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Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery

The Effect of Steroid on Reducing Facial Swelling After Orthognathic Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01431014
Enrollment
56
Registered
2011-09-09
Start date
2011-08-31
Completion date
2013-01-31
Last updated
2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swelling

Keywords

orthognathic surgery, steroid, swelling, 3-dimensional photogrammetry

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.

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.

Interventions

DRUGDexamethasonelow-dose

5mg

DRUGDexamethasonehigh-dose

15 mg

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery1 yearMeasure 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.

Countries

Taiwan

Participant flow

Participants by arm

ArmCount
DexamethasoneHigh-dose
15mg Dexamethasonehigh-dose : 15 mg
31
DexamethasoneLow-dose
5mg Dexamethasonelow-dose : 5mg
25
Total56

Baseline characteristics

CharacteristicDexamethasoneLow-doseDexamethasoneHigh-doseTotal
Age, Categorical
<=18 years
5 Participants1 Participants6 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants30 Participants50 Participants
Age, Continuous20.92 years
STANDARD_DEVIATION 4.79
23.16 years
STANDARD_DEVIATION 4.19
22.16 years
STANDARD_DEVIATION 4.6
Region of Enrollment
Taiwan
25 participants31 participants56 participants
Sex: Female, Male
Female
13 Participants15 Participants28 Participants
Sex: Female, Male
Male
12 Participants16 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 250 / 31
serious
Total, serious adverse events
0 / 250 / 31

Outcome results

Primary

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.

Time frame: 1 year

ArmMeasureGroupValue (MEAN)Dispersion
DexamethasoneHigh-doseEffect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery36 hours postoperatively167.06 mlStandard Deviation 55.93
DexamethasoneHigh-doseEffect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery1week postoperatively61.39 mlStandard Deviation 30.14
DexamethasoneHigh-doseEffect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery1month postoperatively29.85 mlStandard Deviation 19.4
DexamethasoneLow-doseEffect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery36 hours postoperatively190.73 mlStandard Deviation 78.74
DexamethasoneLow-doseEffect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery1week postoperatively57.62 mlStandard Deviation 36.13
DexamethasoneLow-doseEffect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery1month postoperatively19.34 mlStandard Deviation 16.56
p-value: >0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026