Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
Contents lists available at ScienceDirect
Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com
Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review Liya Yang 1, Meibang Xu 1, Xiaolei Jin, Jiajie Xu, Jianjian Lu, Chao Zhang, Shuyuan Li, Li Teng* Department 2 of Cranio-Maxillo-Facial Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR China
a r t i c l e i n f o
a b s t r a c t
Article history: Paper received 27 February 2013 Accepted 28 August 2013
Background: Over the past 20 years, there has been an increase in the use of bioresorbable fixation system in orthognathic surgery, but concerns remain about the stability of fixation. This review is to seek evidence for the effectiveness of bioresorbable fixation systems compared to titanium systems used for orthognathic surgery. Methods: A systematic review of the scientific literature listed on PubMed, Embase, Cochrane Central Register of Systemic Reviews and Cochrane Central Register of Controlled Trials was performed, up to December 2012. Results: Twenty articles were selected based on inclusion and exclusion criteria: five RCTs and fifteen prospective. We compared these studies, published between 1997 and 2012 and involving 1092 participants examining skeletal stability of bioresorbable fixation in orthognathic surgery. Conclusion: This review found that the published data have shown that bioresorbable fixation systems produce reliable skeletal stability. Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Keywords: Skeletal stability Bioresorbable fixation Orthognathic surgery Systemic review
1. Introduction Internal fixation using titanium plates and screws in orthognathic surgery is considered as the “gold standard”. Their widespread use has arisen because of their high biocompatibility, resistance to corrosion (Linder et al., 1983), minimal scatter in computerized tomography (CT) scanning, and compatibility with plain radiography and with the use of magnetic resonance imaging (MRI) (Disegi, 1992; Eppley et al., 1993). In addition, titanium fixation produces stability for the osteotomy site and allows patients to use their masticatory system functionally immediately after surgery. The currently available metal plating systems have the advantage of combining excellent mechanical and handling properties. However, palpability can be a problem for metallic fixation. Long-term studies on the effects of metal osteosynthesis have identified the presence of metal ions in the vicinity of the site, leading to speculation that metal is gradually leached out by the
* Corresponding author. Department of Cranio-Maxillo-Facial Surgery, No.33, Badachu Road, Shijingshan District, Beijing 100144, PR China. Tel.: þ861088771948; fax: þ861088772513. E-mail address: [email protected] (L. Teng). 1 These authors contributed equally to this work.
action of body fluids (Meningaud et al., 2001). Recently, Siniscalchi et al. reported that titanium miniplates are a new risk factor for the development of the bisphosphonate-related osteonecrosis of the jaw (Siniscalchi et al., 2013). Therefore, there was a recommendation for removal of titanium plates (Matthew and Frame, 1999). The limitations of titanium systems has led to the development of plates manufactured from bioresorbable materials which, in some cases, omits the necessity for the second surgery, but concerns remain about the stability of fixation. An observational study of resorbable osteosynthesis in bimaxillary orthognathic surgery suggests that bimaxillary orthognathic procedures performed with bioresorbable osteosynthesis is a reliable and reproducible technique (Moure et al., 2012). After Le Fort I osteotomy with absorbable plate fixation, inserting Biopex(Ò) in the gap between the maxillary segments was useful for new bone formation (Ueki et al., 2013). A previous systemic review of resorbable versus titanium plates for orthognathic surgery only included two randomised controlled trials involving 103 participants, although it suggested no statistically significant difference for plate and screw fixation using either titanium or resorbable materials (Fedorowicz and Tim Newton, 2008). This systematic review of the international literature was performed to better understand whether there is a correlation of skeletal stability between the methods of bioresobable fixation and titanium fixation in orthognathic surgeries.
1010-5182/$ e see front matter Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jcms.2013.08.003
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
2
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
2. Materials and methods The aim of this systemic review was to include all publicly available literature on the skeletal stability of orthognathic surgery with an absorbable plate and/or screws fixation from prospective, comparative studies or randomized controlled trials (RCTs). A thorough systematic review was performed of all English-language literature located in the PubMed, Embase, Cochrane Central Register of Systemic Reviews and Cochrane Central Register of Controlled Trials according to a standardized protocol, up to December 2012. We conducted a comprehensive literature search with the following medical subject headings: bicortical resorbable, Poly-L-Lactic Acid(PLLA), PLLAePGA, resorbable, bioresorbale, biodegradable and titanium, nonresorbable, and metal. For the plates and/or screws, we also performed searches for each type separately such as screw, plate, miniplate and miniscrew. The search was limited to the English-language and studies conducted in humans. Paired reviewers (L.-Y.Y. and M.-B.X.) independently evaluated references for eligibility using a two-stage procedure. In the first stage, all identified abstracts were evaluated for appropriateness to the study aim. All potentially relevant trials were retrieved and selected for full-text review to determine whether or not they met all eligibility criteria in the second stage. Articles were then eliminated or selected based on the inclusion and exclusion criteria (Table 1). 3. Results Fig. 1. Study flow diagram.
The process of identifying eligible studies is summarized in Fig. 1. 598 articles were located, of which 20 articles met the inclusion criteria and included 5 RCTs and 15 compared studies published between 1997 and 2012 and involving 1092 participants. The numbers of articles found per topic are summarized in Table 2. The outcome measurements of the studies included were analysed by cephalometrics or coronal computed tomography, mainly including sella (S), nasion (N), A-point, B-point, upper and lower incisor tip (U1, L1), pogonion (Pog) and menton (M); anterior nasal spine (ANS); posterior nasal spine (PNS); B-PointeNasion (BPN); APointeNasion (APN); anteroposterior length (RmAeRmL); mediolateral width (RmMeRmL) and bone healing. The range of participants number in each group was 11e117 (Table 3). 3.1. Bilateral sagittal split ramus osteotomy (BSSRO) Nine articles included prospective studies examining skeletal stability of human absorbable fixation versus titanium. Two RCTs and seven comparative studies were identified. Table 1 Inclusion and exclusion criteria. Inclusion criteria: Patients received maxillofacial surgery Fixed by absorbable plates and screws Outcome measures were skeletal stability Full papers on original patient data reporting absorbable treatment Prospective, comparative studies Randomized controlled trials English article only Exclusion criteria: Alveolar bone implant Maxillofacial model Cadaver Animals Non-English articles Complications only Fracture fixation
Table 2 Absorbable fixation: Reporting Topics. RCTs indicate randomized controlled trials. Topics
RCTs
Comparative studies
BSSRO Le Fort I Bimaxillary operation Mixed
2 2 0 1
7 3 3 2
3.1.1. Absorbable screws In 1997, Harada et al. observed patients with Class III malocclusion treated with bilateral sagittal split ramus osteotomy (BSSRO) and mandibular setback, fixing by Poly-L-Lactic Acid (PLLA) (Takiron Co., Osaka Japan; 2.7 mm in diameter) or titanium (OSW Leibinger Co., Freiburg, Germany; 2.7 mm in diameter, self-tap). They concluded that bony fixation with PLLA screws after SSRO is a useful method for treating mandibular prognathism after 23 months follow-up. However, the relapse tendency was greater in the PLLA group than in titanium group, it might be necessary to select the most appropriate indications for PLLA screw fixation (Harada and Enomoto, 1997). Ferretti et al. traced and digitized relevant skeletal points to evaluate 2-dimensional skeletal change in patients who underwent mandibular advancement by means of SSRO performed with a standardized technique fixed by copolymer (poly-L-lactic/polyglycolic acid) screws (LactoSorb, Walter Lorenz Surgical, Jacksonville, Fla; 2.5 mm in diameter) or titanium screws (2 mm in diameter). They found no statistically significant difference in long-term stability between the 2 groups and no clinical or radiographic evidence of wound healing problems were noted (Ferretti and Reyneke, 2002). This finding was corroborated by Matthews et al., who compared skeletal stability after SSRO for mandibular advancement using self-reinforced poly-L-lactide (SRPLLA) (Biofix screw 3.5 mm in diameter and 20 mm long) or
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
3
Table 3 The basic characteristics of included trials. FU indicates follow-up. Mo indicates months. SSRO indicates sagittal split ramus osteotomy. Nu indicates number. Orth sur indicates orthognathic surgery. Ang II and III indicate Angle class II and III dysgnathia. Bi orth sur indicates bimaxillary orthognathic surgery. Faci ammes indicates facial ammestry. Maxi sur indicates maxillofacial surgery. Mandi defi indicates mandibular deficiency; Mandi jaw dis indicates mandibular jaw disproportion. Maxi dis indicates maxillary growth disturbances. Maxi retro indicates maxillary retrognathia. ANS indicates anterior nasal spine. PNS indicates posterior nasal spine. BPN indicates B-PointeNasion. APN indicates A-PointeNasion. RmAeRmL indicates anteroposterior length. RmMeRmL indicates mediolateral width. S indicates sella. N indicates nasion. U1 and L1 indicate upper and lower incisor tip. Pog indicates pogonion. M indicates and menton. CT indicates coronal computed tomography. Author
Disease
Operation
Material
Nu
Outcome M
FU (mo)
Ueki, 2006
Mandi prog þ
Landes, 2006
Ang II and III
SSRO/IVRO Le Fort I Bi orth sur
Costa, 2006
Ang III
Bi orth sur
Landes, 2007
Ang II and III
Bi orth sur
Tuovinen, 2010
Mandi/maxi growth disturb
Buijs, 2012
Mandi/maxi disturb/frac
Le Fort I SSRO Maxi sur
Ang III
SSRO
Ferretti, 2002
Ang II
SSRO
Matthews, 2003
Mandi retro
SSRO
Ueki, 2005
Mandi prog
SSRO
Turvey, 2006
Mandi defi
SSRO
12 12 12 12 12 12 12 12 76 76 2 2 23e31 23e31 12 12 12 12 12 12 12 12
Ueki, 2009
Mandi prog
SSRO
Stockmann, 2010
Mandi jaw dis
SSRO
Paeng, 2012
Ang III
SSRO
Ueki, 2011
Mandi prog
SSRO
Norholt, 2004
Maxi dis
Le Fort I
Landes, 2006
Maxi retro
Le Fort I
Dhol, 2008
Maxi impac
Le Fort I
Cheung, 2008
Maxi dis
Le Fort I
Ueki, 2012
Mandi prog
Le Fort I
21 26 15 15 10 12 15 30 51 50 117 113 10 10 20 20 11 11 20 20 34 35 11 12 33 33 25 25 20 20 20 28 27 11 11 25 25 20 20 20 20 20
ANS PNS ANS; APN BPN A; ANS; Me PNS; Pg; Go APN; BPN Ar-Go-Gn Angle SN/ML; SN/NL; ML/NL angles; SNA; ANB; ANB Orthopantomogram
Harada, 1997
PLAP Titanium P(L/DL)LA Titanium PLLA/PGA Titanium PLGA Titanium PLDLA Titanium Biodegradable Titanium PLLA Titanium PLLA/PGA Titanium SR-PLLA Titanium PLLA Titanium Biodegradable Titanium Absorbable Titanium Resorbable Titanium Biodegradable Titanium uHA/PLLA PLLA Titanium PLLA/PGA titanium Resorbable Titanium Resorbable Titanium Bioresorbable Titanium uHA/PLLA PLLA Titanium
titanium screws, demonstrated no significant difference between the two groups regarding the median extent of relapse 1-year after operation (Matthews et al., 2003). Turvey et al. also suggested that 2-mm self-reinforced 70L-lactide-co-30DL-lactide (PLLDL 70/30) screws can be used as effectively as 2-mm titanium screws to stabilize the mandible after BSSRO for mandibular advancement (Turvey et al., 2006). A two centre randomized clinical study with an eight-year follow-up showed [Poly-(L-co-DL-LA) (90/10)]/Poly(DL-LA) (80/20) (core diameters 3.5 mm, variable lengths 14e 20 mm) and titanium (core diameter 2.7 mm, variable lengths 10e 20 mm; Mandibulaschrauben System, Howmedica Leibinger, Freiburg, Germany) positioning screws were equally effective as fixation devices in SSRO (Stockmann et al., 2010). In the last two years, the results became slightly different. Paeng et al. compared the results of resorbable bicortical screws (diameter, 2.5 mm; length, 14e18 mm; Inion CPS, Inion Ltd., Finland) and titanium (diameter 2.4 mm, length 12e16 mm, Le Forte system, Jeil, Korea) in BSSRO in mandibular protrusion and found bicortical resorbable screws offered a clinically stable outcome, but the resorbable screws showed less stable results vertically than the titanium screws (Paeng et al., 2012).
U1; L1; B-point Pogonion Radiographic examination Mandibular length; Saddle angle; Gonial angle Condylar long axis ANS; PNS RmAeRmL; RmMeRmL Occlusion stable S; N; A; B; U1; L1; Pog; M SNB; ANB; Right condyle Angle; Left condyle angle Intercondylar axes angle SNP; IAL/SNP angle IAR/SNP; OP/SNP APNeNasion; ANSeNasion ANS; PNS Palatal plane A-point; P-point SePNS parallel to SN SeA perpend to SN SeANS parallel to SN
96 96 6 6 3 3 3 12 12 31.6137 31.6137 12 12 12 12 12 12 12
3.1.2. Absorbable plates Ueki et al. specifically examined changes in condylar long axis and skeletal stability after BSSRO with PLLA (28 mm 4.5 mm 1.5 mm; FixorbÒ-MX, Takiron Co., Osaka, Japan) or titanium plate (four holes/ bur 8 mm, thickness 0.55 mm; Würzburg titanium miniplate system, Leibinger Co., Freiburg, Germany) fixation. They found that change in condylar angle after BSSO and fixation with a titanium plate was greater than that after BSSO and fixation with a PLLA plate, but skeletal stability related to the occlusion was similar for the two procedures (Ueki et al., 2005). In 2011, the same group demonstrated the titanium (long miniplate: 4 holes/bur, 8 mm thickness, 1.0 mm; Würzburg titanium miniplate system; Leibinger, Freiburg, Germany) group showed a significantly greater change in the right condyle angle between initial and 1 month and intercondylar axes angle between 1 and 3 months compared with the uHA/PLLA (28 4.5 1.4 mm; SuperFixsorb-MX; Takiron) group. The PLLA (28 4.5 1.5 mm; FixsorbMX, Takiron) group showed a significantly greater change than the titanium group and uHA/PLLA group in terms of ramus inclination between 1 and 3 months (Ueki et al., 2011). In addition, they found the gap between the proximal and distal segments can fill with new bone after SSRO with both titanium and absorbable plates (Ueki et al., 2009).
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
4
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
In summary, resorbable bicortical screws and plates fixation of a BSSRO is a viable alternative to titanium screws and plates for the fixation of BSSRO. However, it might be better to select the most appropriate indications for absorbable screw fixation. 3.2. Le Fort I Three comparative studies and two RCTs were identified that focused on absorbable fixation in the Le Fort I osteotomy. Norholt performed a prospective, randomized, comparison study that compared resorbable PLLA/polyglycolic acid (PLLA/PGA) (2.0 mm LactoSorb system; W. Lorenz Surgical, Jacksonville, Florida) with titanium (2.0 mm titanium miniplates system W. Lorenz Surgical, Jacksonville, Florida) in the operation of Le Fort I. At 12 months, the changes in maxillary position were not clinically noticeable in either of the treatment groups (Norholt et al., 2004). In a second study, Landes et al. compared PLLDL (70/30) (MacroSorb, MacroPore, SanDiego, CA; or PolyMax, Synthes, Oberdorf, Switzerland) or titanium (Leibinger-mini, Tuttlingen, Germany) miniplates in 22 cleft lip and palate maxillary retrognathia cases. At two years, they found horizontal maxillary stability appeared inferior to vertical stability (Landes and Ballon, 2006a, 2006b). A third study by Dhol et al. treated 25 patients with PLLA/PGA fixation and 25 patients with titanium fixation who underwent maxillary impaction with a nonsegmental monopiece Le Fort I osteotomy. Statistical analysis showed no significant radiographic differences in long-term stability in or between the 2 groups (Dhol et al., 2008). In the same year, Cheung et al. led a randomized controlled trial, which indicated that patients with bioresorbable plate fixation showed significantly more upward displacement in the anterior maxilla following impaction and posterior maxilla following down grafting from the 2nd to 6th week after Le Fort I osteotomy. In the fifth study, Ueki et al. evaluated skeletal stabilization in 60 patients divided into three groups: uHA/PLLA miniplates (10 m 22 mm 1.4 mm, Super-Fixorb1-MX, Takiron Co., Osaka, Japan) group, PLLA (10 mm 22 mm 1.5 mm, Fixorb-MX; Takiron Co., Osaka, Japan) miniplates group and titanium miniplates (4 holes/thickness 0.55 mm, Würzburg titanium miniplate system; Leibinger Co., Freiburg, Germany) group. The results followed-up at 1 month, 3 months and 1 year suggests that there was a slight difference in maxillary stability between the uHA/PLLA and PLLA plate systems in Le Fort I osteotomy, but generally the authors were satisfied with the outcomes (Ueki et al., 2012). In summary, the body of evidence supports the use of absorbable fixation as being as stable as titanium in Le Fort I osteotomy, but there might be a little difference in maxillary stability which does not affect the overall outcomes. 3.3. Bimaxillary operation There were 3 trials comparing the complications of absorbable and titanium fixation in the bimaxillary operation category (BSSRO plus Le Fort I). In 2006, Landes published on patients receiving bimaxillary orthognathic surgery, using PLLDL (2.0 mm; MacroSorb, MacroPore, SanDiego, CA; and PolyMax, Synthes, Oberdorf, Switzerland) and titanium (2.0 mm; Standard Wuerzburg Titanium System, Strykere Leibinger, Tuttlingen, Germany) osteofixation. Resorbable fixation as tested proved to be as reliable as titanium (Landes and Ballon, 2006b). In the same year, Costa et al. compared skeletal stability of double jaw surgery for correction of skeletal Class III malocclusion using PLLA/PGA (2 mm L-shaped; LactoSorb; Walter Lorenz Surgical, Jacksonville, FL) and titanium (2 mm) plates. No significant differences were observed for maxillary advancements up to
5 mm, but they indicated that resorbable devices should be used with caution for bony movements of greater magnitude (Costa et al., 2006). In 2007, the same team of Landes et al. published a study concerning the effect of poly(L-lactide-co-glycolide) (PLGA) (82:18 LactoSorb; Lorenz Surgical, Jacksonville, FL, and 85:15 RapidSorb; Synthes, Oberdorf, Switzerland) osteosynthesis and 2.0 mm titanium miniplate (Standard Würzburg Titanium System; StrykereLeibinger Tuttlingen, Germany) osteosynthesis. They concluded the tested resorbable PLGA osteofixation proved to be as reliable in segment fixation as titanium, although this conclusion should be interpreted as preliminary (Landes et al., 2007). In summary, the body of evidence supports absorbable fixation could be an alternative option in bimaxillary operation. 3.4. Mixed operations The remaining three studies cannot be classified as they included different kinds of orthognathic surgery. Two comparative studies and one RCT were identified that focused on absorbable fixation in ‘mixed operations’. In 2006, Ueki et al. investigated the stability of titanium plate (4 holes/thickness 0.55 mm; Würzburg titanium miniplate system; Leibinger Co., Freiburg, Germany) and PLLA plate (10 22 1.5 mm; Fixorb-MX) groups in Le Fort I osteotomy combined with SSRO/IVRO. Arbitrary points for anterior nasal spine (ANS) and posterior nasal spine (PNS) were assessed. They concluded that there was a slight tendency for vertical impaction after Le Fort I osteotomy both in combination with SSRO and IVRO with PLLA plates (Ueki et al., 2006). In 2010, a prospective randomized controlled study regarding orthognathic surgery, Orthognathic surgery included different groups of BSSRO, Le Fort I osteotomy, bimaxillary osteotomies, was performed by Tuovinen et al., who compared poly(L-lactide-co-Dlactide) (PLDLA) (Biosorb FX, Conmed Linvatec, Tampere, Finland) and titanium osteosynthesis (Tuovinen et al., 2010). In 2012, another multi-centre randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery (mandibular and/or Le Fort I osteotomies or zygomatic/ mandibular fracture) was performed by Buijs et al., who concluded that biodegradable plates and screws could be safely used when it was possible to apply them (Buijs et al., 2012). 3.5. Complications Part of the complications, including infection, temporomandibular disorders (TMD), paraesthesia, foreign body reaction, fistulation, palpability, dehiscence, malocclusion, exposure, relapse and mobility were recorded during their followed-up period in enrolled trials. The main concern was relapse, which was related to the movements in orthognathic surgery. Most of the trials indicated that in their study there were no significant differences between bioresorbable fixation system and titanium group (Table 4). 4. Discussion Over the past 20 years, there has been an increase in the use of bioresorbable fixation for bone healing and to avoid a second operation to reduce the operative risk in maxillofacial surgery. Since Bos et al. demonstrated the use of biodegradable plates and screws for zygomatic fracture fixation in 1987 (Bos et al., 1987), it has been extended for a variety of indications such as mandibular fracture (Bayat et al., 2010), BSSRO (Moure et al., 2012) and Le Fort I (Norholt et al., 2004). The purpose of this systematic review was to identify the scientific evidence base for the use of these materials. In addition to the method of fixation, occlusion, muscle strength and displacement distance contribute to maxillofacial skeletal
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
5
Table 4 Movements and relapse. mm indicates millimetre. R indicates right. L indicates left. X indicates maxillary. N indicates mandible. SD indicates significant difference. NS indicates non-significance. Author
Operation
Material
Movements (mm)
Relapse
Ueki, 2006
Costa, 2006
Bi orth sur
Landes, 2007
Bi orth sur
Tuovinen, 2010 Buijs, 2012
Le Fort I SSRO Maxi sur
R 5.2 4.2; L 6.3 3.3 R 7.0 2.9; L 5.45 4.0 R 2.1 4.4; L 2.2 3.6 R 1.4 1.9; L 2.1 2.5 3.5 4.5 5.4 3.5 X 3.54 1.54; N 4.29 6.79 X 3.50 1.65; N 7.00 4.61 X 2.5 1.0; N 5.5 3.7 X 5.4 3.5; N 6.3 8.8 e e e
Harada, 1997
SSRO
Ferretti, 2002
SSRO
Matthews, 2003
SSRO
Ueki, 2005
SSRO
Turvey, 2006
SSRO
Ueki, 2009
SSRO
Stockmann, 2010
SSRO
Paeng, 2012
SSRO
Ueki, 2011
SSRO
Norholt, 2004
Le Fort I
Landes, 2006
Le Fort I
Dhol, 2008
Le Fort I
Cheung, 2008
Le Fort I
Ueki, 2012
Le Fort I
PLAP Titanium PLAP Titanium P(L/DL)LA Titanium PLLA/PGA Titanium PLGA Titanium PLDLA Titanium Biodegradable Titanium PLLA Titanium PLLA/PGA Titanium SR-PLLA Titanium PLLA Titanium Biodegradable Titanium Absorbable Titanium Resorbable Titanium Biodegradable Titanium uHA/PLLA PLLA Titanium PLLA/PGA Titanium Resorbable Titanium Resorbable Titanium Bioresorbable Titanium uHA/PLLA PLLA Titanium
NS
Landes, 2006
SSROþ Le Fort I IVROþ Le Fort I Bi orth sur
stability. Therefore, bioresorbable fixation should be chosen in appropriate conditions, taking into consideration of the distance involved in moving forward or setting back the mandible or maxilla. The bioresorbable fixation systems seem to be reliable in bimaxillary surgery, in spite of little difference compared with titanium fixation. 4.1. Future directions The stability of fixation, the length of time required for their degradation and especially the possibility of complications remain a concern (Uygur et al., 2009). It was reported that the process of degradation of these devices into carbon dioxide and water may take as long as 2 years (Dorri et al., 2009). In addition, absorbable fixation systems cost more in clinical use. The use of bioresorbable plates and screws remains unpopular for internal fixation among oral and maxillofacial surgeons, especially in China. New bioresorbable materials characterized by a shorter degradation time, adequate strength and better safety are worthy of exploration. 5. Conclusions This review sought high level (level 2) evidence for the effectiveness of bioresorbable fixation systems compared with titanium
e e
0.2 2.9 1.4 2.8 X 0.16 0.72; N 1.33 1.59 X 0.90 1.37; N 3.15 1.96 X 1.2 0.8; N 0.8 4.0 X 1.4 2.8; N 4.2 8.7 NS e e NS 0.83 1.25 0.25 1.38 NS
9.3, 8.6e9.9 9.4, 9.3e9.7 R 7.2 2.8; L 6.3 2.6 R 6.7 3.2; L 6.4 3.2 e e e
e
e
NS
6.7 2.2 6.7 3.2 R 6.4 2.6; L 6.3 3.1 R 6.7 3.2; L 6.4 3.2 R 7.0 2.9; L 6.5 2.6 2e3 2e3 3.5 4.1 5.4 3.5 2.02 0.39 2.45 0.57 e
NS
R 6.5 3.5; L 6.1 3.7 R 5.9 3.1; L 6.1 2.5 R 6.3 3.5; L 6.0 2.6
NS NS
NS
NS 0.2 2.9 1.4 2.8 0.20 0.43 0.80 0.43 e SD
systems used for orthognathic surgery, including 5 RCTs and 15 compared studies. This review has found that published data show that bioresorbable fixation systems are reliable in terms of skeletal stability. Funding None. Conflict of interest None. References Bayat M, Garajei A, Ghorbani K, Motamedi MH: Treatment of mandibular angle fractures using a single bioresorbable miniplate. J Oral Maxillofac Surg 68: 1573e1577, 2010 Bos RR, Boering G, Rozema FR, Leenslag JW: Resorbable poly(L-lactide) plates and screws for the fixation of zygomatic fractures. J Oral Maxillofac Surg 45: 751e 753, 1987 Buijs GJ, van BNB, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, et al: A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery. J Dent Res 91: 299e304, 2012 Costa F, Robiony M, Zorzan E, Zerman N, Politi M: Stability of skeletal Class III malocclusion after combined maxillary and mandibular procedures: titanium versus resorbable plates and screws for maxillary fixation. J Oral Maxillofac Surg 64: 642e651, 2006
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
6
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
Dhol WS, Reyneke JP, Tompson B, Sandor GK: Comparison of titanium and resorbable copolymer fixation after Le Fort I maxillary impaction. Am J Orthod Dentofacial Orthop 134: 67e73, 2008 Disegi JA: Magnetic resonance imaging of AO/ASIF stainless steel and titanium implants. Injury 23(Suppl. 2): S1eS4, 1992 Dorri M, Nasser M, Oliver R: Resorbable versus titanium plates for facial fractures. Cochrane Database Syst Rev, 2009 CD007158 Eppley BL, Sparks C, Herman E, Edwards M, McCarty M, Sadove AM: Effects of skeletal fixation on craniofacial imaging. J Craniofac Surg 4: 67e73, 1993 Fedorowicz MN, Tim Newton RO: Resorbable versus titanium plates for orthognathic surgery. The Cochrane Collab 18(2): CD006204. 2008 Ferretti C, Reyneke JP: Mandibular, sagittal split osteotomies fixed with biodegradable or titanium screws: a prospective, comparative study of postoperative stability. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 93: 534e537, 2002 Harada K, Enomoto S: Stability after surgical correction of mandibular prognathism using the sagittal split ramus osteotomy and fixation with poly-L-lactic acid (PLLA) screws. J Oral Maxillofac Surg 55: 464e468, 1997 discussion 468e469 Landes CA, Ballon A: Five-year experience comparing resorbable to titanium miniplate osteosynthesis in cleft lip and palate orthognathic surgery. Cleft Palate Craniofac J 43: 67e74, 2006a Landes CA, Ballon A: Skeletal stability in bimaxillary orthognathic surgery: P(L/DL) LA-resorbable versus titanium osteofixation. Plast Reconstr Surg 118: 703e721, 2006b discussion 722 Landes CA, Ballon A, Sader R: Segment stability in bimaxillary orthognathic surgery after resorbable Poly(L-lactide-co-glycolide) versus titanium osteosyntheses. J Craniofac Surg 18: 1216e1229, 2007 Linder L, Albrektsson T, Branemark PI, Hansson HA, Ivarsson B, Jonsson U, et al: Electron microscopic analysis of the boneetitanium interface. Acta Orthop Scand 54: 45e52, 1983 Matthew IR, Frame JW: Policy of consultant oral and maxillofacial surgeons towards removal of miniplate components after jaw fracture fixation: pilot study. Br J Oral Maxillofac Surg 37: 110e112, 1999 Matthews NS, Khambay BS, Ayoub AF, Koppel D, Wood G: Preliminary assessment of skeletal stability after sagittal split mandibular advancement using a bioresorbable fixation system. Br J Oral Maxillofac Surg 41: 179e184, 2003 Meningaud JP, Poupon J, Bertrand JC, Chenevier C, Galliot-Guilley M, Guilbert F: Dynamic study about metal release from titanium miniplates in maxillofacial surgery. Int J Oral Maxillofac Surg 30: 185e188, 2001 Moure C, Qassemyar Q, Dunaud O, Neiva C, Testelin S, Devauchelle B: Skeletal stability and morbidity with self-reinforced P (L/DL) LA resorbable osteosynthesis in bimaxillary orthognathic surgery. J Craniomaxillofac Surg 40: 55e60, 2012 Norholt SE, Pedersen TK, Jensen J: Le Fort I miniplate osteosynthesis: a randomized, prospective study comparing resorbable PLLA/PGA with titanium. Int J Oral Maxillofac Surg 33: 245e252, 2004
Paeng JY, Hong J, Kim CS, Kim MJ: Comparative study of skeletal stability between bicortical resorbable and titanium screw fixation after sagittal split ramus osteotomy for mandibular prognathism. J Craniomaxillofac Surg 40: 660e664, 2012 Siniscalchi EN, Catalfamo L, Allegra A, Musolino C, De Ponte FS: Titanium miniplates: a new risk factor for the development of the bisphosphonate-related osteonecrosis of the jaw. J Craniofac Surg 24: e1e2, 2013 Stockmann P, Bohm H, Driemel O, Muhling J, Pistner H: Resorbable versus titanium osteosynthesis devices in bilateral sagittal split ramus osteotomy of the mandible e the results of a two centre randomised clinical study with an eightyear follow-up. J Craniomaxillofac Surg 38: 522e528, 2010 Tuovinen V, Suuronen R, Teittinen M, Nurmenniemi P: Comparison of the stability of bioabsorbable and titanium osteosynthesis materials for rigid internal fixation in orthognathic surgery. A prospective randomized controlled study in 101 patients with 192 osteotomies. Int J Oral Maxillofac Surg 39: 1059e1065, 2010 Turvey TA, Bell RB, Phillips C, Proffit WR: Self-reinforced biodegradable screw fixation compared with titanium screw fixation in mandibular advancement. J Oral Maxillofac Surg 64: 40e46, 2006 Ueki K, Hashiba Y, Marukawa K, Okabe K, Nakagawa K, Alam S, et al: Evaluation of bone formation after sagittal split ramus osteotomy with bent plate fixation using computed tomography. J Oral Maxillofac Surg 67: 1062e1068, 2009 Ueki K, Marukawa K, Shimada M, Nakagawa K, Alam S, Yamamoto E: Maxillary stability following Le Fort I osteotomy in combination with sagittal split ramus osteotomy and intraoral vertical ramus osteotomy: a comparative study between titanium miniplate and poly-L-lactic acid plate. J Oral Maxillofac Surg 64: 74e80, 2006 Ueki K, Marukawa K, Shimada M, Nakagawa K, Yamamoto E: Change in condylar long axis and skeletal stability following sagittal split ramus osteotomy and intraoral vertical ramus osteotomy for mandibular prognathia. J Oral Maxillofac Surg 63: 1494e1499, 2005 Ueki K, Okabe K, Marukawa K, Mukozawa A, Moroi A, Miyazaki M, et al: Assessment of bone healing and hypoesthesia in the upper lip after Le Fort I osteotomy with self-setting alpha-tricalcium phosphate and absorbable plates. J Craniomaxillofac Surg 41: 129e134, 2013 Ueki K, Okabe K, Miyazaki M, Mukozawa A, Moroi A, Marukawa K, et al: Skeletal stability after mandibular setback surgery: comparisons among unsintered hydroxyapatite/poly-L-lactic acid plate, poly-L-lactic acid plate, and titanium plate. J Oral Maxillofac Surg 69: 1464e1468, 2011 Ueki K, Okabe K, Moroi A, Marukawa K, Sotobori M, Ishihara Y, et al: Maxillary stability after Le Fort I osteotomy using three different plate systems. Int J Oral Maxillofac Surg 41: 942e948, 2012 Uygur S, Cukurluoglu O, Ozmen S, Guclu TH, Sezgin B: Resorbable mesh plate in the treatment of blow-out fracture might cause gaze restriction. J Craniofac Surg 20: 71e72, 2009
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
Contents lists available at ScienceDirect
Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com
Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review Liya Yang 1, Meibang Xu 1, Xiaolei Jin, Jiajie Xu, Jianjian Lu, Chao Zhang, Shuyuan Li, Li Teng* Department 2 of Cranio-Maxillo-Facial Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR China
a r t i c l e i n f o
a b s t r a c t
Article history: Paper received 27 February 2013 Accepted 28 August 2013
Background: Over the past 20 years, there has been an increase in the use of bioresorbable fixation system in orthognathic surgery, but concerns remain about the stability of fixation. This review is to seek evidence for the effectiveness of bioresorbable fixation systems compared to titanium systems used for orthognathic surgery. Methods: A systematic review of the scientific literature listed on PubMed, Embase, Cochrane Central Register of Systemic Reviews and Cochrane Central Register of Controlled Trials was performed, up to December 2012. Results: Twenty articles were selected based on inclusion and exclusion criteria: five RCTs and fifteen prospective. We compared these studies, published between 1997 and 2012 and involving 1092 participants examining skeletal stability of bioresorbable fixation in orthognathic surgery. Conclusion: This review found that the published data have shown that bioresorbable fixation systems produce reliable skeletal stability. Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Keywords: Skeletal stability Bioresorbable fixation Orthognathic surgery Systemic review
1. Introduction Internal fixation using titanium plates and screws in orthognathic surgery is considered as the “gold standard”. Their widespread use has arisen because of their high biocompatibility, resistance to corrosion (Linder et al., 1983), minimal scatter in computerized tomography (CT) scanning, and compatibility with plain radiography and with the use of magnetic resonance imaging (MRI) (Disegi, 1992; Eppley et al., 1993). In addition, titanium fixation produces stability for the osteotomy site and allows patients to use their masticatory system functionally immediately after surgery. The currently available metal plating systems have the advantage of combining excellent mechanical and handling properties. However, palpability can be a problem for metallic fixation. Long-term studies on the effects of metal osteosynthesis have identified the presence of metal ions in the vicinity of the site, leading to speculation that metal is gradually leached out by the
* Corresponding author. Department of Cranio-Maxillo-Facial Surgery, No.33, Badachu Road, Shijingshan District, Beijing 100144, PR China. Tel.: þ861088771948; fax: þ861088772513. E-mail address: [email protected] (L. Teng). 1 These authors contributed equally to this work.
action of body fluids (Meningaud et al., 2001). Recently, Siniscalchi et al. reported that titanium miniplates are a new risk factor for the development of the bisphosphonate-related osteonecrosis of the jaw (Siniscalchi et al., 2013). Therefore, there was a recommendation for removal of titanium plates (Matthew and Frame, 1999). The limitations of titanium systems has led to the development of plates manufactured from bioresorbable materials which, in some cases, omits the necessity for the second surgery, but concerns remain about the stability of fixation. An observational study of resorbable osteosynthesis in bimaxillary orthognathic surgery suggests that bimaxillary orthognathic procedures performed with bioresorbable osteosynthesis is a reliable and reproducible technique (Moure et al., 2012). After Le Fort I osteotomy with absorbable plate fixation, inserting Biopex(Ò) in the gap between the maxillary segments was useful for new bone formation (Ueki et al., 2013). A previous systemic review of resorbable versus titanium plates for orthognathic surgery only included two randomised controlled trials involving 103 participants, although it suggested no statistically significant difference for plate and screw fixation using either titanium or resorbable materials (Fedorowicz and Tim Newton, 2008). This systematic review of the international literature was performed to better understand whether there is a correlation of skeletal stability between the methods of bioresobable fixation and titanium fixation in orthognathic surgeries.
1010-5182/$ e see front matter Ó 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jcms.2013.08.003
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
2
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
2. Materials and methods The aim of this systemic review was to include all publicly available literature on the skeletal stability of orthognathic surgery with an absorbable plate and/or screws fixation from prospective, comparative studies or randomized controlled trials (RCTs). A thorough systematic review was performed of all English-language literature located in the PubMed, Embase, Cochrane Central Register of Systemic Reviews and Cochrane Central Register of Controlled Trials according to a standardized protocol, up to December 2012. We conducted a comprehensive literature search with the following medical subject headings: bicortical resorbable, Poly-L-Lactic Acid(PLLA), PLLAePGA, resorbable, bioresorbale, biodegradable and titanium, nonresorbable, and metal. For the plates and/or screws, we also performed searches for each type separately such as screw, plate, miniplate and miniscrew. The search was limited to the English-language and studies conducted in humans. Paired reviewers (L.-Y.Y. and M.-B.X.) independently evaluated references for eligibility using a two-stage procedure. In the first stage, all identified abstracts were evaluated for appropriateness to the study aim. All potentially relevant trials were retrieved and selected for full-text review to determine whether or not they met all eligibility criteria in the second stage. Articles were then eliminated or selected based on the inclusion and exclusion criteria (Table 1). 3. Results Fig. 1. Study flow diagram.
The process of identifying eligible studies is summarized in Fig. 1. 598 articles were located, of which 20 articles met the inclusion criteria and included 5 RCTs and 15 compared studies published between 1997 and 2012 and involving 1092 participants. The numbers of articles found per topic are summarized in Table 2. The outcome measurements of the studies included were analysed by cephalometrics or coronal computed tomography, mainly including sella (S), nasion (N), A-point, B-point, upper and lower incisor tip (U1, L1), pogonion (Pog) and menton (M); anterior nasal spine (ANS); posterior nasal spine (PNS); B-PointeNasion (BPN); APointeNasion (APN); anteroposterior length (RmAeRmL); mediolateral width (RmMeRmL) and bone healing. The range of participants number in each group was 11e117 (Table 3). 3.1. Bilateral sagittal split ramus osteotomy (BSSRO) Nine articles included prospective studies examining skeletal stability of human absorbable fixation versus titanium. Two RCTs and seven comparative studies were identified. Table 1 Inclusion and exclusion criteria. Inclusion criteria: Patients received maxillofacial surgery Fixed by absorbable plates and screws Outcome measures were skeletal stability Full papers on original patient data reporting absorbable treatment Prospective, comparative studies Randomized controlled trials English article only Exclusion criteria: Alveolar bone implant Maxillofacial model Cadaver Animals Non-English articles Complications only Fracture fixation
Table 2 Absorbable fixation: Reporting Topics. RCTs indicate randomized controlled trials. Topics
RCTs
Comparative studies
BSSRO Le Fort I Bimaxillary operation Mixed
2 2 0 1
7 3 3 2
3.1.1. Absorbable screws In 1997, Harada et al. observed patients with Class III malocclusion treated with bilateral sagittal split ramus osteotomy (BSSRO) and mandibular setback, fixing by Poly-L-Lactic Acid (PLLA) (Takiron Co., Osaka Japan; 2.7 mm in diameter) or titanium (OSW Leibinger Co., Freiburg, Germany; 2.7 mm in diameter, self-tap). They concluded that bony fixation with PLLA screws after SSRO is a useful method for treating mandibular prognathism after 23 months follow-up. However, the relapse tendency was greater in the PLLA group than in titanium group, it might be necessary to select the most appropriate indications for PLLA screw fixation (Harada and Enomoto, 1997). Ferretti et al. traced and digitized relevant skeletal points to evaluate 2-dimensional skeletal change in patients who underwent mandibular advancement by means of SSRO performed with a standardized technique fixed by copolymer (poly-L-lactic/polyglycolic acid) screws (LactoSorb, Walter Lorenz Surgical, Jacksonville, Fla; 2.5 mm in diameter) or titanium screws (2 mm in diameter). They found no statistically significant difference in long-term stability between the 2 groups and no clinical or radiographic evidence of wound healing problems were noted (Ferretti and Reyneke, 2002). This finding was corroborated by Matthews et al., who compared skeletal stability after SSRO for mandibular advancement using self-reinforced poly-L-lactide (SRPLLA) (Biofix screw 3.5 mm in diameter and 20 mm long) or
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
3
Table 3 The basic characteristics of included trials. FU indicates follow-up. Mo indicates months. SSRO indicates sagittal split ramus osteotomy. Nu indicates number. Orth sur indicates orthognathic surgery. Ang II and III indicate Angle class II and III dysgnathia. Bi orth sur indicates bimaxillary orthognathic surgery. Faci ammes indicates facial ammestry. Maxi sur indicates maxillofacial surgery. Mandi defi indicates mandibular deficiency; Mandi jaw dis indicates mandibular jaw disproportion. Maxi dis indicates maxillary growth disturbances. Maxi retro indicates maxillary retrognathia. ANS indicates anterior nasal spine. PNS indicates posterior nasal spine. BPN indicates B-PointeNasion. APN indicates A-PointeNasion. RmAeRmL indicates anteroposterior length. RmMeRmL indicates mediolateral width. S indicates sella. N indicates nasion. U1 and L1 indicate upper and lower incisor tip. Pog indicates pogonion. M indicates and menton. CT indicates coronal computed tomography. Author
Disease
Operation
Material
Nu
Outcome M
FU (mo)
Ueki, 2006
Mandi prog þ
Landes, 2006
Ang II and III
SSRO/IVRO Le Fort I Bi orth sur
Costa, 2006
Ang III
Bi orth sur
Landes, 2007
Ang II and III
Bi orth sur
Tuovinen, 2010
Mandi/maxi growth disturb
Buijs, 2012
Mandi/maxi disturb/frac
Le Fort I SSRO Maxi sur
Ang III
SSRO
Ferretti, 2002
Ang II
SSRO
Matthews, 2003
Mandi retro
SSRO
Ueki, 2005
Mandi prog
SSRO
Turvey, 2006
Mandi defi
SSRO
12 12 12 12 12 12 12 12 76 76 2 2 23e31 23e31 12 12 12 12 12 12 12 12
Ueki, 2009
Mandi prog
SSRO
Stockmann, 2010
Mandi jaw dis
SSRO
Paeng, 2012
Ang III
SSRO
Ueki, 2011
Mandi prog
SSRO
Norholt, 2004
Maxi dis
Le Fort I
Landes, 2006
Maxi retro
Le Fort I
Dhol, 2008
Maxi impac
Le Fort I
Cheung, 2008
Maxi dis
Le Fort I
Ueki, 2012
Mandi prog
Le Fort I
21 26 15 15 10 12 15 30 51 50 117 113 10 10 20 20 11 11 20 20 34 35 11 12 33 33 25 25 20 20 20 28 27 11 11 25 25 20 20 20 20 20
ANS PNS ANS; APN BPN A; ANS; Me PNS; Pg; Go APN; BPN Ar-Go-Gn Angle SN/ML; SN/NL; ML/NL angles; SNA; ANB; ANB Orthopantomogram
Harada, 1997
PLAP Titanium P(L/DL)LA Titanium PLLA/PGA Titanium PLGA Titanium PLDLA Titanium Biodegradable Titanium PLLA Titanium PLLA/PGA Titanium SR-PLLA Titanium PLLA Titanium Biodegradable Titanium Absorbable Titanium Resorbable Titanium Biodegradable Titanium uHA/PLLA PLLA Titanium PLLA/PGA titanium Resorbable Titanium Resorbable Titanium Bioresorbable Titanium uHA/PLLA PLLA Titanium
titanium screws, demonstrated no significant difference between the two groups regarding the median extent of relapse 1-year after operation (Matthews et al., 2003). Turvey et al. also suggested that 2-mm self-reinforced 70L-lactide-co-30DL-lactide (PLLDL 70/30) screws can be used as effectively as 2-mm titanium screws to stabilize the mandible after BSSRO for mandibular advancement (Turvey et al., 2006). A two centre randomized clinical study with an eight-year follow-up showed [Poly-(L-co-DL-LA) (90/10)]/Poly(DL-LA) (80/20) (core diameters 3.5 mm, variable lengths 14e 20 mm) and titanium (core diameter 2.7 mm, variable lengths 10e 20 mm; Mandibulaschrauben System, Howmedica Leibinger, Freiburg, Germany) positioning screws were equally effective as fixation devices in SSRO (Stockmann et al., 2010). In the last two years, the results became slightly different. Paeng et al. compared the results of resorbable bicortical screws (diameter, 2.5 mm; length, 14e18 mm; Inion CPS, Inion Ltd., Finland) and titanium (diameter 2.4 mm, length 12e16 mm, Le Forte system, Jeil, Korea) in BSSRO in mandibular protrusion and found bicortical resorbable screws offered a clinically stable outcome, but the resorbable screws showed less stable results vertically than the titanium screws (Paeng et al., 2012).
U1; L1; B-point Pogonion Radiographic examination Mandibular length; Saddle angle; Gonial angle Condylar long axis ANS; PNS RmAeRmL; RmMeRmL Occlusion stable S; N; A; B; U1; L1; Pog; M SNB; ANB; Right condyle Angle; Left condyle angle Intercondylar axes angle SNP; IAL/SNP angle IAR/SNP; OP/SNP APNeNasion; ANSeNasion ANS; PNS Palatal plane A-point; P-point SePNS parallel to SN SeA perpend to SN SeANS parallel to SN
96 96 6 6 3 3 3 12 12 31.6137 31.6137 12 12 12 12 12 12 12
3.1.2. Absorbable plates Ueki et al. specifically examined changes in condylar long axis and skeletal stability after BSSRO with PLLA (28 mm 4.5 mm 1.5 mm; FixorbÒ-MX, Takiron Co., Osaka, Japan) or titanium plate (four holes/ bur 8 mm, thickness 0.55 mm; Würzburg titanium miniplate system, Leibinger Co., Freiburg, Germany) fixation. They found that change in condylar angle after BSSO and fixation with a titanium plate was greater than that after BSSO and fixation with a PLLA plate, but skeletal stability related to the occlusion was similar for the two procedures (Ueki et al., 2005). In 2011, the same group demonstrated the titanium (long miniplate: 4 holes/bur, 8 mm thickness, 1.0 mm; Würzburg titanium miniplate system; Leibinger, Freiburg, Germany) group showed a significantly greater change in the right condyle angle between initial and 1 month and intercondylar axes angle between 1 and 3 months compared with the uHA/PLLA (28 4.5 1.4 mm; SuperFixsorb-MX; Takiron) group. The PLLA (28 4.5 1.5 mm; FixsorbMX, Takiron) group showed a significantly greater change than the titanium group and uHA/PLLA group in terms of ramus inclination between 1 and 3 months (Ueki et al., 2011). In addition, they found the gap between the proximal and distal segments can fill with new bone after SSRO with both titanium and absorbable plates (Ueki et al., 2009).
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
4
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
In summary, resorbable bicortical screws and plates fixation of a BSSRO is a viable alternative to titanium screws and plates for the fixation of BSSRO. However, it might be better to select the most appropriate indications for absorbable screw fixation. 3.2. Le Fort I Three comparative studies and two RCTs were identified that focused on absorbable fixation in the Le Fort I osteotomy. Norholt performed a prospective, randomized, comparison study that compared resorbable PLLA/polyglycolic acid (PLLA/PGA) (2.0 mm LactoSorb system; W. Lorenz Surgical, Jacksonville, Florida) with titanium (2.0 mm titanium miniplates system W. Lorenz Surgical, Jacksonville, Florida) in the operation of Le Fort I. At 12 months, the changes in maxillary position were not clinically noticeable in either of the treatment groups (Norholt et al., 2004). In a second study, Landes et al. compared PLLDL (70/30) (MacroSorb, MacroPore, SanDiego, CA; or PolyMax, Synthes, Oberdorf, Switzerland) or titanium (Leibinger-mini, Tuttlingen, Germany) miniplates in 22 cleft lip and palate maxillary retrognathia cases. At two years, they found horizontal maxillary stability appeared inferior to vertical stability (Landes and Ballon, 2006a, 2006b). A third study by Dhol et al. treated 25 patients with PLLA/PGA fixation and 25 patients with titanium fixation who underwent maxillary impaction with a nonsegmental monopiece Le Fort I osteotomy. Statistical analysis showed no significant radiographic differences in long-term stability in or between the 2 groups (Dhol et al., 2008). In the same year, Cheung et al. led a randomized controlled trial, which indicated that patients with bioresorbable plate fixation showed significantly more upward displacement in the anterior maxilla following impaction and posterior maxilla following down grafting from the 2nd to 6th week after Le Fort I osteotomy. In the fifth study, Ueki et al. evaluated skeletal stabilization in 60 patients divided into three groups: uHA/PLLA miniplates (10 m 22 mm 1.4 mm, Super-Fixorb1-MX, Takiron Co., Osaka, Japan) group, PLLA (10 mm 22 mm 1.5 mm, Fixorb-MX; Takiron Co., Osaka, Japan) miniplates group and titanium miniplates (4 holes/thickness 0.55 mm, Würzburg titanium miniplate system; Leibinger Co., Freiburg, Germany) group. The results followed-up at 1 month, 3 months and 1 year suggests that there was a slight difference in maxillary stability between the uHA/PLLA and PLLA plate systems in Le Fort I osteotomy, but generally the authors were satisfied with the outcomes (Ueki et al., 2012). In summary, the body of evidence supports the use of absorbable fixation as being as stable as titanium in Le Fort I osteotomy, but there might be a little difference in maxillary stability which does not affect the overall outcomes. 3.3. Bimaxillary operation There were 3 trials comparing the complications of absorbable and titanium fixation in the bimaxillary operation category (BSSRO plus Le Fort I). In 2006, Landes published on patients receiving bimaxillary orthognathic surgery, using PLLDL (2.0 mm; MacroSorb, MacroPore, SanDiego, CA; and PolyMax, Synthes, Oberdorf, Switzerland) and titanium (2.0 mm; Standard Wuerzburg Titanium System, Strykere Leibinger, Tuttlingen, Germany) osteofixation. Resorbable fixation as tested proved to be as reliable as titanium (Landes and Ballon, 2006b). In the same year, Costa et al. compared skeletal stability of double jaw surgery for correction of skeletal Class III malocclusion using PLLA/PGA (2 mm L-shaped; LactoSorb; Walter Lorenz Surgical, Jacksonville, FL) and titanium (2 mm) plates. No significant differences were observed for maxillary advancements up to
5 mm, but they indicated that resorbable devices should be used with caution for bony movements of greater magnitude (Costa et al., 2006). In 2007, the same team of Landes et al. published a study concerning the effect of poly(L-lactide-co-glycolide) (PLGA) (82:18 LactoSorb; Lorenz Surgical, Jacksonville, FL, and 85:15 RapidSorb; Synthes, Oberdorf, Switzerland) osteosynthesis and 2.0 mm titanium miniplate (Standard Würzburg Titanium System; StrykereLeibinger Tuttlingen, Germany) osteosynthesis. They concluded the tested resorbable PLGA osteofixation proved to be as reliable in segment fixation as titanium, although this conclusion should be interpreted as preliminary (Landes et al., 2007). In summary, the body of evidence supports absorbable fixation could be an alternative option in bimaxillary operation. 3.4. Mixed operations The remaining three studies cannot be classified as they included different kinds of orthognathic surgery. Two comparative studies and one RCT were identified that focused on absorbable fixation in ‘mixed operations’. In 2006, Ueki et al. investigated the stability of titanium plate (4 holes/thickness 0.55 mm; Würzburg titanium miniplate system; Leibinger Co., Freiburg, Germany) and PLLA plate (10 22 1.5 mm; Fixorb-MX) groups in Le Fort I osteotomy combined with SSRO/IVRO. Arbitrary points for anterior nasal spine (ANS) and posterior nasal spine (PNS) were assessed. They concluded that there was a slight tendency for vertical impaction after Le Fort I osteotomy both in combination with SSRO and IVRO with PLLA plates (Ueki et al., 2006). In 2010, a prospective randomized controlled study regarding orthognathic surgery, Orthognathic surgery included different groups of BSSRO, Le Fort I osteotomy, bimaxillary osteotomies, was performed by Tuovinen et al., who compared poly(L-lactide-co-Dlactide) (PLDLA) (Biosorb FX, Conmed Linvatec, Tampere, Finland) and titanium osteosynthesis (Tuovinen et al., 2010). In 2012, another multi-centre randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery (mandibular and/or Le Fort I osteotomies or zygomatic/ mandibular fracture) was performed by Buijs et al., who concluded that biodegradable plates and screws could be safely used when it was possible to apply them (Buijs et al., 2012). 3.5. Complications Part of the complications, including infection, temporomandibular disorders (TMD), paraesthesia, foreign body reaction, fistulation, palpability, dehiscence, malocclusion, exposure, relapse and mobility were recorded during their followed-up period in enrolled trials. The main concern was relapse, which was related to the movements in orthognathic surgery. Most of the trials indicated that in their study there were no significant differences between bioresorbable fixation system and titanium group (Table 4). 4. Discussion Over the past 20 years, there has been an increase in the use of bioresorbable fixation for bone healing and to avoid a second operation to reduce the operative risk in maxillofacial surgery. Since Bos et al. demonstrated the use of biodegradable plates and screws for zygomatic fracture fixation in 1987 (Bos et al., 1987), it has been extended for a variety of indications such as mandibular fracture (Bayat et al., 2010), BSSRO (Moure et al., 2012) and Le Fort I (Norholt et al., 2004). The purpose of this systematic review was to identify the scientific evidence base for the use of these materials. In addition to the method of fixation, occlusion, muscle strength and displacement distance contribute to maxillofacial skeletal
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
5
Table 4 Movements and relapse. mm indicates millimetre. R indicates right. L indicates left. X indicates maxillary. N indicates mandible. SD indicates significant difference. NS indicates non-significance. Author
Operation
Material
Movements (mm)
Relapse
Ueki, 2006
Costa, 2006
Bi orth sur
Landes, 2007
Bi orth sur
Tuovinen, 2010 Buijs, 2012
Le Fort I SSRO Maxi sur
R 5.2 4.2; L 6.3 3.3 R 7.0 2.9; L 5.45 4.0 R 2.1 4.4; L 2.2 3.6 R 1.4 1.9; L 2.1 2.5 3.5 4.5 5.4 3.5 X 3.54 1.54; N 4.29 6.79 X 3.50 1.65; N 7.00 4.61 X 2.5 1.0; N 5.5 3.7 X 5.4 3.5; N 6.3 8.8 e e e
Harada, 1997
SSRO
Ferretti, 2002
SSRO
Matthews, 2003
SSRO
Ueki, 2005
SSRO
Turvey, 2006
SSRO
Ueki, 2009
SSRO
Stockmann, 2010
SSRO
Paeng, 2012
SSRO
Ueki, 2011
SSRO
Norholt, 2004
Le Fort I
Landes, 2006
Le Fort I
Dhol, 2008
Le Fort I
Cheung, 2008
Le Fort I
Ueki, 2012
Le Fort I
PLAP Titanium PLAP Titanium P(L/DL)LA Titanium PLLA/PGA Titanium PLGA Titanium PLDLA Titanium Biodegradable Titanium PLLA Titanium PLLA/PGA Titanium SR-PLLA Titanium PLLA Titanium Biodegradable Titanium Absorbable Titanium Resorbable Titanium Biodegradable Titanium uHA/PLLA PLLA Titanium PLLA/PGA Titanium Resorbable Titanium Resorbable Titanium Bioresorbable Titanium uHA/PLLA PLLA Titanium
NS
Landes, 2006
SSROþ Le Fort I IVROþ Le Fort I Bi orth sur
stability. Therefore, bioresorbable fixation should be chosen in appropriate conditions, taking into consideration of the distance involved in moving forward or setting back the mandible or maxilla. The bioresorbable fixation systems seem to be reliable in bimaxillary surgery, in spite of little difference compared with titanium fixation. 4.1. Future directions The stability of fixation, the length of time required for their degradation and especially the possibility of complications remain a concern (Uygur et al., 2009). It was reported that the process of degradation of these devices into carbon dioxide and water may take as long as 2 years (Dorri et al., 2009). In addition, absorbable fixation systems cost more in clinical use. The use of bioresorbable plates and screws remains unpopular for internal fixation among oral and maxillofacial surgeons, especially in China. New bioresorbable materials characterized by a shorter degradation time, adequate strength and better safety are worthy of exploration. 5. Conclusions This review sought high level (level 2) evidence for the effectiveness of bioresorbable fixation systems compared with titanium
e e
0.2 2.9 1.4 2.8 X 0.16 0.72; N 1.33 1.59 X 0.90 1.37; N 3.15 1.96 X 1.2 0.8; N 0.8 4.0 X 1.4 2.8; N 4.2 8.7 NS e e NS 0.83 1.25 0.25 1.38 NS
9.3, 8.6e9.9 9.4, 9.3e9.7 R 7.2 2.8; L 6.3 2.6 R 6.7 3.2; L 6.4 3.2 e e e
e
e
NS
6.7 2.2 6.7 3.2 R 6.4 2.6; L 6.3 3.1 R 6.7 3.2; L 6.4 3.2 R 7.0 2.9; L 6.5 2.6 2e3 2e3 3.5 4.1 5.4 3.5 2.02 0.39 2.45 0.57 e
NS
R 6.5 3.5; L 6.1 3.7 R 5.9 3.1; L 6.1 2.5 R 6.3 3.5; L 6.0 2.6
NS NS
NS
NS 0.2 2.9 1.4 2.8 0.20 0.43 0.80 0.43 e SD
systems used for orthognathic surgery, including 5 RCTs and 15 compared studies. This review has found that published data show that bioresorbable fixation systems are reliable in terms of skeletal stability. Funding None. Conflict of interest None. References Bayat M, Garajei A, Ghorbani K, Motamedi MH: Treatment of mandibular angle fractures using a single bioresorbable miniplate. J Oral Maxillofac Surg 68: 1573e1577, 2010 Bos RR, Boering G, Rozema FR, Leenslag JW: Resorbable poly(L-lactide) plates and screws for the fixation of zygomatic fractures. J Oral Maxillofac Surg 45: 751e 753, 1987 Buijs GJ, van BNB, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, et al: A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery. J Dent Res 91: 299e304, 2012 Costa F, Robiony M, Zorzan E, Zerman N, Politi M: Stability of skeletal Class III malocclusion after combined maxillary and mandibular procedures: titanium versus resorbable plates and screws for maxillary fixation. J Oral Maxillofac Surg 64: 642e651, 2006
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
6
L. Yang et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2013) 1e6
Dhol WS, Reyneke JP, Tompson B, Sandor GK: Comparison of titanium and resorbable copolymer fixation after Le Fort I maxillary impaction. Am J Orthod Dentofacial Orthop 134: 67e73, 2008 Disegi JA: Magnetic resonance imaging of AO/ASIF stainless steel and titanium implants. Injury 23(Suppl. 2): S1eS4, 1992 Dorri M, Nasser M, Oliver R: Resorbable versus titanium plates for facial fractures. Cochrane Database Syst Rev, 2009 CD007158 Eppley BL, Sparks C, Herman E, Edwards M, McCarty M, Sadove AM: Effects of skeletal fixation on craniofacial imaging. J Craniofac Surg 4: 67e73, 1993 Fedorowicz MN, Tim Newton RO: Resorbable versus titanium plates for orthognathic surgery. The Cochrane Collab 18(2): CD006204. 2008 Ferretti C, Reyneke JP: Mandibular, sagittal split osteotomies fixed with biodegradable or titanium screws: a prospective, comparative study of postoperative stability. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 93: 534e537, 2002 Harada K, Enomoto S: Stability after surgical correction of mandibular prognathism using the sagittal split ramus osteotomy and fixation with poly-L-lactic acid (PLLA) screws. J Oral Maxillofac Surg 55: 464e468, 1997 discussion 468e469 Landes CA, Ballon A: Five-year experience comparing resorbable to titanium miniplate osteosynthesis in cleft lip and palate orthognathic surgery. Cleft Palate Craniofac J 43: 67e74, 2006a Landes CA, Ballon A: Skeletal stability in bimaxillary orthognathic surgery: P(L/DL) LA-resorbable versus titanium osteofixation. Plast Reconstr Surg 118: 703e721, 2006b discussion 722 Landes CA, Ballon A, Sader R: Segment stability in bimaxillary orthognathic surgery after resorbable Poly(L-lactide-co-glycolide) versus titanium osteosyntheses. J Craniofac Surg 18: 1216e1229, 2007 Linder L, Albrektsson T, Branemark PI, Hansson HA, Ivarsson B, Jonsson U, et al: Electron microscopic analysis of the boneetitanium interface. Acta Orthop Scand 54: 45e52, 1983 Matthew IR, Frame JW: Policy of consultant oral and maxillofacial surgeons towards removal of miniplate components after jaw fracture fixation: pilot study. Br J Oral Maxillofac Surg 37: 110e112, 1999 Matthews NS, Khambay BS, Ayoub AF, Koppel D, Wood G: Preliminary assessment of skeletal stability after sagittal split mandibular advancement using a bioresorbable fixation system. Br J Oral Maxillofac Surg 41: 179e184, 2003 Meningaud JP, Poupon J, Bertrand JC, Chenevier C, Galliot-Guilley M, Guilbert F: Dynamic study about metal release from titanium miniplates in maxillofacial surgery. Int J Oral Maxillofac Surg 30: 185e188, 2001 Moure C, Qassemyar Q, Dunaud O, Neiva C, Testelin S, Devauchelle B: Skeletal stability and morbidity with self-reinforced P (L/DL) LA resorbable osteosynthesis in bimaxillary orthognathic surgery. J Craniomaxillofac Surg 40: 55e60, 2012 Norholt SE, Pedersen TK, Jensen J: Le Fort I miniplate osteosynthesis: a randomized, prospective study comparing resorbable PLLA/PGA with titanium. Int J Oral Maxillofac Surg 33: 245e252, 2004
Paeng JY, Hong J, Kim CS, Kim MJ: Comparative study of skeletal stability between bicortical resorbable and titanium screw fixation after sagittal split ramus osteotomy for mandibular prognathism. J Craniomaxillofac Surg 40: 660e664, 2012 Siniscalchi EN, Catalfamo L, Allegra A, Musolino C, De Ponte FS: Titanium miniplates: a new risk factor for the development of the bisphosphonate-related osteonecrosis of the jaw. J Craniofac Surg 24: e1e2, 2013 Stockmann P, Bohm H, Driemel O, Muhling J, Pistner H: Resorbable versus titanium osteosynthesis devices in bilateral sagittal split ramus osteotomy of the mandible e the results of a two centre randomised clinical study with an eightyear follow-up. J Craniomaxillofac Surg 38: 522e528, 2010 Tuovinen V, Suuronen R, Teittinen M, Nurmenniemi P: Comparison of the stability of bioabsorbable and titanium osteosynthesis materials for rigid internal fixation in orthognathic surgery. A prospective randomized controlled study in 101 patients with 192 osteotomies. Int J Oral Maxillofac Surg 39: 1059e1065, 2010 Turvey TA, Bell RB, Phillips C, Proffit WR: Self-reinforced biodegradable screw fixation compared with titanium screw fixation in mandibular advancement. J Oral Maxillofac Surg 64: 40e46, 2006 Ueki K, Hashiba Y, Marukawa K, Okabe K, Nakagawa K, Alam S, et al: Evaluation of bone formation after sagittal split ramus osteotomy with bent plate fixation using computed tomography. J Oral Maxillofac Surg 67: 1062e1068, 2009 Ueki K, Marukawa K, Shimada M, Nakagawa K, Alam S, Yamamoto E: Maxillary stability following Le Fort I osteotomy in combination with sagittal split ramus osteotomy and intraoral vertical ramus osteotomy: a comparative study between titanium miniplate and poly-L-lactic acid plate. J Oral Maxillofac Surg 64: 74e80, 2006 Ueki K, Marukawa K, Shimada M, Nakagawa K, Yamamoto E: Change in condylar long axis and skeletal stability following sagittal split ramus osteotomy and intraoral vertical ramus osteotomy for mandibular prognathia. J Oral Maxillofac Surg 63: 1494e1499, 2005 Ueki K, Okabe K, Marukawa K, Mukozawa A, Moroi A, Miyazaki M, et al: Assessment of bone healing and hypoesthesia in the upper lip after Le Fort I osteotomy with self-setting alpha-tricalcium phosphate and absorbable plates. J Craniomaxillofac Surg 41: 129e134, 2013 Ueki K, Okabe K, Miyazaki M, Mukozawa A, Moroi A, Marukawa K, et al: Skeletal stability after mandibular setback surgery: comparisons among unsintered hydroxyapatite/poly-L-lactic acid plate, poly-L-lactic acid plate, and titanium plate. J Oral Maxillofac Surg 69: 1464e1468, 2011 Ueki K, Okabe K, Moroi A, Marukawa K, Sotobori M, Ishihara Y, et al: Maxillary stability after Le Fort I osteotomy using three different plate systems. Int J Oral Maxillofac Surg 41: 942e948, 2012 Uygur S, Cukurluoglu O, Ozmen S, Guclu TH, Sezgin B: Resorbable mesh plate in the treatment of blow-out fracture might cause gaze restriction. J Craniofac Surg 20: 71e72, 2009
Please cite this article in press as: Yang L, et al., Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review, Journal of Cranio-Maxillo-Facial Surgery (2013), http://dx.doi.org/10.1016/j.jcms.2013.08.003
