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Is Le Fort I Osteotomy Associated With Maxillary Sinusitis?
Accepted Manuscript Is Le Fort I Osteotomy Associated with Maxillary Sinusitis? P.F. Nocini, A. D’Agostino, L. Trevisiol, V. Favero, M. Pessina, P. Procacci PII:
S0278-2391(15)01369-5
DOI:
10.1016/j.joms.2015.10.006
Reference:
YJOMS 56999
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 2 March 2015 Revised Date:
30 September 2015
Accepted Date: 7 October 2015
Please cite this article as: Nocini P, D’Agostino A, Trevisiol L, Favero V, Pessina M, Procacci P, Is Le Fort I Osteotomy Associated with Maxillary Sinusitis?, Journal of Oral and Maxillofacial Surgery (2015), doi: 10.1016/j.joms.2015.10.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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IS LE FORT I OSTEOTOMY ASSOCIATED WITH MAXILLARY SINUSITIS?
NOCINI PF1, D’AGOSTINO A2, TREVISIOL L2, FAVERO V3, PESSINA M3, PROCACCI P4 1
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MD, DDS, PROFESSOR, CHIEF, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA 2
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MD, ASSOCIATE PROFESSOR, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA 3
MD, MAXILLO-FACIAL SURGEON, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA
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CORRESPONDING AUTHOR:
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PROF. LORENZO TREVISIOL
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MD, ASSISTANT PROFESSOR, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA
DEPARTMENT OF SURGERY, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA
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POLICLINICO “GIOVANNI BATTISTA ROSSI” PIAZZALE LUDOVICO ANTONIO SCURO, 10 37134 VERONA – ITALY
E-MAIL: [email protected] PHONE: +390458124251 FAX: +390458027437
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IS LE FORT I OSTEOTOMY ASSOCIATED WITH MAXILLARY SINUSITIS?
Abstract Purpose: The purpose of this study was to investigate the association between Le Fort I osteotomy and anatomic, radiological, and symptomatic modifications of the maxillary sinus.
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Materials/Methods: Subjects who underwent LeFort I osteotomy between January 2008 and December 2013 were enrolled in a retrospective cohort study. The eligibility criteria were a Cone Beam Computed Tomography (CBCT) scan taken before and 12-24 months after the procedure was carried out. Its exclusion criteria were: unavailability of CBCTs, use of tobacco, previous orthognathic procedures. The primary predictor variable was time (pre- vs. post-operative). The primary outcome variables were sinus volume, mucosal thickening, iatrogenic alterations in sinus anatomy, and rhinosinusitis symptoms evaluated using the Sino-Nasal Outcome Test (SNOT-20). Descriptive statistics were computed for each variable and paired analyses were used to compare pre- and post-operative values.
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Results: Sixty-four subjects [mean age 27; 59.4% female; median follow-up time - range 13 to 66 months, length 32.4 months)] were studied. Post-operatively, 1.6% of the sample (0% preoperatively) had moderate-to-severe and 15.6% (3.1% preoperatively) had mild-to-moderate sinusitis symptoms. The rest of the sample presented mild to no symptoms. The increase in SNOT scores after surgery was statistically significant (p=0.016). Radiological evidence of post-operative inflammatory processes affecting the paranasal sinuses was found in 27.3% of the sinuses (9.4% preoperatively). The post-operative LundMackay scores were signficantly higher (p=0.0005). There was a 19% decrease in the mean post-operative sinus volume and a 37% incidence of iatrogenic injury.
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Conclusions: Study results indicate that Le Fort I osteotomies can have an important impact on sinus health. The post-operative radiological evidence of maxillary sinus inflammatory processes and incidence of rhinosinusitis symptoms and iatrogenic damage in these patients lead us to conclude that CBCTs and SNOT20 questionnaires should be used routinely during post-operative monitoring. Larger long-term studies are warranted to clarify post-operative outcomes/complications.
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Keywords: Le Fort I osteotomy, sinusitis, upper airways
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Introduction
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The impact of orthognathic surgery on the anatomy and function of the upper airways has been studied extensively (1). It has been seen that both linear and rotational movements induce changes to the soft tissues of the pharynx and of the oral cavity and can have a dramatic impact on the upper airway space; maxillomandibular advancement has also proven to be a valid treatment option for obstructive sleep apnea syndrome (OSAS) (2) (3) (4) (5) (6) (7) (8) (9) (10). Despite these considerations, the effect of Le Fort I osteotomy on the anatomy and function of the maxillary sinuses is still not routinely assessed pre-, periand post-operatively in patients who undergo orthognathic surgery. Although the estimated prevalences of rhinosinusitis symptomatology (11) and variations of the paranasal sinuses are high, little is known about the real impact that they have on the outcome of orthognathic surgical procedures. This may in part be explained by the fact that a relatively low rate of complications has been reported during the immediate post-operative period (12). Acute sinusitis, for example, is an uncommon although possible complication following Le Fort I osteotomy (13). There are several surgery-related factors that may induce maxillary sinus pathologies, and conversely, although infrequent, surgery-induced modifications of the anatomy and physiology of the maxillary sinuses may play a role in outcomes such as delayed consolidation of the osteotomy, hardware infections, or post-operative bleeding (14) (15).
Materials and Methods
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Study design
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The investigators hypothesized that Le Fort I osteotomy could have a substantial impact on maxillary sinus physiology especially with regard to iatrogenic alterations in normal anatomy that may persist following the procedure. More specifically, the study evaluated pre- and post-operative clinical and radiological signs of rhinosinusitis using Cone-Beam Computed Tomography (CBCT) scans and the Sino-Nasal Outcome Test (SNOT-20) in a relatively large group of patients who underwent Le Fort I osteotomy.
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A longitudinal retrospective study was designed to investigate anatomical, radiological, and symptomatic modifications involving the maxillary sinus following Le Fort I osteotomy. An electronic search of all patients who underwent orthognathic surgery at the Oral and Maxillofacial Surgery Section of the University Hospital of Verona between January 2008 and December 2013 was carried out. The predetermined inclusion criteria were: having undergone a Le Fort I osteotomy for the first time between January 2008 and December 2013, possession of a pre-operative CBCT (carried out using a NewTom 3G device; QR srl – Verona, Italy) and a post-operative scan taken 12 to 24 months later. The study’s exclusion criteria were: lack of medical records, tobacco use, and/or having undergone other previous orthognathic surgical procedures. The CBCT, which generates 3-D images of dental structures, soft tissues, nerve paths, and bone in the craniofacial region, was acquired while the patient maintained a natural head position. Scans were taken with a single rotation of the device; the dose uptake for each patient was approximately 59μSv. The preoperative CT scan was performed a week before surgery was carried out. Only CT scans carried out 12 to 24 months following surgery were considered acceptable for the purposes of our study.
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The type of surgical intervention (one-piece or multi-segment Le Fort I osteotomy) that was planned depended on each patient’s specific deformity. All of the patients underwent fixation with titanium miniplates and wires. All the procedures were performed by the same surgeons (A.D’A. and L.T.). The radiological and clinical analyses were performed by P.F.N. and V.F. The study was approved by the Ethics Committee of the University Hospital of Verona, and all the patients gave written consent agreeing to participate in the study.
Study Variables
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The primary predictor variable was time. The patients were evaluated pre-operatively a week before the procedure was carried out and post-operatively approximately 12 to 24 months later. Patients’ gender, age, and the duration of the follow-up were registered. The type of dentoskeletal deformity each patient presented and the type of Le Fort I osteotomy (one-piece or multi-segment) that was planned and carried out were recorded. As far as volumetric analysis was concerned, the datasets were processed using the “Dolphin 3D” software (version 11.5, Dolphin Imaging, Chatsworth, California, USA), a powerful tool that facilitates processing 3-D data. Boundary lines were drawn surrounding the sinus cavity in the axial, coronal, and sagittal views to measure the individual volumes within the software. Seed points were then placed within the sinus cavities and boundaries until the entire sinus was included. Sinus volume was then generated by clicking the "Update Volume" tab. Pre- and post-operative maxillary sinus volumes were determined (Fig. 1 and 2). The software allowed us to calculate the air volume inside the sinus cavities or the residual space excluding hypertrophic inflammatory mucosal thickening. With regard to morphological alterations, each patient’s pre- and post-operative CBCT scans were analyzed to detect and evaluate anatomical defects or surgery-induced alterations that could lead to paranasal homeostasis disruption (Figs. 3 and 4). The analysis focused, in particular, on interruption or deviation of the septum, discontinuities in the sinus walls, and protrusion of hardware into the sinuses.
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The Lund-Mackay rhinological staging scale (LMS), a widely used system to assess paranasal sinus abnormalities visible on CT scans, was utilized to grade the patients’ scans (16) (17). The scale analyzes the severity of mucosal thickening or of fluid retention of each cavity (maxillary, frontal, sphenoid, anterior ethmoid and posterior ethmoid) and of the osteomeatal complex, that is six sites on each side. Each sinus is scored a 0 (no abnormality), 1 (partial opacification), or 2 (total opacification), while the ostiomeatal complex is scored either a 0 or 2 (for presence or absence of disease). Scores range from 0-24. (Figs. 5 and 6) Pre-operatively and approximately one year after surgery the patients also completed the Sino-Nasal Outcome Test (SNOT) questionnaire (Table 1). The SNOT-20, which is a validated patient-reported measure of sino-nasal conditions, is one of the most widely adopted tools evaluating a range of health and quality of life variables linked to rhinosinusitis issues (18). Each of its twenty items receives a score ranging from 0 (no limitation) to 5 (extreme limitation). The final overall score can fall between 0 and 100. Higher scores represent worse symptoms and poorer quality of life; lower scores represent less symptoms and better quality of life. A score between 0 and 10 indicates no or minimal problems; a score between 11 and 40 indicates mild to moderate ones; a score between 41 and 70 indicates moderate to severe ones; a score above 70 is considered indicative of severe or critical conditions necessitating the attention of a specialist for possible surgical intervention.
ACCEPTED MANUSCRIPT Outcome variables The main outcome variables were variations in the maxillary sinus volume, alterations in morphological features consequent to surgery, and radiological evidence and/or symptoms or signs of rhinosinusitis. Data analysis
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MedCalc statistical software (MedCalc Software bvba, Ostend, Belgium) was used for statistical analyses. The D’Agostino-Pearson normality test was used to assess the normality of data regarding sinus volumes and the Lund-Mackay scores were used to assess chronic rhinosinusitis. A normal distribution was found for the former but not for the latter. The paired sample t-test was used to analyze the differences in sinus volumes. The independent-samples t-test was used to evaluate the differences in volume variations in the patients who underwent a one-piece or multi-segment osteotomy. The Wilcoxon signed rank test for dependent variables was used to assess differences between pre- and post-operative Lund-Mackay CT scores. The Mann-Whitney test for independent samples was used to evaluate the differences in the postoperative Lund-Mackay scores in the two groups of patients (those who underwent one-piece and multisegment osteotomies). In all cases, the level of significance was set at p<0.05. The Kaplan-Meier survival analysis was performed to examine differences in the prevalence of maxillary symptomatic sinusitis (SNOT20 >20) during the follow-up between the two patient groups.
Results
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Volumetric analysis
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Out of the 243 patients who underwent a Le Fort I osteotomy between January 2008 and December 2013 at our institution, only 64 met the study’s inclusion criteria. Thirty-six patients were excluded because of use of tobacco. Twelve were excluded because they had undergone previous orthognathic surgical procedures. Finally, 131 patients were excluded because they were not in possession of pre- and/or postoperative CBCT scans. Patients’ ages ranged between 17 and 47 years (mean value= 27.06; mode=19). Thirty-eight (59%) of the patients were females and 26 (41%) were males. Forty patients presented with class III dentoskeletal deformities; the remaining 24 presented with class II dentoskeletal deformities. Twenty-two patients underwent one-piece and 42 multi-segment Le Fort I osteotomy. (Table 2) The mean duration of the follow-up was 32.4 months (range 13-66 months).
The mean pre-operative maxillary sinus volume was 16947.14 ± 5973.44 mm3, and the mean postoperative value was 13675.34 ± 5875.38 mm3. The mean difference was 3271.80 ± 4806.24 mm3, corresponding to 19% of the initial volume. The difference proved to be statistically significant (p<0.0001). With regard to the 22 patients who underwent a one-piece Le Fort I osteotomy, the mean pre-operative value was 15061.11 ± 4352.34 mm3 and the post-operative value was 11182.64 ± 5792.20 mm3, corresponding to a mean volume decrease of 3878.48 ± 5289.10 mm3 (26% of the initial volume). The difference proved to be statistically significant (p<0.0001). The mean pre-operative value of the 42 patients who underwent a multi-segment Le Fort I osteotomy was 17935.06 ± 6473.83 mm3 and the post-operative one was 14981.05 ± 5515.39 mm3. The volume decrease in this group was 2954.01 ± 4533.82 mm3 (16% of the initial volume) (Fig. 7). The difference was statistically significant (p<0.0001). The difference in sinus volume variations between the two groups, which was analyzed using an independent- samples t-test, was not statistically significant (p=0.4).
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Several alterations of the nasal cavities and the paranasal sinuses were noted during the post-operative radiological evaluation. An analysis of the post-operative CBCT scans uncovered a loss of continuity of the lateral nasal wall causing an iatrogenic communication between the nasal cavity and the maxillary sinus in 13 patients (20.3%). Six patients (9.4%) showed incomplete healing of the nasal septum with osteocartilaginous deficits. Five patients (7.8%) showed marked deviated nasal septums not noted prior to surgery. Hardware passed through the bony walls into the sinus cavity in all the patients. Radiological analysis
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Coronal CT scans of patients’ sinuses were graded using the Lund-Mackay system. At the pre-operative evaluation, 4 patients presented mucosal thickening in bilateral maxillary sinuses (LMS=1) and 2 presented bilateral maxillary sinus opacification (LMS=2). Post-operatively, 3 out of the 4 patients suffering from mucosal thickening showed radiological improvement; the 4th patient showed a worse condition. The 2 patients with sinus opacification also showed an improvement. Overall, 12 out of the 64 patients showed post-operative evidence of sinus opacification (3 bilateral and 9 monolateral), and 20 showed postoperative mucosal thickening (Table 3). The post-operative Lund-Mackay scores were higher and the difference with respect to the pre-operative ones was statistically significant (p=0.0005).
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The difference in the post-operative Lund-Mackay scores in the patients who underwent one-piece or multi-segment Le Fort I osteotomy was analyzed using the Mann-Whitney test for independent samples; the scores were found to be higher in the former (p=0.035). One of the 22 patients who underwent a onepiece Le Fort I osteotomy presented pre-operative evidence of sinusitis. One year after surgery, that patient showed a relevant, although incomplete, improvement and only mild residual mucosal thickening. Six patients presented pre-operatively with sinusitis (3 bilateral and 3 unilateral). Also in this case, the improvement in the Lund-Mackay score was significant (p=0.015).
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Clinical analysis
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One of the 42 patients who underwent multi-segment Le Fort I osteotomy presented pre-operative total sinus opacification, which disappeared after surgery. Six patients showed post-operative unilateral sinusitis, none presented post-operative bilateral sinusitis. Also in this case, improvement in the Lund-Mackay score was statistically significant (p=0.013).
Sixty-two out of the 64 patients had a pre-operative SNOT 20 score between 0 and 10, and 2 had a score between 11 and 20 (Table 4). None of the patients thus needed to consult with a specialist for rhinosinusitis before orthognathic surgery. One year after surgery, 53 of the patients had a score below 10, and ten had a score between 11 and 40, that is to say, a moderate rhinosinusitis condition. One patient had a score of 67 indicating a moderate to severe problem. Although not suffering from severe symptoms (total SNOT 20 score=22), one patient reported occasional episodes of “airplane headache.” The increase in SNOT scores after surgery was statistically significant (p=0.016). The Kaplan-Meier (Table 5 and Fig. 8) disease free survival rates (with associated 95% CIs) were 55.9% ± 19.1%, respectively, in the one-piece Le Fort I group and 67.1% ± 12.6% in the multi-segment Le Fort I group; the differences between the two groups (p=.74) were not statistically significant
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Discussion
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Orthognathic surgery is one of the main subspecialties of oral and maxillofacial surgery, and numerous procedures are currently performed on a routine worldwide basis. While diverse studies have assessed long-term clinical outcomes and the complications linked to this kind of surgery (19) (20) (21) (22), there is a paucity of material concerning the anatomical and symptomatic alterations of the nasal cavity and paranasal sinuses implicated in orthognathic procedures. The current study set out to examine the anatomical, symptomatic, and radiological alterations in the maxillary sinuses following Le Fort I osteotomies.
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Although the estimated prevalence of sinusitis in the United States ranges from 2 to 16%, definitive diagnostic criteria for sinusitis remain transient and controversial. Some suggest that chronic rhinosinusitis should be defined as the group of disorders characterized by inflammation of the mucosal lining of the nasal passage and paranasal sinuses lasting at least 12 consecutive weeks. Signs of inflammation include nasal drainage, nasal polyps, polypoid swelling, edema or erythema of the middle meatus or CT findings of isolated or diffuse mucosal thickening, bone changes, air-fluid level. In addition, symptoms consistent with rhinosinusitis such as those outlined in the SNOT-20 questionnaire should also be taken into consideration in order to classify the disease as symptomatic or asymptomatic (23).
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That said, the data emerging from our study highlighted a high incidence of post-operative inflammatory processes and iatrogenic alterations that were frequently asymptomatic and could easily be misdiagnosed in patients undergoing the procedure. Following orthognathic surgery, patients are normally monitored to evaluate the occlusal plane and post-surgical joint stability. The CBCT allowed us to focus on traditional dentoskeletal factors as well as to analyze elements that influence sinus homeostasis. When used with appropriate precautionary measures, CBCT was found to be a safe, reliable tool to post-operatively monitor patients to detect signs of rhinosinusitis complications.
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Of the 64 patients meeting the study’s inclusion criteria, 40 presented with Class III and 24 with Class II dentoskeletal deformities. Twenty-two underwent one-piece and 42 multi-segment Le Fort I osteotomies. Analysis of the patients’ data showed that most registered a decrease in sinus volume. Of the 128 sinuses considered, only 17 (13.28%) showed increased volume after surgery: 3 of these had total sinus opacification and 3 had mucosal thickening. This means that the calculated volume corresponded to the minimal residual sinus cavity air volume. These conditions were improved after surgery as there was an increase in sinus cavity air volume. Out of the 122 healthy pre-operative sinuses, 11 (9%) showed a real increase in volume, and 111 (91%) showed decreased air volume. The mean decrease corresponded to 27% of the preoperative volume. All the patients underwent upper jaw advancement: 36 were impacted and 28 were lowered. The decrease in sinus volume can be explained by advancement movements leading to a modification in the posterior maxillary sinus wall with a resulting alteration of the sinus cavity morphology. Impaction in addition to advancement enhances the decrease in sinus volume by lowering the overall height of the sinus walls. Morphological evaluation detected iatrogenic alterations in a relevant percentage of the patients. The most frequent iatrogenic alterations were septal deviation or discontinuity, turbinate hypertrophy, discontinuities of the sinus wall, and hardware infections. Although these alterations are often misdiagnosed by clinicians, together with mucociliary clearance and debridement of healthy inferior sinus mucosa, they may play a role in the onset of rhinosinusitis pathologies. This possibility should be taken into
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consideration when the surgeon is deciding the procedure that is most appropriate for a particular patient. Subspinal osteotomy and stabilization with sutures should always be adopted, and both pre-operative septum deviations and those consequent to maxillary impaction should be corrected by septoplasty. Turbinoplasty can be considered in the event of turbinate hypertrophy or, once again, in the event of impaction. An exception should be made for bone grafting or pre-operative mucosal hypertrophy, in which case the sinus mucosa should be preserved after osteotomy. Even if protrusion of hardware into the sinus, which was detected in all the patients examined, is somewhat unavoidable, it does not seem to necessarily trigger an onset of post-operative sinusitis. In our opinion, short screws should be used to avoid a potential contributing factor to sinus homeostasis disruption.
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CBCT analysis made it possible for us to assess sinus opacities. The results showed that 2 patients with preoperative sinusitis had entirely recovered and presented post-operative sinus radiolucency after one year. Pre-operatively four patients presented mild mucosal thickening; the condition improved after surgery in three and worsened in one. Out of the 64 patients studied, 12 (18.75%) developed radiological evidence of sinusitis one year after surgery. Fifteen out of 128 sinuses obtained a Lund-Mackay score of 2, while 20, showing only mucosal thickening, received a score of 1. Overall 30% of the patients showed post-operative inflammatory processes affecting the paranasal sinuses. As it is often asymptomatic, the complication is frequently misdiagnosed and may lead to the development of more severe conditions. The patients who underwent a multi-segment osteotomy presented with higher Lund-Mackay scores than those undergoing the one-piece type. It is not clear if maxillary sinus volume reduction is responsible for the onset of rhinosinusitis pathologies.
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Analysis of the SNOT-20 questionnaires demonstrated that the rate of symptomatic patients was relatively low in the total patient group (3.13%), but it was higher in the subgroup with radiological signs (16.7%). Our data are consistent with those outlined in the literature (0.24 to 20%). The type of osteotomy (onepiece vs. multi-segment osteotomy) does not seem to affect the onset of sinus pathologies. We can deduce from these data that there is no absolute contraindication to Le Fort I osteotomy in patients suffering from pre-operative sinusitis as long as it is not associated with symptoms; in that case, the rhinosinusitis issues should be addressed before the procedure is undertaken. The patients who showed an improvement in rhinosinusitis status after orthognathic surgery probably benefitted from the procedure and from the removal of the inflamed tissue from the lower part of the sinus which had a positive effect on the airflow within the maxillary sinus. Although epidemiological data concerning sinusitis on a global scale does not seem to be particularly accurate on this point, our study found a salient incidence of mostly asymptomatic, postoperative inflammatory processes affecting the maxillary sinuses. To our knowledge, no studies describing medium- or long-term symtpomatic alterations of the paranasal sinuses following a Le Fort I osteotomy can be found in the literature (15) (24) (25). This can partially be explained by the inadequacy of radiological assessments. As most orthognathic procedures are planned on the basis of 2-dimensional imaging, this has limited the possibility of detecting rhinosinusitis pathologies. The most significant works focusing on this topic were studies by Pereira-Filho et al. (26) and by Valstar et al. (27) The former used a brief questionnaire, radiographs(Waters views), and nasal endoscopy before surgery and 6 to 8 months after to evaluate the incidence of maxillary sinusitis in 21 adult patients who underwent Le Fort I osteotomy. The study’s results, which uncovered a 4% incidence of maxillary sinusitis as a post-operative complication, suggested that orthognathic surgery is not directly linked to the onset of chronic or subacute sinusitis. The latter study used validated questionnaires focusing on sinonasal complaints (RSOM-31 and VAS score), nasal endoscopy, peak nasal inspiratory flow (PNIF) and a computed tomography (CT) scan to evaluate maxillary sinus and nasal ventilation in a group of 20 patients. The
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Our study, which is a preliminary report based on a population of 64 patients, is, as far as we are aware, the largest to investigate post-operative complications linked to Le Fort I osteotomy. None of the references cited here provided comprehensive data beyond a year after the operation, a time period which we are convinced is not sufficient to detect procedure-related rhinosinusitis complications. In fact, a transient rhinosinusitis appears to be a direct consequence of the anatomical modification (28). As far as the diagnostic process is concerned, unlike others, our study chose to use CBCT scan and the SNOT 20 questionnaire with no endoscopy. Our choice was based on the assumption that endoscopy is best utilized in patients affected with nasal discharge or, in any case, with symptomatic sinusitis. We are of the opinion that monitoring these patients for periods longer than a year and the routine use of CBCT, both novel aspects of the current investigation, enabled us to efficaciously detect pathological conditions that might otherwise have been mis- or under-diagnosed.
Conclusion
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Although post-operative rhinosinusitis is often asymptomatic and patients are frequently misdiagnosed, our results show that there is a high incidence of complications in patients who undergo Le Fort I osteotomy. Our findings also demonstrate that clinical follow-up of orthognathic patients should focus not only on the occlusal plane and post-surgical stability of the maxilla but also on factors that may interfere with sinus homeostasis. When used with appropriate precautionary measures, CBCT proved to be a safe, reliable long-term tool to monitor these patients in the effort to detect signs of rhinosinusitis complications. Future studies can assess the impact that variations in the surgical technique may have on patients undergoing Le Fort I osteotomy.
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1. Mattos CT, Vilani GN, Sant'Anna EF, Ruellas AC, Maia LC. Effects of orthognathic surgery on oropharyngeal airway: a meta-analysis. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1347-56. 2. Lye KW. Effect of orthognathic surgery on the posterior airway space (PAS). Ann Acad Med Singapore. 2008 Aug;37(8):677-82. 3. Stellini E, Stomaci D, Stomaci M, Petrone N, Favero L. Fracture strength of tooth fragment reattachments with postpone bevel and overcontour reconstruction. Dent Traumatol. 2008 Jun;24(3):283-8. 4. Boyd SB. Management of obstructive sleep apnea by maxillomandibular advancement. Oral Maxillofac Surg Clin North Am. 2009 Nov;21(4):447-57. 5. Favero L, Giagnorio C, Cocilovo F. Comparative analysis of anchorage systems for micro implant orthodontics. Prog Orthod. 2010;11(2):105-17. 6. Maurer JT. Surgical treatment of obstructive sleep apnea: standard and emerging techniques. Curr Opin Pulm Med. 2010 Nov;16(6):552-8. 7. Susarla SM, Thomas RJ, Abramson ZR, Kaban LB. Biomechanics of the upper airway: Changing concepts in the pathogenesis of obstructive sleep apnea. Int J Oral Maxillofac Surg. 2010 Dec;39(12):1149-59. 8. Jacobson RL, Schendel SA. Treating obstructive sleep apnea: the case for surgery. Am J Orthod Dentofacial Orthop. 2012 Oct;142(4):435, 437, 439, 441-2. 9. Varghese R, Adams NG, Slocumb NL, Viozzi CF, Ramar K, Olson EJ. Maxillomandibular advancement in the management of obstructive sleep apnea. Int J Otolaryngol. 2012;2012:373025. 10. Faria AC, da Silva-Junior SN, Garcia LV, dos Santos AC, Fernandes MR, de Mello-Filho FV. Volumetric analysis of the pharynx in patients with obstructive sleep apnea (OSA) treated with maxillomandibular advancement (MMA). Sleep Breath. 2013 Mar;17(1):395-401. 11. Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-34. 12. Morris DE, Lo LJ, Margulis A. Pitfalls in orthognathic surgery: avoidance and management of complications. Clin Plast Surg. 2007 Jul;34(3):e17-29. 13. Steel BJ, Cope MR. Unusual and rare complications of orthognathic surgery: a literature review. J Oral Maxillofac Surg. 2012 Jul;70(7):1678-91. 14. Perko M. Maxillary sinus and surgical movement of maxilla. Int J Oral Surg. 1972;1(4):177-84. 15. Bell CS, Thrash WJ, Zysset MK. Incidence of maxillary sinusitis following Le Fort I maxillary osteotomy. J Oral Maxillofac Surg. 1986 Feb;44(2):100-3. 16. Sharp HR, Rowe-Jones JM, Mackay IS. The outcome of endoscopic sinus surgery: correlation with computerized tomography score and systemic disease. Clin Otolaryngol Allied Sci. 1999 Feb;24(1):39-42. 17. Basu S, Georgalas C, Kumar BN, Desai S. Correlation between symptoms and radiological findings in patients with chronic rhinosinusitis: an evaluation study using the Sinonasal Assessment Questionnaire and Lund-Mackay grading system. Eur Arch Otorhinolaryngol. 2005 Sep;262(9):7514. 18. Lachanas VA, Woodard TD, Antisdel JL, Kountakis SE. Sino-nasal outcome test tool assessment in patients with chronic rhinosinusitis and obstructive sleep apnea. ORL J Otorhinolaryngol Relat Spec. 2012;74(5):286-9. 19. Panula K, Finne K, Oikarinen K. Incidence of complications and problems related to orthognathic surgery: a review of 655 patients. J Oral Maxillofac Surg. 2001 Oct;59(10):1128-36; discussion 1137.
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20. Bailey L, Cevidanes LH, Proffit WR. Stability and predictability of orthognathic surgery. Am J Orthod Dentofacial Orthop. 2004 Sep;126(3):273-7. 21. D'Agostino A, Trevisiol L, Gugole F, Bondí V, Nocini PF. Complications of orthognathic surgery: the inferior alveolar nerve. J Craniofac Surg. 2010 Jul;21(4):1189-95. 22. Bacci C, Berengo M, Favero L, Zanon E. Safety of dental implant surgery in patients undergoing anticoagulation therapy: a prospective case-control study. Clin Oral Implants Res. 2011 Feb;22(2):151-6. 23. Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. Review. 24. Moses JJ, Lange CR, Arredondo A. Endoscopic treatment of sinonasal disease in patients who have had orthognathic surgery. Br J Oral Maxillofac Surg. 2000 Jun;38(3):177-84. 25. Williams BJ, Isom A, Laureano Filho JR, O'Ryan FS. Nasal airway function after maxillary surgery: a prospective cohort study using the nasal obstruction symptom evaluation scale. J Oral Maxillofac Surg. 2013 Feb;71(2):343-50. 26. Pereira-Filho VA, Gabrielli MF, Gabrielli MA, Pinto FA, Rodrigues-Junior AL, Klüppel LE, Passeri LA. Incidence of maxillary sinusitis following Le Fort I osteotomy: clinical, radiographic, and endoscopic study. J Oral Maxillofac Surg. 2011 Feb;69(2):346-51. 27. Valstar MH, Baas EM, Te Rijdt JP, De Bondt BJ, Laurens E, De Lange J. Maxillary sinus recovery and nasal ventilation after Le Fort I osteotomy: a prospective clinical, endoscopic, functional and radiographic evaluation. Int J Oral Maxillofac Surg. 2013 Nov;42(11):1431-6. 28. Garg S, Kaur S. Evaluation of Post-operative Complication Rate of Le Fort I Osteotomy: A Retrospective and Prospective Study. J Maxillofac Oral Surg. 2014 Jun;13(2):120-7.
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Tables Table 1: SNOT-20 Questionnaire 1. Need to blow nose
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2. Sneezing 3. Runny nose
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4. Cough 5. Postnasal discharge (dripping at the back of your throat) 6. Thick nasal discharge (snot) 7. Ear fullness 8. Dizziness
11. Difficulty in falling asleep 12. Waking up at night 13. Lack of a good night’s sleep 14. Waking up tired
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15. Fatigue 16. Reduced productivity
17. Reduced concentration
18. Frustrated/restless/irritable 19. Sad
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10. Facial pain/pressure
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9. Ear pain
20. Embarassed
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Variables
Results
Men
26 (40.6%)
Women
38 (59.4%)
Age (y) - mean value and range
27.06 (17-47)
Follow-up (m) – mean value and range
32.4 (13-66)
Type of dentoskeletal deformity 24 (37.5%)
Class III
40 (62.5%)
Type of osteotomy One-piece Le Fort I osteotomy
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Class II
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Patients (n=64)
22 (34.4%)
Multi-segment Le Fort I osteotomy
Volumetric analysis
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Average preoperative maxillary sinus volume (mm3)
Average postoperative maxillary sinus volume (mm3)
Morphologic analysis
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Loss of continuity of the lateral nasal wall (No. of patients)
42 (65.6%)
16947.14 ± 5973,44 13675.34 ± 5875,38
13 (20.3%) 6 (9.4%)
Septal deviations (No. of patients)
5 (7.8%)
Protrusion of hardware into the maxillary sinuses (No. of patients)
64 (100%)
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Septal discontinuity (No. of patients)
Radiological analysis
Pre-operative Lund-Mackay Score=0 (No. of sinuses)
116 (90.6%)
Pre-operative Lund-Mackay Score=1 (No. of sinuses)
8 (6.25%)
Pre-operative Lund-Mackay Score=2 (No. of sinuses)
4 (3.15%)
Post-operative Lund-Mackay Score=0 (No. of sinuses)
93 (72.7%)
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20 (15.6%)
Post-operative Lund-Mackay Score=2 (No. of sinuses)
15 (11.7%)
62 (96.9%)
Pre-operative SNOT-20 between 11 and 40
2 (3.1%)
Pre-operative SNOT-20 between 41 and 70
0
Pre-operative SNOT-20 between 71 and 100
0
Post-operative SNOT-20 between 0 and 10
53 (82.8%)
Post-operative SNOT-20 between 11 and 40
10 (15.6%)
Post-operative SNOT-20 between 41 and 70
1 (1.6%)
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Clinical Analysis
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Table 3: Patients’ pre- and post-procedure Lund-Mackay Score (LMS)
116 (90.6%)
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Totally radiolucent (LMS=0)
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Pre-op N° of Sinuses
p-values Post-op N° of Sinuses (Fisher exact test)
93 (72.7%)
0.0003
Mucosal thickening (LMS=1)
8 (6.25%)
20 (15.6%)
0.026
Completely opaque (LMS=2)
4 (3.15%)
15 (11.7%)
0.015
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Table 4: The SNOT-20 scores of the patients studied
Number of patients Snot-20 Score
Post-operative
(Fisher exact test)
53
0.009
2
10
0.03
41-69
0
1
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70-100
0
0
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Number of patients
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Kaplan-Meier Survival Analysis of Sinusitis following One-piece and Multi-segment Le Fort I (LF1) Osteotomy N° one-piece
Survival (%)
N° multi-
Survival (%)
p.
segment LF1
LF1 at risk (months)
(Mantel-
at risk
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22
100
41
100
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22
100
41
100
12
22
100
41
18
21
100
28
24
17
100
30
14
94.1 ± 5,7
36
9
86.9 ± 8,7
42
5
74.5 ± 13,7
48
4
54
3
60
2
100
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91.8 ±4,6
91.8 ±4,6
17
83.1 ± 7,2
12
78.2 ± 8,3
11
78.2 ± 8,3
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24
74.5 ± 13,7
5
67.1 ± 12,6
55.9 ± 19,1
4
67.1 ± 12,6
55.9 ± 19,1
3
67.1 ± 12,6
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0
0.74
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Fig. 1. Volumetric analysis, bidimensional view Fig. 2. Volumetric analysis, sinus volume
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Figure legends
Fig. 3. Radiological findings: post-operative CT scan displaying interruption of the medial walls Fig. 4. Radiological findings: post-operative CT scan displaying discontinuity of the nasal septum Fig. 5. Lund-Mackay CT system: a score of 1 and 0 of the right and left ostiomeatal complex.
Fig. 7. Average volume variation
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Fig. 6. Lund-Mackay CT system: a score of 2 of the right and left ostiomeatal complex.
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Fig. 8. Kaplan-Meier Survival Analysis for Sinusitis in One-piece and Multi-segment Le Fort I Osteotomy
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S0278-2391(15)01369-5
DOI:
10.1016/j.joms.2015.10.006
Reference:
YJOMS 56999
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 2 March 2015 Revised Date:
30 September 2015
Accepted Date: 7 October 2015
Please cite this article as: Nocini P, D’Agostino A, Trevisiol L, Favero V, Pessina M, Procacci P, Is Le Fort I Osteotomy Associated with Maxillary Sinusitis?, Journal of Oral and Maxillofacial Surgery (2015), doi: 10.1016/j.joms.2015.10.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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IS LE FORT I OSTEOTOMY ASSOCIATED WITH MAXILLARY SINUSITIS?
NOCINI PF1, D’AGOSTINO A2, TREVISIOL L2, FAVERO V3, PESSINA M3, PROCACCI P4 1
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MD, DDS, PROFESSOR, CHIEF, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA 2
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MD, ASSOCIATE PROFESSOR, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA 3
MD, MAXILLO-FACIAL SURGEON, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA
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CORRESPONDING AUTHOR:
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PROF. LORENZO TREVISIOL
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MD, ASSISTANT PROFESSOR, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA
DEPARTMENT OF SURGERY, SECTION OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF VERONA
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POLICLINICO “GIOVANNI BATTISTA ROSSI” PIAZZALE LUDOVICO ANTONIO SCURO, 10 37134 VERONA – ITALY
E-MAIL: [email protected] PHONE: +390458124251 FAX: +390458027437
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IS LE FORT I OSTEOTOMY ASSOCIATED WITH MAXILLARY SINUSITIS?
Abstract Purpose: The purpose of this study was to investigate the association between Le Fort I osteotomy and anatomic, radiological, and symptomatic modifications of the maxillary sinus.
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Materials/Methods: Subjects who underwent LeFort I osteotomy between January 2008 and December 2013 were enrolled in a retrospective cohort study. The eligibility criteria were a Cone Beam Computed Tomography (CBCT) scan taken before and 12-24 months after the procedure was carried out. Its exclusion criteria were: unavailability of CBCTs, use of tobacco, previous orthognathic procedures. The primary predictor variable was time (pre- vs. post-operative). The primary outcome variables were sinus volume, mucosal thickening, iatrogenic alterations in sinus anatomy, and rhinosinusitis symptoms evaluated using the Sino-Nasal Outcome Test (SNOT-20). Descriptive statistics were computed for each variable and paired analyses were used to compare pre- and post-operative values.
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Results: Sixty-four subjects [mean age 27; 59.4% female; median follow-up time - range 13 to 66 months, length 32.4 months)] were studied. Post-operatively, 1.6% of the sample (0% preoperatively) had moderate-to-severe and 15.6% (3.1% preoperatively) had mild-to-moderate sinusitis symptoms. The rest of the sample presented mild to no symptoms. The increase in SNOT scores after surgery was statistically significant (p=0.016). Radiological evidence of post-operative inflammatory processes affecting the paranasal sinuses was found in 27.3% of the sinuses (9.4% preoperatively). The post-operative LundMackay scores were signficantly higher (p=0.0005). There was a 19% decrease in the mean post-operative sinus volume and a 37% incidence of iatrogenic injury.
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Conclusions: Study results indicate that Le Fort I osteotomies can have an important impact on sinus health. The post-operative radiological evidence of maxillary sinus inflammatory processes and incidence of rhinosinusitis symptoms and iatrogenic damage in these patients lead us to conclude that CBCTs and SNOT20 questionnaires should be used routinely during post-operative monitoring. Larger long-term studies are warranted to clarify post-operative outcomes/complications.
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Keywords: Le Fort I osteotomy, sinusitis, upper airways
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Introduction
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The impact of orthognathic surgery on the anatomy and function of the upper airways has been studied extensively (1). It has been seen that both linear and rotational movements induce changes to the soft tissues of the pharynx and of the oral cavity and can have a dramatic impact on the upper airway space; maxillomandibular advancement has also proven to be a valid treatment option for obstructive sleep apnea syndrome (OSAS) (2) (3) (4) (5) (6) (7) (8) (9) (10). Despite these considerations, the effect of Le Fort I osteotomy on the anatomy and function of the maxillary sinuses is still not routinely assessed pre-, periand post-operatively in patients who undergo orthognathic surgery. Although the estimated prevalences of rhinosinusitis symptomatology (11) and variations of the paranasal sinuses are high, little is known about the real impact that they have on the outcome of orthognathic surgical procedures. This may in part be explained by the fact that a relatively low rate of complications has been reported during the immediate post-operative period (12). Acute sinusitis, for example, is an uncommon although possible complication following Le Fort I osteotomy (13). There are several surgery-related factors that may induce maxillary sinus pathologies, and conversely, although infrequent, surgery-induced modifications of the anatomy and physiology of the maxillary sinuses may play a role in outcomes such as delayed consolidation of the osteotomy, hardware infections, or post-operative bleeding (14) (15).
Materials and Methods
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Study design
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The investigators hypothesized that Le Fort I osteotomy could have a substantial impact on maxillary sinus physiology especially with regard to iatrogenic alterations in normal anatomy that may persist following the procedure. More specifically, the study evaluated pre- and post-operative clinical and radiological signs of rhinosinusitis using Cone-Beam Computed Tomography (CBCT) scans and the Sino-Nasal Outcome Test (SNOT-20) in a relatively large group of patients who underwent Le Fort I osteotomy.
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A longitudinal retrospective study was designed to investigate anatomical, radiological, and symptomatic modifications involving the maxillary sinus following Le Fort I osteotomy. An electronic search of all patients who underwent orthognathic surgery at the Oral and Maxillofacial Surgery Section of the University Hospital of Verona between January 2008 and December 2013 was carried out. The predetermined inclusion criteria were: having undergone a Le Fort I osteotomy for the first time between January 2008 and December 2013, possession of a pre-operative CBCT (carried out using a NewTom 3G device; QR srl – Verona, Italy) and a post-operative scan taken 12 to 24 months later. The study’s exclusion criteria were: lack of medical records, tobacco use, and/or having undergone other previous orthognathic surgical procedures. The CBCT, which generates 3-D images of dental structures, soft tissues, nerve paths, and bone in the craniofacial region, was acquired while the patient maintained a natural head position. Scans were taken with a single rotation of the device; the dose uptake for each patient was approximately 59μSv. The preoperative CT scan was performed a week before surgery was carried out. Only CT scans carried out 12 to 24 months following surgery were considered acceptable for the purposes of our study.
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The type of surgical intervention (one-piece or multi-segment Le Fort I osteotomy) that was planned depended on each patient’s specific deformity. All of the patients underwent fixation with titanium miniplates and wires. All the procedures were performed by the same surgeons (A.D’A. and L.T.). The radiological and clinical analyses were performed by P.F.N. and V.F. The study was approved by the Ethics Committee of the University Hospital of Verona, and all the patients gave written consent agreeing to participate in the study.
Study Variables
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The primary predictor variable was time. The patients were evaluated pre-operatively a week before the procedure was carried out and post-operatively approximately 12 to 24 months later. Patients’ gender, age, and the duration of the follow-up were registered. The type of dentoskeletal deformity each patient presented and the type of Le Fort I osteotomy (one-piece or multi-segment) that was planned and carried out were recorded. As far as volumetric analysis was concerned, the datasets were processed using the “Dolphin 3D” software (version 11.5, Dolphin Imaging, Chatsworth, California, USA), a powerful tool that facilitates processing 3-D data. Boundary lines were drawn surrounding the sinus cavity in the axial, coronal, and sagittal views to measure the individual volumes within the software. Seed points were then placed within the sinus cavities and boundaries until the entire sinus was included. Sinus volume was then generated by clicking the "Update Volume" tab. Pre- and post-operative maxillary sinus volumes were determined (Fig. 1 and 2). The software allowed us to calculate the air volume inside the sinus cavities or the residual space excluding hypertrophic inflammatory mucosal thickening. With regard to morphological alterations, each patient’s pre- and post-operative CBCT scans were analyzed to detect and evaluate anatomical defects or surgery-induced alterations that could lead to paranasal homeostasis disruption (Figs. 3 and 4). The analysis focused, in particular, on interruption or deviation of the septum, discontinuities in the sinus walls, and protrusion of hardware into the sinuses.
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The Lund-Mackay rhinological staging scale (LMS), a widely used system to assess paranasal sinus abnormalities visible on CT scans, was utilized to grade the patients’ scans (16) (17). The scale analyzes the severity of mucosal thickening or of fluid retention of each cavity (maxillary, frontal, sphenoid, anterior ethmoid and posterior ethmoid) and of the osteomeatal complex, that is six sites on each side. Each sinus is scored a 0 (no abnormality), 1 (partial opacification), or 2 (total opacification), while the ostiomeatal complex is scored either a 0 or 2 (for presence or absence of disease). Scores range from 0-24. (Figs. 5 and 6) Pre-operatively and approximately one year after surgery the patients also completed the Sino-Nasal Outcome Test (SNOT) questionnaire (Table 1). The SNOT-20, which is a validated patient-reported measure of sino-nasal conditions, is one of the most widely adopted tools evaluating a range of health and quality of life variables linked to rhinosinusitis issues (18). Each of its twenty items receives a score ranging from 0 (no limitation) to 5 (extreme limitation). The final overall score can fall between 0 and 100. Higher scores represent worse symptoms and poorer quality of life; lower scores represent less symptoms and better quality of life. A score between 0 and 10 indicates no or minimal problems; a score between 11 and 40 indicates mild to moderate ones; a score between 41 and 70 indicates moderate to severe ones; a score above 70 is considered indicative of severe or critical conditions necessitating the attention of a specialist for possible surgical intervention.
ACCEPTED MANUSCRIPT Outcome variables The main outcome variables were variations in the maxillary sinus volume, alterations in morphological features consequent to surgery, and radiological evidence and/or symptoms or signs of rhinosinusitis. Data analysis
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MedCalc statistical software (MedCalc Software bvba, Ostend, Belgium) was used for statistical analyses. The D’Agostino-Pearson normality test was used to assess the normality of data regarding sinus volumes and the Lund-Mackay scores were used to assess chronic rhinosinusitis. A normal distribution was found for the former but not for the latter. The paired sample t-test was used to analyze the differences in sinus volumes. The independent-samples t-test was used to evaluate the differences in volume variations in the patients who underwent a one-piece or multi-segment osteotomy. The Wilcoxon signed rank test for dependent variables was used to assess differences between pre- and post-operative Lund-Mackay CT scores. The Mann-Whitney test for independent samples was used to evaluate the differences in the postoperative Lund-Mackay scores in the two groups of patients (those who underwent one-piece and multisegment osteotomies). In all cases, the level of significance was set at p<0.05. The Kaplan-Meier survival analysis was performed to examine differences in the prevalence of maxillary symptomatic sinusitis (SNOT20 >20) during the follow-up between the two patient groups.
Results
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Volumetric analysis
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Out of the 243 patients who underwent a Le Fort I osteotomy between January 2008 and December 2013 at our institution, only 64 met the study’s inclusion criteria. Thirty-six patients were excluded because of use of tobacco. Twelve were excluded because they had undergone previous orthognathic surgical procedures. Finally, 131 patients were excluded because they were not in possession of pre- and/or postoperative CBCT scans. Patients’ ages ranged between 17 and 47 years (mean value= 27.06; mode=19). Thirty-eight (59%) of the patients were females and 26 (41%) were males. Forty patients presented with class III dentoskeletal deformities; the remaining 24 presented with class II dentoskeletal deformities. Twenty-two patients underwent one-piece and 42 multi-segment Le Fort I osteotomy. (Table 2) The mean duration of the follow-up was 32.4 months (range 13-66 months).
The mean pre-operative maxillary sinus volume was 16947.14 ± 5973.44 mm3, and the mean postoperative value was 13675.34 ± 5875.38 mm3. The mean difference was 3271.80 ± 4806.24 mm3, corresponding to 19% of the initial volume. The difference proved to be statistically significant (p<0.0001). With regard to the 22 patients who underwent a one-piece Le Fort I osteotomy, the mean pre-operative value was 15061.11 ± 4352.34 mm3 and the post-operative value was 11182.64 ± 5792.20 mm3, corresponding to a mean volume decrease of 3878.48 ± 5289.10 mm3 (26% of the initial volume). The difference proved to be statistically significant (p<0.0001). The mean pre-operative value of the 42 patients who underwent a multi-segment Le Fort I osteotomy was 17935.06 ± 6473.83 mm3 and the post-operative one was 14981.05 ± 5515.39 mm3. The volume decrease in this group was 2954.01 ± 4533.82 mm3 (16% of the initial volume) (Fig. 7). The difference was statistically significant (p<0.0001). The difference in sinus volume variations between the two groups, which was analyzed using an independent- samples t-test, was not statistically significant (p=0.4).
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Several alterations of the nasal cavities and the paranasal sinuses were noted during the post-operative radiological evaluation. An analysis of the post-operative CBCT scans uncovered a loss of continuity of the lateral nasal wall causing an iatrogenic communication between the nasal cavity and the maxillary sinus in 13 patients (20.3%). Six patients (9.4%) showed incomplete healing of the nasal septum with osteocartilaginous deficits. Five patients (7.8%) showed marked deviated nasal septums not noted prior to surgery. Hardware passed through the bony walls into the sinus cavity in all the patients. Radiological analysis
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Coronal CT scans of patients’ sinuses were graded using the Lund-Mackay system. At the pre-operative evaluation, 4 patients presented mucosal thickening in bilateral maxillary sinuses (LMS=1) and 2 presented bilateral maxillary sinus opacification (LMS=2). Post-operatively, 3 out of the 4 patients suffering from mucosal thickening showed radiological improvement; the 4th patient showed a worse condition. The 2 patients with sinus opacification also showed an improvement. Overall, 12 out of the 64 patients showed post-operative evidence of sinus opacification (3 bilateral and 9 monolateral), and 20 showed postoperative mucosal thickening (Table 3). The post-operative Lund-Mackay scores were higher and the difference with respect to the pre-operative ones was statistically significant (p=0.0005).
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The difference in the post-operative Lund-Mackay scores in the patients who underwent one-piece or multi-segment Le Fort I osteotomy was analyzed using the Mann-Whitney test for independent samples; the scores were found to be higher in the former (p=0.035). One of the 22 patients who underwent a onepiece Le Fort I osteotomy presented pre-operative evidence of sinusitis. One year after surgery, that patient showed a relevant, although incomplete, improvement and only mild residual mucosal thickening. Six patients presented pre-operatively with sinusitis (3 bilateral and 3 unilateral). Also in this case, the improvement in the Lund-Mackay score was significant (p=0.015).
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Clinical analysis
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One of the 42 patients who underwent multi-segment Le Fort I osteotomy presented pre-operative total sinus opacification, which disappeared after surgery. Six patients showed post-operative unilateral sinusitis, none presented post-operative bilateral sinusitis. Also in this case, improvement in the Lund-Mackay score was statistically significant (p=0.013).
Sixty-two out of the 64 patients had a pre-operative SNOT 20 score between 0 and 10, and 2 had a score between 11 and 20 (Table 4). None of the patients thus needed to consult with a specialist for rhinosinusitis before orthognathic surgery. One year after surgery, 53 of the patients had a score below 10, and ten had a score between 11 and 40, that is to say, a moderate rhinosinusitis condition. One patient had a score of 67 indicating a moderate to severe problem. Although not suffering from severe symptoms (total SNOT 20 score=22), one patient reported occasional episodes of “airplane headache.” The increase in SNOT scores after surgery was statistically significant (p=0.016). The Kaplan-Meier (Table 5 and Fig. 8) disease free survival rates (with associated 95% CIs) were 55.9% ± 19.1%, respectively, in the one-piece Le Fort I group and 67.1% ± 12.6% in the multi-segment Le Fort I group; the differences between the two groups (p=.74) were not statistically significant
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Discussion
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Orthognathic surgery is one of the main subspecialties of oral and maxillofacial surgery, and numerous procedures are currently performed on a routine worldwide basis. While diverse studies have assessed long-term clinical outcomes and the complications linked to this kind of surgery (19) (20) (21) (22), there is a paucity of material concerning the anatomical and symptomatic alterations of the nasal cavity and paranasal sinuses implicated in orthognathic procedures. The current study set out to examine the anatomical, symptomatic, and radiological alterations in the maxillary sinuses following Le Fort I osteotomies.
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Although the estimated prevalence of sinusitis in the United States ranges from 2 to 16%, definitive diagnostic criteria for sinusitis remain transient and controversial. Some suggest that chronic rhinosinusitis should be defined as the group of disorders characterized by inflammation of the mucosal lining of the nasal passage and paranasal sinuses lasting at least 12 consecutive weeks. Signs of inflammation include nasal drainage, nasal polyps, polypoid swelling, edema or erythema of the middle meatus or CT findings of isolated or diffuse mucosal thickening, bone changes, air-fluid level. In addition, symptoms consistent with rhinosinusitis such as those outlined in the SNOT-20 questionnaire should also be taken into consideration in order to classify the disease as symptomatic or asymptomatic (23).
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That said, the data emerging from our study highlighted a high incidence of post-operative inflammatory processes and iatrogenic alterations that were frequently asymptomatic and could easily be misdiagnosed in patients undergoing the procedure. Following orthognathic surgery, patients are normally monitored to evaluate the occlusal plane and post-surgical joint stability. The CBCT allowed us to focus on traditional dentoskeletal factors as well as to analyze elements that influence sinus homeostasis. When used with appropriate precautionary measures, CBCT was found to be a safe, reliable tool to post-operatively monitor patients to detect signs of rhinosinusitis complications.
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Of the 64 patients meeting the study’s inclusion criteria, 40 presented with Class III and 24 with Class II dentoskeletal deformities. Twenty-two underwent one-piece and 42 multi-segment Le Fort I osteotomies. Analysis of the patients’ data showed that most registered a decrease in sinus volume. Of the 128 sinuses considered, only 17 (13.28%) showed increased volume after surgery: 3 of these had total sinus opacification and 3 had mucosal thickening. This means that the calculated volume corresponded to the minimal residual sinus cavity air volume. These conditions were improved after surgery as there was an increase in sinus cavity air volume. Out of the 122 healthy pre-operative sinuses, 11 (9%) showed a real increase in volume, and 111 (91%) showed decreased air volume. The mean decrease corresponded to 27% of the preoperative volume. All the patients underwent upper jaw advancement: 36 were impacted and 28 were lowered. The decrease in sinus volume can be explained by advancement movements leading to a modification in the posterior maxillary sinus wall with a resulting alteration of the sinus cavity morphology. Impaction in addition to advancement enhances the decrease in sinus volume by lowering the overall height of the sinus walls. Morphological evaluation detected iatrogenic alterations in a relevant percentage of the patients. The most frequent iatrogenic alterations were septal deviation or discontinuity, turbinate hypertrophy, discontinuities of the sinus wall, and hardware infections. Although these alterations are often misdiagnosed by clinicians, together with mucociliary clearance and debridement of healthy inferior sinus mucosa, they may play a role in the onset of rhinosinusitis pathologies. This possibility should be taken into
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consideration when the surgeon is deciding the procedure that is most appropriate for a particular patient. Subspinal osteotomy and stabilization with sutures should always be adopted, and both pre-operative septum deviations and those consequent to maxillary impaction should be corrected by septoplasty. Turbinoplasty can be considered in the event of turbinate hypertrophy or, once again, in the event of impaction. An exception should be made for bone grafting or pre-operative mucosal hypertrophy, in which case the sinus mucosa should be preserved after osteotomy. Even if protrusion of hardware into the sinus, which was detected in all the patients examined, is somewhat unavoidable, it does not seem to necessarily trigger an onset of post-operative sinusitis. In our opinion, short screws should be used to avoid a potential contributing factor to sinus homeostasis disruption.
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CBCT analysis made it possible for us to assess sinus opacities. The results showed that 2 patients with preoperative sinusitis had entirely recovered and presented post-operative sinus radiolucency after one year. Pre-operatively four patients presented mild mucosal thickening; the condition improved after surgery in three and worsened in one. Out of the 64 patients studied, 12 (18.75%) developed radiological evidence of sinusitis one year after surgery. Fifteen out of 128 sinuses obtained a Lund-Mackay score of 2, while 20, showing only mucosal thickening, received a score of 1. Overall 30% of the patients showed post-operative inflammatory processes affecting the paranasal sinuses. As it is often asymptomatic, the complication is frequently misdiagnosed and may lead to the development of more severe conditions. The patients who underwent a multi-segment osteotomy presented with higher Lund-Mackay scores than those undergoing the one-piece type. It is not clear if maxillary sinus volume reduction is responsible for the onset of rhinosinusitis pathologies.
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Analysis of the SNOT-20 questionnaires demonstrated that the rate of symptomatic patients was relatively low in the total patient group (3.13%), but it was higher in the subgroup with radiological signs (16.7%). Our data are consistent with those outlined in the literature (0.24 to 20%). The type of osteotomy (onepiece vs. multi-segment osteotomy) does not seem to affect the onset of sinus pathologies. We can deduce from these data that there is no absolute contraindication to Le Fort I osteotomy in patients suffering from pre-operative sinusitis as long as it is not associated with symptoms; in that case, the rhinosinusitis issues should be addressed before the procedure is undertaken. The patients who showed an improvement in rhinosinusitis status after orthognathic surgery probably benefitted from the procedure and from the removal of the inflamed tissue from the lower part of the sinus which had a positive effect on the airflow within the maxillary sinus. Although epidemiological data concerning sinusitis on a global scale does not seem to be particularly accurate on this point, our study found a salient incidence of mostly asymptomatic, postoperative inflammatory processes affecting the maxillary sinuses. To our knowledge, no studies describing medium- or long-term symtpomatic alterations of the paranasal sinuses following a Le Fort I osteotomy can be found in the literature (15) (24) (25). This can partially be explained by the inadequacy of radiological assessments. As most orthognathic procedures are planned on the basis of 2-dimensional imaging, this has limited the possibility of detecting rhinosinusitis pathologies. The most significant works focusing on this topic were studies by Pereira-Filho et al. (26) and by Valstar et al. (27) The former used a brief questionnaire, radiographs(Waters views), and nasal endoscopy before surgery and 6 to 8 months after to evaluate the incidence of maxillary sinusitis in 21 adult patients who underwent Le Fort I osteotomy. The study’s results, which uncovered a 4% incidence of maxillary sinusitis as a post-operative complication, suggested that orthognathic surgery is not directly linked to the onset of chronic or subacute sinusitis. The latter study used validated questionnaires focusing on sinonasal complaints (RSOM-31 and VAS score), nasal endoscopy, peak nasal inspiratory flow (PNIF) and a computed tomography (CT) scan to evaluate maxillary sinus and nasal ventilation in a group of 20 patients. The
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Our study, which is a preliminary report based on a population of 64 patients, is, as far as we are aware, the largest to investigate post-operative complications linked to Le Fort I osteotomy. None of the references cited here provided comprehensive data beyond a year after the operation, a time period which we are convinced is not sufficient to detect procedure-related rhinosinusitis complications. In fact, a transient rhinosinusitis appears to be a direct consequence of the anatomical modification (28). As far as the diagnostic process is concerned, unlike others, our study chose to use CBCT scan and the SNOT 20 questionnaire with no endoscopy. Our choice was based on the assumption that endoscopy is best utilized in patients affected with nasal discharge or, in any case, with symptomatic sinusitis. We are of the opinion that monitoring these patients for periods longer than a year and the routine use of CBCT, both novel aspects of the current investigation, enabled us to efficaciously detect pathological conditions that might otherwise have been mis- or under-diagnosed.
Conclusion
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Although post-operative rhinosinusitis is often asymptomatic and patients are frequently misdiagnosed, our results show that there is a high incidence of complications in patients who undergo Le Fort I osteotomy. Our findings also demonstrate that clinical follow-up of orthognathic patients should focus not only on the occlusal plane and post-surgical stability of the maxilla but also on factors that may interfere with sinus homeostasis. When used with appropriate precautionary measures, CBCT proved to be a safe, reliable long-term tool to monitor these patients in the effort to detect signs of rhinosinusitis complications. Future studies can assess the impact that variations in the surgical technique may have on patients undergoing Le Fort I osteotomy.
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1. Mattos CT, Vilani GN, Sant'Anna EF, Ruellas AC, Maia LC. Effects of orthognathic surgery on oropharyngeal airway: a meta-analysis. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1347-56. 2. Lye KW. Effect of orthognathic surgery on the posterior airway space (PAS). Ann Acad Med Singapore. 2008 Aug;37(8):677-82. 3. Stellini E, Stomaci D, Stomaci M, Petrone N, Favero L. Fracture strength of tooth fragment reattachments with postpone bevel and overcontour reconstruction. Dent Traumatol. 2008 Jun;24(3):283-8. 4. Boyd SB. Management of obstructive sleep apnea by maxillomandibular advancement. Oral Maxillofac Surg Clin North Am. 2009 Nov;21(4):447-57. 5. Favero L, Giagnorio C, Cocilovo F. Comparative analysis of anchorage systems for micro implant orthodontics. Prog Orthod. 2010;11(2):105-17. 6. Maurer JT. Surgical treatment of obstructive sleep apnea: standard and emerging techniques. Curr Opin Pulm Med. 2010 Nov;16(6):552-8. 7. Susarla SM, Thomas RJ, Abramson ZR, Kaban LB. Biomechanics of the upper airway: Changing concepts in the pathogenesis of obstructive sleep apnea. Int J Oral Maxillofac Surg. 2010 Dec;39(12):1149-59. 8. Jacobson RL, Schendel SA. Treating obstructive sleep apnea: the case for surgery. Am J Orthod Dentofacial Orthop. 2012 Oct;142(4):435, 437, 439, 441-2. 9. Varghese R, Adams NG, Slocumb NL, Viozzi CF, Ramar K, Olson EJ. Maxillomandibular advancement in the management of obstructive sleep apnea. Int J Otolaryngol. 2012;2012:373025. 10. Faria AC, da Silva-Junior SN, Garcia LV, dos Santos AC, Fernandes MR, de Mello-Filho FV. Volumetric analysis of the pharynx in patients with obstructive sleep apnea (OSA) treated with maxillomandibular advancement (MMA). Sleep Breath. 2013 Mar;17(1):395-401. 11. Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-34. 12. Morris DE, Lo LJ, Margulis A. Pitfalls in orthognathic surgery: avoidance and management of complications. Clin Plast Surg. 2007 Jul;34(3):e17-29. 13. Steel BJ, Cope MR. Unusual and rare complications of orthognathic surgery: a literature review. J Oral Maxillofac Surg. 2012 Jul;70(7):1678-91. 14. Perko M. Maxillary sinus and surgical movement of maxilla. Int J Oral Surg. 1972;1(4):177-84. 15. Bell CS, Thrash WJ, Zysset MK. Incidence of maxillary sinusitis following Le Fort I maxillary osteotomy. J Oral Maxillofac Surg. 1986 Feb;44(2):100-3. 16. Sharp HR, Rowe-Jones JM, Mackay IS. The outcome of endoscopic sinus surgery: correlation with computerized tomography score and systemic disease. Clin Otolaryngol Allied Sci. 1999 Feb;24(1):39-42. 17. Basu S, Georgalas C, Kumar BN, Desai S. Correlation between symptoms and radiological findings in patients with chronic rhinosinusitis: an evaluation study using the Sinonasal Assessment Questionnaire and Lund-Mackay grading system. Eur Arch Otorhinolaryngol. 2005 Sep;262(9):7514. 18. Lachanas VA, Woodard TD, Antisdel JL, Kountakis SE. Sino-nasal outcome test tool assessment in patients with chronic rhinosinusitis and obstructive sleep apnea. ORL J Otorhinolaryngol Relat Spec. 2012;74(5):286-9. 19. Panula K, Finne K, Oikarinen K. Incidence of complications and problems related to orthognathic surgery: a review of 655 patients. J Oral Maxillofac Surg. 2001 Oct;59(10):1128-36; discussion 1137.
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20. Bailey L, Cevidanes LH, Proffit WR. Stability and predictability of orthognathic surgery. Am J Orthod Dentofacial Orthop. 2004 Sep;126(3):273-7. 21. D'Agostino A, Trevisiol L, Gugole F, Bondí V, Nocini PF. Complications of orthognathic surgery: the inferior alveolar nerve. J Craniofac Surg. 2010 Jul;21(4):1189-95. 22. Bacci C, Berengo M, Favero L, Zanon E. Safety of dental implant surgery in patients undergoing anticoagulation therapy: a prospective case-control study. Clin Oral Implants Res. 2011 Feb;22(2):151-6. 23. Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. Review. 24. Moses JJ, Lange CR, Arredondo A. Endoscopic treatment of sinonasal disease in patients who have had orthognathic surgery. Br J Oral Maxillofac Surg. 2000 Jun;38(3):177-84. 25. Williams BJ, Isom A, Laureano Filho JR, O'Ryan FS. Nasal airway function after maxillary surgery: a prospective cohort study using the nasal obstruction symptom evaluation scale. J Oral Maxillofac Surg. 2013 Feb;71(2):343-50. 26. Pereira-Filho VA, Gabrielli MF, Gabrielli MA, Pinto FA, Rodrigues-Junior AL, Klüppel LE, Passeri LA. Incidence of maxillary sinusitis following Le Fort I osteotomy: clinical, radiographic, and endoscopic study. J Oral Maxillofac Surg. 2011 Feb;69(2):346-51. 27. Valstar MH, Baas EM, Te Rijdt JP, De Bondt BJ, Laurens E, De Lange J. Maxillary sinus recovery and nasal ventilation after Le Fort I osteotomy: a prospective clinical, endoscopic, functional and radiographic evaluation. Int J Oral Maxillofac Surg. 2013 Nov;42(11):1431-6. 28. Garg S, Kaur S. Evaluation of Post-operative Complication Rate of Le Fort I Osteotomy: A Retrospective and Prospective Study. J Maxillofac Oral Surg. 2014 Jun;13(2):120-7.
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Tables Table 1: SNOT-20 Questionnaire 1. Need to blow nose
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4. Cough 5. Postnasal discharge (dripping at the back of your throat) 6. Thick nasal discharge (snot) 7. Ear fullness 8. Dizziness
11. Difficulty in falling asleep 12. Waking up at night 13. Lack of a good night’s sleep 14. Waking up tired
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15. Fatigue 16. Reduced productivity
17. Reduced concentration
18. Frustrated/restless/irritable 19. Sad
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10. Facial pain/pressure
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9. Ear pain
20. Embarassed
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Variables
Results
Men
26 (40.6%)
Women
38 (59.4%)
Age (y) - mean value and range
27.06 (17-47)
Follow-up (m) – mean value and range
32.4 (13-66)
Type of dentoskeletal deformity 24 (37.5%)
Class III
40 (62.5%)
Type of osteotomy One-piece Le Fort I osteotomy
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Class II
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Patients (n=64)
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Multi-segment Le Fort I osteotomy
Volumetric analysis
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Average preoperative maxillary sinus volume (mm3)
Average postoperative maxillary sinus volume (mm3)
Morphologic analysis
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Loss of continuity of the lateral nasal wall (No. of patients)
42 (65.6%)
16947.14 ± 5973,44 13675.34 ± 5875,38
13 (20.3%) 6 (9.4%)
Septal deviations (No. of patients)
5 (7.8%)
Protrusion of hardware into the maxillary sinuses (No. of patients)
64 (100%)
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Septal discontinuity (No. of patients)
Radiological analysis
Pre-operative Lund-Mackay Score=0 (No. of sinuses)
116 (90.6%)
Pre-operative Lund-Mackay Score=1 (No. of sinuses)
8 (6.25%)
Pre-operative Lund-Mackay Score=2 (No. of sinuses)
4 (3.15%)
Post-operative Lund-Mackay Score=0 (No. of sinuses)
93 (72.7%)
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20 (15.6%)
Post-operative Lund-Mackay Score=2 (No. of sinuses)
15 (11.7%)
62 (96.9%)
Pre-operative SNOT-20 between 11 and 40
2 (3.1%)
Pre-operative SNOT-20 between 41 and 70
0
Pre-operative SNOT-20 between 71 and 100
0
Post-operative SNOT-20 between 0 and 10
53 (82.8%)
Post-operative SNOT-20 between 11 and 40
10 (15.6%)
Post-operative SNOT-20 between 41 and 70
1 (1.6%)
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Clinical Analysis
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Table 3: Patients’ pre- and post-procedure Lund-Mackay Score (LMS)
116 (90.6%)
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Pre-op N° of Sinuses
p-values Post-op N° of Sinuses (Fisher exact test)
93 (72.7%)
0.0003
Mucosal thickening (LMS=1)
8 (6.25%)
20 (15.6%)
0.026
Completely opaque (LMS=2)
4 (3.15%)
15 (11.7%)
0.015
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Table 4: The SNOT-20 scores of the patients studied
Number of patients Snot-20 Score
Post-operative
(Fisher exact test)
53
0.009
2
10
0.03
41-69
0
1
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70-100
0
0
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Number of patients
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Kaplan-Meier Survival Analysis of Sinusitis following One-piece and Multi-segment Le Fort I (LF1) Osteotomy N° one-piece
Survival (%)
N° multi-
Survival (%)
p.
segment LF1
LF1 at risk (months)
(Mantel-
at risk
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100
41
100
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22
100
41
100
12
22
100
41
18
21
100
28
24
17
100
30
14
94.1 ± 5,7
36
9
86.9 ± 8,7
42
5
74.5 ± 13,7
48
4
54
3
60
2
100
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91.8 ±4,6
91.8 ±4,6
17
83.1 ± 7,2
12
78.2 ± 8,3
11
78.2 ± 8,3
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74.5 ± 13,7
5
67.1 ± 12,6
55.9 ± 19,1
4
67.1 ± 12,6
55.9 ± 19,1
3
67.1 ± 12,6
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Fig. 1. Volumetric analysis, bidimensional view Fig. 2. Volumetric analysis, sinus volume
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Figure legends
Fig. 3. Radiological findings: post-operative CT scan displaying interruption of the medial walls Fig. 4. Radiological findings: post-operative CT scan displaying discontinuity of the nasal septum Fig. 5. Lund-Mackay CT system: a score of 1 and 0 of the right and left ostiomeatal complex.
Fig. 7. Average volume variation
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Fig. 6. Lund-Mackay CT system: a score of 2 of the right and left ostiomeatal complex.
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Fig. 8. Kaplan-Meier Survival Analysis for Sinusitis in One-piece and Multi-segment Le Fort I Osteotomy
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