One miniplate compared with two in the fixation of isolated fractures of the mandibular angle.

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British Journal of Oral and Maxillofacial Surgery xxx (2015) xxx–xxx

Systematic review

One miniplate compared with two in the fixation of isolated fractures of the mandibular angle E.A. Al-moraissi ∗ Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Yemen Accepted 9 May 2015

Abstract The purpose of this study was to compare one miniplate with two in the management of isolated fractures of the mandibular angle as regards wound healing, failure of hardware, scarring, weakness of the facial nerve, and overall morbidity, by making a systematic review with a metaanalysis. I made a comprehensive electronic search with no date or language restrictions in October 2014. The inclusion criteria were studies in humans, including randomised or quasirandomised controlled trials (RCT), controlled clinical trials (CCT), and retrospective studies that compared the morbidity after treatment of such fractures with one and two miniplates. Ten publications were included: three RCT, three CCT, and four retrospective studies. Three studies showed a low, and seven a moderate, risk of bias. There was a significant difference between one and two miniplates in the incidence of wound healing, failure of hardware, weakness of the facial nerve, and overall complications (p=0.04, p =0.05, p=0.002, and p=0.05, respectively). The result of the meta-analysis showed that one miniplate placed on the external oblique ridge provided a significant reduction in the incidence of wound infection and dehiscence, failure of hardware, and overall complications, compared with two miniplates, one placed on the external oblique ridge and one placed on to the ventral surface of mandible to fix the fracture. © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Keywords: Mandibular angle fractures; One miniplate; Double miniplate; Wound problems; Postoperative complications; Meta-analysis

Introduction Fractures of the mandibular angle generate more complications than other mandibular fractures, the incidence ranging from 0-32%.1,2 The management of such fractures is controversial, and is made difficult because of the anatomical relations and complex biomechanical aspects of the mandibular angle, including a thin cross-sectional area, abrupt change in curvature, attachment of the masticatory muscles, and the presence of third molars.3 Various techniques have been used for internal fixation, including wire osteosynthesis, a single miniplate on the supe∗ Correspondence to: Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Thamar University, Redaa Street, Yemen. Tel.: +967 777788939. E-mail addresses: dr [email protected], [email protected]

rior border (2.0 mm), a single plate on the inferior border (2.3 or 2.7 mm), 2 plates (1 at the superior border and 1 at the inferior border), geometric plates, or lag screws.4 The controversy still rages between advocates of “rigid” fixation, which usually requires 2 bony plates, and those who use non-rigid but functionally stable fixation with a single miniplate. However, there are those who think that the time-honoured, non-rigid method should be preferred, using either closed or open reduction and internal fixation with a transosseous wire together with several weeks of maxillomandibular fixation (MMF).5 Certainly if a single miniplate can provide similar or better results than 2 bony plates there will be savings both from the cost of the hardware and from the time spent in the operating theatre to insert the second plate. If the patient can return to normal daily activities sooner when using plate or screw fixation (or a combined method), the cost to society of such injuries will be minimised.6 Some studies7,8 have reported no

http://dx.doi.org/10.1016/j.bjoms.2015.05.006 0266-4356/© 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Al-moraissi EA. One miniplate compared with two in the fixation of isolated fractures of the mandibular angle. Br J Oral Maxillofac Surg (2015), http://dx.doi.org/10.1016/j.bjoms.2015.05.006


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ARTICLE IN PRESS E.A. Al-moraissi / British Journal of Oral and Maxillofacial Surgery xxx (2015) xxx–xxx

difference in outcome when a single plate was compared with two miniplates, while Levy et al.9 found that two plates were better than one. I could find no full systematic review with meta-analysis that compared one with two miniplates in the management of such fractures, so have attempted to resolve the issue definitively with a meta-analysis. The null hypothesis was that two miniplates are as effective as a single miniplate in the treatment of fractures of the mandibular angle, and the specific aims of the study were to compare one miniplate to two as far as the incidence of wound healing, failure of hardware, scarring, weakness of the facial nerve, and overall morbidity in the management of these fractures were concerned.

Methods Search I made a comprehensive systematic review of relevant publications in the bibliographic databases PubMed (National Library of Medicine, NCBI), EMBASE, and the Cochrane Central Register of Controlled Trials from inception to October 2014. The review was made in accordance with the recommendations of the PRISMA statement.10 I also made a manual search of journals related to oral and maxillofacial surgery, including the Int J Oral Maxillofac Surg, Br J Oral Maxillofac Surg, J Oral Maxillofac Surg, Oral Surg Oral Med Oral Pathol Oral Radiol Endod, J Craniomaxillofac Surg, J Craniofac Surg, and J Maxillofac Oral Surg.

(S) Type of study: human studies published in English: randomised or quasirandomised controlled clinical trials, controlled clinical trials, and retrospective studies the aim of which was to compare the postoperative complications after fixation of fractures of the angle with two miniplates, in which a single plate is placed onto the superior border of the mandible and the other plate to the lateral aspect of the mandible, with the standard technique of a single miniplate placed on to the superior border as described by Champy et al.11 Exclusion criteria Case reports, technical reports, animal or in vitro studies, review papers, uncontrolled clinical studies, studies that used bioabsorbable materials, studies that included infected or comminuted (or both) fractures, fractures in edentulous mandibles, and fractures in children were excluded. Collection of data I carefully assessed the eligibility of all studies retrieved from the databases, and the following data were extracted from the studies included in the final analysis: author(s), year of publication, study design, number of patients, sex, mean (SD) age (years), duration of follow up, method of fixation of the fractures, postoperative MMF, mean (SD) duration of operation (minutes), surgical approach, and associated mandibular fractures. I contacted the authors if any data were missing. Risk of bias in individual studies

Search terms I used a combination of the following search terms: one miniplate compared with two in mandibular angle fractures AND/OR internal fixation of angle mandibular fractures AND/OR single compared with double miniplate in mandibular angle fractures, superior compared with inferior border miniplate in mandibular angle fractures, Champy technique, postoperative complications in mandibular angle fractures, AND linea oblique compared with lateral in mandibular angle fractures. Selection criteria The following inclusion criteria were adapted using the PICOS criteria: (P) Type of patients: those adults patients having mandibular angle fractures. (I) Type of intervention: two miniplates, one miniplate placed transorally along the external oblique ridge, and 1 miniplate placed along the lateral aspect of the superior border using transbuccal trocar instrumentation. (C) Type of comparator: one miniplate placed transorally along the external oblique ridge. (O) Type of outcomes: infection, wound dehiscence, malocclusion, paraesthesia, failure of hardware, malunion or non-union, scarring, and weakness of the facial nerve.

I rated the quality of the methods used by combining the proposed criteria of the Meta-Analysis of Observational Studies in Epidemiology statement (MOSES),12 the Strengthening the Reporting of Observational Studies in Epidemiology statement (STROBE),13 and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)14 to verify the strength of scientific evidence used in the clinical decision-making. The classification of the potential risk of bias for each study was based on the following 5 criteria: random selection, definitions of criteria for inclusion and exclusion, report of losses to follow up, validated measurements, and statistical analysis. A study that included all the criteria mentioned above was classified as having a low risk, a study that did not include one of these criteria was classified as having a moderate risk, and when two or more criteria were missing, the study was considered to have a high risk of bias. Statistical analysis Meta-analyses were made only if there were studies of similar comparisons, reporting the same outcome measures. For binary outcomes, we planned to calculate a standard estimation of odds ratio (OR) by the random-effects model if


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E.A. Al-moraissi / British Journal of Oral and Maxillofacial Surgery xxx (2015) xxx–xxx

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heterogeneity was detected, otherwise a fixed-effect model with a 95% confidence interval (CI) was performed; using the following formula15 : OR

Odd of event in two miniplate group Odd of event in one miniplate group

The data were analysed using the statistical software Review Manager15 (version 5.2.6, The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark, 2012). Assessment of heterogeneity The significance of any discrepancies in the estimates of the effects of treatment of the different trials was assessed by Cochran’s test for heterogeneity and the I2 statistic, which describes the percentage total variation across studies that results from heterogeneity rather than chance. Heterogeneity was considered significant if p < 0.01. A rough guide to the interpretation of I2 given in the Cochrane Handbook15 as follows: from 0% to 40% the heterogeneity may not be important; from 30% to 60% it may indicate moderate heterogeneity; from 50% to 90% it may indicate substantial heterogeneity; and from 75% to 100% there is considerable heterogeneity. Investigation of publication bias I drew a funnel plot (size of effect against standard error), asymmetry of which may indicate publication bias and other biases related to the size of the sample, although the asymmetry may also indicate a true relation between size of the trial and size of the effect. Sensitivity analysis If sufficient studies were included, I made a sensitivity analysis to assess the robustness of the results of the review by repeating the analysis with studies with a high risk of bias excluded.

Fig. 1. Algorithm showing design of the study.

Characteristics of studies included Detailed characteristics of the studies included are shown in Table 1. Three RCT,8,16,18 3 CCT,6,21,22 and 4 retrospective studies9,17,19,20 were included in the meta-analysis and critical appraisal. A total of 959 patients were enrolled in the 10 studies,6,8,9,16–22 which compared one superior miniplate on the external oblique ridge (n=466) with two miniplates (one superior miniplate on the external oblique ridge and one plate at the inferior border of the mandible) (n= 493). All patients in both groups were placed into MMF intraoperatively, according to occlusal wear facets. Four studies9,17,19,21 used MMF during the postoperative period for between 1 and 4 weeks. For all patients (n=466) allocated to the single miniplate group, a 2.0 mm titanium miniplate was placed by an intraoral approach at the external oblique ridge with two monocortical screws on either side of the fracture line. In the two-miniplate group (n=493), patients had a second miniplate inserted near to the inferior border of mandible with transbuccal trochar, as near as possible to the mandibular angle.

Results Risk of bias within studies The screening process for studies is summarised in Fig. 1. The electronic search resulted in 802 entries, of which 301 were excluded because they were retrieved in more than one search. After the initial screening of the titles and abstracts, 323 articles were excluded because they were not about the right topic. The full texts of the remaining 178 papers led me to exclude a further 168 because they did not meet the inclusion criteria. A total of 10 publications was included in the final review.6,8,9,16–22

Three studies8,16,18 showed a low risk, and 79,17,19–22 showed a moderate risk, of bias. The scores are summarised in Table 2. Results of individual studies Wound healing (infection and wound dehiscence): Nine studies6,8,9,16–18,20–22 assessed the incidence of problems of wound healing such as infection and dehiscence. There was


Study design

Sex (M:F)

Mean (range) age (years)

No of patients*

Follow up period

MAF fixation methods

No with postoperative MMF

Mean duration of operation (minutes)

Surgical approach

Associated fractures

Levy9

1991

RS

(G1+G2): 52:9

(G1+G2): 18-47(28.6)

(G1):19 (G2):22

1,2,4,6, and 12 weeks

(G1): single 2 mm miniplate (G2): two 2 mm miniplates

(G1): 6:3 left 4 right average 24 IMF/days (G2): 14:11 left and 3 right IMMF/25.3 days

NM

(G1): intraoral (G2): intraoral and transbuccal

(G1): 9 (G2): 22#

Schierle8

1997

RCT

NM

NM

(G1): 16 (G2):15

NM


(G1): 3 (G2) 4 (5 parasymphyseal 3 condylar)

Siddiqui16

2007

RCT

(G1+G2):75:10

(G1+G2):17-57

(G1):36 (G2):26

12 weeks

No

NM

(G1): intraoral NM (G2):transbuccal

Mehra17

2008

RS

NM

(G1+G2):1757(24.8)

(G1): 76 (G2): 57

8 – 64 week (12.3 weeks)

(G1): 34 (G2): 119.6

(G1):intraoral and transbuccal (G2): extraoral

Danda18

2010

RCT

(G1):21:6 (G2):23:4

(G1): 32.4 (18-43) (G2): 29.6 (21-49)

(G1): 27 (G2): 27

1, 2, 4, and 6 weeks

(G1): MMF, 2 week, elastic, 4 week (G2): MMF,1 week, elastic 1- 4 week 2 weeks, arch bars for 4 week

NM

(G1): intraoral None (G2):transbuccal

Seemann

2010

RS

(G1+G2):295:63

Men: 29.67 Women: 49.07

(G1): 95 (G2): 170

NM

(G1): 6.06% (G2): 4.46%

NM

NM

(G1): 3.70% (G2): 6.16%

2010

CCT

(G1):55,7 (G2:55:8

(G1): 13-51;(28.5) (G2): 17-54(27.8)

(G1): 62 (G2):63

6 weeks at least

No

(G1): 23.5 (G2): 37


None

19 **

Ellis6

(G1): single 2 mm miniplate (G2): two 2 mm miniplates (G1): single* 2 mm miniplate (G2): two 2 mm miniplates (G1): single 2 mm miniplate (G2): two 2 mm miniplate (G1): single* 2 mm miniplate (G2): two 2 mm miniplates (G1): single 2 mm miniplate (G2): two 2 mm miniplates (G1): single 2 mm miniplate (G2): two 2 mm miniplates

NM

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First author


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Table 1 Comparison between fixation methods for fractures of the mandibular angle (MAF).


Year

Study design

Sex (M:F)

Mean (range) age (years)

No of patients*

Follow up period

MAF fixation methods

No with postoperative MMF

Mean duration of operation (minutes)

Surgical approach

Associated fractures

Kumar20*

2011

RS

(G1+G2): 63:18

(G1+G2): 16-62(26.6)

(G1): 35 (G2): 33 (G3): 15

3 months

NM

NM

(G1): intraoral (G2): extraoral (G3): intraoral and transbuccal

NM

Yazdani 21

2013

CCT

(G1+G2): 73:14

(G1+G2): 16-66

(G1):45 (G2): 42

1,2 week,2,3,6 and 12 months

1 week

NM

(G1): intraoral (G2): intraloral And transbuccal

None

Cillo22

2014

CCT

(G1+G2): 31:2

(G1+G2): 18-48(25.2)

(G1):33 (G2): 33

8 weeks

(G1): single anterior plate (G2): two plate (G3): single ventral plate (G1): single 2 mm miniplate (G2): two 2 mm miniplates (G1): single 2 mm miniplate (G2): two 2 mm miniplates

No

NM

(G1): intraoral (G2): intraoral And transbuccal

None

CCT=controlled clinical trial, RS=retrospective study, MMF=maxillomandibular fixation, NM=not mentioned, G1=one transoral miniplate on external oblique ridge, G2=two miniplates (one as G1, second plate on lateral surface of the mandible), G3=one transbuccal miniplate, G4=one plate at inferior border, G4=lag screw, G=geometric plate, ∗ G1: a single 2 mm miniplate placed transorally on external oblique ridge. G2: two 2 mm miniplates, one plate as G1 and second plate inserted transbuccally, as near as possible to the inferior border. ∗∗ Both in G1 and G2 MMF and associated fractures mentioned as percentage. *** 33 bilateral mandibular angle fractures, one side fixed by 2 superior and inferior miniplate and another side with one superior miniplate. **** This study consist of 3 groups: one superior miniplate (transorally), two miniplates (extraoral) and one miniplate(intraoral and transbuccally) $ consists of 3 groups, G1=15, G2=9, G5=21.

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Table 1 (Continued)

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Table 2 Critical appraisal of the studies included (quality assessment). First author

Year

Random selection in population

Defined inclusion/exclusion criteria

Loss of follow-up

Validated measurement

Statistical analysis

Estimated potential risk of bias

Levy9 Schierle 8 Siddiqui16 Mehra17 Danda18 Seemann 19 Ellis6 Kumar 20 Yazdani 21 Cillo22

1991 1997 2007 2008 2010 2010 2010 2011 2013 2014

No Yes Yes No Yes No No No No No

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes No Yes Yes Yes Yes Yes

Yes No Yes Yes Yes No Yes Yes Yes Yes

Moderate Low Low Moderate Low Moderate Moderate Moderate Moderate Moderate

a significant advantage for the one miniplate technique in fixation of these fractures (OR 0.55, 95% CI 0.31 to 0.89; p=0.004). The test of heterogeneity among all studies showed homogeneity (chi square = 10.31, df=8, p=0.24; I2 = 22%). The cumulative OR was 0.55, meaning that the use of one miniplate in the fixation of fractues of the mandibular angle reduces the risk of wound infection and dehiscence by 45% compared with the use of two miniplates (Fig. 2). Failure of hardware: Seven studies6,8,16–18,20,21 compared the two techniques from the point of view of failure

of hardware. The one miniplate technique had a significant advantage over two miniplates in fixation of fractures of the angle (OR 0.50, 95%CI 0.25 to 0.99; p=0.005). The test of heterogeneity among the studies showed homogeneity (chi square=5.58, df=5, p=0.35; I2 = 10%). The cumulative OR was 0.50, meaning that the use of one miniplate for fixation reduced the risk of failure by 45% compared with the use of two miniplates (Fig. 3). Scarring and weakness of the facial nerve: Three studies16-18 reported the results of scarring and weakness

Fig. 2. Forest plot. One compared with 2 miniplates: problems with wound healing.

Fig. 3. Forest plot. One compared with 2 miniplates: failure of hardware.




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Fig. 4. Forest plot. One compared with 2 miniplates: scarring, and weakness of the facial nerve.

of the facial nerve, there being a significance difference in favour of one miniplate over two (OR 0.09, 95%CI 0.02 to 0.42; p=0.002). The test of heterogeneity among all studies showed homogeneity (chi square=0.17, df =3, p=0.98; I2 = 0). (Fig. 4). Overall morbidity: When all postoperative complications were pooled, there was a significant difference between a single miniplate on the superior border and the use of 2 miniplates (OR 0.70, 95%CI 0.49 to 1.00; p=0.05). The test of heterogeneity among all studies showed significant clinical heterogeneity (chi square=36.11, df = 9, p=0.0001; I2 = 75%). (Fig. 5). Publication bias The funnel plot showed no noticeable asymmetry, indicating an absence of publication bias (Fig. 6).

Discussion The null hypothesis was that two miniplates are as effective as a single miniplate in the treatment of isolated fractures of the mandibular angle. The specific aims of the study were to compare the results between the two in terms of wound healing, failure of hardware, scarring, weakness of the facial nerve, and overall morbidity. The results of the meta-analysis showed that one miniplate placed on the external oblique ridge provides a significant reduction of 30% in the incidence of all these when compared with two miniplates.3 Although in vitro studies22-25 have shown that the fixation of another plate at the inferior border will make fixation under functional loading more stable, the result of the meta-analysis

showed that one miniplate is superior to two, so biomechanics are not the only factors to be considered when selecting internal rigid fixation for these fractures. The results of the present study confirm those of previous studies.6,8,17,19,20,26,27 The high complication rate with two miniplates could be attributed to more periosteal and muscle stripping in the region of the angle, which would compromise both blood supply and healing. In addition to contamination with oral bacteria, all these factors could increase the risk of problems with wound healing.3 It was proposed that the threedimensional bends placed in a ridge plate to contour it to the external oblique ridge may reduce its rigidity, but the ridge plate’s superficial placement on the ridge may also make it prone to exposure and consequent infection from breakdown of the wound.28 The limitations of the present study were firstly that only 3 RCT8,17,19 were included in the meta-analysis together with 3 CCT6,22,23 and 4 retrospective studies.9,18,20,21 The results of RCT give the most reliable data for inclusion in a true meta-analysis, but I included retrospective studies because the qualitative analysis of all 10 studies indicated that 38,17,19 had only a low risk of bias and 7 6,9,18,20–23 had only a moderate risk. Secondly, four studies did not deal with isolated fractures alone, whereas 6 were associated with other mandibular fractures (such as those of the contralateral body or symphysis) in addition to the angle. It has been thought that a second fracture of the mandible would confound the outcome data because the fixation requirements for a double fracture will often differ from those of an isolated fracture,3 and the real complication rates for the treatment of more than one fracture can be overestimated. For example, if there is a malocclusion, it is not always possible to decide which of the fractures might be causing it. 3 Only analysis of isolated


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Fig. 5. Forest plot. One compared with 2 miniplates: overall morbidity.

Ethics statement/confirmation of patient permission Ethics approval not required. References: please check them carefully to make sure that they are numbered correctly in the text. In addition they required a lot of editing to put them into the style of the journal (see Instructions to Authors if in doubt).

References

Fig. 6. Funnel plot. Publication bias according to the reported incidence of problems with wound healing showing a symmetrical distribution.

fractures of the angle will allow us to establish their true morbidity. In conclusion, the result of this meta-analysis have shown that one miniplate placed on the external oblique ridge significantly reduces the incidence of wound infection and dehiscence, failure of hardware, and overall morbidity when compared with two miniplates, one placed on external oblique ridge and one placed onto the ventral surface of mandible in fixation of isolated fractures of the mandibular angle. Better-designed, prospective, randomised, controlled clinical trials with adequate samples and long periods of follow-up that compare one and two miniplates in the fixation of isolated fractures in adults would be useful in exploring this question further. Other variables such as cost of treatment and assessment of bone density at fracture sites using cone-beam computed tomography should also be studied to find out what differences there are between open and closed treatment of fractures of the condyle in adults.

Conflict of interest I have no conflict of interest.

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