Cochrane
Library
Cochrane Database of Systematic Reviews

   
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  

  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.

  www.cochranelibrary.com  

 
Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
BACKGROUND.............................................................................................................................................................................................. 3
OBJECTIVES.................................................................................................................................................................................................. 3
METHODS..................................................................................................................................................................................................... 3
RESULTS........................................................................................................................................................................................................ 5
DISCUSSION.................................................................................................................................................................................................. 6
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 6
ACKNOWLEDGEMENTS................................................................................................................................................................................ 6
REFERENCES................................................................................................................................................................................................ 7
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 8
ADDITIONAL TABLES.................................................................................................................................................................................... 9
APPENDICES................................................................................................................................................................................................. 10
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 11
DECLARATIONS OF INTEREST..................................................................................................................................................................... 11
INDEX TERMS............................................................................................................................................................................................... 11

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

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

[Intervention Review]

Interventions for the treatment of fractures of the mandibular condyle

Mohammad O Sharif1, Zbys Fedorowicz2, Peter Drews3, Mona Nasser4, Mojtaba Dorri5, Tim Newton6, Richard Oliver7

1School of Dentistry, The University of Manchester, Manchester, UK. 2UKCC (Bahrain Branch), Ministry of Health, Bahrain, Awali,
Bahrain. 3Naval Medical Center San Diego, Dental Department, San Diego, USA. 4Department of Health Information, Institute for
Quality and Efficiency in Health care, Cologne, Germany. 5Department of Epidemiology and Public Health, University College London
Medical School, London, UK. 6Division of Health and Social Care Research, KCL Dental Institute, London, UK. 7Department of Oral and
Maxillofacial Surgery, School of Dentistry, The University of Manchester, Manchester, 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.

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 fixation. 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 Group's 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 identified 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 fixation was considered.

Data collection and analysis

Review authors screened trials for inclusion. Extracted data were to be synthesised using the fixed-effect model but if substantial clinical
diversity was identified 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% confidence intervals.

Interventions for the treatment of fractures of the mandibular condyle (Review) 1

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

Main results
No high quality evidence matching the inclusion criteria was identified.

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.

Interventions for the treatment of fractures of the mandibular condyle (Review) 2

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
Library Better health.
BACKGROUND
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 in
one reported series (Ellis 2005).
Classification
There are numerous classifications of fractures of the condylar
process of the mandible. They can be classified 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 influence the degree and the direction of
bone displacement in condylar fractures such as the direction of
the traumatic force, the position of the mandible during impact, the
influence 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).
Diagnosis
The diagnosis of a fracture of the mandibular condyle can be made
by clinical and radiographic examinations. Clinical signs, such as
bone deflection, difficulty 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).
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 influences 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
Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Database of Systematic Reviews
options, namely conservative treatment or open reduction with
fixation.
Conservative management (closed reduction)
There are problems with the definition of conservative
management as it can range from absolutely no active intervention
to the use of some form of intermaxillary (maxillary-mandibular)
fixation 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 fixation
Most fractures occurring elsewhere in the mandible are openly
reduced and fixed 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
by the use of osteosynthesis miniplates, lag screws or pin fixation.
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.
METHODS
Criteria for considering studies for this review
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 fixation. Any
studies that compared methods of management of fractures of the
mandibular condyle were considered.
Various definitions of conservative management of mandibular
condyle fractures exist including no active intervention (other
than soft diet, analgesics or antibiotics), intermaxillary (maxillary-
mandibular) fixation with rigid or elastic (traction); if any of these
were compared to an open method of reduction and fixation 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) post-
operatively including mouth opening and mobility, protrusive or
translatory movements, facial nerve function, ankylosis.
3. Aesthetics (symmetry, vertical facial height).
3
 Cochrane Trusted evidence.
Informed decisions.
Library Better health.
4. Post-operative pain measured using any validated analogue
scale, e.g. VAS (visual analogue scales), or measures of
medication used and any pain scale used to measure chronic or
lasting pain during the recovery period.
Secondary outcomes
1. Quality of life as assessed by a validated questionnaire.
2. Patient satisfaction assessed by questionnaire.
Adverse effects
1. Inflammatory complications: osteomyelitis, hematoma,
pseudarthrosis, wound dehiscence, persistent dysaesthesia,
post-operative 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.
Costs
We considered any direct costs related to the types of splints or
fixation devices, hospital bed days and indirect cost implications
due to delayed healing of the fracture or 'lost time'.
Search methods for identification of studies
Electronic searches
For the identification 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 Group's 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.
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 Group's 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.
Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Database of Systematic Reviews
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.
Language
There was no language restriction on included studies and we
arranged for the translation of five potentially eligible non-English
language studies.
Data collection and analysis
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 insufficient 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 identified 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.
3. Intervention: type, duration and length of time in follow-up.
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 identified 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.
4
 Cochrane Trusted evidence.
Informed decisions.
Library Better health.
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% confidence intervals for all dichotomous data and for
continuous data the mean difference and 95% confidence 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 identified 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 specified 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 significant
when the P value is less than 0.10 (Higgins 2003).
Assessment of reporting biases
In the future if trials are identified 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 identified, 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 identified 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 specified in Chapter 9 of the Cochrane Handbook
for Systematic Reviews of Interventions 5.0.2 (updated September
Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Database of Systematic Reviews
2009) (Higgins 2009). Analysis will be conducted at the same level
as the allocation.
Pooling of data to provide estimates of the efficacy of the
interventions will only be undertaken if the included studies have
similar interventions received by similar participants. Number
needed to treat to benefit (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 fixed-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 identified for inclusion in this review.
Sensitivity analysis
For future updates and if there are sufficient 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
Description of studies
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 five 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 identified.
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 confirmation 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 finally excluded them.
5
 Cochrane Trusted evidence.
Informed decisions.
Library Better health.
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
• High risk of bias (plausible bias that seriously weakens
confidence in the results) if one or more criteria were not met.
Effects of interventions
In view of the lack of high quality trials no firm conclusions
could be reached about the effectiveness or otherwise of the two
interventions considered in this review.
DISCUSSION
This review identified 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.
Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Database of Systematic Reviews
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
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.
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 identified 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.
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.
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, Stéphanie Tubert, Toru Naito, Shi Zongdao and
Dr Anja Scheiwe for their help in the translation and the assessment
of relevant articles.
6
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

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):22-5.
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):306-14.
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 fixation. Scandinavian Journal of Plastic and
Reconstructive Surgery and Hand Surgery 2002;36(6):356-61.
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):370-5.
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):334-5.
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):16-22.
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):1586-94.
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):230-6.
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 Maxillo-Faciale
1994;95(4):268-73.
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):1087-92.
Schneider 2008 {published data only}
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,
multicentre study with special evaluation of fracture level.
Journal of Oral and Maxillofacial Surgery 2008;66(12):2537-44.
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):301-8.
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):421-7.
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):127-38.
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):353-60.
Zajdela 1975 {published data only}
Zajdela Z. Treatment of fractures of processus articularis in the
lower jaw. Zobozdravstveni Vestnik 1975;30(3):49-53.
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):1324-32.
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):804-6.
Costa e Silva 2003
Costa e Silva AP, Antunes JL, Cavalcanti MG. Interpretation
of mandibular condyle fractures using 2D- and 3D-computed
tomography. Brazilian Dental Journal 2003;14(3):203-8.
De Riu 2001
De Riu G, Gamba U, Anghinoni M, Sesenna E. A comparison
of open and closed treatment of condylar fractures: a change

Interventions for the treatment of fractures of the mandibular condyle (Review) 7

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

in philosophy. International Journal of Oral and Maxillofacial Higgins 2003

Surgery 2001;30(5):384-9.
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):629-34.
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):260-8.
Ellis 2005
Ellis E, Throckmorton GS. Treatment of mandibular condylar
process fractures: biological considerations. Journal of Oral and
Maxillofacial Surgery 2005;63(1):115-34.
CHARACTERISTICS OF STUDIES
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring
inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
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. Classification
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):12-21.

Characteristics of excluded studies [ordered by study ID]

 
Study Reason for exclusion

Crivello 2002 Non-RCT. (Translated from French to English by Stéphanie Tubert.)

Eckelt 2006 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.

Gorgu 2002 Study does not discuss fractured condyles.

Haug 2001 A retrospective cohort study.

Hu 2002 Non-RCT. (Translated from Chinese to English by Shi Zongdao.)

Ishihama 2007 Non-RCT, a retrospective comparison.

Landes 2008 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.

Mitchell 1997 Observational cohort study/audit.

Moritz 1994 Non-RCT. (Translated from French to English by Stéphanie Tubert.)

Nussbaum 2008 Relevant meta-analysis which identified one study (Worsaae 1994) which was a non-RCT.

Schneider 2008 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.

Suzuki 1991 Non-RCT. (Translated from Japanese to English by Toru Naito.)

Throckmorton 2000 Non-RCT. Patients self selected their treatment group.

Interventions for the treatment of fractures of the mandibular condyle (Review) 8

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

Study Reason for exclusion

Throckmorton 2004 Non-RCT. Patients self selected their treatment group.

Worsaae 1994 Non-RCT.

Zajdela 1975 Non-RCT. (Translated from Croatian to English by Dario Sambunjak.)

RCT = randomised controlled trial

 

 
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 Issues to consider Status of research for this review

Evidence What is the current A systematic review failed to identify any high quality evidence in relation to the ef-
(E) state of evidence? fectiveness or otherwise of open or closed treatment of fractures of the mandibular
condyle.

Population Diagnosis, disease Adults, over 18 years of age, with verified unilateral or bilateral fractures of the
(P) stage, comorbidity, risk mandibular condyles. Stratified according to the type of fracture (i.e. uni- or bilater-
factor, sex, age, ethnic al).
group, specific inclu-
sion or exclusion crite-
ria, clinical setting

Intervention Type, prognostic Any form of open reduction. Prognostic factors include level of fracture and whether
(I) factor fractures are uni- or bilateral.

Comparison Type, prognostic factor Any form of closed reduction. Prognostic factors include level of fracture and
(C) whether fractures are uni- or bilateral.

Outcome Which clinical or patient • Status of occlusion - dichotomous data.

(O) related outcomes will • Degree of function (improvement or impairment) post-operatively - range of move-
the researcher need to ments - measurements, continuous data. Facial nerve function and signs of anky-
measure, improve, in- losis - dichotomous data.
fluence or accomplish? • Aesthetics - symmetry - clinical examination, dichotomous data, vertical facial
Which methods of mea- height - measurement, continuous data.
surement should be
• Post-operative pain measured using a validated analogue scale, e.g. VAS or mea-
used?
sures 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.
• Inflammatory complications: osteomyelitis, hematoma, pseudarthrosis, wound
dehiscence, persistent dysaesthesia, post-operative infection, abscess - dichoto-
mous data.
• Anaesthetic complications - dichotomous data.
• Nerve injury - dichotomous data.
• Need for re-treatment or corrective surgery - dichotomous data.
• Days hospitalised - continuous data.

Time stamp Date of literature search March 2010.

(T) or recommendation

Interventions for the treatment of fractures of the mandibular condyle (Review) 9

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

Table 1.   Research recommendations based on a gap in the evidence on interventions for the treatment of fractures
of the mandibular condyle  (Continued)
Study type What is the most appro- Randomised controlled trial (adequately powered/large sample size).
priate study design to Methods: concealment of allocation sequence.
address the proposed Blinding: Not feasible for participants and operators, however outcomes assessors
question? and data analysts should be blinded.
Setting: Acute settings with an initial follow-up of between 7-14 days and a contin-
ued 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 Group's Trials Register search strategy

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

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 filter 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.
Interventions for the treatment of fractures of the mandibular condyle (Review) 10
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
 
 
Library Better health. Cochrane Database of Systematic Reviews

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

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 financial conflicts 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.

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) 11

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.