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Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes Than Closed Treatment: A Systematic Review and Meta-Analysis
Accepted Manuscript Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A Systematic Review And Meta-Analysis Essam Ahmed Al-moraissi, BDS, M.Sc., PhD Edward Ellis, DDS,MS PII:
S0278-2391(14)01534-1
DOI:
10.1016/j.joms.2014.09.027
Reference:
YJOMS 56518
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 2 September 2014 Revised Date:
29 September 2014
Accepted Date: 30 September 2014
Please cite this article as: Al-moraissi EA, Ellis E, Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A Systematic Review And Meta-Analysis, Journal of Oral and Maxillofacial Surgery (2014), doi: 10.1016/j.joms.2014.09.027. 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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Essam Ahmed Al-moraissi1*, BDS, M.Sc., PhD
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Edward Ellis2, DDS,MS
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Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A Systematic Review And Meta-Analysis
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PhD Student ,Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University, Egypt
1
Master degree in oral and maxillofacial surgery , Faculty of Oral and Dental Medicine, Cairo University, Egypt
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1Lecturer, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen
2
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Professor and Chair, Department of Oral and Maxillofacial Surgery, University of Texas Health Science Center, San Antonio, TX
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* Corresponding author: Essam Ahmed Mohammed Al-Moraissi, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen,. [email protected] or [email protected] Phone: 00201141477753, 0096777788939
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Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A
Essam Ahmed Al-moraissi1*,BDS, M.Sc., PhD
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1
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Edward Ellis III, DDS, MS2
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Systematic Review And Meta-Analysis
PhD Student, Department of Oral and Maxillofacial Surgery,
Faculty of Oral and Dental Medicine, Cairo University, Egypt 1
Lecturer, Department of Oral and Maxillofacial Surgery, Faculty
Professor and Chair, Department of Oral and Maxillofacial
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2
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of Dentistry, Thamar University, Yemen
TX
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Surgery, University of Texas Health Science Center, San Antonio,
* Corresponding author: Essam Ahmed Al-Moraissi, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen,. [email protected]; [email protected] Phone: 00201141477753, 0096777788939 1
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Abstract:
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Purpose: The purpose of this study was to identify significant differences in clinical outcomes between open reduction and rigid internal fixation (ORIF) and closed treatment (CT) for adult
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mandibular condylar fractures (MCFs) and also to support or refute the superiority of one method over the other.
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Methods: To address our purpose ,we designed and implemented a systematic review with meta-analysis .A comprehensive electronic search without date and language restrictions was performed in May 2014. The inclusion criteria were studies in humans,
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including randomized or quasi-randomized controlled trials (RCTs), controlled clinical trials (CCTs), and retrospective studies that comparing ORIF to CT with regard to maximal interincisal
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opening (MIO), laterotrusive and protrusive movements, pain, malocclusion, and chin deviation on mouth opening and TMJ
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signs/symptoms for the management of unilateral or bilateral adult MCFs fractures. Meta-analyses were conducted only if there were studies of similar comparisons reporting the same outcome measures. For binary outcomes, we calculated a standard estimation of odds ratio (OR) by the random-effects model if heterogeneity was detected, otherwise a fixed-effect models with a
2
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95% confidence interval (CI) was performed. Weighted mean differences (WMD) or standard mean difference (SMD) were used
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to construct forest plots of continuous data. Results: 23 publications were included: five RCTs, sixteen CCTs and two retrospective studies. Five studies showed a low risk of
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bias, eighteen a moderate risk of bias. There was a statistically significant difference between ORIF and CT with regard to MIO,
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laterotrusive and protrusive movement, malocclusion, pain and chin deviation on mouth opening (P = 0.001, P = 0.001 , P = 0.001, P = 0.001, P = 0.001 and P = 0.05 respectively ). Conclusion: The result of the meta-analysis confirmed that ORIF
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provides superior functional clinical outcomes (subjective and
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objective) than CT in the management of adult MCFs.
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INTRODUCTION The mandible is frequently injured following facial trauma, and 25-40%
of
mandibular
fractures
involve
the
condyle.1-3
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Management of mandibular condylar fractures (MCFs) remains an ongoing matter of controversy in maxillofacial surgery. This
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controversy is reflected in the wide variety of opinions and proposed treatment modalities offered in the literature.
4
For
decades closed treatment (CT) has been the preferred treatment5 because treatment is easier and less invasive, and the results are
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comparable with no surgical complications. However, CT may employ varying periods of intermaxillary fixation (IMF) (0 to 6 weeks) followed by aggressive physiotherapy.6 Also, long-term
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complications like pain, arthritis, malocclusion, deviation of the mandible on opening and closing movements, temporomandibular
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joint (TMJ) dysfunction, facial asymmetry, and ankylosis may occur in condylar injuries treated closed.6,7 If there is severe displacement or dislocation, surgical management seems to be preferred.8,9,10 Open reduction and internal fixation (ORIF) allows anatomical repositioning and immediate functional
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movements of the jaw,11 but has the potential complications of damaging the facial nerve and of forming visible scars.4 With the implementation of rigid internal fixation over the past 30 years,
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indications for surgical treatment of MCFs have broadened. A
review of the literature revealed several studies comparing CT to ORIF in the treatment of MCFs, but there is still a continuing
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debate over how to best manage this type of fracture. Therefore,
the overall goal of this study was to test the null hypothesis of no
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difference between CT and ORIF in adult MCFs against the hypothesis of a difference. The specific aims of this study were : 1) to compare clinical outcomes between ORIF and CT for MCFs and, 2) to support or refute the superiority of one method over the
METHODS:
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Inclusion criteria
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other.
Any randomized or quasi-randomized controlled trials (RCTs),
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controlled clinical trials (CCTs), and retrospective studies that compared the maximal interincisal opening (MIO), laterotrusion, protrusion, pain, malocclusion, chin deviation on mouth opening and the incidence of postoperative complications for patients treated by ORIF or CT for unilateral or bilateral MCFs and reporting were included. 5
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Exclusion criteria were case reports, technical reports, animal studies, in vitro studies, review papers, pediatric or edentulous MCFs patients and studies that did not report data (mean and
comparison group.
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Search methods for identification of studies:
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standard deviation), the outcomes of interest and absence of the
To address the research purpose, the investigators designed and
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implemented a systematic review with meta-analysis. This systematic review and meta-analysis is conducted according to the PRISMA-E 2012 checklist12. A comprehensive electronic search without date and language restrictions was performed in May 2014
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using the following electronic databases: PubMed, Cochrane Database of Systematic Reviews, the Cochrane central register of controlled trials (CENTRAL), EMBASE, MEDLINE, CINAH,
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Electronic Journal Center, using one or combination of the following search terms: "surgical versus nonsurgical treatment in
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mandibular condylar fractures “AND/OR " open versus closed reduction in treatment of unilateral OR bilateral mandibular condylar
process
fractures"
conservative/functional
AND/OR
treatment
of
"surgical
mandibular
versus condylar
/subcondylar fractures"," condylar/masticatory motion after open and closed treatment of mandibular condylar fractures”, clinical outcomes after open versus closed treatment of mandibular 6
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condylar fractures", "surgical complication/occlusal results AND mandibular condylar/diacapitular fractures AND/OR open versus closed approach”. “displaced/dislocated mandibular condylar
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fractures AND surgical versus nonsurgical treatment”
A manual search of oral and maxillofacial surgery-related journals,
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including International Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, Journal of Oral
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and Maxillofacial Surgery, Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontology, Journal of Cranio-Maxillofacial Surgery, Journal of Craniofacial Surgery, Journal of TRAUMA Injury, Infection, and Critical Care and
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Journal of Maxillofacial and Oral Surgery, was also performed. The reference list of the identified studies and the relevant reviews on the subject were also scanned for possible additional studies.
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Moreover, online databases providing information about clinical trials in progress were checked
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(clinicaltrials.gov;www.centerwatch.com/clinicaltrials;www.clinic alconnection.com). Data collection process The authors carefully assessed the eligibility of all studies retrieved from the databases. From the included studies in the final analysis the following data were extracted (when available): authors, year 7
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of publication, study design, number of patients, gender (male: female), mean age in years, follow-up period, MCF fixation method, associated mandibular fractures and outcome variables
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(maximal interincisal opening (MIO), laterotrusive* and protrusive movements, pain, malocclusion, chin deviation on mouth opening,
data was performed.
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Risk of bias in individual studies
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TMJ signs/symptoms). Contact with authors for possible missing
A methodological quality rating was performed by combining the proposed criteria by MOOSE statement,13 STROBE statement,14 and PRISMA,15 in order to verify the strength of scientific
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evidence in clinical decision-making.
The classification of the risk of bias potential for each study was based on the five following criteria: random selection in the
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population, definition of inclusion/exclusion criteria; report of losses to follow-up, validated measurements and statistical
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analysis. A study that included all the criteria mentioned above was classified as having a low risk of bias, a study that did not include one of these criteria was classified as having a moderate risk of bias. When two or more criteria were missing, the study was considered to have a high risk of bias. *
Laterotrusion refers to excursive movement away from side of the condylar fracture
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Meta-analysis Meta-analyses were conducted only if there were studies of similar
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comparisons reporting the same outcome measures. For binary outcomes, we calculated a standard estimation of odds ratio (OR) by the random-effects model if heterogeneity was detected,
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otherwise a fixed-effect models with a 95% confidence interval (CI) was performed. Weighted mean differences (WMD) or
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standard mean difference (SMD) were used to construct forest plots of continuous data. The data were analyzed using the statistical software Review Manager (version 5.2.6, The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen,
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Denmark, 2012). Assessment of heterogeneity
The significance of any discrepancies in the estimates of the
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treatment effects of the different trials was assessed by means of Cochran’s test for heterogeneity and the I² statistic, which
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describes the percentage total variation across studies that is due to heterogeneity rather than by chance. Heterogeneity was considered statistically significant if P < 0.1. A rough guide to the interpretation of I² given in the Cochrane Handbook16 is as follows (1) from 0 to 40% the heterogeneity might not be important, (2) from 30 to 60% may represent moderate heterogeneity, (3) from 50 9
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to 90% may represent the substantial heterogeneity, and (4) from 75 to 100% there is considerable heterogeneity.
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Investigation of publication bias A funnel plot (plot of effect size versus standard error) was drawn. Asymmetry of the funnel plot could indicate publication bias and
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other biases related to sample size, although the asymmetry may also represent a true relationship between trial size and effect size.
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Sensitivity analysis
Where there were sufficient included studies, a sensitivity analysis was performed to assess the robustness of the review results by repeating the analysis after exclusion of studies with a high risk of
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bias. RESULTS
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The study selection process is summarized in Figure 1. The electronic search resulted in 905 entries. Of 905, 143 articles were
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excluded because they were in-vitro studies. After the initial screening of the titles and abstracts, 537 articles were excluded because they were off-topic or duplicated. The full-text reports of the remaining 225 articles led to the exclusion of 202 because they did not meet the inclusion criteria. Thus, a total of 23 publications4,17-38
were
included 10
in
the
review.
Fifteen
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studies17,19,20,22,23,26,28-33,35,36,38 compared CT to ORIF in the management of MCFs with regard to MIO and laterotrusion, Fourteen studies17,19,29,22,23,25,26,29-,33,35,36compared CT to ORIF in studies4,17,18,21,24,25,26,27,29,30,33,34,36,37,38
assessed
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the management of MCFs with regard to protrusion. Sixteen malocclusion
between CT and ORIF. Five studies23,26,31,33,36 investigated pain via
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visual analogue scale (VAS) between CT and ORIF. Lastly, ten studies4,18,20,23,23,25,26,29,30,33 evaluated chin deviation on mouth
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opening between CT and ORIF and five studies4,25,32,33,34 compared CT to ORIF with regard to TMJ pain, tenderness, noise and clicking.
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Characteristics of included studies
Detailed characteristics of the included studies are shown in Table. 1. Five RCTs,26,31,32,33,38 sixteen CCTs,4,17-22,24,25,27,28-30,34-36 and two
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retrospective studies23,37 were included in the meta-analysis and critical appraisal. A total of 1,318 patients were enrolled in 23
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studies4,17-38 comparing surgical (n = 615) versus nonsurgical ( n = 703) treatment in the management of MCFs at follow up periods from 6 months to 3 years. Concerning the surgical technique, for all patients allocated to the CT group, the surgical technique consisted of IMF for a period of 0 to 35 days (according to the study). Either initially or after any 11
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period of IMF, guiding elastics were used for a variable period, to maintain proper occlusion followed by mouth opening exercises and physiotherapy. In the ORIF group, the surgical approaches
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were preauricular, submandibular, transmassetric anterior parotid, retromandibular, or endoscope-assisted intraoral approach. The fractures were stabilized with miniplates or lag screws plus IMF
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with elastics for 3 days or less (according to the study). Postoperative instructions regarding mouth opening exercises and
Risk of bias within studies
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physiotherapy were given to all the patients in both groups.
Concerning the quality assessment of the included studies, five 30,34-37
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studies26,31-33,38 showed a low risk of bias, eighteen studies4,17-25,27showed a moderate risk of bias. The scores are summarized
in Table 2.
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MIO
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Results of individual variables
Fifteen studies17,19,20,22,23,26,28-33,35,36,38 compared MIO between CT (n = 464) and ORIF (n = 332) groups. There was a statistically significant advantage for the ORIF group (fixed: WMD = 3.32 mm, 95% CI, 2.42 to 4.04 mm, P < 0.001). The test of heterogeneity showed no significant heterogeneity (Chi² = 64.61, df = 14 (P < 0.001); I² = 78%). (Fig. 2) 12
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Latrotrusive movement Fifteen
studies17,19,20,22,23,26,28-33,35,36,38
compared
laterotrusive
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excursions between CT (n = 434) and ORIF (n = 338) groups. There was a statistical difference in favor of the ORIF group (fixed: WMD = 1,14 mm, 95% CI, 0.73 to 1.55 mm, P < 0.001).
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The test of heterogeneity showed no significant heterogeneity
Protrusive movement Fourteen
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(Chi² = 44.20, df = 14 (P < 0.001); I² = 68%). (Fig. 3)
studies17,19,29,22,23,25,26,29-33,35,36compared
protrusive
movement between CT (n = 422) and ORIF (n = 328) groups. There was a statistical difference in favor of ORIF (fixed: WMD =
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0,99 mm, 95% CI, 0.70to 1.29 mm, P < 0.001). The test of heterogeneity showed no significant heterogeneity (Chi² = 48.48,
Pain via VAS
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df = 13 (P < 0.001); I² = 73%). (Fig. 4)
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Four studies23,26, 33,36 assessed the pain via visual analogue scale after 6 months (VAS) between CT (n = 155) and ORIF (n = 74) groups. Although pain was less in the ORIF group, it did not reach statistical significance (fixed: SMD = 0.74 mm VAS, 95% CI, 1.07 to 0.41, P = 0.001). There was no heterogeneity (Chi² = 0.25, df = 1 (P <0.62); I² = 0%). (Fig. 5)
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Malocclusion Sixteen studies4,17,18,21,24,25,26,27,29,30,33,34,36,37,38 assessed malocclusion
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between CT (n = 388) and ORIF (n = 388) groups. There was a significant difference in favor of the ORIF group with regard to postoperative malocclusion (fixed: OD = 0.41 , 95% CI, 0. 26to
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0.62 mm, P = 0.001). The test of heterogeneity indicated absence of heterogeneity (Chi² = 10.79, df = 14 (P = 0.70); I² = 0%). The
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OR was 0.41, meaning that the use of the ORIF in the treatment of MCFs decreases the incidence of malocclusion by 59 % compared to using CT. (Fig. 6)
Chin deviation on mouth opening
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Ten studies4,18,20,23,23,25,26,29,30,33 evaluated chin deviation on mouth opening between CT (n = 294) and ORIF (n = 227) groups. There was a significant advantage for the ORIF group in preventing chin
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deviation (fixed: OD = 0.62 , 95% CI, 0. 39to 0.99 mm, P = 0.05). There was no heterogeneity among studies (Chi² = 14.46, df = 8 (P
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= 0.07); I² = 45%). The OR was 0.62, meaning that the use of the ORIF in the treatment of MCFs decreases the incidence of chin deviation on opening 48 % compared to using CT. (Fig. 7) TMJ pain, tenderness, noise and clicking Five studies4,25,32,33,34 compared TMJ pain, tenderness, noise and clicking between CT (n = 117) and ORIF (n = 129) groups after 6 14
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months . There was an advantage for the ORIF group in reducing TMJ pain, noise and clicking but this advantage did not reach significant levels (fixed: OD = 0.57 , 95% CI, 0. 31 to 1.04 mm, P
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= 0.07). There was no heterogeneity among studies (Chi² = 7.96, df = 4 (P = 0.09); I² = 50%). The OR was 0.57 , meaning that the use of ORIF in the treatment of MCFs decreases the incidence of TMJ
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pain, tenderness, noise and clicking by 43 % compared to using
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CT. (Fig. 7) Sensitivity analysis and publication bias:
The results after the exclusion of the retrospective studies did not change the overall results. The funnel plot did not show any
8).
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DISCUSSION
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noticeable asymmetry, indicating absence of publication bias (Fig.
The purpose of this study was to determine if the literature shows
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superiority of open vs closed treatment for adult condyle fractures. In general, the results of this study show that ORIF leads to improvements in most measures of condylar and/or mandibular mobility (MIO, laterotrusion, protrusion, lack of chin deviation). Additionally, improvements in postoperative pain reduction and occlusion were better for patients treated open. For instance, this meta-analysis revealed that ORIF patients had a greater 15
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postoperative MIO than patients treated with CT (WMD = 3.23 mm, CI, 2.42 to 4.04, P = 0.001). This is consistent with some studies19, 22,23,26,28,31-33,36,83and inconsistent with others.4,17,20,29,30,35,42
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Similarly, latrotrusive movement was better in ORIF patients indicating better condylar motion (WMD = 1.14 MM, CI 0.73 to 1.55, P = 0.001). This is compatible with the results of some 23,25,31-33
but disagrees with the results of others.
29,30,35
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studies
Again, the ORIF group had greater protrusive movement when
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compared to CT (WMD = 0.99 mm, CI 0.70, 1.29, P = 0.001), similar to the results of previous literature19,23,22,25,26,31,32,33,36 and opposite to others 30,35
Chin deviation toward the fractured side on mouth opening was
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lower in the ORIF group than patients treated with CT. This also indicates that the mobility of the condyle on the fractured side is better in patients treated open. The OR was 0.62, meaning that the
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use of the ORIF in the treatment of MCFs decreases the incidence
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of chin deviation by 48% compared to using CT. This is in agreement of most studies.4,
23,25,26,33
Concerning occlusal
discrepancies, the ORIF group was superior in reducing postoperative malocclusion (OR = 0.41, CI 0.26 to 0.62, P = 0.001).
This
is
in
accordance
results.17,18,21,24,26,27,29,32,33,37,38
16
with
most
previous
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The five studies23,26,31,33,36 that assessed pain via VAS 6 months or more after treatment showed better pain reduction in the ORIF group. Also the results of the present study showed that there was
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an advantage for ORIF in reducing TMJ pain, noise and clicking but this advantage did not reach a statistically significant level. The OR was 0.57, meaning that the use of the ORIF in the treatment of
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clicking by 43 % compared to using CT.
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MCFs decreases the incidence of TMJ pain, tenderness, noise and
Although there are various guidelines regarding the management of condylar fractures of the mandible by open or closed treatment, there is still continuing debate over how to best manage these fractures. This is in part attributable to a potential misinterpretation
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of the literature from decades prior, a lack of uniformity of classification of the various anatomical components of the mandibular condyle, lack of scientifically-valid studies comparing
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treatments, and a perceived potential to cause harm through the
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open approach based in part on the surgeon’s lack of experience and critical examination of the literature.39 Other factors confounding the strategy for the management of condylar fractures are the anatomic position of this fracture, the influence of the fracture and surgery on facial growth, and the potential complications such as malocclusion, chin deviation, ankylosis of TMJ, and internal derangement of the joint.40,41 17
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The limitations of this study were first, fourteen of the studies that were used in our analysis4,
17,19,24,26,27-31,33,37,38
included patients
with associated mandibular and midface fractures. It is believed
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that a second fracture in the mandible can confound the outcome data because the fixation requirements of a double fracture are often
different
from
those
for
an
isolated
fracture.51
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Biomechanically, a mandible with bilateral condylar fractures is a much more complicated construct than one with a unilateral
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condylar fracture. Rehabilitating such patients using CT is more difficult because of the deficiency in structural support from lack of both craniomandibular articulations. We included patients with bilateral fractures because some of the studies had them included
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and they were impossible to separate. Theoretically, their inclusion can blur the data because some of the measures (laterotrusion, protrusion, deviation on opening) make less sense when used for
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the patient with bilateral fractures of the condyle. However, the
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number patients with bilateral fractures was small. Another potential weakness of this study is that only five studies26,31-33,38 were RCTSs, sixteen CCTs4, 17-22,24,25,27,28-30,34-36 and two retrospective studies.23,37 While many of these studies are not ideally-designed, an ethical prospective randomized trial may not be possible given that one treatment arm includes surgery.52,53 Therefore, we performed a sensitivity analysis to assess the 18
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robustness of the present results by repeating the analysis with exclusion of the retrospective studies.23,37 After doing so, the
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overall results did not change. While the above makes it sound like ORIF is superior to CT, it must be remembered that when one selects ORIF, one is increasing
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the cost of treatment because ORIF engenders more operating room time, more expensive hardware, and a longer general
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anesthetic. One is also imposing a potential set of complications that must be carefully weighed to determine if the potential benefits of open treatment are worth the potential surgical and postsurgical risks. The potential complications include injury to nerves and blood vessels, sialocele/salivary fistulae, facial scarring,
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loosening of hardware, infection, etc. It should also be mentioned that individuals who publish studies on
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the treatment of condylar fractures usually have a great experience at whatever treatment they are providing. Even though the
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outcomes of the studies in the literature might favor ORIF over CT for many of the outcome variables, individual practitioners may not see that benefit if their surgical experience is not great. One must be able to safely perform ORIF with minimal complications if one is to see improved outcomes. For those with little experience, it may be better to use CT and should a malocclusion occur, one can correct it later with orthognathic surgery. 19
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While not all potential complications have been adequately studied, ten studies8,17,18,19,20,26,30,33,43-45 evaluated VII nerve function after ORIF of condylar fractures. The incidence of facial
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nerve injury ranged from 0 to 21%, but it was temporary in most of the patients. Overall, from the available data, 22 patients out of 265 treated with ORIF (5.83%) had postoperative facial nerve
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weakness; but in the vast majority of the cases the nerve function totally recovered in less than 6 months (16/22). Data about
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unacceptable scarring were limited, but in most studies45 the scar was described as imperceptible and acceptable by the patient. New technology to facilitate transoral ORIF has offered the promise of eliminating some of the adverse sequelae associated
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with ORIF through a transfacial approach, such as facial nerve injury and scarring. For instance, using an endoscope to assist in visualization and right-angle drills and screw drivers has made
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transoral surgical approaches a reality, minimizing the risk of an
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injury to the facial nerve and eliminating the risk of facial scarring.46 This technique has been used in the management of mandibular condyle fractures39 but after a decade of development, the technique has not been widely accepted.47-50
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In conclusion, the result of the present meta-analysis confirmed that ORIF provides superior clinical outcomes (subjective and objective) than CT in the management of adult MCFs. Better
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designed prospective randomized controlled clinical trials with adequate sample sizes and long follow-up periods comparing open and closed treatment of isolated adult MCFs would be useful in
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exploring this question further. Other variables such as treatment cost and patient satisfaction should be additionally studied to
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adult condylar fractures.
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determine the differences between open and closed treatment of
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References
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8. Manisali M, Amin M, Aghabeigi B, et al: Retromandibular approach to the mandibular condyle: A clinical and cadaveric study. Int J Oral Maxillofac Surg 2003;32:253.
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9. Sagiura T, Yamamoto K, Murakami K, et al: A comparative evaluation of osteosynthesis with lag-screws, miniplates, or Kirschner wires for mandibular condylar process fractures. J Oral Maxillofac Surg 2001;59:1161.
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10. Iizuka T, Lädrach K, Geering AH: Open reduction without fixation of dislocated condylar process fractures: Long-term clinical and radiologic analysis. J Oral Maxillofac Surg 1998;56:553.
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11. Undt G, Kermer C, Rasse M, et al: Transoral miniplate osteosynthesis of condylar neck fractures. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;88:534.
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12. Welch V, Petticrew M, Tugwell P, Moher D, O'Neill J, Waters E, White H, and the PRISMA-Equity Bellagio Group. PRISMAEquity 2012 Extension: Reporting Guidelines for Systematic Reviews with a Focus on Health Equity. PLoS Med 2012 ;9(10): e1001333. 13. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Metaanalysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000;283:2008-12.
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14. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007;370:1453-7.
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15. Moher D, Liberati A, Tetzlaff J, The ADG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009;6:e1000097.
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16. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
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17. Worsaae N, Thorn JJ: Surgical versus nonsurgical treatment of unilateral dislocated low subcondylar fractures: a clinical study of 52 cases. J Oral Maxillofac Surg 1994; 52: 353-360.
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18. Oezmen Y, Mischkowski RA, Lenzen J, Fischbach R: MRI examination of the TMJ and functional results after conservative and surgical treatment of mandibular condyle fractures. Int J Oral Maxillofac Surg 1998; 27: 33-37.
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19. Cebo Palmieri, Edward Ellis III, Gaylord Tbrockmorton: Mandibular Motion After Closed and Open Treatment of Unilateral Mandibular Condylar Process Fractures. J Oral Maxiliofac Surg 1999;7:764-775. 20. Santler G, Karcher H, Ruda C, Kole E: Fractures of the condylar process: surgical versus nonsurgical treatment. J Oral Maxillofac Surg 1999;57: 392-397.
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21. Ellis III E, Simon P, Throckmorton GS: Occlusal results after open or closed treatment of fractures of the mandibular condylar process. J Oral Maxillofac Surg 2000;58: 260-268.
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22. G. De Riu, U. Gamba, M. Anghinoni, E. Sesenna: A comparison of open and closed treatment of condylar fractures: a change in philosophy. Int. J. Oral Maxillofac. Surg. 2001; 30: 384– 389.
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23. Haug RH, Assael LA: Outcomes of open versus closed treatment of mandibular subcondylar fractures. J Oral Maxillofac Surg 2001;59: 370-375. 24. Hlawitschka M, Loukota R, Eckelt U: Functional and radiological results of open and closed treatment of intracapsular (diacapitular) condylar fractures of the mandible. Int J Oral Maxillofac Surg 2005; 34: 597-604.
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25. Meike Stiesch-Scholz, Stephan Schmidt, André Eckardt: Condylar Motion After Open and Closed Treatment of Mandibular Condylar Fractures. J Oral Maxillofac Surg 2005; 63:1304-1309.
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26. Eckelt U, Schneider M, Erasmus F, Gerlach KL, Kuhlisch E, Loukota R, et al: Open versus closed treatment of fractures of the mandibular condylar process a prospective randomized multicentre study. J Craniomaxillofac Surg 2006;34: 306-314. 27. Landes CA, Lipphardt R: Prospective evaluation of a pragmatic treatment rationale: open reduction and internal fixation of displaced and dislocated condyle and condylar head fractures and closed reduction of non-displaced, non-dislocated fractures Part II: high condylar and condylar head fractures. Int J Oral Maxillofac Surg 2006;35: 115-126. 25
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28. Ishihama K, Iida S, Kimura T, Koizumi H, Yamazawa M, Kogo M: Comparison of surgical and nonsurgical treatment of bilateral condylar fractures based on maximal mouth opening. Cranio 2007;25: 16-22.
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29. Constantin A. Landes, Kai Day, Ruben Lipphardt, Robert Sader: Prospective closed treatment of nondisplaced and nondislocated condylar neck and head fractures versus open reposition internal fixation of displaced and dislocated fracture. Oral Maxillofac Surg 2008;12:79–88.
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30. Landes CA, Day K, Lipphardt R, Sader R: Closed versus open operative treatment of nondisplaced diacapitular (Class VI) fractures. J Oral Maxillofac Surg 2008a ;66: 1586-1594,.
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31. Schneider M, Erasmus F, Gerlach KL, Kuhlisch E, Loukota RA, Rasse M, et al: Open reduction and internal fixation versus closed treatment and mandibulomaxillary fixation of fractures of the mandibular condylar process: a randomized, prospective, multicenter study with special evaluation of fracture level. J Oral Maxillofac Surg 2008; 66: 2537-2544.
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32. Danda AK, Muthusekhar MR, Narayanan V, Baig MF, Siddareddi A: Open versus closed treatment of unilateral subcondylar and condylar neck fractures: a prospective, randomized clinical study. J Oral Maxillofac Surg 2010; 68: 12381241. 33. Singh V, Bhagol A, Goel M, Kumar I, Verma A: Outcomes of open versus closed treatment of mandibular subcondylar fractures: a prospective randomized study. J Oral Maxillofac Surg 2010; 68: 1304-1309.
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34. Park JM, Jang YW, Kim SG, Park YW, Rotaru H, Baciut G, et al: Comparative study of the prognosis of an extracorporeal reduction and a closed treatment in mandibular condyle head and/or neck fractures. J Oral Maxillofac Surg 2010; 68: 29862993.
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35. Chiarella Sforza, Alessandro Ugolini, Davide Sozzi, Domenico Galante, Andrea Mapelli, Alberto Bozzetti: three-dimensional mandibular motion after closed and open reduction of unilateral mandibular condylar process fractures. J Craniomaxillofac Surg 2011;39 : 249-255. 36. Gupta M, Iyer N, Das D, Nagaraj J: Analysis of different treatment protocols for fractures of condylar process of mandible. J Oral Maxillofac Surg 2012; 70: 83-91.
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37. Singh V, Bhagol A, Dhingra R: A comparative clinical evaluation of the outcome of patients treated for bilateral fracture of the mandibular condyles. J Craniomaxillofac Surg 2012;40: 464-466.
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38. S. M. Kotrashetti, J. B. Lingaraj, and Vishal Khurana: A comparative study of closed versus open reduction and internal fixation (using retromandibular approach) in the management of subcondylar fracture. Oral Surg Oral Med Oral Pathol Oral Radiol 2013;115:e7-e11. 39. Richard H. Haug, M Todd Brandt: Closed Reduction, Open Reduction, and Endoscopic Assistance: Current Thoughts on the Management of Mandibular Condyle Fractures. Plast. Reconstr. Surg.2007;120 (Suppl. 2): 90S.
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40. Assael LA: Open versus closed treatment of adult mandibular condyle fractures: An alternative interpretation of the evidence. J Oral Maxillofac Surg 2003; 61:1333.
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41. Brandt MT, Haug RH: Open versus closed treatment of adult Mandibular condyle fractures: A review of the literature regarding the evolution of current thoughts on management. J Oral Maxillofac Surg 2003; 61:1324.
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42. Yasuharu Takenoshita, Hiroaki Ishibashi, , Masuichiro Oka: Comparison of Functional Recovery After Nonsurgical and Surgical Treatment of Condylar Fractures. J Oral Maxillofac Surg 1990;48:1191-1195.
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43. Konstantinovic VS, Dimitrijevic B: Surgical versus conservative treatment of unilateral condylar process fractures: clinical and radiographic evaluation of 80 patients. J Oral Maxillofac Surg 1992;50: 349-352.
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44. Hyde N, Manisali M, Aghabeigi B, Sneddon K, Newman L: The role of open reduction and internal fixation in unilateral fractures of the mandibular condyle: a prospective study. Br J Oral Maxillofac Surg 2002;40: 19-22.
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45. Edward Ellis III, David McFadden, Patricia Simon, and Gaylord Throckmorton: Surgical Complications With Open Treatment of Mandibular Condylar Process Fractures. J Oral Maxillofac Surg 2002;58:950-958. 46. Edward Ellis III: Method to Determine When Open Treatment of Condylar Process Fractures Is Not Necessary. J Oral Maxillofac Surg 2009;67:1685-1690.
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47. Troulis, M. J., and Kaban, L. B. Endoscopic approach to the ramus/condyle unit: Clinical applications.J. Oral Maxillofac. Surg 2001;59: 503.
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48. Lauer, G., and Schmelzeisen, R. Endoscope-assisted fixation of mandibular condylar process fractures. J. Oral Maxillofac. 1999;Surg.57: 36.
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49. Sandler, N. A., Andreasen, K. H., and Johns, F. R. The use of endoscopy in the management of subcondylar fractures of the mandible: A cadaver study. Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 1999;88: 529. 50. Lee, C., Stiebel, M., and Young, D. M. Cranial nerve VII region of the traumatized facial skeleton: Optimizing fracture repair with the endoscope. J. Trauma2000; 48: 423.
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51. Ellis E: Open reduction and internal fixation of combined angle and body/symphysis fractures of the mandible: How much fixation is enough? J Oral Maxillofac Surg 2013; 71:726-733.
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52. Bos RRM, Ward RP, de Bont LGM: Mandibular condyle fractures: A consensus. Br J Oral Maxillofac Surg 1999;37:87, editorial.
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53. Pedro M. Villarreal, Florencio Monje, Luis M. Junquera, Jesu ´s Mateo, Antonio J. Morillo, and Cristina Gonza´lez: Mandibular Condyle Fractures: Determinants of Treatment and Outcome. J Oral Maxillofac Surg 2004; 62:155-163.
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Figures and Tables Captions Fig. 1: Study screening process
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Fig. 2: Forest plot – maximal interincisal opening, ORIF versus CT (continuous data) Fig. 3: Forest plot – latrotrusive movement, ORIF versus CT (continuous data)
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Fig. 4: Forest plot– protrusive movement, ORIF versus CT (continuous data)
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Fig. 5: Forest plot – pain via VAS, ORIF versus CT (continuous data) Fig. 6: Forest plot – malocclusion, ORIF versus CT (dichotomous data)
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Fig. 7: Forest plot – TMJ pain, tenderness, noise and clicking and chin deviation on mouth opening, ORIF versus CT (dichotomous data)
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Fig. 8: Funnel plot– publication bias according to the reported incidence of postoperative malocclusion.
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Tab. 1: Characteristics of the included studies Tab. 2: Results of quality assessment
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Table 1 : Characteristics of included studies
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Years
Study design
Age (mean) Female/male Ratio
Worsaae et al. 17
1994
CCT
Oezmen et al.18
1998
CCT
Palmieri et al.19
1999
CCT
Santler et al.20
1999
CCT
Ellis et al.21
2000
CCT
De riu et al.22
2001
CCT
ORIF:(29) 16:8 CT:(37) 21:7 ORIF,CT :(31.5) 23:7 ORIF,CT: (16-70) 121:27 ORIF: (24) 20:17 CT: (23) 90:23 (16-70) CRT: 62:10 ORIF: 51:14 ORIF,CT:(1369)
Haug t al.23
2001
RS
Yang et al.4
2001
CCT
Hlawitschka et al.24
2005
CCT
StieschScholz et al.25 Eckelt et al.26
2005
CCT
2006
RCT
Landes and Lipphard27
2006
CCT
Ishihama et al.28
2007
CCT
Constantin et al.29
2008
CCT
Patients numbers ORIF CT 24 28
Follow up period
MCFs Fixation Method
Surgical Approach
Associated Mandibular Fractures
OR:21 months CR:30 months 24 months
CT: IMF for 5-6 weeks ORIF: transosseous wire osteosynthesis CT: IMF ORIF: ORIF
NM
Yes
ORIF: submandibular incision
No
10
62
85
Up to 3 years
CT: IMF for 2 weeks ORIF: ORIF
ORIF: retro mandibular approach
Yes
37
113
6-130 months
CT: IMF ORIF: ORIF
NM
ORIF:13 CT:59
65
77
Up to 3 years
CT: IMF ORIF: ORIF
ORIF: retro mandibular approach
Yes
20
19
ORIF: submandibular or preauricular Approach
NM
CT: (36.1) 8:2 ORIF: (36.5) 7:3 ORIF,CT: (25.53) 41:25
10
10
6 months
CRT: IMF for 5–7 days ORIF: ORIF+IMF for 3-5 days CT: IMF ORIF: ORIF
NM
NM
36
30
One year
ORIF: (30) 13:1 CT: (28) 25:4 ORIF,CT: (32) 117:17 ORIF,CT: (32) 52:14
14
29
24
13
36
33
> 16 ORIF: (33) CT: (15) ORIF: (34.8) 17:7 CT:(33.5) 26:17 ORIF:(39) year
24
14
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CT: IMF for 3 weeks ORIF: ORIF+IMF for 1 week
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6 months
42 months
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CRT: 20 months ORIF: 11 months
18
43
6 months to 2.5 years
30
29
One year
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20
CT: IMF for 10 days+8 weeks functional therapy ORIF: ORIF+IMF for 2 days CT: IMF ORIF: ORIF CT:IMF+elastic for 10 days ORIF:miniplates/ Miniscrews Lag screws CT: IMF for 2 weeks ORIF: ORIF
CT: IMF+elastic for 1-3 weeks ORIF: lag screw/miniplate/wire CT: IMF+elastic for 2 weeks
ORIF: Preauricular extraoral approach, endoscope-assisted intraoral approach ORIF: modified auricular approach
Yes
NM
No
ORIF:peraruicular, Submandibular, Perangular, transoral
Yes
ORIF: preauricular approach
Yes
ORIF: submandibular approach
Yes
ORIF: perauricular and retromandibular
Yes
Yes
Table 1 : Characteristics of included studies
CCT
CT: (31) ORIF: (27) ORIF,CT: >18 years
9
13
2008
RCT
Danda et al.32
2010
Singh et al.33
36
30
RCT
ORIF,CT: 27:5
16
16
CRT:21.5 Months ORIF:22.3 Months
2010
RCT
ORIF,CT: (30.6) year 33:7
18
22
6 months
Park et al.34
2010
CCT
ORIF,CT: (27.5) 52:19
63
35
12 months
C. Sforza et al.35
2011
CCT
ORIF:( 26.8) CT: ( 27.1)
9
12
Gupta et al.36
2012
CCT
10
10
V. Singh et al.37
2012
RS
CT: (15-65) 8:2 ORIF: (28.2) 10:0 (28.2) CT: 16:4 ORIF: 19:5
ORIF: 16.4 months CR: 32.8 months 1-, 4-, 8-, and 12week
24
20
Kotrashetti et al.38
2013
RCT
10
12
NM
12 months 6 months
6 months
6 months
approach
ORIF: preauricular approach ORIF:preauricular, transoral and retromandibular approach
CT: IMF ORIF: 2-mm stainless steel plates and screws CT: IMF for 21- 35 days ORIF: ORIF+IMF for 3-5 days CT:IMF+elastic for 34 weeks ORIF: titanium miniplates and 2×6 mm titanium screws
Yes Yes
ORIF:preauricular, submandibular, transmassetric anterior parotid, or retromandibular approach ORIF:retromandibular, anteroparotid approach
NM
ORIF:intraoral and submandibular approaches
No
NM
No
Yes
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2008
miniplate/T shape microplate CT: IMF for 2 weeks ORIF: ORIF CT:IMF for 10 days + elastic ORIF: ORIF using 1 or 2 Miniplate/lag screw CT:IMF for 2 weeks + elastic For 2 weeks ORIF: ORIF using 1 or 2 Miniplate+ IMF for 2 weeks CT: IMF+elastic for 7 to 35 days ORIF: 2 mm titanium Miniplates+IMF with elastic for 3-5 days CT: IMF for 2 weeks ORIF: ORIF+IMF for 1 week CT: IMF ORIF: ORIF
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CT:(36)
ORIF: preauricular and/or retromandibular approaches
NO
ORIF: retromandibular, anteroparotid approach ORIF: retromandibular approach
Yes
Yes
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RCT-randomized controlled trials, CCT- controlled clinical trial, RS- retrospective study, CT-closed reduction treatment, ORIFopen reduction and internal fixation, NM- not mentioned
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Table 2. Results of the quality assessment Published
Random selection in population
Defined inclusion/exclusion criteria
Loss of followup
Validated measurement
Statistical analysis
Estimated potential risk of bias
Worsaae et al. 17 Oezmen et al.18 Palmieri et al.19 Santler et al.20 Ellis et al.21 De riu et al.22 Haug t al.23 Yang et al.4 Hlawitschka et al.24 StieschScholz et al.25 Eckelt et al.26 Landes and Lipphard27 Ishihama et al.28 Constantin et al.29 C. Landes et al.30 Schneider et al.31 Danda et al.32 Singh et al.33 Park et al.34 C. Sforza et al.35 Gupta et al.36 V. Singh et al.37 Kotrashetti et al.38
1994
No
Yes
Yes
Yes
Yes
Moderate
1998
No
Yes
Yes
Yes
Yes
Moderate
1999
No
Yes
Yes
Yes
Yes
Moderate
1999
No
Yes
Yes
Yes
Yes
Moderate
2000 2001
No No
Yes Yes
Yes Yes
Yes Yes
Yes Yes
Moderate Moderate
2001 2001 2005
No No No
Yes Yes Yes
Yes Yes Yes
Yes Yes Yes
Yes Yes Yes
Moderate Moderate Moderate
2005
No
Yes
Yes
Yes
Yes
Moderate
2006
Yes
Yes
Yes
Yes
Yes
Low
2006
No
Yes
Yes
Yes
2007
No
Yes
Yes
Yes
2008
No
Yes
Yes
Yes
2008
No
Yes
2008
Yes
Yes
2010
Yes
Yes
2010
Yes
Yes
2010 2011
No No
Yes Yes Yes
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2012
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Authors
Yes
Moderate
Yes
Moderate
Yes
Moderate
Yes
Yes
Yes
Moderate
Yes
Yes
Yes
Low
Yes
Yes
Yes
Low
Yes
Yes
Yes
Low
Yes Yes
Yes Yes
Yes Yes
Moderate Moderate
Yes
Yes
Yes
Moderate
No
Yes
Yes
Yes
Yes
Moderate
2013
Yes
Yes
Yes
Yes
Yes
Low
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2012
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905 article identified through database searching
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143 articles excluded due to they were in vitro
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762 articles screened through titles and abstracts
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537 articles excluded due to duplication and off-topic
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225 articles of full text assessed for eligibility
202 articles excluded due to they did not met inclusion criteria
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23 articles included in quantitative (meta-analysis) and qualitative assessment
Figure . 1: selection study process
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S0278-2391(14)01534-1
DOI:
10.1016/j.joms.2014.09.027
Reference:
YJOMS 56518
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 2 September 2014 Revised Date:
29 September 2014
Accepted Date: 30 September 2014
Please cite this article as: Al-moraissi EA, Ellis E, Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A Systematic Review And Meta-Analysis, Journal of Oral and Maxillofacial Surgery (2014), doi: 10.1016/j.joms.2014.09.027. 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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Essam Ahmed Al-moraissi1*, BDS, M.Sc., PhD
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Edward Ellis2, DDS,MS
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Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A Systematic Review And Meta-Analysis
1
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PhD Student ,Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University, Egypt
1
Master degree in oral and maxillofacial surgery , Faculty of Oral and Dental Medicine, Cairo University, Egypt
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1Lecturer, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen
2
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Professor and Chair, Department of Oral and Maxillofacial Surgery, University of Texas Health Science Center, San Antonio, TX
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* Corresponding author: Essam Ahmed Mohammed Al-Moraissi, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen,. [email protected] or [email protected] Phone: 00201141477753, 0096777788939
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Surgical Treatment of Adult Mandibular Condylar Fractures Provides Better Outcomes than Closed Treatment: A
Essam Ahmed Al-moraissi1*,BDS, M.Sc., PhD
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1
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Edward Ellis III, DDS, MS2
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Systematic Review And Meta-Analysis
PhD Student, Department of Oral and Maxillofacial Surgery,
Faculty of Oral and Dental Medicine, Cairo University, Egypt 1
Lecturer, Department of Oral and Maxillofacial Surgery, Faculty
Professor and Chair, Department of Oral and Maxillofacial
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2
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of Dentistry, Thamar University, Yemen
TX
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Surgery, University of Texas Health Science Center, San Antonio,
* Corresponding author: Essam Ahmed Al-Moraissi, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen,. [email protected]; [email protected] Phone: 00201141477753, 0096777788939 1
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Abstract:
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Purpose: The purpose of this study was to identify significant differences in clinical outcomes between open reduction and rigid internal fixation (ORIF) and closed treatment (CT) for adult
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mandibular condylar fractures (MCFs) and also to support or refute the superiority of one method over the other.
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Methods: To address our purpose ,we designed and implemented a systematic review with meta-analysis .A comprehensive electronic search without date and language restrictions was performed in May 2014. The inclusion criteria were studies in humans,
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including randomized or quasi-randomized controlled trials (RCTs), controlled clinical trials (CCTs), and retrospective studies that comparing ORIF to CT with regard to maximal interincisal
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opening (MIO), laterotrusive and protrusive movements, pain, malocclusion, and chin deviation on mouth opening and TMJ
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signs/symptoms for the management of unilateral or bilateral adult MCFs fractures. Meta-analyses were conducted only if there were studies of similar comparisons reporting the same outcome measures. For binary outcomes, we calculated a standard estimation of odds ratio (OR) by the random-effects model if heterogeneity was detected, otherwise a fixed-effect models with a
2
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95% confidence interval (CI) was performed. Weighted mean differences (WMD) or standard mean difference (SMD) were used
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to construct forest plots of continuous data. Results: 23 publications were included: five RCTs, sixteen CCTs and two retrospective studies. Five studies showed a low risk of
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bias, eighteen a moderate risk of bias. There was a statistically significant difference between ORIF and CT with regard to MIO,
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laterotrusive and protrusive movement, malocclusion, pain and chin deviation on mouth opening (P = 0.001, P = 0.001 , P = 0.001, P = 0.001, P = 0.001 and P = 0.05 respectively ). Conclusion: The result of the meta-analysis confirmed that ORIF
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provides superior functional clinical outcomes (subjective and
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objective) than CT in the management of adult MCFs.
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INTRODUCTION The mandible is frequently injured following facial trauma, and 25-40%
of
mandibular
fractures
involve
the
condyle.1-3
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Management of mandibular condylar fractures (MCFs) remains an ongoing matter of controversy in maxillofacial surgery. This
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controversy is reflected in the wide variety of opinions and proposed treatment modalities offered in the literature.
4
For
decades closed treatment (CT) has been the preferred treatment5 because treatment is easier and less invasive, and the results are
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comparable with no surgical complications. However, CT may employ varying periods of intermaxillary fixation (IMF) (0 to 6 weeks) followed by aggressive physiotherapy.6 Also, long-term
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complications like pain, arthritis, malocclusion, deviation of the mandible on opening and closing movements, temporomandibular
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joint (TMJ) dysfunction, facial asymmetry, and ankylosis may occur in condylar injuries treated closed.6,7 If there is severe displacement or dislocation, surgical management seems to be preferred.8,9,10 Open reduction and internal fixation (ORIF) allows anatomical repositioning and immediate functional
4
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movements of the jaw,11 but has the potential complications of damaging the facial nerve and of forming visible scars.4 With the implementation of rigid internal fixation over the past 30 years,
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indications for surgical treatment of MCFs have broadened. A
review of the literature revealed several studies comparing CT to ORIF in the treatment of MCFs, but there is still a continuing
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debate over how to best manage this type of fracture. Therefore,
the overall goal of this study was to test the null hypothesis of no
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difference between CT and ORIF in adult MCFs against the hypothesis of a difference. The specific aims of this study were : 1) to compare clinical outcomes between ORIF and CT for MCFs and, 2) to support or refute the superiority of one method over the
METHODS:
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Inclusion criteria
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other.
Any randomized or quasi-randomized controlled trials (RCTs),
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controlled clinical trials (CCTs), and retrospective studies that compared the maximal interincisal opening (MIO), laterotrusion, protrusion, pain, malocclusion, chin deviation on mouth opening and the incidence of postoperative complications for patients treated by ORIF or CT for unilateral or bilateral MCFs and reporting were included. 5
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Exclusion criteria were case reports, technical reports, animal studies, in vitro studies, review papers, pediatric or edentulous MCFs patients and studies that did not report data (mean and
comparison group.
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Search methods for identification of studies:
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standard deviation), the outcomes of interest and absence of the
To address the research purpose, the investigators designed and
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implemented a systematic review with meta-analysis. This systematic review and meta-analysis is conducted according to the PRISMA-E 2012 checklist12. A comprehensive electronic search without date and language restrictions was performed in May 2014
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using the following electronic databases: PubMed, Cochrane Database of Systematic Reviews, the Cochrane central register of controlled trials (CENTRAL), EMBASE, MEDLINE, CINAH,
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Electronic Journal Center, using one or combination of the following search terms: "surgical versus nonsurgical treatment in
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mandibular condylar fractures “AND/OR " open versus closed reduction in treatment of unilateral OR bilateral mandibular condylar
process
fractures"
conservative/functional
AND/OR
treatment
of
"surgical
mandibular
versus condylar
/subcondylar fractures"," condylar/masticatory motion after open and closed treatment of mandibular condylar fractures”, clinical outcomes after open versus closed treatment of mandibular 6
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condylar fractures", "surgical complication/occlusal results AND mandibular condylar/diacapitular fractures AND/OR open versus closed approach”. “displaced/dislocated mandibular condylar
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fractures AND surgical versus nonsurgical treatment”
A manual search of oral and maxillofacial surgery-related journals,
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including International Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, Journal of Oral
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and Maxillofacial Surgery, Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontology, Journal of Cranio-Maxillofacial Surgery, Journal of Craniofacial Surgery, Journal of TRAUMA Injury, Infection, and Critical Care and
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Journal of Maxillofacial and Oral Surgery, was also performed. The reference list of the identified studies and the relevant reviews on the subject were also scanned for possible additional studies.
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Moreover, online databases providing information about clinical trials in progress were checked
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(clinicaltrials.gov;www.centerwatch.com/clinicaltrials;www.clinic alconnection.com). Data collection process The authors carefully assessed the eligibility of all studies retrieved from the databases. From the included studies in the final analysis the following data were extracted (when available): authors, year 7
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of publication, study design, number of patients, gender (male: female), mean age in years, follow-up period, MCF fixation method, associated mandibular fractures and outcome variables
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(maximal interincisal opening (MIO), laterotrusive* and protrusive movements, pain, malocclusion, chin deviation on mouth opening,
data was performed.
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Risk of bias in individual studies
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TMJ signs/symptoms). Contact with authors for possible missing
A methodological quality rating was performed by combining the proposed criteria by MOOSE statement,13 STROBE statement,14 and PRISMA,15 in order to verify the strength of scientific
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evidence in clinical decision-making.
The classification of the risk of bias potential for each study was based on the five following criteria: random selection in the
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population, definition of inclusion/exclusion criteria; report of losses to follow-up, validated measurements and statistical
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analysis. A study that included all the criteria mentioned above was classified as having a low risk of bias, a study that did not include one of these criteria was classified as having a moderate risk of bias. When two or more criteria were missing, the study was considered to have a high risk of bias. *
Laterotrusion refers to excursive movement away from side of the condylar fracture
8
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Meta-analysis Meta-analyses were conducted only if there were studies of similar
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comparisons reporting the same outcome measures. For binary outcomes, we calculated a standard estimation of odds ratio (OR) by the random-effects model if heterogeneity was detected,
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otherwise a fixed-effect models with a 95% confidence interval (CI) was performed. Weighted mean differences (WMD) or
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standard mean difference (SMD) were used to construct forest plots of continuous data. The data were analyzed using the statistical software Review Manager (version 5.2.6, The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen,
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Denmark, 2012). Assessment of heterogeneity
The significance of any discrepancies in the estimates of the
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treatment effects of the different trials was assessed by means of Cochran’s test for heterogeneity and the I² statistic, which
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describes the percentage total variation across studies that is due to heterogeneity rather than by chance. Heterogeneity was considered statistically significant if P < 0.1. A rough guide to the interpretation of I² given in the Cochrane Handbook16 is as follows (1) from 0 to 40% the heterogeneity might not be important, (2) from 30 to 60% may represent moderate heterogeneity, (3) from 50 9
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to 90% may represent the substantial heterogeneity, and (4) from 75 to 100% there is considerable heterogeneity.
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Investigation of publication bias A funnel plot (plot of effect size versus standard error) was drawn. Asymmetry of the funnel plot could indicate publication bias and
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other biases related to sample size, although the asymmetry may also represent a true relationship between trial size and effect size.
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Sensitivity analysis
Where there were sufficient included studies, a sensitivity analysis was performed to assess the robustness of the review results by repeating the analysis after exclusion of studies with a high risk of
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bias. RESULTS
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The study selection process is summarized in Figure 1. The electronic search resulted in 905 entries. Of 905, 143 articles were
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excluded because they were in-vitro studies. After the initial screening of the titles and abstracts, 537 articles were excluded because they were off-topic or duplicated. The full-text reports of the remaining 225 articles led to the exclusion of 202 because they did not meet the inclusion criteria. Thus, a total of 23 publications4,17-38
were
included 10
in
the
review.
Fifteen
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studies17,19,20,22,23,26,28-33,35,36,38 compared CT to ORIF in the management of MCFs with regard to MIO and laterotrusion, Fourteen studies17,19,29,22,23,25,26,29-,33,35,36compared CT to ORIF in studies4,17,18,21,24,25,26,27,29,30,33,34,36,37,38
assessed
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the management of MCFs with regard to protrusion. Sixteen malocclusion
between CT and ORIF. Five studies23,26,31,33,36 investigated pain via
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visual analogue scale (VAS) between CT and ORIF. Lastly, ten studies4,18,20,23,23,25,26,29,30,33 evaluated chin deviation on mouth
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opening between CT and ORIF and five studies4,25,32,33,34 compared CT to ORIF with regard to TMJ pain, tenderness, noise and clicking.
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Characteristics of included studies
Detailed characteristics of the included studies are shown in Table. 1. Five RCTs,26,31,32,33,38 sixteen CCTs,4,17-22,24,25,27,28-30,34-36 and two
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retrospective studies23,37 were included in the meta-analysis and critical appraisal. A total of 1,318 patients were enrolled in 23
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studies4,17-38 comparing surgical (n = 615) versus nonsurgical ( n = 703) treatment in the management of MCFs at follow up periods from 6 months to 3 years. Concerning the surgical technique, for all patients allocated to the CT group, the surgical technique consisted of IMF for a period of 0 to 35 days (according to the study). Either initially or after any 11
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period of IMF, guiding elastics were used for a variable period, to maintain proper occlusion followed by mouth opening exercises and physiotherapy. In the ORIF group, the surgical approaches
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were preauricular, submandibular, transmassetric anterior parotid, retromandibular, or endoscope-assisted intraoral approach. The fractures were stabilized with miniplates or lag screws plus IMF
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with elastics for 3 days or less (according to the study). Postoperative instructions regarding mouth opening exercises and
Risk of bias within studies
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physiotherapy were given to all the patients in both groups.
Concerning the quality assessment of the included studies, five 30,34-37
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studies26,31-33,38 showed a low risk of bias, eighteen studies4,17-25,27showed a moderate risk of bias. The scores are summarized
in Table 2.
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MIO
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Results of individual variables
Fifteen studies17,19,20,22,23,26,28-33,35,36,38 compared MIO between CT (n = 464) and ORIF (n = 332) groups. There was a statistically significant advantage for the ORIF group (fixed: WMD = 3.32 mm, 95% CI, 2.42 to 4.04 mm, P < 0.001). The test of heterogeneity showed no significant heterogeneity (Chi² = 64.61, df = 14 (P < 0.001); I² = 78%). (Fig. 2) 12
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Latrotrusive movement Fifteen
studies17,19,20,22,23,26,28-33,35,36,38
compared
laterotrusive
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excursions between CT (n = 434) and ORIF (n = 338) groups. There was a statistical difference in favor of the ORIF group (fixed: WMD = 1,14 mm, 95% CI, 0.73 to 1.55 mm, P < 0.001).
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The test of heterogeneity showed no significant heterogeneity
Protrusive movement Fourteen
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(Chi² = 44.20, df = 14 (P < 0.001); I² = 68%). (Fig. 3)
studies17,19,29,22,23,25,26,29-33,35,36compared
protrusive
movement between CT (n = 422) and ORIF (n = 328) groups. There was a statistical difference in favor of ORIF (fixed: WMD =
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0,99 mm, 95% CI, 0.70to 1.29 mm, P < 0.001). The test of heterogeneity showed no significant heterogeneity (Chi² = 48.48,
Pain via VAS
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df = 13 (P < 0.001); I² = 73%). (Fig. 4)
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Four studies23,26, 33,36 assessed the pain via visual analogue scale after 6 months (VAS) between CT (n = 155) and ORIF (n = 74) groups. Although pain was less in the ORIF group, it did not reach statistical significance (fixed: SMD = 0.74 mm VAS, 95% CI, 1.07 to 0.41, P = 0.001). There was no heterogeneity (Chi² = 0.25, df = 1 (P <0.62); I² = 0%). (Fig. 5)
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Malocclusion Sixteen studies4,17,18,21,24,25,26,27,29,30,33,34,36,37,38 assessed malocclusion
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between CT (n = 388) and ORIF (n = 388) groups. There was a significant difference in favor of the ORIF group with regard to postoperative malocclusion (fixed: OD = 0.41 , 95% CI, 0. 26to
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0.62 mm, P = 0.001). The test of heterogeneity indicated absence of heterogeneity (Chi² = 10.79, df = 14 (P = 0.70); I² = 0%). The
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OR was 0.41, meaning that the use of the ORIF in the treatment of MCFs decreases the incidence of malocclusion by 59 % compared to using CT. (Fig. 6)
Chin deviation on mouth opening
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Ten studies4,18,20,23,23,25,26,29,30,33 evaluated chin deviation on mouth opening between CT (n = 294) and ORIF (n = 227) groups. There was a significant advantage for the ORIF group in preventing chin
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deviation (fixed: OD = 0.62 , 95% CI, 0. 39to 0.99 mm, P = 0.05). There was no heterogeneity among studies (Chi² = 14.46, df = 8 (P
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= 0.07); I² = 45%). The OR was 0.62, meaning that the use of the ORIF in the treatment of MCFs decreases the incidence of chin deviation on opening 48 % compared to using CT. (Fig. 7) TMJ pain, tenderness, noise and clicking Five studies4,25,32,33,34 compared TMJ pain, tenderness, noise and clicking between CT (n = 117) and ORIF (n = 129) groups after 6 14
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months . There was an advantage for the ORIF group in reducing TMJ pain, noise and clicking but this advantage did not reach significant levels (fixed: OD = 0.57 , 95% CI, 0. 31 to 1.04 mm, P
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= 0.07). There was no heterogeneity among studies (Chi² = 7.96, df = 4 (P = 0.09); I² = 50%). The OR was 0.57 , meaning that the use of ORIF in the treatment of MCFs decreases the incidence of TMJ
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pain, tenderness, noise and clicking by 43 % compared to using
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CT. (Fig. 7) Sensitivity analysis and publication bias:
The results after the exclusion of the retrospective studies did not change the overall results. The funnel plot did not show any
8).
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DISCUSSION
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noticeable asymmetry, indicating absence of publication bias (Fig.
The purpose of this study was to determine if the literature shows
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superiority of open vs closed treatment for adult condyle fractures. In general, the results of this study show that ORIF leads to improvements in most measures of condylar and/or mandibular mobility (MIO, laterotrusion, protrusion, lack of chin deviation). Additionally, improvements in postoperative pain reduction and occlusion were better for patients treated open. For instance, this meta-analysis revealed that ORIF patients had a greater 15
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postoperative MIO than patients treated with CT (WMD = 3.23 mm, CI, 2.42 to 4.04, P = 0.001). This is consistent with some studies19, 22,23,26,28,31-33,36,83and inconsistent with others.4,17,20,29,30,35,42
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Similarly, latrotrusive movement was better in ORIF patients indicating better condylar motion (WMD = 1.14 MM, CI 0.73 to 1.55, P = 0.001). This is compatible with the results of some 23,25,31-33
but disagrees with the results of others.
29,30,35
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studies
Again, the ORIF group had greater protrusive movement when
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compared to CT (WMD = 0.99 mm, CI 0.70, 1.29, P = 0.001), similar to the results of previous literature19,23,22,25,26,31,32,33,36 and opposite to others 30,35
Chin deviation toward the fractured side on mouth opening was
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lower in the ORIF group than patients treated with CT. This also indicates that the mobility of the condyle on the fractured side is better in patients treated open. The OR was 0.62, meaning that the
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use of the ORIF in the treatment of MCFs decreases the incidence
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of chin deviation by 48% compared to using CT. This is in agreement of most studies.4,
23,25,26,33
Concerning occlusal
discrepancies, the ORIF group was superior in reducing postoperative malocclusion (OR = 0.41, CI 0.26 to 0.62, P = 0.001).
This
is
in
accordance
results.17,18,21,24,26,27,29,32,33,37,38
16
with
most
previous
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The five studies23,26,31,33,36 that assessed pain via VAS 6 months or more after treatment showed better pain reduction in the ORIF group. Also the results of the present study showed that there was
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an advantage for ORIF in reducing TMJ pain, noise and clicking but this advantage did not reach a statistically significant level. The OR was 0.57, meaning that the use of the ORIF in the treatment of
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clicking by 43 % compared to using CT.
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MCFs decreases the incidence of TMJ pain, tenderness, noise and
Although there are various guidelines regarding the management of condylar fractures of the mandible by open or closed treatment, there is still continuing debate over how to best manage these fractures. This is in part attributable to a potential misinterpretation
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of the literature from decades prior, a lack of uniformity of classification of the various anatomical components of the mandibular condyle, lack of scientifically-valid studies comparing
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treatments, and a perceived potential to cause harm through the
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open approach based in part on the surgeon’s lack of experience and critical examination of the literature.39 Other factors confounding the strategy for the management of condylar fractures are the anatomic position of this fracture, the influence of the fracture and surgery on facial growth, and the potential complications such as malocclusion, chin deviation, ankylosis of TMJ, and internal derangement of the joint.40,41 17
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The limitations of this study were first, fourteen of the studies that were used in our analysis4,
17,19,24,26,27-31,33,37,38
included patients
with associated mandibular and midface fractures. It is believed
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that a second fracture in the mandible can confound the outcome data because the fixation requirements of a double fracture are often
different
from
those
for
an
isolated
fracture.51
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Biomechanically, a mandible with bilateral condylar fractures is a much more complicated construct than one with a unilateral
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condylar fracture. Rehabilitating such patients using CT is more difficult because of the deficiency in structural support from lack of both craniomandibular articulations. We included patients with bilateral fractures because some of the studies had them included
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and they were impossible to separate. Theoretically, their inclusion can blur the data because some of the measures (laterotrusion, protrusion, deviation on opening) make less sense when used for
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the patient with bilateral fractures of the condyle. However, the
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number patients with bilateral fractures was small. Another potential weakness of this study is that only five studies26,31-33,38 were RCTSs, sixteen CCTs4, 17-22,24,25,27,28-30,34-36 and two retrospective studies.23,37 While many of these studies are not ideally-designed, an ethical prospective randomized trial may not be possible given that one treatment arm includes surgery.52,53 Therefore, we performed a sensitivity analysis to assess the 18
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robustness of the present results by repeating the analysis with exclusion of the retrospective studies.23,37 After doing so, the
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overall results did not change. While the above makes it sound like ORIF is superior to CT, it must be remembered that when one selects ORIF, one is increasing
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the cost of treatment because ORIF engenders more operating room time, more expensive hardware, and a longer general
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anesthetic. One is also imposing a potential set of complications that must be carefully weighed to determine if the potential benefits of open treatment are worth the potential surgical and postsurgical risks. The potential complications include injury to nerves and blood vessels, sialocele/salivary fistulae, facial scarring,
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loosening of hardware, infection, etc. It should also be mentioned that individuals who publish studies on
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the treatment of condylar fractures usually have a great experience at whatever treatment they are providing. Even though the
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outcomes of the studies in the literature might favor ORIF over CT for many of the outcome variables, individual practitioners may not see that benefit if their surgical experience is not great. One must be able to safely perform ORIF with minimal complications if one is to see improved outcomes. For those with little experience, it may be better to use CT and should a malocclusion occur, one can correct it later with orthognathic surgery. 19
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While not all potential complications have been adequately studied, ten studies8,17,18,19,20,26,30,33,43-45 evaluated VII nerve function after ORIF of condylar fractures. The incidence of facial
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nerve injury ranged from 0 to 21%, but it was temporary in most of the patients. Overall, from the available data, 22 patients out of 265 treated with ORIF (5.83%) had postoperative facial nerve
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weakness; but in the vast majority of the cases the nerve function totally recovered in less than 6 months (16/22). Data about
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unacceptable scarring were limited, but in most studies45 the scar was described as imperceptible and acceptable by the patient. New technology to facilitate transoral ORIF has offered the promise of eliminating some of the adverse sequelae associated
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with ORIF through a transfacial approach, such as facial nerve injury and scarring. For instance, using an endoscope to assist in visualization and right-angle drills and screw drivers has made
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transoral surgical approaches a reality, minimizing the risk of an
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injury to the facial nerve and eliminating the risk of facial scarring.46 This technique has been used in the management of mandibular condyle fractures39 but after a decade of development, the technique has not been widely accepted.47-50
20
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In conclusion, the result of the present meta-analysis confirmed that ORIF provides superior clinical outcomes (subjective and objective) than CT in the management of adult MCFs. Better
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designed prospective randomized controlled clinical trials with adequate sample sizes and long follow-up periods comparing open and closed treatment of isolated adult MCFs would be useful in
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exploring this question further. Other variables such as treatment cost and patient satisfaction should be additionally studied to
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adult condylar fractures.
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determine the differences between open and closed treatment of
21
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29. Constantin A. Landes, Kai Day, Ruben Lipphardt, Robert Sader: Prospective closed treatment of nondisplaced and nondislocated condylar neck and head fractures versus open reposition internal fixation of displaced and dislocated fracture. Oral Maxillofac Surg 2008;12:79–88.
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30. Landes CA, Day K, Lipphardt R, Sader R: Closed versus open operative treatment of nondisplaced diacapitular (Class VI) fractures. J Oral Maxillofac Surg 2008a ;66: 1586-1594,.
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31. Schneider M, Erasmus F, Gerlach KL, Kuhlisch E, Loukota RA, Rasse M, et al: Open reduction and internal fixation versus closed treatment and mandibulomaxillary fixation of fractures of the mandibular condylar process: a randomized, prospective, multicenter study with special evaluation of fracture level. J Oral Maxillofac Surg 2008; 66: 2537-2544.
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32. Danda AK, Muthusekhar MR, Narayanan V, Baig MF, Siddareddi A: Open versus closed treatment of unilateral subcondylar and condylar neck fractures: a prospective, randomized clinical study. J Oral Maxillofac Surg 2010; 68: 12381241. 33. Singh V, Bhagol A, Goel M, Kumar I, Verma A: Outcomes of open versus closed treatment of mandibular subcondylar fractures: a prospective randomized study. J Oral Maxillofac Surg 2010; 68: 1304-1309.
26
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40. Assael LA: Open versus closed treatment of adult mandibular condyle fractures: An alternative interpretation of the evidence. J Oral Maxillofac Surg 2003; 61:1333.
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41. Brandt MT, Haug RH: Open versus closed treatment of adult Mandibular condyle fractures: A review of the literature regarding the evolution of current thoughts on management. J Oral Maxillofac Surg 2003; 61:1324.
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42. Yasuharu Takenoshita, Hiroaki Ishibashi, , Masuichiro Oka: Comparison of Functional Recovery After Nonsurgical and Surgical Treatment of Condylar Fractures. J Oral Maxillofac Surg 1990;48:1191-1195.
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43. Konstantinovic VS, Dimitrijevic B: Surgical versus conservative treatment of unilateral condylar process fractures: clinical and radiographic evaluation of 80 patients. J Oral Maxillofac Surg 1992;50: 349-352.
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44. Hyde N, Manisali M, Aghabeigi B, Sneddon K, Newman L: The role of open reduction and internal fixation in unilateral fractures of the mandibular condyle: a prospective study. Br J Oral Maxillofac Surg 2002;40: 19-22.
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45. Edward Ellis III, David McFadden, Patricia Simon, and Gaylord Throckmorton: Surgical Complications With Open Treatment of Mandibular Condylar Process Fractures. J Oral Maxillofac Surg 2002;58:950-958. 46. Edward Ellis III: Method to Determine When Open Treatment of Condylar Process Fractures Is Not Necessary. J Oral Maxillofac Surg 2009;67:1685-1690.
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47. Troulis, M. J., and Kaban, L. B. Endoscopic approach to the ramus/condyle unit: Clinical applications.J. Oral Maxillofac. Surg 2001;59: 503.
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48. Lauer, G., and Schmelzeisen, R. Endoscope-assisted fixation of mandibular condylar process fractures. J. Oral Maxillofac. 1999;Surg.57: 36.
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49. Sandler, N. A., Andreasen, K. H., and Johns, F. R. The use of endoscopy in the management of subcondylar fractures of the mandible: A cadaver study. Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 1999;88: 529. 50. Lee, C., Stiebel, M., and Young, D. M. Cranial nerve VII region of the traumatized facial skeleton: Optimizing fracture repair with the endoscope. J. Trauma2000; 48: 423.
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51. Ellis E: Open reduction and internal fixation of combined angle and body/symphysis fractures of the mandible: How much fixation is enough? J Oral Maxillofac Surg 2013; 71:726-733.
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52. Bos RRM, Ward RP, de Bont LGM: Mandibular condyle fractures: A consensus. Br J Oral Maxillofac Surg 1999;37:87, editorial.
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53. Pedro M. Villarreal, Florencio Monje, Luis M. Junquera, Jesu ´s Mateo, Antonio J. Morillo, and Cristina Gonza´lez: Mandibular Condyle Fractures: Determinants of Treatment and Outcome. J Oral Maxillofac Surg 2004; 62:155-163.
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Figures and Tables Captions Fig. 1: Study screening process
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Fig. 2: Forest plot – maximal interincisal opening, ORIF versus CT (continuous data) Fig. 3: Forest plot – latrotrusive movement, ORIF versus CT (continuous data)
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Fig. 4: Forest plot– protrusive movement, ORIF versus CT (continuous data)
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Fig. 5: Forest plot – pain via VAS, ORIF versus CT (continuous data) Fig. 6: Forest plot – malocclusion, ORIF versus CT (dichotomous data)
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Fig. 7: Forest plot – TMJ pain, tenderness, noise and clicking and chin deviation on mouth opening, ORIF versus CT (dichotomous data)
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Fig. 8: Funnel plot– publication bias according to the reported incidence of postoperative malocclusion.
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Tab. 1: Characteristics of the included studies Tab. 2: Results of quality assessment
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Table 1 : Characteristics of included studies
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Years
Study design
Age (mean) Female/male Ratio
Worsaae et al. 17
1994
CCT
Oezmen et al.18
1998
CCT
Palmieri et al.19
1999
CCT
Santler et al.20
1999
CCT
Ellis et al.21
2000
CCT
De riu et al.22
2001
CCT
ORIF:(29) 16:8 CT:(37) 21:7 ORIF,CT :(31.5) 23:7 ORIF,CT: (16-70) 121:27 ORIF: (24) 20:17 CT: (23) 90:23 (16-70) CRT: 62:10 ORIF: 51:14 ORIF,CT:(1369)
Haug t al.23
2001
RS
Yang et al.4
2001
CCT
Hlawitschka et al.24
2005
CCT
StieschScholz et al.25 Eckelt et al.26
2005
CCT
2006
RCT
Landes and Lipphard27
2006
CCT
Ishihama et al.28
2007
CCT
Constantin et al.29
2008
CCT
Patients numbers ORIF CT 24 28
Follow up period
MCFs Fixation Method
Surgical Approach
Associated Mandibular Fractures
OR:21 months CR:30 months 24 months
CT: IMF for 5-6 weeks ORIF: transosseous wire osteosynthesis CT: IMF ORIF: ORIF
NM
Yes
ORIF: submandibular incision
No
10
62
85
Up to 3 years
CT: IMF for 2 weeks ORIF: ORIF
ORIF: retro mandibular approach
Yes
37
113
6-130 months
CT: IMF ORIF: ORIF
NM
ORIF:13 CT:59
65
77
Up to 3 years
CT: IMF ORIF: ORIF
ORIF: retro mandibular approach
Yes
20
19
ORIF: submandibular or preauricular Approach
NM
CT: (36.1) 8:2 ORIF: (36.5) 7:3 ORIF,CT: (25.53) 41:25
10
10
6 months
CRT: IMF for 5–7 days ORIF: ORIF+IMF for 3-5 days CT: IMF ORIF: ORIF
NM
NM
36
30
One year
ORIF: (30) 13:1 CT: (28) 25:4 ORIF,CT: (32) 117:17 ORIF,CT: (32) 52:14
14
29
24
13
36
33
> 16 ORIF: (33) CT: (15) ORIF: (34.8) 17:7 CT:(33.5) 26:17 ORIF:(39) year
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14
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CT: IMF for 3 weeks ORIF: ORIF+IMF for 1 week
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6 months
42 months
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CRT: 20 months ORIF: 11 months
18
43
6 months to 2.5 years
30
29
One year
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CT: IMF for 10 days+8 weeks functional therapy ORIF: ORIF+IMF for 2 days CT: IMF ORIF: ORIF CT:IMF+elastic for 10 days ORIF:miniplates/ Miniscrews Lag screws CT: IMF for 2 weeks ORIF: ORIF
CT: IMF+elastic for 1-3 weeks ORIF: lag screw/miniplate/wire CT: IMF+elastic for 2 weeks
ORIF: Preauricular extraoral approach, endoscope-assisted intraoral approach ORIF: modified auricular approach
Yes
NM
No
ORIF:peraruicular, Submandibular, Perangular, transoral
Yes
ORIF: preauricular approach
Yes
ORIF: submandibular approach
Yes
ORIF: perauricular and retromandibular
Yes
Yes
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CCT
CT: (31) ORIF: (27) ORIF,CT: >18 years
9
13
2008
RCT
Danda et al.32
2010
Singh et al.33
36
30
RCT
ORIF,CT: 27:5
16
16
CRT:21.5 Months ORIF:22.3 Months
2010
RCT
ORIF,CT: (30.6) year 33:7
18
22
6 months
Park et al.34
2010
CCT
ORIF,CT: (27.5) 52:19
63
35
12 months
C. Sforza et al.35
2011
CCT
ORIF:( 26.8) CT: ( 27.1)
9
12
Gupta et al.36
2012
CCT
10
10
V. Singh et al.37
2012
RS
CT: (15-65) 8:2 ORIF: (28.2) 10:0 (28.2) CT: 16:4 ORIF: 19:5
ORIF: 16.4 months CR: 32.8 months 1-, 4-, 8-, and 12week
24
20
Kotrashetti et al.38
2013
RCT
10
12
NM
12 months 6 months
6 months
6 months
approach
ORIF: preauricular approach ORIF:preauricular, transoral and retromandibular approach
CT: IMF ORIF: 2-mm stainless steel plates and screws CT: IMF for 21- 35 days ORIF: ORIF+IMF for 3-5 days CT:IMF+elastic for 34 weeks ORIF: titanium miniplates and 2×6 mm titanium screws
Yes Yes
ORIF:preauricular, submandibular, transmassetric anterior parotid, or retromandibular approach ORIF:retromandibular, anteroparotid approach
NM
ORIF:intraoral and submandibular approaches
No
NM
No
Yes
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miniplate/T shape microplate CT: IMF for 2 weeks ORIF: ORIF CT:IMF for 10 days + elastic ORIF: ORIF using 1 or 2 Miniplate/lag screw CT:IMF for 2 weeks + elastic For 2 weeks ORIF: ORIF using 1 or 2 Miniplate+ IMF for 2 weeks CT: IMF+elastic for 7 to 35 days ORIF: 2 mm titanium Miniplates+IMF with elastic for 3-5 days CT: IMF for 2 weeks ORIF: ORIF+IMF for 1 week CT: IMF ORIF: ORIF
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CT:(36)
ORIF: preauricular and/or retromandibular approaches
NO
ORIF: retromandibular, anteroparotid approach ORIF: retromandibular approach
Yes
Yes
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RCT-randomized controlled trials, CCT- controlled clinical trial, RS- retrospective study, CT-closed reduction treatment, ORIFopen reduction and internal fixation, NM- not mentioned
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Table 2. Results of the quality assessment Published
Random selection in population
Defined inclusion/exclusion criteria
Loss of followup
Validated measurement
Statistical analysis
Estimated potential risk of bias
Worsaae et al. 17 Oezmen et al.18 Palmieri et al.19 Santler et al.20 Ellis et al.21 De riu et al.22 Haug t al.23 Yang et al.4 Hlawitschka et al.24 StieschScholz et al.25 Eckelt et al.26 Landes and Lipphard27 Ishihama et al.28 Constantin et al.29 C. Landes et al.30 Schneider et al.31 Danda et al.32 Singh et al.33 Park et al.34 C. Sforza et al.35 Gupta et al.36 V. Singh et al.37 Kotrashetti et al.38
1994
No
Yes
Yes
Yes
Yes
Moderate
1998
No
Yes
Yes
Yes
Yes
Moderate
1999
No
Yes
Yes
Yes
Yes
Moderate
1999
No
Yes
Yes
Yes
Yes
Moderate
2000 2001
No No
Yes Yes
Yes Yes
Yes Yes
Yes Yes
Moderate Moderate
2001 2001 2005
No No No
Yes Yes Yes
Yes Yes Yes
Yes Yes Yes
Yes Yes Yes
Moderate Moderate Moderate
2005
No
Yes
Yes
Yes
Yes
Moderate
2006
Yes
Yes
Yes
Yes
Yes
Low
2006
No
Yes
Yes
Yes
2007
No
Yes
Yes
Yes
2008
No
Yes
Yes
Yes
2008
No
Yes
2008
Yes
Yes
2010
Yes
Yes
2010
Yes
Yes
2010 2011
No No
Yes Yes Yes
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2012
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Authors
Yes
Moderate
Yes
Moderate
Yes
Moderate
Yes
Yes
Yes
Moderate
Yes
Yes
Yes
Low
Yes
Yes
Yes
Low
Yes
Yes
Yes
Low
Yes Yes
Yes Yes
Yes Yes
Moderate Moderate
Yes
Yes
Yes
Moderate
No
Yes
Yes
Yes
Yes
Moderate
2013
Yes
Yes
Yes
Yes
Yes
Low
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905 article identified through database searching
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762 articles screened through titles and abstracts
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225 articles of full text assessed for eligibility
202 articles excluded due to they did not met inclusion criteria
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23 articles included in quantitative (meta-analysis) and qualitative assessment
Figure . 1: selection study process
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