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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

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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 (cm2) 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.

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Conflict of interest

All authors disclose any financial and personal relationships with other people or organisations that could inappropriately influence their work.

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Authors and Affiliations

  1. Multidisciplinary Department of Medical and Dental Specialties, Oral and Maxillofacial Surgery Unit, AOU – SUN (Second University of Naples), Naples, Italy

    U. Tozzi, V. Santillo, G. P. Tartaro & M. Santagata

  2. Department of Industrial and Information Engineering, SUN (Second University of Naples), Aversa, Italy

    A. Sellitto & G. R. Gravino

  3. Via P. Riverso, 102, 81031, Aversa, CE, Italy

    U. Tozzi

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  1. U. Tozzi
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  2. V. Santillo
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  3. G. P. Tartaro
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  4. A. Sellitto
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  5. G. R. Gravino
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  6. M. Santagata
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Correspondence to U. Tozzi.

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Tozzi, U., Santillo, V., Tartaro, G.P. et al. 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. 14, 386–392 (2015). https://doi.org/10.1007/s12663-014-0685-x

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  • DOI: https://doi.org/10.1007/s12663-014-0685-x

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