Interventions for the treatment of fractures of the mandibular condyle (Review)

Sharif MO, Fedorowicz Z, Drews P, Nasser M, Dorri M, Newton T, Oliver R

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 4 http://www.thecochranelibrary.com

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS HEADER . . . . . . . . . . ABSTRACT . . . . . . . . . PLAIN LANGUAGE SUMMARY . BACKGROUND . . . . . . . OBJECTIVES . . . . . . . . METHODS . . . . . . . . . RESULTS . . . . . . . . . . DISCUSSION . . . . . . . . AUTHORS CONCLUSIONS . . ACKNOWLEDGEMENTS . . . REFERENCES . . . . . . . . CHARACTERISTICS OF STUDIES DATA AND ANALYSES . . . . . ADDITIONAL TABLES . . . . . APPENDICES . . . . . . . . HISTORY . . . . . . . . . . CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST . INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 2 3 3 5 6 7 7 7 8 10 10 11 12 13 13 13

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

[Intervention Review]

Interventions for the treatment of fractures of the mandibular condyle

Mohammad O Sharif2 , Zbys Fedorowicz3 , Peter Drews4 , Mona Nasser5 , Mojtaba Dorri6 , Tim Newton7 , Richard Oliver1
1

Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, UK. 2 School of Dentistry, The University of Manchester, Manchester, UK. 3 UKCC (Bahrain Branch), Ministry of Health, Bahrain, Awali, Bahrain. 4 Naval Medical Center San Diego, Dental Department, San Diego, USA. 5 Department of Health Information, Institute for Quality and Efciency in Health care, Cologne, Germany. 6 Department of Epidemiology and Public Health, University College London Medical School, London, UK. 7 Division of Health and Social Care Research, KCL Dental Institute, London, UK

Contact address: Richard Oliver, Department of Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Higher Cambridge Street, Manchester, M15 6FH, UK. richard.j.oliver@manchester.ac.uk. Editorial group: Cochrane Oral Health Group. Publication status and date: New, published in Issue 4, 2010. Review content assessed as up-to-date: 11 March 2010. Citation: Sharif MO, Fedorowicz Z, Drews P, Nasser M, Dorri M, Newton T, Oliver R. Interventions for the treatment of fractures of the mandibular condyle. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD006538. DOI: 10.1002/14651858.CD006538.pub2. Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background Fractures of the condylar process account for between 25% and 35% of all mandibular fractures. Treatment options for fractures of the condyles consist of either the closed method or by open reduction with xation. Complications may be associated with either treatment option; for the closed approach these can include malocclusion, particularly open bites, reduced posterior facial height and facial asymmetry in addition to chronic pain and reduced mobility. A cutaneous scar and temporary paralysis of the facial nerve are not infrequent complications associated with the open approach. There is a lack of consensus currently surrounding the indications for either surgical or non-surgical treatment of fractures of the mandibular condyle. Objectives To evaluate the effectiveness of interventions that can be used in the treatment of fractures of the mandibular condyle. Search methods The databases searched were: the Cochrane Oral Health Groups Trials Register (to 12th March 2010), CENTRAL (The Cochrane Library 2010, Issue 2), MEDLINE (from 1950 to 12th March 2010), and EMBASE (from 1980 to 12th March 2010). The reference lists of all trials identied were cross checked for additional trials. Authors were contacted by electronic mail to ask for details of additional published and unpublished trials. There were no language restrictions and several articles were translated. Selection criteria Randomised controlled trials (RCTs) which included adults, over 18 years of age, with unilateral or bilateral fractures of the mandibular condyles. Any form of open or closed method of reduction and xation was considered.
Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1

Data collection and analysis Review authors screened trials for inclusion. Extracted data were to be synthesised using the xed-effect model but if substantial clinical diversity was identied between the studies we planned to use the random-effects model with studies grouped by action and we would explore the heterogeneity between the included studies. Mean differences were to be calculated for continuous outcomes and risk ratios for dichotomous outcomes together with their 95% condence intervals. Main results No high quality evidence matching the inclusion criteria was identied. Authors conclusions No high quality evidence is available in relation to this review question and no conclusions could be reached about the effectiveness or otherwise of the two interventions considered in this review. A need for further well designed randomised controlled trials exists. The trialists should account for all losses to follow-up and assess patient related outcomes. They should also report the direct and indirect costs associated with the interventions.

PLAIN LANGUAGE SUMMARY Interventions for the treatment of fractures of the mandibular condyle Fractures of the condylar process of the mandible (lower jaw) are common. Two treatment options are available: either closed treatment (without surgery) or open reduction (involving surgery). Complications are associated with both treatment modalities. With a closed approach the complications include disturbances in the way the teeth meet, facial asymmetry, chronic pain and reduced mobility of the lower jaw. With an open approach the complications include a scar on the overlying skin and also the possibility of temporary paralysis of the nerve supplying some of the facial muscles involved in smiling and eye opening/closing. Currently there is much controversy regarding the most appropriate method for the management of fractured mandibular condyles. This review revealed that there is a lack of high quality evidence for the effectiveness of either approach, and that there is a need for further research to help clinicians and patients to make informed choices of treatment options.

BACKGROUND

in one reported series (Ellis 2005).

Aetiology and incidence

Fractures of the facial bones are very common. The mandible (lower jaw) and zygoma (cheek bone), by nature of their location and anatomy are the two bones most commonly fractured. In the developed world, interpersonal violence is the most common cause of facial fractures; this is often exacerbated by the use of alcohol or illicit drugs. The mandible is a unique horse-shoe shaped bone with an identical joint at both ends with the condyle articulating in the glenoid fossa of the middle cranial fossa of the skull. Inherently weak areas of the bone are commonly fractured namely the articular condyle, the angle and the parasymphysis. Fractures of the condylar process of the mandible are common, accounting for between 25% and 35% of all mandibular fractures

Classication
There are numerous classications of fractures of the condylar process of the mandible. They can be classied with respect to fracture level, dislocation at the fracture level, and condylar head relationship to the articular fossa (Lindahl 1977). In everyday clinical practice it is the level and degree of displacement of the fracture that is the most relevant. Fractures tend to occur at one of three positions: the condylar head (and therefore usually within the joint capsule), high subcondylar (below the condyle and joint capsule but above the sigmoid notch) or low subcondylar where the fracture runs from the sigmoid notch to the posterior aspect of the mandibular ramus. A number of factors may inuence the degree and the direction of
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Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

bone displacement in condylar fractures such as the direction of the traumatic force, the position of the mandible during impact, the inuence of the lateral pterygoid muscle, and the presence of other fractures in the mandible or in the articular fossa. In some studies it was observed that bone displacements were more frequent in the medial and anterior directions, but other directions were also possible (Costa e Silva 2003).

by the use of osteosynthesis miniplates, lag screws or pin xation. Complications of this treatment may include a cutaneous scar and temporary paralysis of the facial nerve (Brandt 2003).

OBJECTIVES
The objective of this review was to evaluate the effectiveness of interventions that can be used in the management of fractures of the mandibular condyle.

Diagnosis
The diagnosis of a fracture of the mandibular condyle can be made by clinical and radiographic examinations. Clinical signs, such as bone deection, difculty in opening the mouth, malocclusion (particularly open bite of the contralateral side), and oedema in the peripheral region of the auricle, may be indicative of traumatic uni- or bilateral fractures of the mandibular condyle (Costa e Silva 2003).

METHODS

Criteria for considering studies for this review

Treatment
Several factors may determine the treatment decision for these types of fractures, notably the level of the fracture and the degree of displacement. The level of the fracture inuences the degree of pre-operative coronal and sagittal displacement (neck fractures have greater medial and anterior displacement than head and subcondylar fractures) and the treatment applied. In some studies the functional improvement, particularly the occlusion, obtained by open methods was greater than that obtained by closed treatment (De Riu 2001; Ellis 2000). Controversy exists regarding the management of mandibular condyle fractures. At the simplest level there are two treatment options, namely conservative treatment or open reduction with xation. Conservative management (closed reduction) There are problems with the denition of conservative management as it can range from absolutely no active intervention to the use of some form of intermaxillary (maxillary-mandibular) xation or traction. Complications of this method of treatment include malocclusion, particularly open bites, reduced posterior facial height and facial asymmetry, chronic pain and reduced mobility (Brandt 2003). Open reduction and xation Most fractures occurring elsewhere in the mandible are openly reduced and xed usually through intraoral incisions. Although the mandibular condyles can be reached through intraoral incisions, visualisation can only be via endoscopic means. Most open reductions are undertaken via an extraoral incision; either pre-auricular, retromandibular or submandibular. Fixation is achieved

Types of studies Only randomised controlled clinical trials (RCTs) were considered in this review. Types of participants Adults, over 18 years of age, with unilateral or bilateral fractures of the mandibular condyles. Types of interventions Any form of open or closed method of reduction and xation. Any studies that compared methods of management of fractures of the mandibular condyle were considered. Various denitions of conservative management of mandibular condyle fractures exist including no active intervention (other than soft diet, analgesics or antibiotics), intermaxillary (maxillarymandibular) xation with rigid or elastic (traction); if any of these were compared to an open method of reduction and xation they were considered eligible for inclusion. Types of outcome measures

Primary outcomes

1. Status of occlusion as assessed by the trialists. 2. Degree of function (improvement or impairment) postoperatively including mouth opening and mobility, protrusive or translatory movements, facial nerve function, ankylosis. 3. Aesthetics (symmetry, vertical facial height). 4. Post-operative pain measured using any validated analogue scale, e.g. VAS (visual analogue scales), or measures of
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Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

medication used and any pain scale used to measure chronic or lasting pain during the recovery period.

Searching other resources No handsearching was carried out for this review. All relevant journals had either been handsearched as part of the Cochrane Oral Health Groups handsearching programme (see www.ohg.cochrane.org/handsearching.html for information) or were fully indexed on MEDLINE and retrieved as part of the electronic searches. We examined the reference lists of relevant articles and contacted the investigators of potentially eligible studies by electronic mail to clarify items of trial conduct and to ask for details of additional published and unpublished trials.

Secondary outcomes

1. Quality of life as assessed by a validated questionnaire. 2. Patient satisfaction assessed by questionnaire.

Adverse effects

1. Inammatory complications: osteomyelitis, hematoma, pseudarthrosis, wound dehiscence, persistent dysaesthesia, postoperative infection, abscess. 2. Anaesthetic complications. 3. Nerve injury. 4. Disturbance of occlusal function, deviation of the mandible, internal derangements of the temporomandibular joint (TMJ), and ankylosis of the joint with resultant inability to move the jaw. 5. Need for re-treatment or corrective surgery.

Language

There was no language restriction on included studies and we arranged for the translation of ve potentially eligible non-English language studies.

Data collection and analysis

Costs

Selection of studies Two review authors (Richard Oliver (RJO) and Mohammad O Sharif (MOS)) independently assessed the abstracts of studies resulting from the searches. Full copies of all potentially relevant studies and those appearing to meet the inclusion criteria, or for which there were insufcient data in the title and abstract to make a clear decision, were obtained. The full text papers were assessed independently by the two review authors and any disagreement on the eligibility of included studies was resolved through discussion. Where resolution was not possible, a third review author (Zbys Fedorowicz (ZF)) was consulted. All irrelevant records were excluded and details of these studies and the reasons for their exclusion were noted in the Characteristics of excluded studies table. Data extraction and management Although no studies were included in this review the following methods will be used for data extraction and management when further studies are identied for inclusion in this review. Data will be extracted independently and in duplicate by two review authors (MOS and RJO) and only included if there was a consensus. Data will be entered into the Characteristics of included studies table and outcome data reported in these studies would be extracted using a pre-determined form designed for this purpose. The following details will be extracted. 1. Study methods: method of allocation, exclusion of participants after randomisation and proportion of follow-up losses. 2. Participants: country of origin, sample size, age, sex, inclusion and exclusion criteria.
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We considered any direct costs related to the types of splints or xation devices, hospital bed days and indirect cost implications due to delayed healing of the fracture or lost time.

Search methods for identication of studies

Electronic searches For the identication of studies included or considered for this review, detailed search strategies were developed for each database to be searched. These were based on the search strategy developed for MEDLINE (Appendix 1) but revised appropriately for each database. For the MEDLINE search, we ran the subject search with the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying reports of randomised controlled trials (as described in the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2, Box 6.4.c (Higgins 2009)). The following databases were searched on 12th March 2010: The Cochrane Oral Health Groups Trials Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 2); MEDLINE (1950 to 12th March 2010); and EMBASE (1980 to 12th March 2010). For the detailed search strategies applied to each of the databases see Appendix 1; Appendix 2; Appendix 3 and Appendix 4.

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

3. Intervention: type, duration and length of time in followup. 4. Control: type, duration and length of time in follow-up. 5. Outcomes: primary and secondary outcomes as described in the Types of outcome measures section of this review. If stated, the sources of funding will be recorded. The review authors would then use this information to help them assess heterogeneity and the external validity of any included trials. Assessment of risk of bias in included studies If relevant studies had been identied for inclusion in this review two review authors (MOS and RJO) would have independently graded these studies using a simple contingency form following the domain-based evaluation described in the Cochrane Handbook for Systematic Reviews of Interventions 5.0.2 (updated September 2009) (Higgins 2009). The authors would have then compared evaluations and discussed and resolved any disagreements. An assessment of the overall risk of bias would have involved the consideration of the relative importance of different domains, and studies were to be categorised as low, high or unclear risk of bias. The authors would assess the following domains as Yes (i.e. low risk of bias), Unclear (uncertain risk of bias) or No (i.e. high risk of bias): 1. sequence generation; 2. allocation concealment; 3. blinding (of participants, personnel and outcome assessors); 4. incomplete outcome data; 5. selective outcome reporting; 6. free of other bias. The authors would have reported these assessments for the included study in a Risk of bias in included studies table. Measures of treatment effect Data obtained from any categorical outcomes would be converted if appropriate into dichotomous data prior to analysis. Risk ratios and their 95% condence intervals for all dichotomous data and for continuous data the mean difference and 95% condence intervals would be calculated. Dealing with missing data Authors in any trial to be included would have been contacted to obtain missing data. Assessment of heterogeneity Lack of studies for inclusion precluded any assessment of heterogeneity but if further trials are identied the following methods of assessment will be used. We will assess clinical heterogeneity by examining the characteristics of the studies, the similarity between the types of participants,

the interventions and the outcomes as specied in the Criteria for considering studies for this review section of this review. Statistical heterogeneity will be assessed using a Chi2 test and the I2 statistic where I2 values over 50% indicate moderate to high heterogeneity. We will consider heterogeneity to be signicant when the P value is less than 0.10 (Higgins 2003). Assessment of reporting biases In the future if trials are identied for inclusion in this review, publication bias will be assessed according to the recommendations on testing for funnel plot asymmetry (Egger 1997) as described in section 10.4.3.1 of the Cochrane Handbook for Systematic Reviews of Interventions 5.0.2 (updated September 2009) (Higgins 2009), and if asymmetry is identied, we will try to assess other possible causes and these will be explored in the discussion if appropriate. Data synthesis As no studies were included in this review data synthesis was not carried out but if studies are identied for inclusion in this review in the future, the following methods of data synthesis will be used. Two review authors (MOS and ZF) will analyse the data and report them as specied in Chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions 5.0.2 (updated September 2009) (Higgins 2009). Analysis will be conducted at the same level as the allocation. Pooling of data to provide estimates of the efcacy of the interventions will only be undertaken if the included studies have similar interventions received by similar participants. Number needed to treat to benet (NNTB) and number needed to treat to harm (NNTH) would be calculated for the whole pooled estimate. In general for the synthesis of any quantitative data the xed-effect model would be used but if there is substantial clinical diversity between the included studies we will use the random-effects model with studies grouped by action. Subgroup analysis and investigation of heterogeneity Subgroup analysis or investigation of heterogeneity was not carried out because no studies were identied for inclusion in this review. Sensitivity analysis For future updates and if there are sufcient included studies we plan to conduct sensitivity analyses to assess the robustness of the review results by repeating the analysis with the following adjustments: exclusion of studies with unclear or inadequate allocation concealment and completeness of follow-up.

RESULTS
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Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Description of studies
See: Characteristics of excluded studies.

High risk of bias (plausible bias that seriously weakens condence in the results) if one or more criteria were not met.

Results of the search The search retrieved 102 references to studies. After examination of the titles and abstracts of these references, all but 14 were eliminated and excluded from further evaluation. We obtained full text copies of the remaining studies and arranged for the translation of ve of them (Crivello 2002; Hu 2002; Moritz 1994; Suzuki 1991; Zajdela 1975). All of the potentially eligible studies were then subjected to further evaluation which included examination of their bibliographical references but no additional citations to potentially eligible studies were identied. Our search also retrieved a relevant meta-analysis (Nussbaum 2008) which had included a study (Worsaae 1994) that had been previously assessed as ineligible for our review and is listed in the Characteristics of excluded studies section. Two studies (Eckelt 2006; Schneider 2008) did appear initially to meet our inclusion criteria but after further examination and subsequent conrmation with the investigators it was clear that the study participants and interventions in both studies were identical. However, these studies were eventually excluded because of substantial losses (25%) to follow-up. The investigators provided very few details about these participants, did not report which interventions they were allocated to or the reason for the losses to follow-up or the time during follow-up and data were not analysed according to the intention-to-treat principle. We contacted one of the study authors by email but were unsuccessful in obtaining any further information or explanation about the losses to follow-up, further attempts to contact an additional investigator also proved unsuccessful. The review authors discussed the eligibility of these two remaining studies for inclusion in this review, resolved any uncertainties by consensus, and nally excluded them.

Effects of interventions
In view of the lack of high quality trials no rm conclusions could be reached about the effectiveness or otherwise of the two interventions considered in this review.

DISCUSSION
This review identied no high quality trials comparing open with closed reduction of fractures of mandibular condyles. One multicentre randomised controlled trial which was published as Eckelt 2006 and Schneider 2008 was conducted in Europe and data collected. However, a large number of methodological shortcomings mean the published results should be interpreted with caution.

Summary of main results

One trial published as Eckelt 2006 and Schneider 2008 met our inclusion criteria, but was subsequently excluded as a result of missing data which we were unable to obtain even after contact with the authors. Therefore no conclusions can be reached about the effectiveness or otherwise of open versus closed treatment of fractures of the mandibular condyle.

Overall completeness and applicability of evidence

With regards to the Eckelt 2006; Schneider 2008 articles the review authors were concerned about the 25% of randomised patients who were lost to follow-up and the analysed data in the study were of the remaining 66 patients. There was no intention-to-treat analysis. Given the high risk of bias and the overall quality of the evidence, no clear decisions can be made about the applicability of the evidence to support the use of one technique over another. Even if the outcomes assessed in the study had favoured open or closed reduction, there were few patient centred outcomes which will be more important to patients than objective measurements made by a clinician.

Excluded studies All of the studies which were excluded from this review and the reasons for their exclusion are listed in the Characteristics of excluded studies table.

Risk of bias in included studies

If any studies had been included in this review we would have categorised risk of bias according to the following: Low risk of bias (plausible bias unlikely to seriously alter the results) if all criteria were met; Unclear risk of bias (plausible bias that raises some doubt about the results) if one or more criteria were assessed as unclear; or

Potential biases in the review process

The possibility of bias in the review process cannot be excluded because the one trial which was potentially eligible (Eckelt 2006; Schneider 2008) was, in general methodologically sound, however it was incompletely reported and we were unable to obtain the
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Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

missing data. If the data had been accessible to us it is likely the trial would have been included and could have potentially added to the evidence base for these interventions.

Implications for research

There is a need for well conducted randomised controlled clinical trials, these should be designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement ( www.consort-statement.org/). Important consideration should be given to the method of randomisation, justifying sample size, allocation concealment, blinding of the outcome assessor and reasons for patients lost to follow-up should be considered during the planning, conducting and reporting phase of the study. Factors such as quality of life, patient satisfaction levels and costs should also be investigated and reported. For further research recommendations based on the EPICOT format (Brown 2006) please see Additional Table 1.

Agreements and disagreements with other studies or reviews

A recent systematic review and meta-analysis (Nussbaum 2008) included non-randomised controlled clinical trials as well as one randomised controlled trial (Worsaae 1994) which was excluded from our Cochrane review. The review of Nussbaum 2008 did not even identify the Eckelt 2006 study and because of the heterogeneity of the studies identied could not draw any conclusions.

AUTHORS CONCLUSIONS Implications for practice

There is a lack of high quality evidence relevant to interventions considered in this review topic and so the effectiveness of the two interventions considered in this review cannot be ascertained. Therefore, clinical decisions should be based on clinical experience, individual circumstances and in conjunction with patient preferences and choices where appropriate.

ACKNOWLEDGEMENTS
The review authors would like to acknowledge the assistance they have received from members of the Cochrane Oral Health Group and the comments from the referees. We would also like to thank Dario Sambunjak, Stphanie Tubert, Toru Naito, Shi Zongdao and Dr Anja Scheiwe for their help in the translation and the assessment of relevant articles.

REFERENCES

References to studies excluded from this review

Crivello 2002 {published data only} Crivello O. Evaluation of mandibular movement after condylar fracture. Revue de Stomatologie et de Chirurgie Maxillo-Faciale 2002;103(1):225. Eckelt 2006 {published data only} 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 multi-centre study. Journal of Craniomaxillofacial Surgery 2006;34(5):30614. Gorgu 2002 {published data only} Gorgu M, Deren O, Sakman B, Ciliz D, Erdogan B. Prospective comparative study of the range of movement of temporomandibular joints after mandibular fractures: rigid or non-rigid xation. Scandinavian Journal of Plastic and Reconstructive Surgery and Hand Surgery 2002;36(6): 35661. Haug 2001 {published data only} Haug RH, Assael LA. Outcomes of open versus closed treatment of mandibular subcondylar fractures. Journal of Oral and Maxillofacial Surgery 2001;59(4):3705.

Hu 2002 {published data only} Hu X, Zhang R, Ouyang J. Surgical versus nonsurgical treatment of condyle fractures. Journal of Modern Stomatology 2002;16(4):3345. Ishihama 2007 {published data only} 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(1):1622. Landes 2008 {published data only} Landes CA, Day K, Lipphardt R, Sader R. Closed versus open operative treatment of nondisplaced diacapitular (Class VI) fractures. Journal of Oral and Maxillofacial Surgery 2008;66(8):158694. Mitchell 1997 {published data only} Mitchell DA. A multicentre audit of unilateral fractures of the mandibular condyle. The British Journal of Oral & Maxillofacial Surgery 1997;35(4):2306. Moritz 1994 {published data only} Moritz M, Niederdellmann H, Dammer R. Mandibular condyle fractures: conservative treatment versus surgical treatment. Revue de Stomatologie et de Chirurgie MaxilloFaciale 1994;95(4):26873.
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Nussbaum 2008 {published data only} Nussbaum ML, Laskin DM, Best AM. Closed versus open reduction of mandibular condylar fractures in adults: a meta-analysis. Journal of Oral and Maxillofacial Surgery 2008;66(6):108792. Schneider 2008 {published data only} Schneider M, Erasmus F, Gerlach KL, Kuhlisch E, Loukota RA, Rasse M, et al.Open reduction and internal xation versus closed treatment and mandibulomaxillary xation of fractures of the mandibular condylar process: a randomized, prospective, multicentre study with special evaluation of fracture level. Journal of Oral and Maxillofacial Surgery 2008;66(12):253744. Suzuki 1991 {published data only} Suzuki S, Hinoshita M, Ochiai H, Kamiya Y, Umemura M, Koie M, et al.The treatment of condyle neck fracture: statistics gathered by multi centric study and related prognosis. Aichi Gakuin Daigaku Shigakkai Shi 1991;29(2): 3018. Throckmorton 2000 {published data only} Throckmorton GS, Ellis E 3rd. Recovery of mandibular motion after closed and open treatment of unilateral mandibular condylar process fractures. International Journal of Oral and Maxillofacial Surgery 2000;29(6):4217. Throckmorton 2004 {published data only} Thockmorton GS, Ellis E 3rd, Hayasaki H. Masticatory motion after surgical or nonsurgical treatment for unilateral fractures of the mandibular condylar process. Journal of Oral and Maxillofacial Surgery 2004;62(2):12738. Worsaae 1994 {published data only} Worsaae N, Thorn JJ. Surgical versus nonsurgical treatment of unilateral dislocated low subcondylar fractures: a clinical study of 52 cases. Journal of Oral and Maxillofacial Surgery 1994;52(4):35360. Zajdela 1975 {published data only} Zajdela Z. Treatment of fractures of processus articularis in the lower jaw. Zobozdravstveni Vestnik 1975;30(3):4953.

Brown 2006 Brown P, Brunnhuber K, Chalkidou K, Chalmers I, Clarke M, Fenton M, et al.How to formulate research questions. BMJ 2006;333(7572):8046. Costa e Silva 2003 Costa e Silva AP, Antunes JL, Cavalcanti MG. Interpretation of mandibular condyle fractures using 2D- and 3Dcomputed tomography. Brazilian Dental Journal 2003;14 (3):2038. De Riu 2001 De Riu G, Gamba U, Anghinoni M, Sesenna E. A comparison of open and closed treatment of condylar fractures: a change in philosophy. International Journal of Oral and Maxillofacial Surgery 2001;30(5):3849. Egger 1997 Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315(7109):62934. Ellis 2000 Ellis E 3rd, Simon P, Throckmorton GS. Occlusal results after open or closed treatment of fractures of the mandibular condylar process. Journal of Oral and Maxillofacial Surgery 2000;58(3):2608. Ellis 2005 Ellis E, Throckmorton GS. Treatment of mandibular condylar process fractures: biological considerations. Journal of Oral and Maxillofacial Surgery 2005;63(1): 11534. Higgins 2003 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327 (7414):55760. Higgins 2009 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions version 5.0.2 (updated September 2009). The Cochrane Collaboration, 2009. Available from www.cochrane-handbook.org. Lindahl 1977 Lindahl L. Condylar fractures of the mandible. I. Classication and relation to age, occlusion, and concomitant injuries of teeth and teeth-supporting structures, and fractures of the mandibular body. International Journal of Oral Surgery 1977;6(1):1221. Indicates the major publication for the study

Additional references
Brandt 2003 Brandt MT, Haug RH. Open versus closed reduction of adult mandibular condyle fractures: a review of the literature regarding the evolution of current thoughts on management. Journal of Oral and Maxillofacial Surgery 2003;61(11):132432.

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

CHARACTERISTICS OF STUDIES

Characteristics of excluded studies [ordered by study ID]

Study Crivello 2002 Eckelt 2006

Reason for exclusion Non-RCT. (Translated from French to English by Stphanie Tubert.) 25% drop out in the follow-up without mention of the groups the participants were randomised to or the reason for the losses to follow-up or the time during follow-up. No intention-to-treat analysis was performed. No further information obtained by contact with authors. Study does not discuss fractured condyles. A retrospective cohort study. Non-RCT. (Translated from Chinese to English by Shi Zongdao.) Non-RCT, a retrospective comparison. Quote: After the two treatment modalities had been thoroughly discussed with each patient, the patient could decide either ORIF or CTR of the Class VI fracture, according to personal preference. Comment: Method of randomisation inadequate. Observational cohort study/audit. Non-RCT. (Translated from French to English by Stphanie Tubert.) Relevant meta-analysis which identied one study (Worsaae 1994) which was a non-RCT. 25% drop out in the follow-up without mention of the groups the participants were randomised to or the reason for the losses to follow-up or the time during follow-up. No intention-to-treat analysis was performed. No further information obtained by contact with authors. Non-RCT. (Translated from Japanese to English by Toru Naito.) Non-RCT. Patients self selected their treatment group. Non-RCT. Patients self selected their treatment group. Non-RCT. Non-RCT. (Translated from Croatian to English by Dario Sambunjak.)

Gorgu 2002 Haug 2001 Hu 2002 Ishihama 2007 Landes 2008

Mitchell 1997 Moritz 1994 Nussbaum 2008 Schneider 2008

Suzuki 1991 Throckmorton 2000 Throckmorton 2004 Worsaae 1994 Zajdela 1975

RCT = randomised controlled trial

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 9

DATA AND ANALYSES

This review has no analyses.

ADDITIONAL TABLES
Table 1. Research recommendations based on a gap in the evidence on interventions for the treatment of fractures of the mandibular condyle

Core elements Evidence (E)

Issues to consider What is the current state of evidence?

Status of research for this review A systematic review failed to identify any high quality evidence in relation to the effectiveness or otherwise of open or closed treatment of fractures of the mandibular condyle

Population (P)

Diagnosis, disease stage, comorbidity, risk factor, sex, Adults, over 18 years of age, with veried unilateral or age, ethnic group, specic inclusion or exclusion crite- bilateral fractures of the mandibular condyles. Stratied ria, clinical setting according to the type of fracture (i.e. uni- or bilateral) Type, prognostic factor Any form of open reduction. Prognostic factors include level of fracture and whether fractures are uni- or bilateral Any form of closed reduction. Prognostic factors include level of fracture and whether fractures are uni- or bilateral

Intervention (I )

Comparison (C )

Type, prognostic factor

Outcome (O)

Which clinical or patient related outcomes will the re Status of occlusion - dichotomous data. searcher need to measure, improve, inuence or accom Degree of function (improvement or plish? impairment) post-operatively - range of movements Which methods of measurement should be used? measurements, continuous data. Facial nerve function and signs of ankylosis - dichotomous data. Aesthetics - symmetry - clinical examination, dichotomous data, vertical facial height measurement, continuous data. Post-operative pain measured using a validated analogue scale, e.g. VAS or measures of medication used and any pain scale used to measure chronic or lasting pain during the recovery period - continuous data. Quality of life as assessed by a validated questionnaire - qualitative data. Patient satisfaction assessed by questionnaire qualitative data. Inammatory complications: osteomyelitis, hematoma, pseudarthrosis, wound dehiscence, persistent dysaesthesia, post-operative infection,

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Table 1. Research recommendations based on a gap in the evidence on interventions for the treatment of fractures of the mandibular condyle (Continued) abscess - dichotomous data. Anaesthetic complications - dichotomous data. Nerve injury - dichotomous data. Need for re-treatment or corrective surgery dichotomous data. Days hospitalised - continuous data. Time stamp (T) Study type Date of literature search or recommendation March 2010.

What is the most appropriate study design to address Randomised controlled trial (adequately powered/large the proposed question? sample size). Methods: concealment of allocation sequence. Blinding: Not feasible for participants and operators, however outcomes assessors and data analysts should be blinded. Setting: Acute settings with an initial follow-up of between 7-14 days and a continued follow-up to 2 years

APPENDICES Appendix 1. MEDLINE (OVID) search strategy

(Controlled vocabulary terms (MeSH) are presented in uppercase text, free text terms in lowercase.) 1. MANDIBULAR CONDYLE/ 2. ((mandib$ or (lower adj jaw$)) and condyl$).mp. [mp=title, original title, abstract, name of substance word, subject heading word] 3. or/1-2 4. MANDIBULAR FRACTURES/ 5. MANDIBULAR INJURIES/ 6. fractur$.mp. 7. or/4-6 8. 3 and 7

Appendix 2. Cochrane Oral Health Groups Trials Register search strategy

((mandibular condyle* or ((mandib* or lower jaw*) AND condyl*)) AND fractur*)

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Appendix 3. CENTRAL search strategy

#1 MANDIBULAR CONDYLE #2 (mandib* or (lower next jaw)) AND condyl* #3 #1 or #2 #4 MANDIBULAR FRACTURES/ #5 MANDIBULAR INJURIES #6 fractur* #7 #4 or #5 or #6 #8 #3 AND #7

Appendix 4. EMBASE (OVID) search strategy

1. Mandible Condyle/ 2. ((mandib$ or (lower adj jaw$)) and condyl$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] 3. or/1-2 4. Mandible Fracture/ 5. fractur$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name] 6. or/4-5 7. 3 and 6 RCT lter for EMBASE: 1. random$.ti,ab. 2. factorial$.ti,ab. 3. (crossover$ or cross over$ or cross-over$).ti,ab. 4. placebo$.ti,ab. 5. (doubl$ adj blind$).ti,ab. 6. (singl$ adj blind$).ti,ab. 7. assign$.ti,ab. 8. allocat$.ti,ab. 9. volunteer$.ti,ab. 10. CROSSOVER PROCEDURE.sh. 11. DOUBLE-BLIND PROCEDURE.sh. 12. RANDOMIZED CONTROLLED TRIAL.sh. 13. SINGLE BLIND PROCEDURE.sh. 14. or/1-13 15. ANIMAL/ or NONHUMAN/ or ANIMAL EXPERIMENT/ 16. HUMAN/ 17. 16 and 15 18. 15 not 17 19. 14 not 18

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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HISTORY
Protocol rst published: Issue 2, 2007 Review rst published: Issue 4, 2010

CONTRIBUTIONS OF AUTHORS
Richard J Oliver (RJO), Zbys Fedorowicz (ZF) and Mohammad O Sharif (MOS) were responsible for designing and co-ordinating the review. MOS, RJO, Mona Nasser (MN) and Mojtaba Dorri (MD) were responsible for: Data collection for the review Screening search results Screening retrieved papers against inclusion criteria Appraising quality of papers Extracting data from papers Obtaining and screening data on unpublished studies Entering data into RevMan Analysis of data Interpretation of data Writing the review. MOS, RJO, Tim Newton (TN) and Peter Drews (PD) were responsible for: Organising retrieval of papers Writing to authors of papers for additional information Providing additional data about papers. RJO conceived the idea for the review and is also the guarantor for the review.

DECLARATIONS OF INTEREST
Mohammad Owaise Sharif is a National Institute for Health Research (NIHR) In-Practice Research Fellow. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health, UK. There are no nancial conicts of interest and the review authors declare that they do not have any associations with any parties who may have vested interests in the results of this review.

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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INDEX TERMS Medical Subject Headings (MeSH)

Mandibular Condyle [ injuries]; Mandibular Fractures [ therapy]

MeSH check words

Adult; Humans

Interventions for the treatment of fractures of the mandibular condyle (Review) Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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