Clinical Trial: Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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

Detailed Summary:

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
Sponsor: The University of Hong Kong

Current Primary Outcome:

• Subjective neurosensory disturbance [ Time Frame: Baseline ]
  VAS score of numbness / hyperaesthesia
• Subjective neurosensory disturbance [ Time Frame: Post-operative 1 week ]
  VAS score of numbness / hyperaesthesia
• Subjective neurosensory disturbance [ Time Frame: Post-operative 1 month ]
  VAS score of numbness / hyperaesthesia
• Subjective neurosensory disturbance [ Time Frame: Post-operative 3 months ]
  VAS score of numbness / hyperaesthesia
• Subjective neurosensory disturbance [ Time Frame: Post-operative 6 months ]
  VAS score of numbness / hyperaesthesia
• Objective neurosensory disturbance [ Time Frame: Baseline ]
  Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure
• Objective neurosensory disturbance [ Time Frame: Post-operative 1 week ]
  Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure
• Objective neurosensory disturbance [ Time Frame: Post-operative 1 month ]
  Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure
• Objective neurosensory disturbance [ Time Frame: Post-ope
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Pain [ Time Frame: Post-operative day 0 ]
    VAS pain score; time to first analgesic intake and dosage
  • Pain [ Time Frame: Post-operative day 1 ]
    VAS pain score
  • Pain [ Time Frame: Post-operative day 2 ]
    VAS pain score
  • Pain [ Time Frame: Post-operative day 3 ]
    VAS pain score
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: The University of Hong Kong
  

  Dates:
  Date Received: August 31, 2016
  Date Started: June 2016
  Date Completion: September 2017
  Last Updated: September 5, 2016
  Last Verified: September 2016