NCT01431014

Brief Summary

Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons after orthognathic surgery. The purpose of this study is to develop a steroid regimen protocol for minimizing postoperative facial swelling after orthognathic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 21, 2014

Completed
Last Updated

March 21, 2014

Status Verified

September 1, 2011

Enrollment Period

1.4 years

First QC Date

August 28, 2011

Results QC Date

February 6, 2014

Last Update Submit

February 6, 2014

Conditions

Swelling

Keywords

orthognathic surgerysteroidswelling3-dimensional photogrammetry

Outcome Measures

Primary Outcomes (1)

  • Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery

    Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.

    1 year

Study Arms (2)

Dexamethasone"low-dose"

ACTIVE COMPARATOR

5mg

Drug: Dexamethasone"low-dose"

Dexamethasone"high-dose"

EXPERIMENTAL

15mg

Drug: Dexamethasone"high-dose"

Interventions

Dexamethasone"low-dose"DRUG

5mg

Also known as: dexan
Dexamethasone"low-dose"
Dexamethasone"high-dose"DRUG

15 mg

Also known as: dexan
Dexamethasone"high-dose"

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who receive LeFort I osteotomy of maxilla and bilateral sagittal split osteotomy of mandible

You may not qualify if:

  • patients with local or systemic diseases
  • patients taking aspirin, steroid, nonsteroidal anti-inflammatory drugs, or having contraindications for steroids
  • patients with history of psychosis
  • patients with active or chronic infection
  • patients with active or latent peptic ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

Location

Related Publications (21)

  • Kau CH, Cronin AJ, Richmond S. A three-dimensional evaluation of postoperative swelling following orthognathic surgery at 6 months. Plast Reconstr Surg. 2007 Jun;119(7):2192-2199. doi: 10.1097/01.prs.0000260707.99001.79.

    PMID: 17519721RESULT

  • van Loon B, Maal TJ, Plooij JM, Ingels KJ, Borstlap WA, Kuijpers-Jagtman AM, Spauwen PH, Berge SJ. 3D Stereophotogrammetric assessment of pre- and postoperative volumetric changes in the cleft lip and palate nose. Int J Oral Maxillofac Surg. 2010 Jun;39(6):534-40. doi: 10.1016/j.ijom.2010.03.022. Epub 2010 Apr 27.

    PMID: 20427150RESULT

  • Schaberg SJ, Stuller CB, Edwards SM. Effect of methylprednisolone on swelling after orthognathic surgery. J Oral Maxillofac Surg. 1984 Jun;42(6):356-61. doi: 10.1016/s0278-2391(84)80006-3.

    PMID: 6585512RESULT

  • Meyer-Marcotty P, Alpers GW, Gerdes AB, Stellzig-Eisenhauer A. Impact of facial asymmetry in visual perception: a 3-dimensional data analysis. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):168.e1-8; discussion 168-9. doi: 10.1016/j.ajodo.2008.11.023.

    PMID: 20152669RESULT

  • Rana M, Gellrich NC, Joos U, Piffko J, Kater W. 3D evaluation of postoperative swelling using two different cooling methods following orthognathic surgery: a randomised observer blind prospective pilot study. Int J Oral Maxillofac Surg. 2011 Jul;40(7):690-6. doi: 10.1016/j.ijom.2011.02.015. Epub 2011 Mar 15.

    PMID: 21411291RESULT

  • Chegini S, Dhariwal DK. Review of evidence for the use of steroids in orthognathic surgery. Br J Oral Maxillofac Surg. 2012 Mar;50(2):97-101. doi: 10.1016/j.bjoms.2010.11.019. Epub 2011 Feb 12.

    PMID: 21316821RESULT

  • Dan AE, Thygesen TH, Pinholt EM. Corticosteroid administration in oral and orthognathic surgery: a systematic review of the literature and meta-analysis. J Oral Maxillofac Surg. 2010 Sep;68(9):2207-20. doi: 10.1016/j.joms.2010.04.019. Epub 2010 Jun 29.

    PMID: 20591548RESULT

  • Bourke DL. Use of steroids during orthognathic surgery. J Oral Maxillofac Surg. 1986 Jan;44(1):2-3. doi: 10.1016/0278-2391(86)90004-2. No abstract available.

    PMID: 3455720RESULT

  • Weber CR, Griffin JM. Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg. 1994 Jan;52(1):35-9. doi: 10.1016/0278-2391(94)90010-8.

    PMID: 8263640RESULT

  • Mocan A, Kisnisci R, Ucok C. Stereophotogrammetric and clinical evaluation of morbidity after removal of lower third molars by two different surgical techniques. J Oral Maxillofac Surg. 1996 Feb;54(2):171-5. doi: 10.1016/s0278-2391(96)90441-3.

    PMID: 8604065RESULT

  • Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x.

    PMID: 10513866RESULT

  • Seo K, Tanaka Y, Terumitsu M, Someya G. Efficacy of steroid treatment for sensory impairment after orthognathic surgery. J Oral Maxillofac Surg. 2004 Oct;62(10):1193-7. doi: 10.1016/j.joms.2004.06.033.

    PMID: 15452804RESULT

  • Day CJ, Robert T. Three-dimensional assessment of the facial soft tissue changes that occur postoperatively in orthognathic patients. World J Orthod. 2006 Spring;7(1):15-26.

    PMID: 16548302RESULT

  • Laureano Filho JR, Maurette PE, Allais M, Cotinho M, Fernandes C. Clinical comparative study of the effectiveness of two dosages of Dexamethasone to control postoperative swelling, trismus and pain after the surgical extraction of mandibular impacted third molars. Med Oral Patol Oral Cir Bucal. 2008 Feb 1;13(2):E129-32.

    PMID: 18223530RESULT

  • Huaman ET, Juvet LM, Nastri A, Denman WT, Kaban LB, Dodson TB. Changing patterns of hospital length of stay after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):492-7. doi: 10.1016/j.joms.2007.08.025.

    PMID: 18280382RESULT

  • Meisami T, Musa M, Keller MA, Cooper R, Clokie CM, Sandor GK. Magnetic resonance imaging assessment of airway status after orthognathic surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Apr;103(4):458-63. doi: 10.1016/j.tripleo.2006.07.006. Epub 2006 Oct 27.

    PMID: 17395062RESULT

  • Sotto-Maior BS, Senna PM, de Souza Picorelli Assis NM. Corticosteroids or cyclooxygenase 2-selective inhibitor medication for the management of pain and swelling after third-molar surgery. J Craniofac Surg. 2011 Mar;22(2):758-62. doi: 10.1097/SCS.0b013e318207f3fe.

    PMID: 21415660RESULT

  • Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34. doi: 10.1016/j.clinthera.2006.07.005.

    PMID: 16990080RESULT

  • Fleming PS, Flood TR. Steroid-induced psychosis complicating orthognathic surgery: a case report. Br Dent J. 2005 Nov 26;199(10):647-8. doi: 10.1038/sj.bdj.4812929.

    PMID: 16311560RESULT

  • Galen DM, Beck M, Buchbinder D. Steroid psychosis after orthognathic surgery: a case report. J Oral Maxillofac Surg. 1997 Mar;55(3):294-7. doi: 10.1016/s0278-2391(97)90546-2. No abstract available.

    PMID: 9054921RESULT

  • Precious D, Armstrong J, Morrison A, Field C. The incidence of total hip replacement in orthognathic surgery patients receiving short-term steroid therapy. J Oral Maxillofac Surg. 1992 Sep;50(9):956-7. doi: 10.1016/0278-2391(92)90054-4.

    PMID: 1506971RESULT

Results Point of Contact

Title
Lun-Jou Lo, MD,Hye-Young Kim, MD
Organization
Chang Gung Memorial Hospital
lunjoulo@cgmh.org.tw

Study Officials

  • Lun-Jou Lo, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Hye-Young Kim, MD

    Chang Gung Memorial Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2011

First Posted

September 9, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 21, 2014

Results First Posted

March 21, 2014

Record last verified: 2011-09

Locations

TW(1)