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Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02889432
Recruitment Status : Unknown
Verified September 2016 by The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : September 5, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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


Condition or disease Intervention/treatment Phase
Dentofacial Deformities Drug: Oral Melatonin 10mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies - A Randomised, Controlled Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin
Oral Melatonin 10mg Taken 30 minutes before bedtime for 3 weeks First dose starts the night before surgery
Drug: Oral Melatonin 10mg
Placebo Comparator: Placebo
Placebo tabs Taken 30 minutes before bedtime for 3 weeks First dose starts the night before surgery
Drug: Placebo



Primary Outcome Measures :
  1. Subjective neurosensory disturbance [ Time Frame: Baseline ]
    VAS score of numbness / hyperaesthesia

  2. Subjective neurosensory disturbance [ Time Frame: Post-operative 1 week ]
    VAS score of numbness / hyperaesthesia

  3. Subjective neurosensory disturbance [ Time Frame: Post-operative 1 month ]
    VAS score of numbness / hyperaesthesia

  4. Subjective neurosensory disturbance [ Time Frame: Post-operative 3 months ]
    VAS score of numbness / hyperaesthesia

  5. Subjective neurosensory disturbance [ Time Frame: Post-operative 6 months ]
    VAS score of numbness / hyperaesthesia

  6. Objective neurosensory disturbance [ Time Frame: Baseline ]
    Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure

  7. Objective neurosensory disturbance [ Time Frame: Post-operative 1 week ]
    Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure

  8. Objective neurosensory disturbance [ Time Frame: Post-operative 1 month ]
    Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure

  9. Objective neurosensory disturbance [ Time Frame: Post-operative 3 months ]
    Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure

  10. Objective neurosensory disturbance [ Time Frame: Post-operative 6 months ]
    Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure

  11. Biochemical analysis [ Time Frame: Baseline ]
    Concentration of lipid peroxidase, superoxide dismutase, catalase, and glutathione peroxidase in plasma

  12. Biochemical analysis [ Time Frame: Post-operative day 2 ]
    Concentration of lipid peroxidase, superoxide dismutase, catalase, and glutathione peroxidase in plasma


Secondary Outcome Measures :
  1. Pain [ Time Frame: Post-operative day 0 ]
    VAS pain score; time to first analgesic intake and dosage

  2. Pain [ Time Frame: Post-operative day 1 ]
    VAS pain score

  3. Pain [ Time Frame: Post-operative day 2 ]
    VAS pain score

  4. Pain [ Time Frame: Post-operative day 3 ]
    VAS pain score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889432


Contacts
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Contact: Justin Curtin, MB BS, BDS 2859 0534 jpcurtin@hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Justin Curtin, MB BS, BDS    2859 0534    jpcurtin@hku.hk   
Principal Investigator: Crystal TY Lee, BDS (HKU)         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Crystal TY Lee, BDS (HKU) The University of Hong Kong
Publications:

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02889432    
Other Study ID Numbers: UW 16-095
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dentofacial Deformities
Congenital Abnormalities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants