SwellingPhase 4NCT01431014
Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery
A Phase 4 study testing Dexamethasone"low-dose" and Dexamethasone"high-dose" in people with Swelling, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Swelling
- What is being tested?
- Dexamethasone"low-dose" and Dexamethasone"high-dose"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients who receive LeFort I osteotomy of maxilla and bilateral sagittal split osteotomy of mandible
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Steroid on Reducing Facial Swelling After Orthognathic Surgery
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.
Read the detailed description
Postoperative swelling is an annoying problem after orthognathic surgery. There are two reasons to minimize postoperative swelling. The first is a functional consideration. Orthognathic surgery is performed in oromaxillary area, and consequently swelling in this area can compromise airway. The second is esthetic one, as patients feel uncomfortable and embarrassing with a swollen face. Reducing facial swelling after orthognathic surgery helps to reduce airway complication and patient down time.
Several methods are used to reduce postoperative facial swelling, including controlled hypotension during operation, meticulous operative procedures, postoperative facial ice packing, head elevation, and suction drainage. Perioperative use of steroid has been applied for reduction of facial swelling after oral surgery and 3rd molar extraction. Cyclooxygenase-1 (COX1) and COX2 have been reported to be important enzymes for inflammatory process, and steroids inhibit their synthesis, consequently reducing postoperative edema. Steroid has also been used to decrease edema after orthognathic surgery, as well as to reduce pain, nausea and vomiting.
There were three randomized controlled studies looking at the effect of steroid on postoperative facial swelling after orthognathic surgery, separately by Dr. Weber et al, Peillon et al, and Munro et al. However, the results were controversial. The first two studies concluded that the steroid use could reduce facial swelling. The other one did not find significant difference between the experimental and control groups. Another limitation of the previous studies was that they all used two-dimensional or non-objective methods for evaluation of the amount of swelling, which could be less accurate. Three-dimensional photogrammetry has been introduced in recent years, and has obtained satisfactory results over the conventional methods. The investigators have experience of applying the device for facial surface study, and the accuracy has been validated in our imaging laboratory.
The purpose of this study is to determine the effect of steroid for reduction of postoperative facial swelling determined by three-dimensional photographic method. 3dMD face scanner will be used. The 3-dimensional method makes no harm to patients. Patients will be seated during scanning and thus reducing possible inconvenience. There is no radiation hazard with this method. The image acquisition time is 2 milliseconds or less, and therefore no concern of motion artifacts. The first part of this study is to get information about the swelling curve after orthognathic surgery. 3dMD face scanning will be performed 5 times postoperatively every 12 hours after 24 hours of operation. When the postoperative timing of maximal facial swelling is obtained, the investigators will proceed to perform the second part of study, and the number of facial scanning is reduced. The second part of study involves recruiting 70 patients with prognathism. The patients will be carefully screened and selected by craniofacial surgeons. The patients will take preoperative and postoperative 3dMD image scanning. The recovery course and clinical outcome will be monitored. 3dMD face image data analysis will be performed for quantitative comparisons between the experimental and control groups.
- Conditions
- Swelling
- Being tested
- Dexamethasone"low-dose", Dexamethasone"high-dose"
- Keywords
- orthognathic surgery, steroid, swelling, 3-dimensional photogrammetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone"low-dose"Drug
Also called dexan
5mg
Dexamethasone"high-dose"Drug
Also called dexan
15 mg
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone"low-dose" | Active comparator | 5mg Receives: Drug: Dexamethasone"low-dose" |
| Dexamethasone"high-dose" | Experimental | 15mg Receives: Drug: Dexamethasone"high-dose" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for SwellingStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lun-Jou Lo, MD, Principal investigator, Chang Gung Memorial HospitalHye-Young Kim, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431014
- Sponsor's protocol ID
- 99-2811-B-182A-003
- Other IDs
- CGMH-IRB-100-2191B
- Status last verified
- Sep 2011
- First submitted
- 28 Aug 2011
- Last updated
- 21 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17519721van 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.
PubMed 20427150Schaberg 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.
PubMed 6585512Meyer-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.
PubMed 20152669Rana 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.
PubMed 21411291Chegini 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.
PubMed 21316821Dan 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.
PubMed 20591548Bourke 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.
PubMed 3455720Weber 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.
PubMed 8263640Mocan 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.
PubMed 8604065Esen 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.
PubMed 10513866Seo 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.
PubMed 15452804Day 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.
PubMed 16548302Laureano 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.
PubMed 18223530Huaman 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.
PubMed 18280382
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Steroid on Reducing Facial Swelling After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT01431014
- Acronym / sponsor ID
- 99-2811-B-182A-003
- Conditions
- Swelling
- Keywords
- orthognathic surgery, steroid, swelling, 3-dimensional photogrammetry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative swelling is an annoying problem after orthognathic surgery. There are two reasons to minimize postoperative swelling. The first is a functional consideration. Orthognathic surgery is performed in oromaxillary area, and consequently swelling in this area can compromise airway. The second is esthetic one, as patients feel uncomfortable and embarrassing with a swollen face. Reducing facial swelling after orthognathic surgery helps to reduce airway complication and patient down time.
Several methods are used to reduce postoperative facial swelling, including controlled hypotension during operation, meticulous operative procedures, postoperative facial ice packing, head elevation, and suction drainage. Perioperative use of steroid has been applied for reduction of facial swelling after oral surgery and 3rd molar extraction. Cyclooxygenase-1 (COX1) and COX2 have been reported to be important enzymes for inflammatory process, and steroids inhibit their synthesis, consequently reducing postoperative edema. Steroid has also been used to decrease edema after orthognathic surgery, as well as to reduce pain, nausea and vomiting.
There were three randomized controlled studies looking at the effect of steroid on postoperative facial swelling after orthognathic surgery, separately by Dr. Weber et al, Peillon et al, and Munro et al. However, the results were controversial. The first two studies concluded that the steroid use could reduce facial swelling. The other one did not find significant difference between the experimental and control groups. Another limitation of the previous studies was that they all used two-dimensional or non-objective methods for evaluation of the amount of swelling, which could be less accurate. Three-dimensional photogrammetry has been introduced in recent years, and has obtained satisfactory results over the conventional methods. The investigators have experience of applying the device for facial surface study, and the accuracy has been validated in our imaging laboratory.
The purpose of this study is to determine the effect of steroid for reduction of postoperative facial swelling determined by three-dimensional photographic method. 3dMD face scanner will be used. The 3-dimensional method makes no harm to patients. Patients will be seated during scanning and thus reducing possible inconvenience. There is no radiation hazard with this method. The image acquisition time is 2 milliseconds or less, and therefore no concern of motion artifacts. The first part of this study is to get information about the swelling curve after orthognathic surgery. 3dMD face scanning will be performed 5 times postoperatively every 12 hours after 24 hours of operation. When the postoperative timing of maximal facial swelling is obtained, the investigators will proceed to perform the second part of study, and the number of facial scanning is reduced. The second part of study involves recruiting 70 patients with prognathism. The patients will be carefully screened and selected by craniofacial surgeons. The patients will take preoperative and postoperative 3dMD image scanning. The recovery course and clinical outcome will be monitored. 3dMD face image data analysis will be performed for quantitative comparisons between the experimental and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone"low-dose" | Active comparator | Drug: Dexamethasone"low-dose"5mg |
| Dexamethasone"high-dose" | Experimental | Drug: Dexamethasone"high-dose"15mg |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who receive LeFort I osteotomy of maxilla and bilateral sagittal split osteotomy of mandible
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone"low-dose"Also: dexan5mg | Drug | Dexamethasone"low-dose" |
| Dexamethasone"high-dose"Also: dexan15 mg | Drug | Dexamethasone"high-dose" |
Primary outcome
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery
Time frame: 1 year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17519721Kau 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.
- Results publication: PubMed 20427150van 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.
- Results publication: PubMed 6585512Schaberg 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.
- Results publication: PubMed 20152669Meyer-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.
- Results publication: PubMed 21411291Rana 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.
- Results publication: PubMed 21316821Chegini 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.
- Results publication: PubMed 20591548Dan 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.
- Results publication: PubMed 3455720Bourke 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.
- Results publication: PubMed 8263640Weber 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.
- Results publication: PubMed 8604065Mocan 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.
- Results publication: PubMed 10513866Esen 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.
- Results publication: PubMed 15452804Seo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lun-Jou Lo, MD principal investigator
Chang Gung Memorial Hospital
Hye-Young Kim, MD study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone"low-dose" and Dexamethasone"high-dose" in people with Swelling, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431014, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.