Phase 4 N=68 Randomized Double-blind Prevention

Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery

Swelling

Bottom Line

View on ClinicalTrials.gov: NCT01431014 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery — 167.06; 190.73; 61.39; 57.62 ml — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone"low-dose" (Drug); Dexamethasone"high-dose" (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Chang Gung Memorial Hospital
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery	167.06; 190.73; 61.39; 57.62; 29.85; 19.34	>0.05

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01431014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.