effect after nerve injuries.

Pharmacology of Melatonin:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No systemic neuropathies
  • Clear medical history
  • Patients requiring bilateral sagittal split osteotomies, Hofer osteotomy, genioplasty, and/or Le-Fort I osteotomies

排除标准

  • Patients with existing neurosensory deficit at the inferior alveolar nerve and/or infraorbital nerve from previous trauma or systemic condition
  • Patients with iatrogenic severance of nerve intra-operatively
  • Patients who underwent previous orthognathic surgery (i.e. reoperation)
  • Patients undergoing distraction osteogenesis
  • Patients who developed allergic reactions

研究组 & 干预措施

Melatonin

Experimental

Oral Melatonin 10mg Taken 30 minutes before bedtime for 3 weeks First dose starts the night before surgery

干预措施: Oral Melatonin 10mg (Drug)

Placebo

Placebo Comparator

Placebo tabs Taken 30 minutes before bedtime for 3 weeks First dose starts the night before surgery

干预措施: Placebo (Drug)

结局指标

主要结局

Subjective neurosensory disturbance

时间窗: Post-operative 6 months

VAS score of numbness / hyperaesthesia

Objective neurosensory disturbance

时间窗: Post-operative 6 months

Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure

Biochemical analysis

时间窗: Post-operative day 2

Concentration of lipid peroxidase, superoxide dismutase, catalase, and glutathione peroxidase in plasma

次要结局

  • Pain(Post-operative day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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