Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• No systemic neuropathies

• Clear medical history

• Patients requiring bilateral sagittal split osteotomies, Hofer osteotomy, genioplasty, and/or Le-Fort I osteotomies

Exclusion Criteria:

• 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