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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.
T A B L E O F C O N T E N T S
1 HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13 DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13 INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
i 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 Sharif
2
, Zbys Fedorowicz
3
, Peter Drews
4
, Mona Nasser
5
, Mojtaba Dorri
6
, Tim Newton
7
, Richard Oliver
1
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.
A B S T R A C T
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 strategy
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.
1 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
P L A I N L A N G U A G E S U M M A R Y
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.
B A C K G R O U N D
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 commoncause
of facial fractures; this is often exacerbated by the use of alcohol
or illicit drugs.
The mandible is a unique horse-shoe shapedbone withanidentical
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).
Classication
There are numerous classications of fractures of the condylar pro-
cess of the mandible. They can be classied with respect to frac-
ture level, dislocation at the fracture level, and condylar head rela-
tionship 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
(belowthe condyle and joint capsule but above the sigmoid notch)
or lowsubcondylar where the fracture runs fromthe sigmoid notch
to the posterior aspect of the mandibular ramus.
A number of factors may inuence the degree and the direction of
2 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
bone displacement incondylar fractures suchas the directionof 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).
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).
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 sub-
condylar 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 manage-
ment as it can range from absolutely no active intervention to the
use of some form of intermaxillary (maxillary-mandibular) xa-
tion or traction. Complications of this method of treatment in-
clude malocclusion, particularly open bites, reduced posterior fa-
cial height and facial asymmetry, chronic pain and reduced mo-
bility (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 inci-
sions, visualisation can only be via endoscopic means. Most open
reductions are undertaken via an extraoral incision; either pre-au-
ricular, retromandibular or submandibular. Fixation is achieved
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).
O B J E C T I V E S
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.
M E T H O D S
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 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 (maxillary-
mandibular) 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) post-
operatively 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
3 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.
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, 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
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 identi-
fying 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.
Searching other resources
No handsearching was carried out for this review. All rele-
vant 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 elec-
tronic 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.
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
Selection of studies
Two review authors (Richard Oliver (RJO) and Mohammad O
Sharif (MOS)) independently assessed the abstracts of studies re-
sulting 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 reviewauthors and any disagreement on
the eligibility of included studies was resolved through discussion.
Where resolution was not possible, a third reviewauthor (Zbys Fe-
dorowicz (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 reviewauthors
(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 ex-
tracted 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.
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 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 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 in-
cluded study in a Risk of bias in included studies table.
Measures of treatment effect
Data obtained fromany 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 in-
tervals 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 hetero-
geneity but if further trials are identied the following methods of
assessment will be used.
We will assess clinical heterogeneity by examining the characteris-
tics 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 reviewsection of this review. Statistical
heterogeneity will be assessed using a Chi
2
test and the I
2
statistic
where I
2
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,
publicationbias will be assessedaccording tothe 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 inter-
ventions will only be undertaken if the included studies have simi-
lar 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 investigationof 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 adjust-
ments: exclusion of studies with unclear or inadequate allocation
concealment and completeness of follow-up.
R E S U L T S
5 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.
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 elimi-
nated and excluded fromfurther 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 iden-
tical. 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 in-
terventions 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 reviewauthors discussed the eligibility of these two remaining
studies for inclusion in this review, resolved any uncertainties by
consensus, and nally excluded them.
Excluded studies
All of the studies which were excluded fromthis reviewand the rea-
sons 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
condence in the results) if one or more criteria were not met.
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 inter-
ventions considered in this review.
D I S C U S S I O N
This review identied no high quality trials comparing open with
closed reduction of fractures of mandibular condyles. One multi-
centre randomised controlled trial which was published as Eckelt
2006 and Schneider 2008 was conducted in Europe and data col-
lected. 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
Withregards tothe 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.
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
6 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.
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
fromour Cochrane review. The reviewof Nussbaum 2008 did not
even identify the Eckelt 2006 study and because of the hetero-
geneity of the studies identied could not draw any conclusions.
A U T H O R S C O N C L U S I O N S
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 experi-
ence, 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 Con-
solidated Standards of Reporting Trials (CONSORT) statement (
www.consort-statement.org/). Important consideration should be
given to the method of randomisation, justifying sample size, al-
location concealment, blinding of the outcome assessor and rea-
sons 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 for-
mat (Brown 2006) please see Additional Table 1.
A C K N O W L E D G E M E N T S
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.
R E F E R E N C E S
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.
7 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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 Maxillo-
Faciale 1994;95(4):26873.
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.
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.
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 3D-
computed 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


8 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Crivello 2002 Non-RCT. (Translated from French to English by Stphanie 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 Stphanie Tubert.)
Nussbaum 2008 Relevant meta-analysis which identied 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.
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
9 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
D A T A A N D A N A L Y S E S
This review has no analyses.
A D D I T I O N A L T A B L E S
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
(E)
What is the current state of evidence? 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,
age, ethnic group, specic inclusion or exclusion crite-
ria, clinical setting
Adults, over 18 years of age, with veried unilateral or
bilateral fractures of the mandibular condyles. Stratied
according to the type of fracture (i.e. uni- or bilateral)
Intervention
(I)
Type, prognostic
factor
Any formof open reduction. Prognostic factors include
level of fracture and whether fractures are uni- or bilat-
eral
Comparison
(C)
Type, prognostic factor Any form of closed reduction. Prognostic factors in-
clude level of fracture and whether fractures are uni- or
bilateral
Outcome
(O)
Which clinical or patient related outcomes will the re-
searcher need to measure, improve, inuence or accom-
plish?
Which methods of measurement should be used?
Status of occlusion - dichotomous data.
Degree of function (improvement or
impairment) post-operatively - range of movements -
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,
abscess - dichotomous data.
Anaesthetic complications - dichotomous data.
10 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. Research recommendations based on a gap in the evidence on interventions for the treatment of fractures of the
mandibular condyle (Continued)
Nerve injury - dichotomous data.
Need for re-treatment or corrective surgery -
dichotomous data.
Days hospitalised - continuous data.
Time stamp
(T)
Date of literature search or recommendation March 2010.
Study type What is the most appropriate study design to address
the proposed question?
Randomised controlled trial (adequately powered/large
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 be-
tween 7-14 days and a continued follow-up to 2 years
A P P E N D I C E S
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$.mp.
7. or/4-6
8. 3 and 7
Appendix 2. Cochrane Oral Health Groups Trials Register search strategy
((mandibular condyle* or ((mandib* or lower jaw*) AND condyl*)) AND fractur*)
Appendix 3. CENTRAL search strategy
#1 MANDIBULAR CONDYLE
#2 (mandib* or (lower next jaw)) AND condyl*
#3 #1 or #2
#4 MANDIBULAR FRACTURES/
#5 MANDIBULAR INJURIES
#6 fractur*
#7 #4 or #5 or #6
#8 #3 AND #7
11 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Appendix 4. EMBASE (OVID) search strategy
1. Mandible Condyle/
2. ((mandib$ 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$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manu-
facturer name]
6. or/4-5
7. 3 and 6
RCT lter for EMBASE:
1. random$.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
H I S T O R Y
Protocol rst published: Issue 2, 2007
Review rst published: Issue 4, 2010
C O N T R I B U T I O N S O F A U T H O R S
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
12 Interventions for the treatment of fractures of the mandibular condyle (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
D E C L A R A T I O N S O F I N T E R E S T
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.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Mandibular Condyle [

injuries]; Mandibular Fractures [

therapy]
MeSH check words
Adult; Humans
13 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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