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

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 TM for measuring softtissue 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 Ò ) and group 2 (control group); the differences T0-T2 are significant (p \ 0.05) between group 1 (treated with Venoplant Ò ) and group 2 (control group). The differences T1-T3 are significant (p \ 0.05) between group 1 (treated with Venoplant Ò ) and group 2 (control group). Discussion The present study suggests that Venoplant Ò significantly decreases postoperative edema in orthognathic surgery, thus precluding long-term corticosteroid use.

Effectiveness of Corticoid Administration in Orthognathic Surgery for Edema and Neurosensorial Disturbance: A Systematic Literature Review

“…11 Thus, 8 articles were selected for qualitative analysis, and none presented sufficient data for quantitative analysis (Fig 1). [11][12][13][14][15][16][17][18] EXPERIMENTAL DRAW All 8 articles were prospective studies and were published from 1994 to 2016. The number of patients in each study ranged from 12 to 172, and 5 studies had no control group.…”

“…The number of patients in each study ranged from 12 to 172, and 5 studies had no control group. [12][13][14]16,18 One study used betamethasone 17 and another used methylprednisolone 13 (Table 1).…”

“…In a 1-day postoperative analysis of edema, the control group presented greater edema 11,17 compared with the groups treated with CSs in the pre-and postoperative 11,12,[16][17][18] and postoperative 11,17 periods. The maximum (control group) 11 and minimum preoperative values (13.3%) 17 values were recorded.…”

“…All articles discriminated between the osteotomy types. Of these, 2 reported performing Le Fort I plus sagittal split ramus osteotomy, 16,18 2 reported performing only sagittal split ramus osteotomy, 11,17 and 4 reported performing Le Fort I with or without sagittal split ramus osteotomy [12][13][14][15] (Table 1). 1528.e5…”

“…Six studies evaluated the degree of edema. 11,12,14,[16][17][18] However, 1 study performed a volumetric evaluation of edema regression 14 ; for this reason, it was not included in Table 3, which presents the influence of CSs on this parameter. Different percentages were observed for the regression rate of edema.…”