Prevalence TON is classified as direct or indirect. Direct



Prevalence and Association of Orbital Trauma with Zygomatic Complex Fracture and Treatment Outcome Amongst Patients Attending Hospital Universiti Sains Malaysia from 2013-2015.

“Elective report as prerequisite for professional examination in the Doctor of Dental Surgery course”

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Student :
Praveena a/p S Subramaniam
Supervisor :
Dr Jawaad Ahmed Asif


Table of content




Title Page


Table of content


Chapter 1 : Research proposal
1.0  Introduction
1.1  Background study
1.2  Statement of problem
1.3  Justification
2.0   Objective
2.1 General objective
2.2 Specific objectives
2.3 Research questions
2.4 Research hypothesis
3.0  Literature review
4.0  Methodology
4.1  Study design
4.2  Population and sample
4.3  Material and research tools
4.4  Data collection method
4.5  Ethical consideration
5.0  Flow chart of study
6.0  Expected result (dummy table)
7.0  Limitation of study
8.0  Gantt chart and milestones
9.0 Budget
10.0 References





Chapter 1

             Research proposal







1.1 Background study

The zygomatic complex, which makes up the prominence of the cheek, refers to a combination of the zygomatic bone, frontal process of the maxilla, and zygomatic portion of the temporal bone. The zygomatic bone is a roughly four-sided pyramid that articulates with the frontal, sphenoid, maxillary and temporal bones. Due to the thin bones supporting the zygomatic cornplex, fracture can occur with minimal force. (Furst, Austin, Pharoah, & Mahoney, 2001) Thus, zygomatic complex fractures are reported to be the second commonest type of facial fracture second to the nasal bone fractures.(Kristensen & Tveteras, 1986).  

Traumatic optic neuropathy (TON) is a serious vision threatening condition that can be caused by ocular or head trauma. TON is classified as direct or indirect. Direct TON usually presents as severe visual loss with minimal chances for recovery. It is caused by a penetrating injury to the area of optic nerve. Indirect TON is caused by acceleration/deceleration forces due to the blunt head or closed globe trauma. The vision loss may vary from mild to total blindness. The incidence of TON after craniofacial trauma has been reported to be 2-5% (al-Qurainy, Stassen, Dutton, Moos, & el-Attar, 1991). Traumatic optic neuropathy in patients suffering from severe maxillofacial trauma is usually caused either by direct injury to the eye, or injury to proximal structures such as the optic nerve, chiasma, optic tract and brain tissue. (Kallela, Hyrkas, Paukku, Iizuka, & Lindqvist, 1994).

In local literature, there are many research conducted on the zygomatic complex fracture but most are limited to and focused only on the prevalence and management techniques. No research in Malaysia has attempted to assess the relationship between zygomatic complex fracture and orbital trauma associated with traumatic optic neuropathy.

This research aims to study the prevalence and type of zygomatic complex fracture according to age, gender, aetiology, as well as its association with orbital trauma and traumatic optic neuropathy. Next, we are looking to analyse treatment outcomes of patients having traumatic optic neuropathy who underwent surgical reduction in HUSM.

1.2 Statement of problem

Many studies report the prevalence of zygomatic complex fractures associated with orbital trauma can lead to traumatic optic neuropathy but some studies fail to report the treatment outcome of those with traumatic optic neuropathy.

1.3 Justification

To relate the incidence of traumatic optic neuropathy and treatment outcome among patients in HUSM as to urge surgeons to perform fracture reductions as soon as possible if it tends to improve traumatic optic neuropathy conditions.








2.1 General Objective: 

To study the prevalence of orbital trauma with zygomatic complex fracture in patients attending Hospital Universiti Sains Malaysia from 2013-2015.


2.2 Specific Objective:

To identify the different aetiology leading to zygomatic complex fracture in patients in HUSM.
To identify the association of zygomatic complex fracture with orbital trauma and traumatic optic neuropathy amongst patients in HUSM.

3.      To identify the correlation between influences of surgical reduction treatment approach of zygomatic complex fractures in resolving traumatic optic neuropathy and their outcome post-operatively.


2.3 Research Question

What are the different aetiology of zygomatic complex fracture in patients in HUSM?
What is the association between zygomatic complex fracture with orbital trauma and traumatic optic neuropathy among patients in HUSM.
Can the surgical reduction treatment approach affect the outcome of traumatic optic neuropathy post-operatively?



2.4 Research hypothesis

Motor vehicle accident is the most common etiology of zygomatic complex fracture.
There is an association between zygomatic complex fracture with orbital trauma and traumatic optic neuropathy.
The treatment approach cannot affect the outcome of traumatic optic neuropathy post-operatively.




Fasola et al. found that the zygomatic complex was the most common site for middle third facial fracture with 63.0% incidence at that region (Fasola, Obiechina, & Arotiba, 2001). Ozyzagan et al. used both clinical reports and radiological images such as Waters, submentovertex and CT in the research to distinguish the subtypes of zygomatic arch fractures. (Ozyazgan, Gunay, Eskitascioglu, Ozkose, & Coruh, 2007).


Urolagin et al. reported that out of 354 maxillofacial trauma cases, 2.25% were diagnosed with traumatic optic neuropathy. The diagnosis of traumatic optic neuropathy was made on clinical grounds. The criteria used were blurring of vision, decreased visual acuity, an absence of light perception, and any relative afferent pupillary defect (RAPD) (Urolagin, Kotrashetti, Kale, & Balihallimath, 2012).


In a 5 year retrospective study conducted by Gomes et al., all patients with zygomatico-orbital complex and/or zygomatic arch injuries, whether admitted to hospital and treated in the operating room or seen as outpatients, were included in this investigation. Patients with isolated orbital fractures were excluded (Gomes, Passeri, & Barbosa, 2006).  


Muhammad et al. discovered that the main aetiology for facial fractures presented to Hospital Kuala Lumpur from 2001-2009 was motor-vehicle accidents (MVA) at 69.08%. (Muhammad, Khairuddin, Zakaria, Yunus, & Wan Mustafa, 2012). 


Riaz et al. reported that in Pakistan ophthalmic complications in orbito-zygomatic fractures occurred in 20% of patients. These injuries were more frequently seen in patients with orbital blowout fractures (60%), versus comminuted orbitozygomatic fractures (28%) or simple zygomatic complex fractures (9%). Of those reported complications, 14% of patients from the comminuted orbitozygomatic fractures had reduced visual acuity. (Riaz et al., 2014).


In a study conducted by Li et al. among 45 surgically treated patients, it was reported that thirty-two patients (71%) showed improved vision after surgery. The remaining 13 patients (29%) did not demonstrate improvement after surgery. No patient had worsening of visual acuity after surgery. (Li, Teknos, Lai, Lauretano, & Joseph, 1999). However, in a separate study done by Levin et al. it was reported that visual acuity increased in 32% of patients treated with surgery, 57% of the untreated group, and 52% of patients treated with corticosteroid. The surgery group had more patients whose initial vision was no light perception but it was concluded that there were no significant differences between any of the treatment groups after adjustment of baseline visual acuity. There was no indication that the dosage or timing of corticosteroid treatment or the timing of surgery was associated with an increased probability of visual improvement (Levin, Beck, Joseph, Seiff, & Kraker, 1999).




4.1 Study design

This study was a cross-sectional study.


4.2  Population and sample

4.2.1        Reference population

Patients with zygomatic complex fracture in Kelantan


4.2.2        Source of population

All patients admitted to HUSM with zygomatic complex fracture from May 2013-December 2015.


4.2.3        Sampling frame

Inclusion criteria :

a)      Patients with zygomatic complex fracture.

b)      Patients with zygomatic complex fracture and orbital fracture

c)      Patient that had digital radiographs, CT or CBCT

d)     Patients admitted to HUSM from 2013-2015


       Exclusion criteria :

a)      Patients with only orbital fracture.

b)      Poor quality of digital radiographs, CT or CBCT

c)      Patient with incomplete medical record


4.2.4        Sample method

Simple convenience sampling method.


4.2.5        Sample size

No sample size calculation is done. All digital radiographs, CT and CBCT from medical and dental archive with those who have had zygomatic complex fracture will be collected by using simple convenience sampling method based on inclusion and exclusion criteria.


4.3  Material and research tool

a.       Patient’s medical record

b.      Patient’s pre-existing radiograph imaging such as digital radiographs, CT scan or CBCT

c.       SPSS

d.       Picture Archiving and Communication System (PACS)




4.4  Data collection method


The data for this study is retrospective and will be collected from medical record and dental archive from May 2013 to December 2015. The age, gender, and race will be identified and catalogued. The pre-existing radiological images including digital radiographs, CT scan, CBCT or other diagnostic imaging will be accessed using the Picture Archiving and Communication System (PACS) to assess the presence and type of zygomatic complex fracture. The aetiology of the fracture will also be identified from 7 groups that are: motor vehicle accidents, motorcycle accidents, assaults, falls, sports, work related and others. The involvement of orbital fracture along with zygomatic complex fracture also will be identified from medical and imaging records. The occurrence of traumatic optic neuropathy, its management techniques and post-operative outcome will also be noted from the patient’s medical records. The data then will be analyzed by using SPSS version 22. Descriptive statistics will be used to summarise the demographic characteristics of subjects. Numerical data will be presented as mean (SD) or median (IQR) based on their normality distribution. Categorical data will be presented as frequency (percentage). For parametric data, Student t-test and for non-parametric data chi square tests will be performed. An association between the variables will be considered significant when the p-value is less than 0.05 (p < 0.05).         4.5  Ethical consideration   4.5.1        Subject vulnerability The data used will be pre-existing medical, dental and radiograph records and therefore there is no subject vulnerability involved. The ethical clearance for usage of above records will be obtained from USM research and human ethic committee.   4.5.2        Declaration of absence of conflict of interest There is an absence of conflict of interest by all researches involved in this study.   4.5.3    Privacy and confidentiality        All data collected will be anonymously identified and will be entered into SPSS software.         Only research team members can access the data. Data will be presented as grouped data          and will not identify the responders individually.   4.5.4    Community sensitivities and benefits This study will benefit the community by helping to improve treatment and management of patients who have traumatic optic neuropathy with zygomatic fracture. Surgeons can use the data presented to quicken surgical reduction if it is proven to improve traumatic optic neuropathy conditions post-operatively.   4.5.5    Honorarium and incentives       Not applicable to this study 5.0  FLOW CHART OF STUDY Oral, Maxillofacial Surgery Department HUSM   All patients fulfilling the inclusion and exclusion criteria will be selected   Ethics clearance : Approval from ethics committee will be required for this study   Data will be collected from medical record and dental archive. Age, gender and race will be identified   Digital radiograph, CT scan and CBCT will be used to assess presence, type of zygomatic complex fracture and involvement of orbital trauma along with incidence of traumatic optic               neuropathy The type of fracture and characteristics will be analysed using Planmeca Romexis   The data then will be analyzed by using SPSS version 22.   Results 6.0  EXPECTED RESULT (DUMMY TABLE)   Table 1: Demographic profile Variable n (%) Age       ? 20       21-30       31-40       41-50       ? 51      Total     Race      Malay      Chinese      Indian      Total    Gender      Male      Female      Total     Table 2 : Aetiology of Zygomatic Complex Fracture Aetiology n (%) Motor Vehicle Accidents   Motorcycle Accident   Assault   Fall   Sports   Work Related   Others   Total                           Table 3 : Zygomatic complex fracture with orbital trauma associated with Traumatic Optic Neuropathy(TON) Zygomatic complex fracture with orbital trauma With TON n(%) Without TON n(%) Unilateral     Bilateral     Total         Table 4 : Effect of Surgical Reduction on Traumatic Optic Neuropathy (TON)   Resolved TON n(%) Unresolved TON n(%)  Total n(%)           7.0  LIMITATION OF STUDY   1.      Not all patients with zygomatic complex fracture in Kelantan would come to HUSM.                           8.0  GANTT CHART   2017 2018 2019 Dec Jan Feb     Mar Apr      May Jun Jul Aug Sep Oct Nov Dec Jan Feb   Preparation of proposal                                 Submission of proposal                                 Proposal Presentation                                 Research proposal correction                                 Ethics clearance                                 Data collection                                 Data entry                                 Data analysis                                 Interpretation                                 Report writing                                 16th Student Scientific Conference                                   MILESTONES AND DATES   No. Details Estimated date 1 Research proposal form synopsis submission 17th December 2017 2 Research proposal submission 7th  January 2018 3 Research proposal and ethical presentation 15 January 2018 4 Research proposal correction January- March 2018 5 Ethics clearance February-June 2018 6 Data collection and data entry July-August 2018 7 Data analysis and data interpretation August 2018 8 Report writing September 2018-January 2019 9 16th Students Scientific Conference February 2019 10 Elective report due April 2019     9.0 BUDGET RM 50 for printing purposes.           10.0 REFERENCES 1.      al-Qurainy, I. A., Stassen, L. F., Dutton, G. N., Moos, K. F., & el-Attar, A. (1991). The characteristics of midfacial fractures and the association with ocular injury: a prospective study. Br J Oral Maxillofac Surg, 29(5), 291-301. 2.      Fasola, A. O., Obiechina, A. E., & Arotiba, J. T. (2001). An audit of midfacial fractures in Ibadan, Nigeria. Afr J Med Med Sci, 30(3), 183-186. 3.      Furst, I. M., Austin, P., Pharoah, M., & Mahoney, J. (2001). The use of computed tomography to define zygomatic complex position. J Oral Maxillofac Surg, 59(6), 647-654. doi:10.1053/joms.2001.23394 4.      Gomes, P. P., Passeri, L. A., & Barbosa, J. R. (2006). A 5-year retrospective study of zygomatico-orbital complex and zygomatic arch fractures in Sao Paulo State, Brazil. J Oral Maxillofac Surg, 64(1), 63-67. doi:10.1016/j.joms.2005.09.012 5.      Kallela, I., Hyrkas, T., Paukku, P., Iizuka, T., & Lindqvist, C. (1994). Blindness after maxillofacial blunt trauma. Evaluation of candidates for optic nerve decompression surgery. J Craniomaxillofac Surg, 22(4), 220-225. 6.      Kristensen, S., & Tveteras, K. (1986). Zygomatic fractures: classification and complications. Clin Otolaryngol Allied Sci, 11(3), 123-129. 7.      Levin, L. A., Beck, R. W., Joseph, M. P., Seiff, S., & Kraker, R. (1999). The treatment of traumatic optic neuropathy: the International Optic Nerve Trauma Study. Ophthalmology, 106(7), 1268-1277. 8.      Li, K. K., Teknos, T. N., Lai, A., Lauretano, A. M., & Joseph, M. P. (1999). Traumatic optic neuropathy: result in 45 consecutive surgically treated patients. Otolaryngol Head Neck Surg, 120(1), 5-11. doi:10.1016/S0194-5998(99)70362-1 9.      Muhammad, H., Khairuddin, N. A., Zakaria, A. R., Yunus, N. N. N., & Wan Mustafa, W. M. (2012). Facial fractures presenting to a tertiary referral centre in Malaysia: A 9- year study. Malaysian Dental Journal, 34(2), 10-15. 10.  Ozyazgan, I., Gunay, G. K., Eskitascioglu, T., Ozkose, M., & Coruh, A. (2007). A new proposal of classification of zygomatic arch fractures. Journal of Oral and Maxillofacial Surgery, 65(3), 462-469. doi:10.1016/j.joms2005.12.079 11.  Riaz, N., Chatha, A. A., Warraich, R. A., Hanif, S., Chinar, K. A., & Khan, S. R. (2014). Ophthalmic injuries in orbito-zygomatic fractures. J Coll Physicians Surg Pak, 24(9), 649-652. doi:09.2014/JCPSP.649652 12.  Urolagin, S. B., Kotrashetti, S. M., Kale, T. P., & Balihallimath, L. J. (2012). Traumatic optic neuropathy after maxillofacial trauma: a review of 8 cases. J Oral Maxillofac Surg, 70(5), 1123-1130. doi:10.1016/j.joms.2011.09.045