Clinical trial NCT01431014
Conditions: Swelling
Keywords: orthognathic surgery steroid swelling 3-dimensional photogrammetry
Sponsor: Chang Gung Memorial Hospital
Start date: 2011-08-01; Completion date: 2013-01-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 5mg arm 2: 15mg
Interventions: intervention 1: Dexamethasone"low-dose" intervention 2: Dexamethasone"high-dose"
Intervention descriptions: intervention 1: 5mg intervention 2: 15 mg

Protocol documents: