title: A prospective, randomized, double-blind, placebo-controlled clinical trial comparing the efficacy of systemic enzyme therapy for edema control in orthognathic surgery using ultrasound scan to measure facial swelling.
abstract: OBJECTIVE
  To evaluate the effectiveness of systemic enzyme therapy for the control of edema in patients who undergo bimaxillary orthognathic surgery.
  
  
  METHODS
  Thirty patients were included in this double-blinded, randomized, control trial. Before surgery, each patient was allotted a code (study or control group). Nine anthropometric points were selected. Thickness of the soft tissue at each of these points was measured using an ultrasound device. These measurements were performed on the day before surgery and 1, 5, and 15 days after surgery. The study group was given a twice-daily dose of systemic enzyme therapy from the first postoperative day for 5 days; the control group was given placebo. The percentage of difference in the thickness of the soft tissue was calculated at each of the 9 points on postoperative days 1, 5, and 15. These data were analyzed and compared using the Mann-Whitney test.
  
  
  RESULTS
  The statistical evaluation showed a significant difference in soft tissue thickness between the 2 groups, especially on days 5 and 15, at most assessed points.
  
  
  CONCLUSIONS
  The results of this study suggest that systemic enzyme therapy significantly decreases postoperative edema in orthognathic surgery, precluding long-term corticosteroid use.
authors.affiliation: Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital, Nitte University, Mangalore, Karnataka, India. vshetty@hotmail.com
authors.forename: Vikram
authors.initials: V
authors.lastname: Shetty
authors.forename: Amit
authors.initials: A
authors.lastname: Mohan
mesh_terms: D001963:Bromelains / Q000627:therapeutic use; D002508:Cephalometry / Q000379:methods; D002680:Chin / Q000000981:diagnostic imaging / Q000601:surgery; D004311:Double-Blind Method; D004338:Drug Combinations; D004487:Edema / Q000000981:diagnostic imaging / Q000517:prevention & control*; D010450:Endopeptidases / Q000627:therapeutic use*; D057487:Enzyme Therapy / Q000379:methods*; D005145:Face / Q000000981:diagnostic imaging; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008046:Lip / Q000000981:diagnostic imaging; D008297:Male; D008334:Mandible / Q000000981:diagnostic imaging; D009333:Neck / Q000000981:diagnostic imaging; D056948:Orthognathic Surgical Procedures / Q000379:methods*; D019340:Osteotomy, Le Fort / Q000379:methods; D059229:Osteotomy, Sagittal Split Ramus / Q000379:methods; D010919:Placebos; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000517:prevention & control*; D011292:Premedication; D011446:Prospective Studies; D012431:Rutin / Q000627:therapeutic use*; D016896:Treatment Outcome; D014357:Trypsin / Q000627:therapeutic use; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D010919:Placebos; D012431:Rutin; D001963:Bromelains; D010450:Endopeptidases; D014357:Trypsin