A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Comparing the Efficacy of Anti-edema Drugs for Edema Control in Orthognathic Surgery Using Digitizer 3-D to Measure Facial Swelling

U Tozzi; V Santillo; G P Tartaro; A Sellitto; G R Gravino; M Santagata

doi:10.1007/s12663-014-0685-x

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Comparing the Efficacy of Anti-edema Drugs for Edema Control in Orthognathic Surgery Using Digitizer 3-D to Measure Facial Swelling

J Maxillofac Oral Surg. 2015 Jun;14(2):386-92. doi: 10.1007/s12663-014-0685-x. Epub 2014 Sep 4.

Authors

U Tozzi¹, V Santillo², G P Tartaro², A Sellitto³, G R Gravino³, M Santagata²

Affiliations

¹ Multidisciplinary Department of Medical and Dental Specialties, Oral and Maxillofacial Surgery Unit, AOU - SUN (Second University of Naples), Naples, Italy ; Via P. Riverso, 102, 81031 Aversa, CE Italy.
² Multidisciplinary Department of Medical and Dental Specialties, Oral and Maxillofacial Surgery Unit, AOU - SUN (Second University of Naples), Naples, Italy.
³ Department of Industrial and Information Engineering, SUN (Second University of Naples), Aversa, Italy.

Abstract

Introduction: Orthognathic surgery involves making several osteotomies. Any osteotomies leads to varying degrees of post-operative swelling. The aim of this study was to evaluate the effectiveness of anti-edema drugs for the control of edema, using Digitizer 3D™ for measuring soft-tissue thickness, in patients who underwent bimaxillaryorthognathic surgery.

Materials and methods: In this double-blinded, randomized, control trial, 24 patients (study group: 12 patients, control group: 12 patients) in whom bimaxillary orthognathic surgery was indicated, were included in this study. All swelling measurements were expressed as total 3-D area of the landmarks (cm(2)) in T0 pre-operative, T1 first day after surgery, T2 fourth day after surgery, T3 4 months after surgery. For each patient we compared, by adding left and right area, the increase of swelling between T1-T0, T2-T0 and T1-T3.

Results: The differences T0-T1 are highly significant (p < 0.01) between group 1 or study group (treated with Venoplant(®)) and group 2 (control group); the differences T0-T2 are significant (p < 0.05) between group 1 (treated with Venoplant(®)) and group 2 (control group). The differences T1-T3 are significant (p < 0.05) between group 1 (treated with Venoplant(®)) and group 2 (control group).

Discussion: The present study suggests that Venoplant(®) significantly decreases postoperative edema in orthognathic surgery, thus precluding long-term corticosteroid use.

Keywords: Anti-edema drugs; Digitizer 3-D; Edema; Orthognathic surgery.