Are bioresorbable polylactate devices comparable to titanium devices for stabilizing Le Fort I advancement?by G.H. Blakey, E. Rossouw, T.A. Turvey, C. Phillips, W.R. Proffit, R.P. White

International Journal of Oral and Maxillofacial Surgery

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Year
2014
DOI
10.1016/j.ijom.2013.10.006
Subject
Otorhinolaryngology / Oral Surgery / Surgery

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Text

Are bioresorbable polylactate G. H. Blakey 1, E. Rossouw2,

Chapel Hill, NC, USA

Int. J. Oral Maxillofac. Surg. 2014; 43: 437–444 nlSince Obwegeser’s description of the use of Le Fort I advancement to improve midface deficiency, the procedure has been adopted by many surgeons.1 In the hierarchy of stability, the operation ranks high for maintaining maxillary projection.2,3

Vertical instability is commonly associated with the procedure, especially when the maxilla is advanced and inferiorly displaced.4,5 This vertical instability is caused by stretching of the muscles of mastication, as occurs when the mandibular angle and ramus are rotated downward and backward. The vertical relapse occurs short-term and is minimal at 6 months postsurgery. When the maxilla is moved superiorly as well as anteriorly, vertical stability is more predictable.

Prior to the availability of bone plates and screws, Le Fort I osteotomy was stabilized with wire fixation alone and/ or in combination with bone grafts and intermaxillary fixation. Once miniplates became commercially available, most surgeons quickly adopted them for stabilizing maxillary advancement, primarily because of the elimination of the need for intermaxillary fixation.6

Bioresorbable materials are not new, but polylactate bioresorbable bone plates and screws have been commercially available in the USA for only the past 12 years.

Multiple studies have been published reporting the use of these materials in the facial skeleton and their benefits, especially with orthognathic surgery. Several 0901-5027/040437 + 08 $36.00/0 # 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.devices comparable to titanium devices for stabilizing Le Fort I advancement?

G. H. Blakey, E. Rossouw, T.A. Turvey, C. Phillips, W.R. Proffit, R.P. White: Are bioresorbable polylactate devices comparable to titanium devices for stabilizing Le

Fort I advancement?. Int. J. Oral Maxillofac. Surg. 2014; 43: 437–444. # 2013

International Association of Oral and Maxillofacial Surgeons. Published by Elsevier

Ltd. All rights reserved.

Abstract. The purpose of this study was to evaluate whether skeletal and dental outcomes following Le Fort I surgery differed when stabilization was performed with polylactate bioresorbable devices or titanium devices. Fifty-seven patients with preoperative records and at least 1 year postoperative records were identified and grouped according to the stabilization method. All cephalometric X-rays were traced and digitized by a single operator. Analysis of covariance was used to compare the postsurgical change between the two stabilization methods. Twentyseven patients received bioresorbable devices (group R), while 30 received titanium devices (group M). There were no statistically significant differences between the two groups with respect to gender, race/ethnicity, age, or dental and skeletal movements during surgery. Subtle postsurgical differences were noted, but were not statistically significant. Stabilization of Le Fort I advancement with polylactate bioresorbable and titanium devices produced similar clinical outcomes at 1 year following surgery.Key words: bioresorbable; titanium; Le Fort; advancement.

Accepted for publication 1 October 2013

Available online 20 November 2013T. A. Turvey1, C. Phillips2,

W. R. Proffit2, R. P. White1 1Department of Oral and Maxillofacial

Surgery, School of Dentistry, University of

North Carolina, Chapel Hill, NC, USA; 2Department of Orthodontics, School of

Dentistry, University of North Carolina,http://dx.doi.org/10.1016/j.ijom.2013.10.006, available o ine at http://www.sciencedirect.comClinical Paper

Orthognathic Surgery

University of North Carolina digitized model. The technique, reliability, and reproducibility of the method have been published previously.12 The principal outcome variables considered most important clinically were the changes in maxillary forward movement from immediately postsurgery to follow-up. Analysis of covariance was used to compare the postsurgical change between the two stabilization methods.

Stabilization method was the primary explanatory variable; the postsurgical position was included as a covariate as well as the interaction term with the stabilization method. Demographic characteristics (sex, race) and clinical covariates different in the two groups, with the average horizontal movement less in group R than in group M. At point A, subjects in group R were advanced a mean of 5.6 mm (SD  1.3 mm) and group M a mean of 7.1 mm (SD  2.3 mm). At the posterior nasal spine (PNS), the forward movement for group M was a mean of 6.9 mm (SD  2.6 mm) and for group R a mean of 5.5 mm (SD  1.8 mm) (Table 2). The mean vertical skeletal movement between the groups was subtly, but not significantly different. The maxilla moved down, increasing face height a mean of 0.6 mm (SD  4.6 mm) in group R, and up, decreasing face height 0.7 mm (SD  3.2 mm) in group M. The vertical 438 Blakey et al. c

R 7  (7 (2 (7 (7 (7 (7 (7 (6 (3 (8 (1studies have demonstrated good stability when they have been used to stabilize mandibular osteotomies, but fewer studies are available demonstrating acceptable stability with their use for stabilizing maxillary osteotomies.7–11 No studies have compared the stability of maxillary advancement via Le Fort I osteotomy over time when stabilized with polylactate bioresorbable versus titanium devices.

The purpose of this study was to analyze the stability of Le Fort I advancement at 1 year postsurgery comparing polylactate (PLLDL 70/30) and titanium devices.

Materials and methods

Fifty-seven patients who had undergone isolated maxillary advancement with at least 1 year of follow-up between the years 2000 and 2010 were identified in the university dentofacial database. This retrospective study was approved by the biomedical institutional review board.

Patients with craniofacial, traumatic, or pathological etiologies were excluded from the study, as were those who did not have preoperative, immediate postoperative, and at least 1 year postoperative cephalometric radiographs. Twenty-seven patients underwent isolated maxillary advancement and each was stabilized with four bioresorbable plates and screws (group R). Thirty patients were identified who underwent a similar operation but were stabilized with titanium bone plates and screws (group M).