Accepted Manuscript

Quality of life in treatment of mandibular fractures using closed reduction andmaxillomandibular fixation in comparison with open reduction and internal fixation - Arandomized prospective study -

Kevin U. Omeje, DDS Majeed Rana, MD, DDS Adetokunbo R. Adebola, DDSAkinwale A. Efunkoya, DDS Hector O. Olasoji, DDS Nicolai Purcz, MD, DDS Nils-Claudius Gellrich, MD, DDS Madiha Rana, MSc, PhD, Prof

PII: S1010-5182(14)00205-4

DOI: 10.1016/j.jcms.2014.06.021

Reference: YJCMS 1842

To appear in: Journal of Cranio-Maxillo-Facial Surgery

Received Date: 24 January 2014

Revised Date: 17 June 2014

Accepted Date: 18 June 2014

Please cite this article as: Omeje KU, Rana M, Adebola AR, Efunkoya AA, Olasoji HO, Purcz N,Gellrich N-C, Rana M, Quality of life in treatment of mandibular fractures using closed reduction andmaxillomandibular fixation in comparison with open reduction and internal fixation - A randomizedprospective study -, Journal of Cranio-Maxillofacial Surgery (2014), doi: 10.1016/j.jcms.2014.06.021.

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Quality of life in treatment of mandibular fractures using closed

reduction and maxillomandibular fixation in comparison with open

reduction and internal fixation

- A randomized prospective study -

Kevin U. Omeje1,#, DDS, Majeed Rana3,#,*, MD, DDS, Adetokunbo R. Adebola1,

DDS, Akinwale A. Efunkoya1, DDS, Hector O. Olasoji2, DDS, Nicolai Purcz3, MD,

DDS, Nils-Claudius Gellrich3, MD, DDS, Prof., Madiha Rana4, MSc, PhD

1Oral and Maxillofacial Surgery Department, Aminu Kano Teaching Hospital, Kano, Nigeria 2Oral and Maxillofacial Surgery Department, Faculty of Dentistry, University of Maiduguri

Teaching Hospital, Maiduguri, Nigeria

3Department of Personality Psychology and Psychological Assessment, Helmut-Schmidt-

University/University of the German Federal Armed Forces Hamburg, Holstenhofweg 85,

22043 Hamburg, Germany

4Department of Craniomaxillofacial Surgery, Hannover Medical School, Carl-Neuberg-Str. 1,

30625 Hannover, Germany

# contributed equally

*Correspondence to:

Majeed Rana, MD, DDS

Department of Craniomaxillofacial Surgery

Hannover Medical School

Carl-Neuberg-Street 1

D-30625 Hannover, Germany

E-mail: rana.majeed@mh-hannover.de

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Quality of life in treatment of mandibular fractures using closed

reduction and maxillomandibular fixation in comparison with

open reduction and internal fixation

- A randomized prospective study -

Abstract

Treatment of mandibular fractures by open reduction and internal fixation (ORIF) is

often assumed to be superior to treatment by close reduction and

maxillomandibular fixation (MMF) because patients managed by ORIF seem to be

rehabilitated earlier according to functional and social aspects. This assumption is

often from surgeon’s perspective, not taking into account patient’s viewpoint. This

study highlights a comparative assessment between ORIF and MMF from the

patients’ perspective.

Fifty six patients with mandibular fractures within the tooth bearing areas of the

mandible were prospectively studied in a randomized controlled pattern for post-

operative Quality of Life (QoL) after ORIF versus MMF. Both groups were analyzed

preoperatively, at 1 day, 6 and 8 weeks regarding their QoL using the General Oral

Health Assessment Index questionnaire (GOHAI). No significant statistical

difference was found between the groups regarding overall QoL. Patients managed

by MMF were more affected by psychosocial and physical domains whereas

patients managed by ORIF were more affected by the pain domain.

The results demonstrate that the treatment affects the psychosocial, physical and

pain domain differentially. When both treatments are possible the patient’s should

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be enlightened on the advantages and disadvantages of both treatment modalities

to guide their choice of treatment.

Keywords: Quality of life, mandibular fracture, open reduction, closed reduction.

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INTRODUCTION

Quality of life can be defined as peoples’ perception of their position in life in the

context of their culture and value systems, also in relation to their goals,

expectations, standards and concerns (WHO, 1996). QoL as it applies to medicine

is specifically known as Health Related QoL (HR-QoL) or subjective health status

(O’Boyle, 1992; Olschewki et. al, 1994; Infante-Cassio et. al, 2009). QoL studies

measure the effect of illness, disease and its treatment on patients’ welfare by

going beyond the physician dominated indicators of patient’s progress. These

studies also allow patients to define those aspects of the disease condition or

treatment they consider most distressing and to take part in therapeutic decisions.

A QoL study to compare different treatment modalities of mandibular fractures was

carried out in Kano, Nigeria.

HR-QoL and its assessment have become increasingly important in health care,

especially in the field of maxillofacial surgery. There are several studies about the

quality of life of head and neck cancer patients but only few studies on HR-QoL of

patients treated for mandibular fractures (Atchison et. al, 2006). There are however

studies on QoL in patients treated for condylar fractures (Worsaae and Thorn,

1994; Kommers et. al, 2013), as well as studies that assess the psychological

response of patients’ to mandibular fracture treatment (Shepherd, 1992; Gironda et

al., 2009). QoL studies confirm that the quality of life of patients following facial

surgeries is often affected since there may be resultant facial disfigurement

(Dropkin, 1999; Katz et al., 2003). Similarly vital functions such as speaking,

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swallowing or chewing might be affected (Mignogna et al., 2001; Van Cann et. al,

2005; Guntinas-Lichius et al., 2007). A low quality of life can also lead to a low

survival rate (Osthus et al., 2011; Tarsitano et al., 2012) and due to this reason it is

important to support patients with a low quality of life.

A search of the literature found only one study on QoL of various types of

mandibular fracture (Atchison et al., 2006), which showed that the patients whose

mandibular fractures were managed by MMF reported fewer problems and had a

better immediate post-operative QoL compared to the ORIF group. To the best of

the authors’ knowledge, there is no prospective study comparing QoL of patients

treated by ORIF or MMF in the tooth-bearing region of the mandible.

Mandibular fracture may be defined as a breach in the continuity of any part of the

mandible as a result of injury (Mosby, 2005). Mandibular fractures are worldwide in

distribution and account for about 36-59% of all maxillofacial fractures (Van Hoof et

al., 1977; Brook and Wood, 1983; Ellis et al., 1985). These fractures are often the

result of road traffic accidents, assaults, falls, missiles, sports injuries and

occasionally from pre-existing pathologies (Sojot et al., 2001).

Mandibular fracture treatment aims to restore form and function, and it involves

reduction, immobilization and fixation of the fractured mandible. Reduction is the

re-apposition of the fracture segments to their normal anatomic forms;

immobilization is the restriction of movement at the temporomandibular joints while

healing occurs while fixation is the maintenance of the fracture segments in the

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reduced position to prevent displacement during healing. Reduction techniques in

mandibular fracture treatment may be classified as open or closed based on the

presence or absence of direct visual access to the fracture site (Iizuka and

Lindqvist, 1992). Closed reduction allows manipulation of the fracture segments

taking advantage of dental occlusion without direct visual access whereas open

reduction involves direct visual access to the fracture site through a surgical

incision. Closed reduction and maxillomandibular fixation may be performed using

splints in the form of bonded orthodontic brackets, arch bars, direct wires or eyelet

wires (Iizuka and Lindqvist, 1992). Open reduction and internal fixation involves the

use of wires, plates and other hard-wares placed directly across the fractured site

via a surgical access.

Treatment of mandibular fractures by ORIF is often assumed to be superior to

treatment by MMF in a simple fracture that can be indicated for either modality.

Patients managed by ORIF have the advantage of immediate or early

postoperative joint mobilization, ability to clean all aspects of their mouth

postoperatively and an absence of limitation in choice of food to eat. They are also

noted to return earlier to work and normal life. This assumption of superiority is

often from surgeon’s perspective not taking into account the patients view point

which is equally a critical element in determining success of surgical treatment.

The aim of the study was to assess patients’ perspective, identifying patients’

expectations and determining aspects of mandibular fracture treatment that affect

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patient’s QoL. It will enhance evidence-based practice in management of

mandibular fractures.

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MATERIAL AND METHODS

This study was a randomized prospective cross sectional comparative analysis of

health related quality of life following treatment for mandibular fractures that

occurred within the tooth bearing portions of the mandible. A comparison of ORIF

versus MMF at Aminu Kano Teaching Hospital (AKTH) Kano from January to

December 2012 was undertaken. Ethical approval for the study was obtained from

the Research and Ethics Committee of Aminu Kano Teaching Hospital Kano

(AKTH/MAC/SUB/12A/P-3/VI/957). Also written informed consent was obtained

from each patient before their enrollment into the study. Inclusion and exclusion

criteria for the study are shown in Table 1.

Study protocol

Patients who met the inclusion criteria were recruited into the study from the

accident and emergency unit and the maxillofacial surgery unit of the hospital. All

patients had prophylactic scaling and polishing by dental therapists retrained for

the purpose of the study to ensure standardization prior to treatment. Mandibular

fracture treatment was paid for by the patients and commenced after routine

preoperative investigations were carried out to ensure fitness for surgery.

The patients were randomly allotted into 2 groups (Group A and B) representing

those to be treated by MMF or ORIF techniques respectively. A research assistant

balloted for the first patient into one of the two groups and allotted subsequent

consecutive patients to the opposite group in alternation until exhaustion of

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patients who met the inclusion criteria for the comparative study. Patients who

were randomized into open reduction were only required to pay the cost for closed

reduction. Healthy patients’ relatives or friends matched for age and sex were

recruited as controls for the study at the last inquiry period 8 weeks

postoperatively.

Maxillary and mandibular Erich type arch bars were employed in patients treated

by MMF and was maintained for 6 weeks while Indian type 2mm stainless steel

mini plates using screws of length 10mm at the lower border and 8mm at the sub-

apical region for the patients treated by ORIF. The patients treated by ORIF had

intraoperative trial occlusion using tie-wires anchored on maxillary and mandibular

eyelet wires. These were removed following insertion of osteosynthetic plates.

General Oral Health Assessment Index questionnaire (GOHAI; original English

version) adopted from Atchison et al. (Atchison et. al, 2006) was completed

preoperatively to obtain a pre-treatment score and post-surgery scores on day 1, 6

weeks and 8 weeks respectively. The respondents independently filled the

questionnaires in the maxillofacial clinic during their admission and postoperative

reviews. Also 28 healthy people were assessed once at the inquiry period 8 weeks

postoperatively for comparison using the same GOHAI questionnaire.

GOHAI questionnaire assesses the oral health function of the patient in three

domains namely physical, psychosocial and pain domains. Physical domain

assesses functions related to eating, speech and swallowing, psychosocial domain

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assesses functions related to worry and concern about oral health, dissatisfaction

with appearance, self-consciousness about oral health and avoidance of social

contacts because of oral problems while pain domain evaluates discomfort and the

use of medications to relive pain from the mouth.

The 12-item GOHAI index score ranges from 12 to 60, reflecting 1 for the least

score (never) and 5 for the maximum score (always) for each individual item

(Atchison and Dolan, 1990). GOHAI is analyzed by summing up all the individual

scores of the 12-items. A higher GOHAI score represents a more positive oral

health status. GOHAI questionnaire also has been shown to demonstrate a high

validity and reliability (Brook et al., 1979)

Statistical analysis

The statistical analysis was conducted using SPSS for Windows version 20.0

(SPSS Inc., Chicago, IL, USA). The socio-demographic data and results of the

questionnaires were analyzed by means of descriptive statistics. The comparison

of the interval-scaled data of the different groups was performed by t-tests and

univariate variance analysis. For categorical variables the χ²-test was used for

comparison. To analyze the groups over the four review periods, the ANOVA for

repeated measures was conducted. For all tests, p values less than 0.05 were

considered statistically significant.

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RESULTS

During the period of study, 152 patients (M/F=135/17) with mandibular fractures

were seen. Only 96 patients had fractures exclusively within the tooth bearing

portion of the mandible. A further 40 patients were excluded based on the outlined

exclusion criteria thus 56 patients (M/F=53/3) with fractures exclusively within the

tooth bearing portion of the mandible participated in the study with 28 patients each

in ORIF and MMF groups (Figure 1).

The average age of patients with mandibular fracture managed by MMF was 30.4

± 10.7 years; the average age of patients managed with ORIF was 30.5 ± 6.7

years, while the average age of the subjects used for control was 29.3 ± 10.3. A

comparison of the mean values of the three groups with univariate variance

analysis showed that they do not significantly vary from themselves with respect to

age (df = 2 , F = 0.125, p = 0.882) and a χ²-test showed that they do not

significantly vary with respect to sex (df = 2 , p = 0.808) (Table 2).

Findings from this study showed that there was no statistical significant difference

in the mean QoL score of subjects treated by MMF when compared with those

treated by ORIF throughout the review periods (GOHAI Baseline, df = 54, T =

0.329, p = 0.744; GOHAI 1st day post-op, df = 54, T = -0.616, p = 0.540; GOHAI 6

weeks post-op, df = 54, T = -0.278, p = 0.782; GOHAI 8 weeks post-op, df = 54, T

= 0.192, p = 0.848) (Figure 2).

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When analyzing the groups over the four review periods, the ANOVA for repeated

measures showed, that the GOHAI scores of the two groups differ significantly

over the review points (df = 3, F = 828.880, p = 0.000).

Regarding the Psychosocial, Physical and Pain domains of the GOHAI 8 weeks

postoperatively, the patients treated with ORIF reported significant higher

impairment in the pain domain (ORIF: 25.82 ± 3.24; MMF: 15.86 ± 1.1; p = 0.000)

compared to the Psychosocial (ORIF: 14.78 ± 1.56; MMF: 20.89 ± 2.53; p = 0.000)

and Physical domain (ORIF: 15.93 ± 1.42; MMF: 19.89 ± 2.44; p = 0.000) (Figure

3).

This study also revealed that there was a significant statistical difference between

subjects that were treated by either ORIF or MMF techniques when compared with

healthy people 8 weeks postoperatively (control group and ORIF, df = 54, T = -

0.708, p = 0.000; control group and MMF, df = 54, T = -5.519, p = 0.000, ORIF and

MMF, df = 54, T = 0.192, p = 0.848) (Figure 4).

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DISCUSSION

Peoples’ perception of life is known to be affected by many factors including their

culture, belief and value systems. Their perception, psychological predisposition or

personality types are intimately related (WHO, 1996). The interplay between these

factors is dynamic and unpredictable thus making their independent assessment

difficult. QoL studies are an attempt to peek into a patients’ mind and assign a

value to his mood, thoughts and thinking at that time.

Patients treated for mandibular fractures in this study were seen to experience a

gradual improvement in their quality of life scores within the postoperative review

periods after an initial decline at the first post-operative day. This decline in the

QoL score within the first postoperative day may be attributed to pain, oedema,

irritation by hard-ware and the stress of surgery.

The findings from the QoL of subjects studied showed that patients managed by

MMF were more affected by the psychosocial and physical domains whereas the

patients managed by ORIF were more affected by the pain domain. Patients

treated with MMF may have been affected psychologically by the presence of MMF

which limits both the types of food eaten as well as social interactions. This is

usually not the case for patients managed by ORIF; the extensive tissue dissection

for placement of osteosynthetic plates in ORIF when compared with the tissue

manipulation in MMF may have been responsible for pain response scores in ORIF

as seen in the present study.

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Since the patients did not differ in overall QoL despite the differences in the scales,

it can not be clearly stated which treatment is superior. The lack of difference

between the two treatment modalities regarding overall QoL may also be related to

the absence of interfragmentary mobility in both groups. Fixation with plates (ORIF)

limits interfragmentary mobility even during function while placement of MMF limits

the masticatory function of the mandible and ultimately also reduces

interfragmentary mobility. Interfragmentary mobility can be a cause of non-union,

mal-union and possibly infection.

Compared to healthy people, there was a significant difference between them and

the patient´s managed by ORIF or MMF techniques at 8 weeks postoperatively.

Posttraumatic stress that is often accompanied by emotional and psychological

depression in the subjects treated for mandibular fractures (Dorval et. al, 1998)

may have contributed to the difference in the QoL outcome between the subjects

that had surgical treatment and the healthy people. It is expected that subjects that

had traumatic injury should have a greater degree of post-traumatic stress. This

assumption should be taken with caution since no analysis of the severity of the

trauma was done in this study. Glynn et al. (2003) argued in a prospective study in

a large urban hospital that the degree of impact is a factor that must be considered

in the development of acute posttraumatic stress disorder after orofacial injury.

It should also be borne in mind that this study was performed on Nigerians who

have been noted to have a positive disposition towards life despite adversity. The

psyche of the Nigerian is also a factor which must be considered as expressed

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above. The study was also limited by the largely male sex distribution thereby not

giving an indication of female perspective to treatment outcome. However, the

largely male preponderance is typical for Maxillofacial trauma. Reasons theorized

for these include male involvement in fights and disputes and greater male

community involvement in this part of the world (Allan and Daly, 2006; Mwaniki and

Guthua, 1990). Studies in Nigeria frequently report more males involved in

mandibular fractures (Adekeye, 1980; Olasoji et al., 2006). Thus the results

presented in this study though representing typical sex distribution of mandibular

fractures in Nigerian environment, does not represent QoL responses from both

sexes. Further study on females response to these issues may be warranted.

Also the age group represented in the study corroborates regional and world data

on ages of subjects affected by facial trauma (Ansari, 2004; Erol et al., 2004).

The level of education of patients surveyed does not represent the population in

Nigeria. Therefore, the results are not representative, which is why illiterated

patients should be asked via interviews in further studies.

Different surgeons managed the cases presented here. No attempt was made to

assess the effect of individual surgeons or their years of experience on patients

postoperative QoL. However, the QoL scores recorded during the study period

(significant postoperative improvement ) suggests that such differences could be

overlooked.

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CONCLUSION

The study found a significant statistical difference in treatment of mandibular

fractures of the tooth-bearing regions using ORIF and MMF based on patients’

perception assessed using GOHAI questionnaire. It was found that the patients

treated with ORIF reported higher values in the pain domain, while the patients

treated with MMF reported higher values in the psychosocial and physical

domains. Although the patients reported different values regarding the domains,

there was no significant difference in the the overall QoL. The choice between

ORIF and MMF in subjects with similar fractures may be aided by considering

other parameters such as patients’ choice, availability of surgical hardware and

competence of the surgeon.

Financial interests: None

Sources of support: None

Conflict of Interest Statement:

The authors declare that they have no conflict of interest.

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INCLUSION CRITERIA EXCLUSION CRITERIA

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Mandibular fractures only within the

tooth bearing region of the mandible.

Fractures bounded on either side by

periodontally healthy teeth.

Fractures treatable by closed

reduction/MMF.

Mandibular fracture of one week

duration or less.

Fractures outside the tooth bearing

region of the mandible.

Comminuted mandibular fractures.

Fractures which were absolutely

indicated for ORIF.

Patients whose medical condition

precluded treatment with MMF.

Patients below the age of 14 years.

Patients who declined to participate in

the study.

Patients with other facial fractures in

addition to mandibular fracture, with a

history of psychiatric illness, with

pathological mandibular fractures, with

mandibular fractures from missile or

blast injuries, with dentoalveolar

fractures.

Table 1: Inclusion and exclusion criteria for the study.

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Closed reduction

(n = 28)

ORIF

(n = 28)

Control group

(n = 28) p

Age (years) ± SD 30.4 ± 10.7 30.5 ± 6.7 29.3 ± 10.3 0.882

Sex m/f 27/1 26/2 26/2 0.808

Table 2. Comparison of the groups with respect to age and sex (N = 84)

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Pre-OP

1st day

post-OP

6 weeks

post-OP

8 weeks

post-OP

p

ORIF

M ± SD 30.86 ± 5.20 29.00 ± 6.99 50.64 ± 4.47 56.79 ± 2.56 0.000

Closed reduction

M ± SD 31.29 ± 4.52 28.00 ± 4.99 50.36 ± 3.11 56.89 ± 1.47 0.000

Table 3. Comparison of the treatment groups with respect to the four times of

review (N = 56)

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Figure 1. Flow diagram of the progress through the phases of a parallel

randomised trial of two groups

Figure 2. Comparison of QoL of the ORIF group with the MMF group throughout

the review periods. Both groups do not differ significantly regarding their QoL over

the four review periods

Figure 3. Comparison of the ORIF and MMF groups regarding the Psychosocial,

Physical and Pain domains of the GOHAI. The differences between the groups

were significant across all scales.

Figure 4. Comparison of the QoL of the ORIF and MMF groups with healthy

people. The healthy people have a higher QoL as the ORIF and MMF group after 8

weeks postoperatively, while the ORIF and the MMF group do not differ

significantly.

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