NCT02889432

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

August 31, 2016

Last Update Submit

September 5, 2016

Conditions

Dentofacial Deformities

Outcome Measures

Primary Outcomes (12)

  • Subjective neurosensory disturbance

    VAS score of numbness / hyperaesthesia

    Baseline

  • Subjective neurosensory disturbance

    VAS score of numbness / hyperaesthesia

    Post-operative 1 week

  • Subjective neurosensory disturbance

    VAS score of numbness / hyperaesthesia

    Post-operative 1 month

  • Subjective neurosensory disturbance

    VAS score of numbness / hyperaesthesia

    Post-operative 3 months

  • Subjective neurosensory disturbance

    VAS score of numbness / hyperaesthesia

    Post-operative 6 months

  • Objective neurosensory disturbance

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

    Baseline

  • Objective neurosensory disturbance

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

    Post-operative 1 week

  • Objective neurosensory disturbance

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

    Post-operative 1 month

  • Objective neurosensory disturbance

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

    Post-operative 3 months

  • Objective neurosensory disturbance

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

    Post-operative 6 months

  • Biochemical analysis

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

    Baseline

  • Biochemical analysis

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

    Post-operative day 2

Secondary Outcomes (4)

  • Pain

    Post-operative day 0

  • Pain

    Post-operative day 1

  • Pain

    Post-operative day 2

  • Pain

    Post-operative day 3

Study Arms (2)

Melatonin

EXPERIMENTAL

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

Drug: Oral Melatonin 10mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oral Melatonin 10mgDRUG
Melatonin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (14)

  • Jedrzejewski M, Smektala T, Sporniak-Tutak K, Olszewski R. Preoperative, intraoperative, and postoperative complications in orthognathic surgery: a systematic review. Clin Oral Investig. 2015 Jun;19(5):969-77. doi: 10.1007/s00784-015-1452-1. Epub 2015 Mar 26.

    PMID: 25804886BACKGROUND

  • Mowafi HA, Ismail SA. Melatonin improves tourniquet tolerance and enhances postoperative analgesia in patients receiving intravenous regional anesthesia. Anesth Analg. 2008 Oct;107(4):1422-6. doi: 10.1213/ane.0b013e318181f689.

    PMID: 18806063BACKGROUND

  • Atik B, Erkutlu I, Tercan M, Buyukhatipoglu H, Bekerecioglu M, Pence S. The effects of exogenous melatonin on peripheral nerve regeneration and collagen formation in rats. J Surg Res. 2011 Apr;166(2):330-6. doi: 10.1016/j.jss.2009.06.002. Epub 2009 Jul 10.

    PMID: 20006352BACKGROUND

  • Kaya Y, Sarikcioglu L, Aslan M, Kencebay C, Demir N, Derin N, Angelov DN, Yildirim FB. Comparison of the beneficial effect of melatonin on recovery after cut and crush sciatic nerve injury: a combined study using functional, electrophysiological, biochemical, and electron microscopic analyses. Childs Nerv Syst. 2013 Mar;29(3):389-401. doi: 10.1007/s00381-012-1936-0. Epub 2012 Oct 9.

    PMID: 23053363BACKGROUND

  • Zencirci SG, Bilgin MD, Yaraneri H. Electrophysiological and theoretical analysis of melatonin in peripheral nerve crush injury. J Neurosci Methods. 2010 Aug 30;191(2):277-82. doi: 10.1016/j.jneumeth.2010.07.008. Epub 2010 Jul 14.

    PMID: 20637233BACKGROUND

  • Fujimoto T, Nakamura T, Ikeda T, Takagi K. Potent protective effects of melatonin on experimental spinal cord injury. Spine (Phila Pa 1976). 2000 Apr 1;25(7):769-75. doi: 10.1097/00007632-200004010-00003.

    PMID: 10751286BACKGROUND

  • de Matos Cavalcante AG, de Bruin PF, de Bruin VM, Nunes DM, Pereira ED, Cavalcante MM, Andrade GM. Melatonin reduces lung oxidative stress in patients with chronic obstructive pulmonary disease: a randomized, double-blind, placebo-controlled study. J Pineal Res. 2012 Oct;53(3):238-44. doi: 10.1111/j.1600-079X.2012.00992.x. Epub 2012 Apr 17.

    PMID: 22507631BACKGROUND

  • Odaci E, Kaplan S. Chapter 16: Melatonin and nerve regeneration. Int Rev Neurobiol. 2009;87:317-35. doi: 10.1016/S0074-7742(09)87016-5.

    PMID: 19682645BACKGROUND

  • Kleszczynski K, Fischer TW. Melatonin and human skin aging. Dermatoendocrinol. 2012 Jul 1;4(3):245-52. doi: 10.4161/derm.22344.

    PMID: 23467217BACKGROUND

  • Di WL, Kadva A, Johnston A, Silman R. Variable bioavailability of oral melatonin. N Engl J Med. 1997 Apr 3;336(14):1028-9. doi: 10.1056/NEJM199704033361418. No abstract available.

    PMID: 9091795BACKGROUND

  • Waldhauser F, Waldhauser M, Lieberman HR, Deng MH, Lynch HJ, Wurtman RJ. Bioavailability of oral melatonin in humans. Neuroendocrinology. 1984 Oct;39(4):307-13. doi: 10.1159/000123997.

    PMID: 6493445BACKGROUND

  • Fischer TW, Greif C, Fluhr JW, Wigger-Alberti W, Elsner P. Percutaneous penetration of topically applied melatonin in a cream and an alcoholic solution. Skin Pharmacol Physiol. 2004 Jul-Aug;17(4):190-4. doi: 10.1159/000078822.

    PMID: 15258450BACKGROUND

  • Vakkuri O, Leppaluoto J, Kauppila A. Oral administration and distribution of melatonin in human serum, saliva and urine. Life Sci. 1985 Aug 5;37(5):489-95. doi: 10.1016/0024-3205(85)90412-6.

    PMID: 4021725BACKGROUND

  • Ma X, Idle JR, Krausz KW, Gonzalez FJ. Metabolism of melatonin by human cytochromes p450. Drug Metab Dispos. 2005 Apr;33(4):489-94. doi: 10.1124/dmd.104.002410. Epub 2004 Dec 22.

    PMID: 15616152BACKGROUND

MeSH Terms

Conditions

Dentofacial Deformities

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Crystal TY Lee, BDS (HKU)

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Curtin, MB BS, BDS

CONTACT

2859 0534jpcurtin@hku.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 5, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)