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Surgically assisted rapid maxillary expansion: a systematic review of complications
YIJOM-4268; No of Pages 8
Int. J. Oral Maxillofac. Surg. 2019; xxx: xxx–xxx https://doi.org/10.1016/j.ijom.2019.08.011, available online at https://www.sciencedirect.com
Systematic Review Orthognathic Surgery
Surgically assisted rapid maxillary expansion: a systematic review of complications
P. H. A. Carvalho1a, L. B. Moura2,a, G. S. Trento1,a, D. Holzinger3,a, M. A. C. Gabrielli1,a, M. F. R. Gabrielli1,a, V. A. Pereira Filho1,a 1
Department of Diagnosis and Surgery, Sa˜o Paulo State University, Dental School of Araraquara – UNESP, Araraquara, Sa˜o Paulo, Brazil; 2School of Dentistry, Catholic University of Pelotas, Pelotas, Rio Grande do Sul, Brazil; 3Department of Oral and Maxillofacial Surgery, Medical University of Vienna, Vienna, Austria
P. H. A. Carvalho, L. B. Moura, G. S. Trento, D. Holzinger, M. A. C. Gabrielli, M. F. R. Gabrielli, V. A. Pereira Filho: Surgically assisted rapid maxillary expansion: a systematic review of complications. Int. J. Oral Maxillofac. Surg. 2019; xxx: xxx–xxx. ã 2019 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Abstract. A systematic review of the literature on the complications of surgically assisted maxillary expansion (SARME) was performed. The search strategy was based on the PRISMA guidelines. The PubMed, SCOPUS, and Cochrane Library databases were searched. Data were extracted from the full texts after screening of the abstracts and titles. Human clinical studies encompassing ‘maxillary expansion’, ‘palatal expansion’, ‘SARME’, or ‘SARPE’ and that reported sufficient data for ‘complication’ were included. In vitro studies, case reports, meta-analyses, reviews, book chapters, animal studies, and studies with missing or insufficient data were excluded. The final selection included 12 articles for data extraction. A total of 851 patients underwent SARME, with 187 reported complications (21.97%). Epistaxis (2.47%) and postoperative pain (2.00%) were the most often reported minor complications, and asymmetric or inadequate expansion presented an occurrence rate of 4.47%. Minor complications were equally distributed between surgical (49.30%) and orthodontic complications (50.70%). The technique without pterygomaxillary disjunction increased the occurrence of minor complications (29.95% vs. 16.87%), and the expansion pattern with less than 0.5 mm/day increased the occurrence of orthodontic complications (30.93% vs. 1.83%), i.e. asymmetric expansion. In conclusion, SARME procedures mostly present minor complications. Although several types of complication are described in the literature, occurrence rates are low, and technical issues such as pterygomaxillary disjunction and the pattern of distraction can be predictors of the complication risk.
Surgically assisted rapid maxillary expansion (SARME) is a procedure used to correct transverse maxillary deficiencies 0901-5027/000001+08
of greater than 5 mm1–3. It is commonly performed in patients with complete skeletal maturity and closed cranial
Key words: maxillary expansion; SARME; complications; systematic review. Accepted for publication 20 August 2019
a All of the authors have reviewed and agree with this submission.
ã 2019 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
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sutures1,3,4. Although SARME is considered a safe and simple procedure, the complication rate remains unclear. Studies published in the literature report variable results, with complications in 1% to 50% of cases2,5,6. Those studies that have found high complication rates have separated them into minor and major complications5–7. Major complications are those associated with high morbidity, a risk of death, or permanent sequelae. Minor complications do not lead to sequelae and require simple outpatient management2,6,8–10. In addition to surgical complications, certain orthodontic complications are often described, such as incorrect maxillary expansion or tooth extrusion11–13. In view of the application of SARME to correct transverse maxillary deformities and the possible associated complications, further surgical techniques have been developed with the aim of achieving better outcomes. These include SARME without pterygomaxillary disjunction (PMD)14, preservation of the nasal septum (no detachment)15, and the parasagittal osteotomy and modified lateral maxillary osteotomy16–18. However, even with the application of new techniques, the incidence of complications remains unclear,
as well as the types of complication associated with each technique. In this study, it was hypothesized that, regardless of the technique employed, SARME presents a significant complication rate. The specific aims were to identify the overall complication rate in SARME and to verify the influence of the expansion device, activation protocol, and surgical technique. Materials and methods
This systematic review followed the PRIMA Statement guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)19 and the Cochrane Collaboration recommendations for systematic reviews20 to answer the following question: ‘‘In surgically assisted rapid maxillary expansion patients, what is the complication rate and what are the aspects related to the surgical or orthodontic complications?’’
Review registration
This study has been registered in the database (number PROSPERO CRD42018091181).
Study design and selection criteria
In this systematic review, studies on the complications following SARME procedures were evaluated. The following inclusion criteria were applied: studies in humans; studies published in the English language; clinical studies (prospective or retrospective) and case series with complete data. Studies published in a language other than English, in vitro and animal studies, cases reports, meta-analyses, reviews, book chapters, and studies with missing or insufficient data (i.e., absence of treatment modality, expansion pattern, follow-up, occurrences, or outcomes) were excluded. In addition, studies reporting complications following segmental Le Fort osteotomy or orthopaedic maxillary expansion were excluded.
Search strategy
The electronic search was performed in the MEDLINE (via PubMed), Elsevier (via SCOPUS), and Cochrane Library databases. The final search was performed in February 2019. The following terms were sought: ‘‘maxillary expansion’’, ‘‘palatal expansion’’, ‘‘SARME’’ or ‘‘SARPE’’ combined with ‘‘complica-
Fig. 1. PRISMA flowchart of the systematic review process.
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
Surgically assisted rapid maxillary expansion: a systematic review of complications tion(s)’’, ‘‘intricacy(ies)’’ or ‘‘difficulty (ies)’’. Thus, the following search strategy was applied: [(‘‘Maxillary Expansion’’ [MESH Terms] OR ‘‘Palatal Expansion’’[All Fields] OR ‘‘SARME’’[All Fields] OR ‘‘SARPE’’[All Fields]) AND (‘‘Complication’’[All Fields] OR ‘‘Difficulty’’[All Fields] OR ‘‘Intricacy’’[All Fields])]. A manual search of the references lists of the included articles and previous reviews was also conducted. Data extraction and variable analysis
Two trained researchers (PHAC and LBM) performed this review. All studies identified in the search had the title and abstract independently analysed and were assessed against the inclusion and exclusion criteria. In the case of disagreement, further discussions were held with an expert researcher (VAPF). The full texts of the selected studies were reviewed and again assessed against the inclusion and exclusion criteria for final selection. The data were independently extracted by the same trained researchers (PHAC and LBM) and compared to identify any discrepancies. Data were tabulated in Microsoft Excel (Microsoft, Redmond, WA, USA) and imported into RevMan 5.3 (The Cochrane Collaboration) to explore the possibility of meta-analysis. The Mantel–Haenszel test, x2 test, and residual analysis were applied to analyse the data that could be compiled and classified. For the data analysis, the type of complication was classified as major or minor. This classification was based on the criteria proposed by Williams et al.2 and Verlinden et al.7. Major complications were those associated with high morbidity, a risk of death, or permanent sequelae. Complications with spontaneous resolution or that required simple outpatient
management were classified as minor2,7. Major complications included asymmetric or incorrect maxillary expansion, tooth loss, tissue necrosis, severe tooth resorption, severe bleeding, palatal fistula, and risk of death complications. Minor complications included pain, tooth darkening or extrusion or mobility, blunting of the dental apices, mild periodontal bone loss or gingival recession, epistaxis or intraoral bleeding, wound dehiscence, transient numbness, local infection or inflammation, transient headache or lacrimation or tinnitus, nausea or vomiting, and device-related complications. Each complication was further classified as surgical or orthodontic, and also as an intraoperative or late complication. In order to categorize the expansion rate described in the included studies, the classification proposed by Algharbi et al.11 was used: ‘slow activation’ was defined as protocols with activation of 0.5 mm daily and with a latency period after surgery; ‘fast activation’ was defined as protocols with immediate postoperative activation or with expansion of >0.5 mm daily. Risk of bias
Publication bias was estimated according to the PRISMA statement criteria to verify the strength of the reviewed papers for clinical decision-making. The following criteria were used to classify the risk of bias: random selection of the sample, definition of inclusion/exclusion criteria, report of losses to follow-up (monitoring, follow-up), valid measurements, and statistical analysis. Studies that fulfilled all criteria were classified as having a low risk of bias, those that did not meet one of the criteria were classified as having a moderate risk of bias, and those that did not
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fulfil two or more criteria were classified as having a high risk of bias. Results
The final electronic search was performed in February 2019, and 504 studies were identified. After initial screening by title and abstract, those that did not meet the inclusion/exclusion criteria and duplicates were excluded. Of the remaining 79 studies, only 58 were available for full-text reading. Suitability for inclusion in the final review was verified. Publications with missing parameter estimators, as well as insufficient follow-up, were excluded: 46 studies did not meet one or more criteria and were excluded. The remaining 12 studies were included2,5–8,10,12,21–25. Fig. 1 shows the flowchart of the systematic review process. Qualitative data and risk of bias analyses were performed for all selected papers. Only two studies presented a low risk of bias22,25 (Table 1 ). The 12 studies included a total of 851 patients who were submitted to SARME. A total of 213 complications were reported. With the exclusion of devicerelated complications and paresthesia lasting less than 4 weeks, there were 187 (21.97%) complications (Table 2 ; Supplementary Material, Table S1). Most were classified as minor complications (168/213, 78.87%) and were well distributed between surgical (49.30%) and orthodontic (50.70%) complications (Table 3 ). Epistaxis (2.47%) and postoperative pain (2.00%) were the most often reported minor complications. Asymmetry and incorrect expansion were the most common major complications (38/45, 84.44%) and both required an additional surgical procedure for correction. Asymmetric or inadequate expansion presented an occurrence rate of 4.47%.
Table 1. Quality assessment and risk of bias of the selected studies.
Author
Year
Study design
Random sample selection
Pereira et al.12 Cakarer et al.8 Verquin et al.6 Zandi et al.22 Dergin et al.5 Adolphs et al.21 Zandi et al.25 Williams et al.2 Verlinden et al.7 Hernandez-Alfaro et al.10 Ferna´ndez-Sanroma´n et al.23 Contar et al.24
2018 2017 2017 2016 2015 2014 2014 2012 2011 2010 2010 2009
Case–control study Clinical retrospective Cohort study Clinical trial Clinical retrospective Clinical retrospective Clinical trial Cohort study Clinical retrospective Cohort study Cohort study Clinical retrospective
No No No Yes No No Yes No No No No No
Inclusion and exclusion criteria
Follow-up reported
Valid measurements
Statistical analysis
Risk of bias
Yes Yes No Yes Yes No Yes Yes No No No No
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Yes Yes No Yes Yes Yes Yes Yes No Yes Yes Yes
Moderate Moderate High Low Moderate High Low Moderate High High High High
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
Number of patients
Sex
Age (years)
Expansion device
PMD
Activation
Latency
Pereira et al.12 2018
90
–
–
Yes (90)
Cakarer et al.8 2017 Verquin et al.6 2017 Zandi et al.22 2016
40 55 30
M 15, F 25 M 20, F 35 M 13, F 17
23.7 5.23 22 (13–27) 15–28
Haas (29) Hyrax (61) Hyrax Hyrax Hyrax
Immediate activation – 7 days 7 days
– 6 4
Dergin et al.5 2015
60
M 37, F 23
17–26
Hyrax
Yes
3 days
6
Adolphs et al.21 2014 Zandi et al.25 2014
50 28
M 22, F 28 M 9, F 19 (G1: M 4, F 9)
24 (6–51) G1: 20.31 3.64 (15–27) G2: 19.4 2.3 (15–23)
Bone-borne device G1: Hyrax (13) G2: Bone-borne device (15)
No (40) Yes
1.6 mm initially and 0.2 mm twice a day – 0.25 mm twice a day 0.5 mm daily with 2 mm of overexpansion 1 mm initially and 0.25 mm twice a day 1 mm daily 0.5 mm daily until 3 mm of overexpansion
5–7 days 7 days
6 4
Williams et al.2 2012
120
(G2: M 5, F 10) M 58, F 62
29.5 (22–39)
Yes
0.25 mm twice a day
5–7 days
–
Verlinden et al.7 2011
73
M 27, F 46
28 (9–59)
Hyrax (118) Bone-borne device (2) Bone-borne device
0.33 mm daily
5–8 days
–
Hernandez-Alfaro et al.10 2010
283
M 172, F 111
18.3 (14–62)
Yes (3) No (70) Yes (modified technique)
0.5–1 mm daily
5–7 days
2–4
Ferna´ndez-Sanroma´n et al.23 2010 Contar et al.24 2009 Total
8
M 2, F 6
28.5 (18–45)
No
0.6 mm daily
7 days
3.6 (3–6)
14 851
M 5, F 9
33.5 (22–54)
No
0.25 mm twice a day
5 days
6 (4–7)
Hyrax (221) Haas (61) Bone-borne device (1) Modified Hyrax device (8) Hyrax (14)
No (40) Yes Yes (15) No (15)
Consolidation (months) 4
F, female; G1, group 1; G2, group 2; M, male; PMD, pterygomaxillary disjunction; SARME, surgically assisted maxillary expansion; SARPE, surgically assisted rapid palatal expansion. For the analysis, the authors disregarded the cases with paresthesia that had resolved after 4 weeks and the device-related complications.
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Author Year
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Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
Table 2. General data collected from the included studies.
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Author
Number of patients
Complications
Types of minor complication
Total
Surgical
Orthodontic
Minor
Major
Types of major complication
Pereira et al.12
90
14
9
5
9
5
Cakarer et al.8
40
8
8
0
7
1
Verquin et al.6
55
27
20
7
23
4
Zandi et al.22 Dergin et al.5
30 60
1 35
0 35
1 0
1 35
0 0
Adolphs et al.21 Zandi et al.25
50 28
1 1
0 0
1 1
1 1
0 0
Williams et al.2
120
68
20
48
43
25
Verlinden et al.7
73
40
1
39
33
7
Device-related complications (18)a; pain at activation (1)a; unstable occlusion (1); molar root perforation (1); periodontal pocket at incisors (11); increased mobility of incisors (1)
Hernandez-Alfaro et al.10
283
3
0
3
0
3
–
Asymmetric expansion (3)
Ferna´ndez-Sanroma´n et al.23 Contar et al.24
8 14
8 7
8 4
0 3
8 7
0 0
Palatal inflammation (8) Device-related complications (1)a; wound dehiscence (2); gingival recession (2); pain (2)
– –
Total
851
213
105
108
168
45
a
Pain (4.4%) (Haas: 4 (14%); Hyrax: 0) Tooth darkening (5.5%) (Haas: 0; Hyrax: 5 (8.2%)) Epistaxis (1); sinus infection (1); infraorbital numbness (4); wound dehiscence (1) Pain (4); intraoral bleeding (1); epistaxis (4); central incisor mobility (2); tooth darkening (1); blunting of apices (2); paresthesia (3)a; haematoma (2); nausea/ vomiting (4) Extrusion of anchor teeth (1) Paresthesia (3)a; epistaxis (12); pain (7); headache (8); haematoma (1); lacrimation (3); tinnitus (1) Incisor mobility (1) First premolar anchored tooth extrusion (G1) Epistaxis (4); haematoma (3); infection (8); hypoesthesia (4); tooth discolouration (5); gingival recession (12); periodontal bone loss (7)
Additional treatment
Asymmetric expansion (Haas: 2 (6.9%); Hyrax: 3 (5.6%))
–
Palatal fistula (1)
Anterior nasal packing in epistaxis; iliac crest grafting in palatal fistula Anterior nasal packing and tranexamic acid in epistaxis
Asymmetric expansion (3); iatrogenic gastrointestinal bleeding (1) – –
– –
– –
Tooth splint –
Asymmetric expansion (10); inadequate expansion (9); asymmetric + inadequate expansion (3); tooth loss (2); tissue necrosis (1) Asymmetric expansion (5); severe incisor root resorption (2)
Nasal packing (3); incision and drainage (2); segmental maxillary surgery for correction (10); periodontal corrective surgery (2)
For the analysis, the authors disregarded the cases with paresthesia that had resolved after 4 weeks and the device-related complications.
Reoperation to correct asymmetric expansion (2); Le Fort I osteotomy to correct asymmetric expansion (3); device changed for tooth-borne (1) Revision of osteotomies under local anaesthesia (3) – –
Surgically assisted rapid maxillary expansion: a systematic review of complications
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
Table 3. Complications reported in the selected studies, according to predetermined classification criteria.
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Table 4. Complications considering the surgical technique for pterygomaxillary disjunction and the maxillary expansion activation protocol. Surgical or orthodontic technique With PMD Without PMD With PMD Without PMD Fast protocol Slow protocol Fast protocol Slow protocol
Complications, type and occurrence No complications 515 (77.56%)* 123 (65.77%)* 638 No complications 515 (77.56%)* 123 (65.77%)* 638 No complications 430 (87.57%)* 176 (55.01%)* 606 No complications 430 (87.57%)* 176 (55.01%)* 606
PMD, pterygomaxillary disjunction. * Statistically significant difference in
Surgical complications 84 (12.65%) 21 (11.23%) 105 Minor complications 112 (16.87%)* 56 (29.95%)* 168 Surgical complications 52 (10.59%)* 45 (14.06%)* 97 Minor complications 53 (10.79%)* 108 (33.75%)* 161
Orthodontic complications 65 (9.79%)* 43 (22.99%)* 108 Major complications 37 (5.72%)* 8 (4.28%)* 45 Orthodontic complications 9 (1.83%)* 99 (30.93%)* 108 Major complications 8 (1.64%)* 36 (11.24%)* 44
Total 664 187 851 Total 664 187 851 Total 491 320 811 Total 491 320 811
(n)
Statistic x2 = 22.91 P < 0.001
(n)
Statistic x2 = 15.08 P < 0.001
(n)
Statistic x2 = 157.2 P < 0.001
(n)
Statistic x2 = 111.99 P < 0.001
x2 test and residual analysis.
Demographic characteristics
Considering the total number of patients enrolled in all included studies, the sex distribution was equal (49.93% female and 50.07% male); however, the reports of complications were not individually addressed in the majority of studies, thus the relationship of sex with the occurrence of complications could not be determined. The patients varied widely in age, and there was heterogeneity in the reporting of age, which also impaired its evaluation. Expansion device
Most studies used tooth-borne devices (66.67%), two studies applied bone-borne devices (16.66%), and two used boneborne and tooth-borne devices (16.66%). Thus, due to this data heterogeneity, a comparative analysis was not possible. Expansion screw activation protocol
There was no study with a prospective design, randomization, or adequate measurements comparing the different patterns of expansion screw activation. Many studies indicated that the activation was done according to the orthodontist. The expansion protocols used in each study were classified as fast5,10,12,21,23 or slow2,6,7,22,24,25. The x2 test was used to compare the occurrence of complications for each activation protocol (Table 4 ). When the slow pattern of activation was used, there was an increased rate of orthodontic (30.93% vs. 1.83%, P < 0.001) and major complications (11.24% vs. 1.64%, P < 0.001), most of which were asymmetric or incorrect expansion. This is a point
that needs to be further clarified through clinical studies. Pterygomaxillary disjunction
The x2 test was used to compare the occurrence of complications with or without PMD (Table 4). The technique without PMD increased the occurrence of minor complications (29.95% vs. 16.87%, P < 0.001). When PMD was not performed, there was an increased rate of orthodontic complications (22.99% vs. 9.79%, P < 0.001); most of these were asymmetric or incorrect expansion (86.67%). Discussion
The purpose of this study was to perform a systematic review of the incidence of complications in SARME, including prospective and retrospective clinical trials. SARME is widely used for the treatment of transverse maxillary discrepancies, but the incidence of complications is still unclear. Data from this review showed the incidence of complications to be 21.97%. Most were late Epistaxis complications2,6–8,10,12,22,23,25. was often reported, but this is a possible outcome of the surgical damage to the soft tissues around the nasal cavity and maxillary sinuses5,6,8. Epistaxis was successfully treated by compression and nasal packing, or had a natural resolution. Asymmetric expansion was the main reported complication that led to consequences for the treatment2,7,10. The occurrence of asymmetric or incorrect expansion can be associated with a slow activation rate and the absence of PMD. Asymmetric expansion requires surgical re-intervention and can sometimes be corrected only by Le Fort I osteotomy and
maxillary repositioning, thereby increasing morbidity2,10. Although the results indicate that an increased major complication rate is to be expected when PMD is not performed, or when a slow activation protocol is used, this should be confirmed in well-designed clinical trials. PMD is currently a topic of discussion in the literature. Some authors support its use, stating that the pterygomaxillary buttress represents an area of resistance for expansion and that the absence of PMD could increase the occurrence of incorrect expansion10,22,26. Another discussion is the increased risk of surgical complications when PMD is performed8,27. In the present review, it was not possible to correlate PMD with an increased rate of surgical complications. However, more studies with a prospective experimental design should be conducted. Zandi et al. (2016)22 performed a randomized clinical trial to evaluate the necessity of PMD. They analysed 30 patients divided into two groups. The patients were submitted to the same procedure, only differing by the presence or not of PMD. Although the main focus of the study was not on the complication rate, they reported no difference in the occurrence of complications between the groups and an overall low complication rate. As this was the only randomized trial concerning PMD identified in this review, it was not possible to verify any association between the presence of PMD and an increase in the surgical complication rate. Although there have been reports of maxillary expansion for over 80 years1,3,18,28, the pattern of screw activation has not been standardized and the ideal amount of daily expansion remains unclear. The expansion rate can be classi-
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
Surgically assisted rapid maxillary expansion: a systematic review of complications fied as fast or slow, with fast expansions defined as those of >0.5 mm daily or expansions with immediate activation >1 mm at the time of surgery. Slow patterns of activation are those of 0.5 mm daily without immediate activation11. In this review, it was found that the slow expansion protocol was related to orthodontic complications, such as asymmetric expansion, possibly due to premature callus formation. Regarding the type of distractor, Zandi et al. (2014)25 performed a randomized clinical trial to evaluate the outcomes of SARME performed with two different devices: a tooth-borne device and a bone-borne device. There was no statistically significant difference in the incidence of complications between the two methods. However, due to heterogeneity of the data related to the type of distractor, comparison was not possible in this review. Tooth-related complications are frequently reported in SARME procedures2,6,7. The affected teeth are usually molars and premolars2, because they anchor the expansion device. Periodontal problems such as gingival pockets or buccal bone loss, which can even lead to tooth loss, have often been described. Also, complications are observed at the central incisors, associated with the median osteotomy2,12,29. Incisor discolouration, periodontal pockets, mobility, and even the loss of incisors have been reported2,6,7. Due to their aesthetic importance, the loss of a central incisor due to SARME procedures is considered a major complication. Tooth loss will require additional surgical procedures, such as dental implant placement and alveolar reconstruction with bone grafts. As this review focused on reported complications, the exclusion of studies with unclear data related to the subject may have affected the incidence rate, which is clearly a limitation of this review. However, it was necessary for the reviewed studies to include a comprehensive description in order to perform a descriptive analysis. Another limitation of this review was the lack of randomized clinical trials, which prevented a complete analysis. Therefore, future randomized clinical trials with standardized variables are necessary to obtain a more complete picture of the complications in SARME. According to the studies evaluated, it is possible to conclude that SARME is a lowrisk procedure for major complications. Complications following SARME are usually late and minor, and can be resolved by simple postoperative management.
Regarding risk factors for complications, the use of a slow expansion screw activation protocol and the absence of pterygomaxillary disjunction were found to be associated with an increased incidence of major complications. Funding
This study was financed in part by the Coordenac¸a˜o de Aperfeic¸oamento de Pessoal de Nı´vel Superior – Brasil (CAPES) (Finance Code 001). Competing interests
The authors declare that they have no conflicts of interest. Ethical approval
Not applicable. Patient consent
Not applicable. Acknowledgements. We would like to thank CAPES and FAPESP for scholarships awarded to the PhD students involved in this work. Appendix A. Supplementary data
Supplementary material related to this article can be found, in the online version, at doi:https://doi.org/10.1016/j.ijom.2019. 08.011. References 1. Koudstaal MJ, Poort LJ, van der Wal KGH, Wolvius EB, Prahl-Andersen B, Schulten AJM. Surgically assisted rapid maxillary expansion (SARME): a review of the literature. Int J Oral Maxillofac Surg 2006;34:709–14. 2. Williams BJD, Currimbhoy S, Silva A, O’Ryan FS. Complications following surgically assisted rapid palatal expansion: a retrospective cohort study. J Oral Maxillofac Surg 2012;70:2394–402. http://dx.doi.org/ 10.1016/j.joms.2011.09.050. 3. Pogrel MA, Kaban LB, Vargervik K, Baumrind S. Surgically assisted rapid maxillary expansion in adults. Int J Adult Orthodon Orthognath Surg 1992;7:37–41. 4. Moralis A, Zitzmann K, Gosau M, Schlegel D. The effects of surgical expansion of the maxillary arch and its consequences for the incisor axis. J Craniomaxillofac Surg 2016;44:569–73. http://dx.doi.org/10.1016/ j.jcms.2016.02.002.
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5. Dergin G, Aktop S, Varol A, Ugurlu F, Garip H. Complications related to surgically assisted rapid palatal expansion. Oral Surg Oral Med Oral Pathol Oral Radiol 2015;119:601–7. 6. Verquin M, Daems L, Politis C. Short-term complications after surgically assisted rapid palatal expansion: a retrospective cohort study. Int J Oral Maxillofac Surg 2017;46:303–8. 7. Verlinden CRA, Gooris PG, Becking AG. Complications in transpalatal distraction osteogenesis: a retrospective clinical study. J Oral Maxillofac Surg 2011;69:899–905. 8. Cakarer S, Keskin B, Isler SC, Cansiz E, Uzun A, Keskin C. Complications associated with surgically assisted rapid palatal expansion without pterygomaxillary separation. J Stomatol Oral Maxillofac Surg 2017;118:279–82. http://dx. doi.org/10.1016/j.jormas.2017.06.008. 9. Hamedi Sangsari A, Sadr-Eshkevari P, AlDam A, Friedrich RE, Freymiller E, Rashad A. Surgically assisted rapid palatomaxillary expansion with or without pterygomaxillary disjunction: a systematic review and metaanalysis. J Oral Maxillofac Surg 2016;74:338–48. http://dx.doi.org/10.1016/ j.joms.2015.06.161. 10. Hernandez-Alfaro F, Bueno JM, Diaz A, Page´s CM. Minimally invasive surgically assisted rapid palatal expansion with limited approach under sedation: a report of 283 consecutive cases. J Oral Maxillofac Surg 2010;68:2154–8. http://dx.doi.org/10.1016/ j.joms.2009.09.080. 11. Algharbi M, Bazargani F, Dimberg L. Do different maxillary expansion appliances influence the outcomes of the treatment? Eur J Orthod 2018;40:97–106. http://dx.doi.org/ 10.1093/ejo/cjx035. 12. Pereira MD, Koga AF, Prado GPR, Ferreira LM. Complications from surgically assisted rapid maxillary expansion with Haas and Hyrax expanders. J Craniofac Surg 2018;29:275–8. 13. Moura LB, Spin-Neto R, Sverzut CE, Monnazzi Mda S, Trivellato AE, Gabrielli MA, Pereira-Filho VA. Evaluation of the palatal split pattern in surgically rapid maxillary expansion—comparison of two techniques. Oral Maxillofac Surg 2016;20:255–8. http:// dx.doi.org/10.1007/s10006-016-0562-5. 14. Seeberger R, Kater W, Davids R, Thiele OC. Long term effects of surgically assisted rapid maxillary expansion without performing osteotomy of the pterygoid plates. J Craniomaxillofac Surg 2010;38:175–8. 15. Reinbacher KE, Wallner J, Pau M, Feichtinger M, Ka¨rcher H, Quehenberger F, Zemann W. Surgically assisted rapid maxillary expansion: feasibility of not releasing the nasal septum. Int J Oral Maxillofac Surg 2013;42:321–5. 16. Habersack K, Becker J, Ristow O, Paulus GW. Dental and skeletal effects of two-piece and three-piece surgically assisted rapid maxillary expansion with complete mobilization: a retrospective cohort study. J Oral
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
8
Carvalho et al.
17.
18.
19.
20.
21.
22.
Maxillofac Surg 2014;72:2278–88. http://dx. doi.org/10.1016/j.joms.2014.04.013. Seeberger R, Gander E, Hoffmann J, Engel M. Surgical management of cross-bites in orthognathic surgery: surgically assisted rapid maxillary expansion (SARME) versus two-piece maxilla. J Craniomaxillofac Surg 2015;43:1109–12. http://dx.doi.org/ 10.1016/j.jcms.2015.05.012. Betts NJ, Vanarsdall RL, Barber HD, Higgins-Barber K, Fonseca RJ. Diagnosis and treatment of transverse maxillary deficiency. Int J Adult Orthodon Orthognath Surg 1995;10:75–96. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA, PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration; 2011. Adolphs N, Ernst N, Menneking H, Hoffmeister B. Transpalatal distraction—state of the art for the individual management of transverse maxillary deficiency—a review of 50 consecutive cases. J Craniomaxillofac Surg 2014;42:1669–74. http://dx.doi.org/ 10.1016/j.jcms.2014.05.011. Zandi M, Miresmaeili A, Heidari A, Lamei A. The necessity of pterygomaxillary dis-
23.
24.
25.
26.
27.
junction in surgically assisted rapid maxillary expansion: a short-term, double-blind, historical controlled clinical trial. J Craniomaxillofac Surg 2016;44:1181–6. http://dx. doi.org/10.1016/j.jcms.2016.04.026. Ferna´ndez-Sanroma´n J, Donascimento MG, Lo´pez AC, Ferro MF, Berrondo IA. Transverse maxillary distraction in patients with periodontal pathology or insufficient tooth anchorage using custom-made devices. J Oral Maxillofac Surg 2010;68:1530–6. Contar CMM, Muller PR, Brunetto AR, Machado MAN, Rappoport A. Surgical treatment of maxillary transverse deficiency: retrospective study of 14 patients. J Maxillofac Oral Surg 2009;8:249–53. http://dx. doi.org/10.1007/s12663-009-0061-4. Zandi M, Miresmaeili A, Heidari A. Shortterm skeletal and dental changes following bone-borne versus tooth-borne surgically assisted rapid maxillary expansion: a randomized clinical trial study. J Craniomaxillofac Surg 2014;42:1190–5. Lima SM, De Moraes M, Asprino L. Photoelastic analysis of stress distribution of surgically assisted rapid maxillary expansion with and without separation of the pterygomaxillary suture. J Oral Maxillofac Surg 2011;69:1771–5. http://dx.doi.org/10.1016/ j.joms.2010.07.035. Politis C. Life-threatening haemorrhage after 750 Le Fort I osteotomies and 376
SARPE procedures. Int J Oral Maxillofac Surg 2012;41:702–8. http://dx.doi.org/ 10.1016/j.ijom.2012.02.015. 28. Goddard R, Witherow H. Surgically assisted rapid palatal expansion (SARPE). Br J Oral Maxillofac Surg 2011;49:65–6. http://dx.doi. org/10.1016/j.bjoms.2009.11.013. 29. de Oliveira TFM, Santos-Pinto A, Gabrielli MFR, Pereira Filho VA. Lack of bone healing: an unusual complication following surgically assisted rapid palatal expansion. Oral Surg 2014;7:21–6. http://dx.doi.org/ 10.1111/ors.12095.
Address: Pedro Henrique de Azambuja Carvalho Dental School of Araraquara – UNESP 1680 Humaita´ Street 14801-903 Araraquara Sa˜o Paulo Brazil Tel.:/Fax: +55 16 3301 6359 [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected]
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
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Systematic Review Orthognathic Surgery
Surgically assisted rapid maxillary expansion: a systematic review of complications
P. H. A. Carvalho1a, L. B. Moura2,a, G. S. Trento1,a, D. Holzinger3,a, M. A. C. Gabrielli1,a, M. F. R. Gabrielli1,a, V. A. Pereira Filho1,a 1
Department of Diagnosis and Surgery, Sa˜o Paulo State University, Dental School of Araraquara – UNESP, Araraquara, Sa˜o Paulo, Brazil; 2School of Dentistry, Catholic University of Pelotas, Pelotas, Rio Grande do Sul, Brazil; 3Department of Oral and Maxillofacial Surgery, Medical University of Vienna, Vienna, Austria
P. H. A. Carvalho, L. B. Moura, G. S. Trento, D. Holzinger, M. A. C. Gabrielli, M. F. R. Gabrielli, V. A. Pereira Filho: Surgically assisted rapid maxillary expansion: a systematic review of complications. Int. J. Oral Maxillofac. Surg. 2019; xxx: xxx–xxx. ã 2019 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Abstract. A systematic review of the literature on the complications of surgically assisted maxillary expansion (SARME) was performed. The search strategy was based on the PRISMA guidelines. The PubMed, SCOPUS, and Cochrane Library databases were searched. Data were extracted from the full texts after screening of the abstracts and titles. Human clinical studies encompassing ‘maxillary expansion’, ‘palatal expansion’, ‘SARME’, or ‘SARPE’ and that reported sufficient data for ‘complication’ were included. In vitro studies, case reports, meta-analyses, reviews, book chapters, animal studies, and studies with missing or insufficient data were excluded. The final selection included 12 articles for data extraction. A total of 851 patients underwent SARME, with 187 reported complications (21.97%). Epistaxis (2.47%) and postoperative pain (2.00%) were the most often reported minor complications, and asymmetric or inadequate expansion presented an occurrence rate of 4.47%. Minor complications were equally distributed between surgical (49.30%) and orthodontic complications (50.70%). The technique without pterygomaxillary disjunction increased the occurrence of minor complications (29.95% vs. 16.87%), and the expansion pattern with less than 0.5 mm/day increased the occurrence of orthodontic complications (30.93% vs. 1.83%), i.e. asymmetric expansion. In conclusion, SARME procedures mostly present minor complications. Although several types of complication are described in the literature, occurrence rates are low, and technical issues such as pterygomaxillary disjunction and the pattern of distraction can be predictors of the complication risk.
Surgically assisted rapid maxillary expansion (SARME) is a procedure used to correct transverse maxillary deficiencies 0901-5027/000001+08
of greater than 5 mm1–3. It is commonly performed in patients with complete skeletal maturity and closed cranial
Key words: maxillary expansion; SARME; complications; systematic review. Accepted for publication 20 August 2019
a All of the authors have reviewed and agree with this submission.
ã 2019 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
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sutures1,3,4. Although SARME is considered a safe and simple procedure, the complication rate remains unclear. Studies published in the literature report variable results, with complications in 1% to 50% of cases2,5,6. Those studies that have found high complication rates have separated them into minor and major complications5–7. Major complications are those associated with high morbidity, a risk of death, or permanent sequelae. Minor complications do not lead to sequelae and require simple outpatient management2,6,8–10. In addition to surgical complications, certain orthodontic complications are often described, such as incorrect maxillary expansion or tooth extrusion11–13. In view of the application of SARME to correct transverse maxillary deformities and the possible associated complications, further surgical techniques have been developed with the aim of achieving better outcomes. These include SARME without pterygomaxillary disjunction (PMD)14, preservation of the nasal septum (no detachment)15, and the parasagittal osteotomy and modified lateral maxillary osteotomy16–18. However, even with the application of new techniques, the incidence of complications remains unclear,
as well as the types of complication associated with each technique. In this study, it was hypothesized that, regardless of the technique employed, SARME presents a significant complication rate. The specific aims were to identify the overall complication rate in SARME and to verify the influence of the expansion device, activation protocol, and surgical technique. Materials and methods
This systematic review followed the PRIMA Statement guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)19 and the Cochrane Collaboration recommendations for systematic reviews20 to answer the following question: ‘‘In surgically assisted rapid maxillary expansion patients, what is the complication rate and what are the aspects related to the surgical or orthodontic complications?’’
Review registration
This study has been registered in the database (number PROSPERO CRD42018091181).
Study design and selection criteria
In this systematic review, studies on the complications following SARME procedures were evaluated. The following inclusion criteria were applied: studies in humans; studies published in the English language; clinical studies (prospective or retrospective) and case series with complete data. Studies published in a language other than English, in vitro and animal studies, cases reports, meta-analyses, reviews, book chapters, and studies with missing or insufficient data (i.e., absence of treatment modality, expansion pattern, follow-up, occurrences, or outcomes) were excluded. In addition, studies reporting complications following segmental Le Fort osteotomy or orthopaedic maxillary expansion were excluded.
Search strategy
The electronic search was performed in the MEDLINE (via PubMed), Elsevier (via SCOPUS), and Cochrane Library databases. The final search was performed in February 2019. The following terms were sought: ‘‘maxillary expansion’’, ‘‘palatal expansion’’, ‘‘SARME’’ or ‘‘SARPE’’ combined with ‘‘complica-
Fig. 1. PRISMA flowchart of the systematic review process.
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
Surgically assisted rapid maxillary expansion: a systematic review of complications tion(s)’’, ‘‘intricacy(ies)’’ or ‘‘difficulty (ies)’’. Thus, the following search strategy was applied: [(‘‘Maxillary Expansion’’ [MESH Terms] OR ‘‘Palatal Expansion’’[All Fields] OR ‘‘SARME’’[All Fields] OR ‘‘SARPE’’[All Fields]) AND (‘‘Complication’’[All Fields] OR ‘‘Difficulty’’[All Fields] OR ‘‘Intricacy’’[All Fields])]. A manual search of the references lists of the included articles and previous reviews was also conducted. Data extraction and variable analysis
Two trained researchers (PHAC and LBM) performed this review. All studies identified in the search had the title and abstract independently analysed and were assessed against the inclusion and exclusion criteria. In the case of disagreement, further discussions were held with an expert researcher (VAPF). The full texts of the selected studies were reviewed and again assessed against the inclusion and exclusion criteria for final selection. The data were independently extracted by the same trained researchers (PHAC and LBM) and compared to identify any discrepancies. Data were tabulated in Microsoft Excel (Microsoft, Redmond, WA, USA) and imported into RevMan 5.3 (The Cochrane Collaboration) to explore the possibility of meta-analysis. The Mantel–Haenszel test, x2 test, and residual analysis were applied to analyse the data that could be compiled and classified. For the data analysis, the type of complication was classified as major or minor. This classification was based on the criteria proposed by Williams et al.2 and Verlinden et al.7. Major complications were those associated with high morbidity, a risk of death, or permanent sequelae. Complications with spontaneous resolution or that required simple outpatient
management were classified as minor2,7. Major complications included asymmetric or incorrect maxillary expansion, tooth loss, tissue necrosis, severe tooth resorption, severe bleeding, palatal fistula, and risk of death complications. Minor complications included pain, tooth darkening or extrusion or mobility, blunting of the dental apices, mild periodontal bone loss or gingival recession, epistaxis or intraoral bleeding, wound dehiscence, transient numbness, local infection or inflammation, transient headache or lacrimation or tinnitus, nausea or vomiting, and device-related complications. Each complication was further classified as surgical or orthodontic, and also as an intraoperative or late complication. In order to categorize the expansion rate described in the included studies, the classification proposed by Algharbi et al.11 was used: ‘slow activation’ was defined as protocols with activation of 0.5 mm daily and with a latency period after surgery; ‘fast activation’ was defined as protocols with immediate postoperative activation or with expansion of >0.5 mm daily. Risk of bias
Publication bias was estimated according to the PRISMA statement criteria to verify the strength of the reviewed papers for clinical decision-making. The following criteria were used to classify the risk of bias: random selection of the sample, definition of inclusion/exclusion criteria, report of losses to follow-up (monitoring, follow-up), valid measurements, and statistical analysis. Studies that fulfilled all criteria were classified as having a low risk of bias, those that did not meet one of the criteria were classified as having a moderate risk of bias, and those that did not
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fulfil two or more criteria were classified as having a high risk of bias. Results
The final electronic search was performed in February 2019, and 504 studies were identified. After initial screening by title and abstract, those that did not meet the inclusion/exclusion criteria and duplicates were excluded. Of the remaining 79 studies, only 58 were available for full-text reading. Suitability for inclusion in the final review was verified. Publications with missing parameter estimators, as well as insufficient follow-up, were excluded: 46 studies did not meet one or more criteria and were excluded. The remaining 12 studies were included2,5–8,10,12,21–25. Fig. 1 shows the flowchart of the systematic review process. Qualitative data and risk of bias analyses were performed for all selected papers. Only two studies presented a low risk of bias22,25 (Table 1 ). The 12 studies included a total of 851 patients who were submitted to SARME. A total of 213 complications were reported. With the exclusion of devicerelated complications and paresthesia lasting less than 4 weeks, there were 187 (21.97%) complications (Table 2 ; Supplementary Material, Table S1). Most were classified as minor complications (168/213, 78.87%) and were well distributed between surgical (49.30%) and orthodontic (50.70%) complications (Table 3 ). Epistaxis (2.47%) and postoperative pain (2.00%) were the most often reported minor complications. Asymmetry and incorrect expansion were the most common major complications (38/45, 84.44%) and both required an additional surgical procedure for correction. Asymmetric or inadequate expansion presented an occurrence rate of 4.47%.
Table 1. Quality assessment and risk of bias of the selected studies.
Author
Year
Study design
Random sample selection
Pereira et al.12 Cakarer et al.8 Verquin et al.6 Zandi et al.22 Dergin et al.5 Adolphs et al.21 Zandi et al.25 Williams et al.2 Verlinden et al.7 Hernandez-Alfaro et al.10 Ferna´ndez-Sanroma´n et al.23 Contar et al.24
2018 2017 2017 2016 2015 2014 2014 2012 2011 2010 2010 2009
Case–control study Clinical retrospective Cohort study Clinical trial Clinical retrospective Clinical retrospective Clinical trial Cohort study Clinical retrospective Cohort study Cohort study Clinical retrospective
No No No Yes No No Yes No No No No No
Inclusion and exclusion criteria
Follow-up reported
Valid measurements
Statistical analysis
Risk of bias
Yes Yes No Yes Yes No Yes Yes No No No No
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Yes Yes No Yes Yes Yes Yes Yes No Yes Yes Yes
Moderate Moderate High Low Moderate High Low Moderate High High High High
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
Number of patients
Sex
Age (years)
Expansion device
PMD
Activation
Latency
Pereira et al.12 2018
90
–
–
Yes (90)
Cakarer et al.8 2017 Verquin et al.6 2017 Zandi et al.22 2016
40 55 30
M 15, F 25 M 20, F 35 M 13, F 17
23.7 5.23 22 (13–27) 15–28
Haas (29) Hyrax (61) Hyrax Hyrax Hyrax
Immediate activation – 7 days 7 days
– 6 4
Dergin et al.5 2015
60
M 37, F 23
17–26
Hyrax
Yes
3 days
6
Adolphs et al.21 2014 Zandi et al.25 2014
50 28
M 22, F 28 M 9, F 19 (G1: M 4, F 9)
24 (6–51) G1: 20.31 3.64 (15–27) G2: 19.4 2.3 (15–23)
Bone-borne device G1: Hyrax (13) G2: Bone-borne device (15)
No (40) Yes
1.6 mm initially and 0.2 mm twice a day – 0.25 mm twice a day 0.5 mm daily with 2 mm of overexpansion 1 mm initially and 0.25 mm twice a day 1 mm daily 0.5 mm daily until 3 mm of overexpansion
5–7 days 7 days
6 4
Williams et al.2 2012
120
(G2: M 5, F 10) M 58, F 62
29.5 (22–39)
Yes
0.25 mm twice a day
5–7 days
–
Verlinden et al.7 2011
73
M 27, F 46
28 (9–59)
Hyrax (118) Bone-borne device (2) Bone-borne device
0.33 mm daily
5–8 days
–
Hernandez-Alfaro et al.10 2010
283
M 172, F 111
18.3 (14–62)
Yes (3) No (70) Yes (modified technique)
0.5–1 mm daily
5–7 days
2–4
Ferna´ndez-Sanroma´n et al.23 2010 Contar et al.24 2009 Total
8
M 2, F 6
28.5 (18–45)
No
0.6 mm daily
7 days
3.6 (3–6)
14 851
M 5, F 9
33.5 (22–54)
No
0.25 mm twice a day
5 days
6 (4–7)
Hyrax (221) Haas (61) Bone-borne device (1) Modified Hyrax device (8) Hyrax (14)
No (40) Yes Yes (15) No (15)
Consolidation (months) 4
F, female; G1, group 1; G2, group 2; M, male; PMD, pterygomaxillary disjunction; SARME, surgically assisted maxillary expansion; SARPE, surgically assisted rapid palatal expansion. For the analysis, the authors disregarded the cases with paresthesia that had resolved after 4 weeks and the device-related complications.
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Author Year
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Table 2. General data collected from the included studies.
YIJOM-4268; No of Pages 8
Author
Number of patients
Complications
Types of minor complication
Total
Surgical
Orthodontic
Minor
Major
Types of major complication
Pereira et al.12
90
14
9
5
9
5
Cakarer et al.8
40
8
8
0
7
1
Verquin et al.6
55
27
20
7
23
4
Zandi et al.22 Dergin et al.5
30 60
1 35
0 35
1 0
1 35
0 0
Adolphs et al.21 Zandi et al.25
50 28
1 1
0 0
1 1
1 1
0 0
Williams et al.2
120
68
20
48
43
25
Verlinden et al.7
73
40
1
39
33
7
Device-related complications (18)a; pain at activation (1)a; unstable occlusion (1); molar root perforation (1); periodontal pocket at incisors (11); increased mobility of incisors (1)
Hernandez-Alfaro et al.10
283
3
0
3
0
3
–
Asymmetric expansion (3)
Ferna´ndez-Sanroma´n et al.23 Contar et al.24
8 14
8 7
8 4
0 3
8 7
0 0
Palatal inflammation (8) Device-related complications (1)a; wound dehiscence (2); gingival recession (2); pain (2)
– –
Total
851
213
105
108
168
45
a
Pain (4.4%) (Haas: 4 (14%); Hyrax: 0) Tooth darkening (5.5%) (Haas: 0; Hyrax: 5 (8.2%)) Epistaxis (1); sinus infection (1); infraorbital numbness (4); wound dehiscence (1) Pain (4); intraoral bleeding (1); epistaxis (4); central incisor mobility (2); tooth darkening (1); blunting of apices (2); paresthesia (3)a; haematoma (2); nausea/ vomiting (4) Extrusion of anchor teeth (1) Paresthesia (3)a; epistaxis (12); pain (7); headache (8); haematoma (1); lacrimation (3); tinnitus (1) Incisor mobility (1) First premolar anchored tooth extrusion (G1) Epistaxis (4); haematoma (3); infection (8); hypoesthesia (4); tooth discolouration (5); gingival recession (12); periodontal bone loss (7)
Additional treatment
Asymmetric expansion (Haas: 2 (6.9%); Hyrax: 3 (5.6%))
–
Palatal fistula (1)
Anterior nasal packing in epistaxis; iliac crest grafting in palatal fistula Anterior nasal packing and tranexamic acid in epistaxis
Asymmetric expansion (3); iatrogenic gastrointestinal bleeding (1) – –
– –
– –
Tooth splint –
Asymmetric expansion (10); inadequate expansion (9); asymmetric + inadequate expansion (3); tooth loss (2); tissue necrosis (1) Asymmetric expansion (5); severe incisor root resorption (2)
Nasal packing (3); incision and drainage (2); segmental maxillary surgery for correction (10); periodontal corrective surgery (2)
For the analysis, the authors disregarded the cases with paresthesia that had resolved after 4 weeks and the device-related complications.
Reoperation to correct asymmetric expansion (2); Le Fort I osteotomy to correct asymmetric expansion (3); device changed for tooth-borne (1) Revision of osteotomies under local anaesthesia (3) – –
Surgically assisted rapid maxillary expansion: a systematic review of complications
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
Table 3. Complications reported in the selected studies, according to predetermined classification criteria.
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Table 4. Complications considering the surgical technique for pterygomaxillary disjunction and the maxillary expansion activation protocol. Surgical or orthodontic technique With PMD Without PMD With PMD Without PMD Fast protocol Slow protocol Fast protocol Slow protocol
Complications, type and occurrence No complications 515 (77.56%)* 123 (65.77%)* 638 No complications 515 (77.56%)* 123 (65.77%)* 638 No complications 430 (87.57%)* 176 (55.01%)* 606 No complications 430 (87.57%)* 176 (55.01%)* 606
PMD, pterygomaxillary disjunction. * Statistically significant difference in
Surgical complications 84 (12.65%) 21 (11.23%) 105 Minor complications 112 (16.87%)* 56 (29.95%)* 168 Surgical complications 52 (10.59%)* 45 (14.06%)* 97 Minor complications 53 (10.79%)* 108 (33.75%)* 161
Orthodontic complications 65 (9.79%)* 43 (22.99%)* 108 Major complications 37 (5.72%)* 8 (4.28%)* 45 Orthodontic complications 9 (1.83%)* 99 (30.93%)* 108 Major complications 8 (1.64%)* 36 (11.24%)* 44
Total 664 187 851 Total 664 187 851 Total 491 320 811 Total 491 320 811
(n)
Statistic x2 = 22.91 P < 0.001
(n)
Statistic x2 = 15.08 P < 0.001
(n)
Statistic x2 = 157.2 P < 0.001
(n)
Statistic x2 = 111.99 P < 0.001
x2 test and residual analysis.
Demographic characteristics
Considering the total number of patients enrolled in all included studies, the sex distribution was equal (49.93% female and 50.07% male); however, the reports of complications were not individually addressed in the majority of studies, thus the relationship of sex with the occurrence of complications could not be determined. The patients varied widely in age, and there was heterogeneity in the reporting of age, which also impaired its evaluation. Expansion device
Most studies used tooth-borne devices (66.67%), two studies applied bone-borne devices (16.66%), and two used boneborne and tooth-borne devices (16.66%). Thus, due to this data heterogeneity, a comparative analysis was not possible. Expansion screw activation protocol
There was no study with a prospective design, randomization, or adequate measurements comparing the different patterns of expansion screw activation. Many studies indicated that the activation was done according to the orthodontist. The expansion protocols used in each study were classified as fast5,10,12,21,23 or slow2,6,7,22,24,25. The x2 test was used to compare the occurrence of complications for each activation protocol (Table 4 ). When the slow pattern of activation was used, there was an increased rate of orthodontic (30.93% vs. 1.83%, P < 0.001) and major complications (11.24% vs. 1.64%, P < 0.001), most of which were asymmetric or incorrect expansion. This is a point
that needs to be further clarified through clinical studies. Pterygomaxillary disjunction
The x2 test was used to compare the occurrence of complications with or without PMD (Table 4). The technique without PMD increased the occurrence of minor complications (29.95% vs. 16.87%, P < 0.001). When PMD was not performed, there was an increased rate of orthodontic complications (22.99% vs. 9.79%, P < 0.001); most of these were asymmetric or incorrect expansion (86.67%). Discussion
The purpose of this study was to perform a systematic review of the incidence of complications in SARME, including prospective and retrospective clinical trials. SARME is widely used for the treatment of transverse maxillary discrepancies, but the incidence of complications is still unclear. Data from this review showed the incidence of complications to be 21.97%. Most were late Epistaxis complications2,6–8,10,12,22,23,25. was often reported, but this is a possible outcome of the surgical damage to the soft tissues around the nasal cavity and maxillary sinuses5,6,8. Epistaxis was successfully treated by compression and nasal packing, or had a natural resolution. Asymmetric expansion was the main reported complication that led to consequences for the treatment2,7,10. The occurrence of asymmetric or incorrect expansion can be associated with a slow activation rate and the absence of PMD. Asymmetric expansion requires surgical re-intervention and can sometimes be corrected only by Le Fort I osteotomy and
maxillary repositioning, thereby increasing morbidity2,10. Although the results indicate that an increased major complication rate is to be expected when PMD is not performed, or when a slow activation protocol is used, this should be confirmed in well-designed clinical trials. PMD is currently a topic of discussion in the literature. Some authors support its use, stating that the pterygomaxillary buttress represents an area of resistance for expansion and that the absence of PMD could increase the occurrence of incorrect expansion10,22,26. Another discussion is the increased risk of surgical complications when PMD is performed8,27. In the present review, it was not possible to correlate PMD with an increased rate of surgical complications. However, more studies with a prospective experimental design should be conducted. Zandi et al. (2016)22 performed a randomized clinical trial to evaluate the necessity of PMD. They analysed 30 patients divided into two groups. The patients were submitted to the same procedure, only differing by the presence or not of PMD. Although the main focus of the study was not on the complication rate, they reported no difference in the occurrence of complications between the groups and an overall low complication rate. As this was the only randomized trial concerning PMD identified in this review, it was not possible to verify any association between the presence of PMD and an increase in the surgical complication rate. Although there have been reports of maxillary expansion for over 80 years1,3,18,28, the pattern of screw activation has not been standardized and the ideal amount of daily expansion remains unclear. The expansion rate can be classi-
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
Surgically assisted rapid maxillary expansion: a systematic review of complications fied as fast or slow, with fast expansions defined as those of >0.5 mm daily or expansions with immediate activation >1 mm at the time of surgery. Slow patterns of activation are those of 0.5 mm daily without immediate activation11. In this review, it was found that the slow expansion protocol was related to orthodontic complications, such as asymmetric expansion, possibly due to premature callus formation. Regarding the type of distractor, Zandi et al. (2014)25 performed a randomized clinical trial to evaluate the outcomes of SARME performed with two different devices: a tooth-borne device and a bone-borne device. There was no statistically significant difference in the incidence of complications between the two methods. However, due to heterogeneity of the data related to the type of distractor, comparison was not possible in this review. Tooth-related complications are frequently reported in SARME procedures2,6,7. The affected teeth are usually molars and premolars2, because they anchor the expansion device. Periodontal problems such as gingival pockets or buccal bone loss, which can even lead to tooth loss, have often been described. Also, complications are observed at the central incisors, associated with the median osteotomy2,12,29. Incisor discolouration, periodontal pockets, mobility, and even the loss of incisors have been reported2,6,7. Due to their aesthetic importance, the loss of a central incisor due to SARME procedures is considered a major complication. Tooth loss will require additional surgical procedures, such as dental implant placement and alveolar reconstruction with bone grafts. As this review focused on reported complications, the exclusion of studies with unclear data related to the subject may have affected the incidence rate, which is clearly a limitation of this review. However, it was necessary for the reviewed studies to include a comprehensive description in order to perform a descriptive analysis. Another limitation of this review was the lack of randomized clinical trials, which prevented a complete analysis. Therefore, future randomized clinical trials with standardized variables are necessary to obtain a more complete picture of the complications in SARME. According to the studies evaluated, it is possible to conclude that SARME is a lowrisk procedure for major complications. Complications following SARME are usually late and minor, and can be resolved by simple postoperative management.
Regarding risk factors for complications, the use of a slow expansion screw activation protocol and the absence of pterygomaxillary disjunction were found to be associated with an increased incidence of major complications. Funding
This study was financed in part by the Coordenac¸a˜o de Aperfeic¸oamento de Pessoal de Nı´vel Superior – Brasil (CAPES) (Finance Code 001). Competing interests
The authors declare that they have no conflicts of interest. Ethical approval
Not applicable. Patient consent
Not applicable. Acknowledgements. We would like to thank CAPES and FAPESP for scholarships awarded to the PhD students involved in this work. Appendix A. Supplementary data
Supplementary material related to this article can be found, in the online version, at doi:https://doi.org/10.1016/j.ijom.2019. 08.011. References 1. Koudstaal MJ, Poort LJ, van der Wal KGH, Wolvius EB, Prahl-Andersen B, Schulten AJM. Surgically assisted rapid maxillary expansion (SARME): a review of the literature. Int J Oral Maxillofac Surg 2006;34:709–14. 2. Williams BJD, Currimbhoy S, Silva A, O’Ryan FS. Complications following surgically assisted rapid palatal expansion: a retrospective cohort study. J Oral Maxillofac Surg 2012;70:2394–402. http://dx.doi.org/ 10.1016/j.joms.2011.09.050. 3. Pogrel MA, Kaban LB, Vargervik K, Baumrind S. Surgically assisted rapid maxillary expansion in adults. Int J Adult Orthodon Orthognath Surg 1992;7:37–41. 4. Moralis A, Zitzmann K, Gosau M, Schlegel D. The effects of surgical expansion of the maxillary arch and its consequences for the incisor axis. J Craniomaxillofac Surg 2016;44:569–73. http://dx.doi.org/10.1016/ j.jcms.2016.02.002.
7
5. Dergin G, Aktop S, Varol A, Ugurlu F, Garip H. Complications related to surgically assisted rapid palatal expansion. Oral Surg Oral Med Oral Pathol Oral Radiol 2015;119:601–7. 6. Verquin M, Daems L, Politis C. Short-term complications after surgically assisted rapid palatal expansion: a retrospective cohort study. Int J Oral Maxillofac Surg 2017;46:303–8. 7. Verlinden CRA, Gooris PG, Becking AG. Complications in transpalatal distraction osteogenesis: a retrospective clinical study. J Oral Maxillofac Surg 2011;69:899–905. 8. Cakarer S, Keskin B, Isler SC, Cansiz E, Uzun A, Keskin C. Complications associated with surgically assisted rapid palatal expansion without pterygomaxillary separation. J Stomatol Oral Maxillofac Surg 2017;118:279–82. http://dx. doi.org/10.1016/j.jormas.2017.06.008. 9. Hamedi Sangsari A, Sadr-Eshkevari P, AlDam A, Friedrich RE, Freymiller E, Rashad A. Surgically assisted rapid palatomaxillary expansion with or without pterygomaxillary disjunction: a systematic review and metaanalysis. J Oral Maxillofac Surg 2016;74:338–48. http://dx.doi.org/10.1016/ j.joms.2015.06.161. 10. Hernandez-Alfaro F, Bueno JM, Diaz A, Page´s CM. Minimally invasive surgically assisted rapid palatal expansion with limited approach under sedation: a report of 283 consecutive cases. J Oral Maxillofac Surg 2010;68:2154–8. http://dx.doi.org/10.1016/ j.joms.2009.09.080. 11. Algharbi M, Bazargani F, Dimberg L. Do different maxillary expansion appliances influence the outcomes of the treatment? Eur J Orthod 2018;40:97–106. http://dx.doi.org/ 10.1093/ejo/cjx035. 12. Pereira MD, Koga AF, Prado GPR, Ferreira LM. Complications from surgically assisted rapid maxillary expansion with Haas and Hyrax expanders. J Craniofac Surg 2018;29:275–8. 13. Moura LB, Spin-Neto R, Sverzut CE, Monnazzi Mda S, Trivellato AE, Gabrielli MA, Pereira-Filho VA. Evaluation of the palatal split pattern in surgically rapid maxillary expansion—comparison of two techniques. Oral Maxillofac Surg 2016;20:255–8. http:// dx.doi.org/10.1007/s10006-016-0562-5. 14. Seeberger R, Kater W, Davids R, Thiele OC. Long term effects of surgically assisted rapid maxillary expansion without performing osteotomy of the pterygoid plates. J Craniomaxillofac Surg 2010;38:175–8. 15. Reinbacher KE, Wallner J, Pau M, Feichtinger M, Ka¨rcher H, Quehenberger F, Zemann W. Surgically assisted rapid maxillary expansion: feasibility of not releasing the nasal septum. Int J Oral Maxillofac Surg 2013;42:321–5. 16. Habersack K, Becker J, Ristow O, Paulus GW. Dental and skeletal effects of two-piece and three-piece surgically assisted rapid maxillary expansion with complete mobilization: a retrospective cohort study. J Oral
Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011
YIJOM-4268; No of Pages 8
8
Carvalho et al.
17.
18.
19.
20.
21.
22.
Maxillofac Surg 2014;72:2278–88. http://dx. doi.org/10.1016/j.joms.2014.04.013. Seeberger R, Gander E, Hoffmann J, Engel M. Surgical management of cross-bites in orthognathic surgery: surgically assisted rapid maxillary expansion (SARME) versus two-piece maxilla. J Craniomaxillofac Surg 2015;43:1109–12. http://dx.doi.org/ 10.1016/j.jcms.2015.05.012. Betts NJ, Vanarsdall RL, Barber HD, Higgins-Barber K, Fonseca RJ. Diagnosis and treatment of transverse maxillary deficiency. Int J Adult Orthodon Orthognath Surg 1995;10:75–96. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA, PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration; 2011. Adolphs N, Ernst N, Menneking H, Hoffmeister B. Transpalatal distraction—state of the art for the individual management of transverse maxillary deficiency—a review of 50 consecutive cases. J Craniomaxillofac Surg 2014;42:1669–74. http://dx.doi.org/ 10.1016/j.jcms.2014.05.011. Zandi M, Miresmaeili A, Heidari A, Lamei A. The necessity of pterygomaxillary dis-
23.
24.
25.
26.
27.
junction in surgically assisted rapid maxillary expansion: a short-term, double-blind, historical controlled clinical trial. J Craniomaxillofac Surg 2016;44:1181–6. http://dx. doi.org/10.1016/j.jcms.2016.04.026. Ferna´ndez-Sanroma´n J, Donascimento MG, Lo´pez AC, Ferro MF, Berrondo IA. Transverse maxillary distraction in patients with periodontal pathology or insufficient tooth anchorage using custom-made devices. J Oral Maxillofac Surg 2010;68:1530–6. Contar CMM, Muller PR, Brunetto AR, Machado MAN, Rappoport A. Surgical treatment of maxillary transverse deficiency: retrospective study of 14 patients. J Maxillofac Oral Surg 2009;8:249–53. http://dx. doi.org/10.1007/s12663-009-0061-4. Zandi M, Miresmaeili A, Heidari A. Shortterm skeletal and dental changes following bone-borne versus tooth-borne surgically assisted rapid maxillary expansion: a randomized clinical trial study. J Craniomaxillofac Surg 2014;42:1190–5. Lima SM, De Moraes M, Asprino L. Photoelastic analysis of stress distribution of surgically assisted rapid maxillary expansion with and without separation of the pterygomaxillary suture. J Oral Maxillofac Surg 2011;69:1771–5. http://dx.doi.org/10.1016/ j.joms.2010.07.035. Politis C. Life-threatening haemorrhage after 750 Le Fort I osteotomies and 376
SARPE procedures. Int J Oral Maxillofac Surg 2012;41:702–8. http://dx.doi.org/ 10.1016/j.ijom.2012.02.015. 28. Goddard R, Witherow H. Surgically assisted rapid palatal expansion (SARPE). Br J Oral Maxillofac Surg 2011;49:65–6. http://dx.doi. org/10.1016/j.bjoms.2009.11.013. 29. de Oliveira TFM, Santos-Pinto A, Gabrielli MFR, Pereira Filho VA. Lack of bone healing: an unusual complication following surgically assisted rapid palatal expansion. Oral Surg 2014;7:21–6. http://dx.doi.org/ 10.1111/ors.12095.
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Please cite this article in press as: Carvalho PHA, et al. Surgically assisted rapid maxillary expansion: a systematic review of complications, Int J Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.ijom.2019.08.011