Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary Fractures A Randomized Clinical Controlled Study
Phase: NA
Conditions: Facial Bone Fracture, Maxillofacial Injury, Zygomaticomaxillary Complex Fracture
Sponsor: Suez Canal University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Official Study Title: Accuracy of Virtual Surgical Planning in 
Reduction of Zygomatico-Maxillary Fractures: A 
Randomized Clinical Controlled Study 
NCT Number: 
Not yet assigned 
 
Document Type: 
Study Protocol (Protocol PDF/A) 
 
Version: 
Version 1.0 
 
Document Date: 
30 September 2025 
 
Faculty of Dentistry, Suez Canal University 
 
Principal Investigator: 
Hossam Shaban El Fadly Mohamed 
Email: Hossax20@gmail.com 
Phone: +201145007231 

 
 
 
 
 
 
Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary 
Fractures 
A Randomized Clinical Controlled Study 
A Thesis Protocol 
Submitted for partial fulfillment of the requirements of the 
Master degree 
In dental science 
Oral and Maxillofacial Surgery 
Research code: HE-11 
Submitted By 
Hossam Shaban El Fadly Mohamed 
B.D.S Ahram Canadian University, 2019 
Resident Mataryah Teaching Hospital, 2021 
Supervisors: 
Title 
Name 
Job Title 
University 
Signature 
Prof. 
Mohamed 
Ahmed 
Elsholkamy 
Professor of Oral and 
Maxillofacial Surgery, 
Faculty of 
Dentistry 
Suez Canal 
University 
Prof. 
Morres 
Fekry 
Khalil 
Consultant 
Mataryah 
Teaching 
Hospital 
Dr 
Mohamed 
Nageh 
Lecturer of Oral and 
Maxillofacial Surgery, 
Faculty of Dentistry 
Suez Canal 
University 
Suez Canal University 
Faculty of Dentistry 
2025 

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 “Thesis Research Protocol” 
Student Name: Hossam Shaban El 
Fadly Mohamed 
Student 
ID: 
29508010104079 
Submission 
Date: 
29/4/2025 
Degree: 
☒ M.D.Sc. 
☐ D.D.Sc 
☐  PH.D. 
Department: 
Oral and Maxillofacial Surgery 
Thesis Title in 
English: 
Accuracy of Virtual Surgical Planning in Reduction of 
Zygomatico-Maxillary Fractures A Randomized Clinical 
Controlled Study 

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1. Abstract 
Introduction: The zygomaticomaxillary complex (ZMC) is particularly 
susceptible to trauma, often resulting in noticeable midfacial deformities and 
asymmetry. Accurate fracture reduction is crucial for restoring facial aesthetics 
and minimizing long-term psychosocial impacts. Virtual surgical planning, along 
with the use of prebent miniplates on surgical guides, enhances precision by 
allowing detailed 3D visualization and manipulation of fracture fragments for 
optimal reconstruction. This improves the facial symmetry and patient 
satisfaction after surgery. 
 
Aim: To investigate the accuracy of virtual surgical planning (VSP) and 
prebending of conventional miniplates in management of zygomaticomaxillary 
complex (ZMC) trauma. 
 
Methodology: 
This study will be conducted on 20 patients with 
zygomaticomaxillary complex fracture sites. The patients will be divided into 
two 
groups 
(Group 
I 
and 
Group 
II) 
randomly 
and 
equally 
via 
www.randomizer.org Group I: Ten patients with zygomaticomaxillary complex 
fracture undergo open reduction and internal fixation will be managed with 
virtual planning and prebending surgical guide, Group II: Ten patients with 
zygomaticomaxillary complex fracture undergo open reduction and internal 
fixation will be managed without virtual planning and prebending surgical guide. 
Postoperative evaluation clinically inflammation, facial symmetry and eye 
movement using 2D photos and radiographically for CT discrepancy and bone 
formation using postoperative C.T after 3 months. 

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2. Introduction and Background 
 
The zygomaticomaxillary complex (ZMC) is one of the facial regions most 
prone to trauma due to its prominent position. Patients with ZMC fractures 
regularly suffer from deformity and asymmetry of the midface, since the 
zygomatic bone plays a key role in defining midfacial width, height, and 
projection (Dubron et al., 2022) 
The zygomatic bone, with its articular processes, accounting for 30–50% of 
all fractures of the facial massif (Committeri et al., 2023) 
The zygomatic bone articulates with the frontal, sphenoid, temporal, and 
maxillary bones, composing the zygomatic complex with those adjacent 
structures. The zygomatic complex strongly contributes to midfacial width 
and protrusion, thus playing a vital role in facial contour (Bitter, Huber and 
Schmid, 2021). 
The origin of maxillofacial fractures includes traffic accidents, physical 
assaults, falls, and sports-related trauma. These causes vary by region and 
population, influenced by economic, cultural, and environmental factors 
(Mittal et al., 2020). 
 
If untreated, they can cause both functional (diplopia, enophthalmos, 
limitation of mouth opening) and cosmetic (facial asymmetry, loss of 
zygomatic projection) impairments (Longeac et al., 2021). 
Correct anatomical reduction of the ZMC is the keystone for functional and 
cosmetic restoration. (Boffano et al., 2013). 
 
Therefore, accurate reduction of ZMC fractures is imperative in restoring the 
anatomical contour of the face and its aesthetic appearance. Failure to re-
establish facial contour will cause asymmetry of the midface and may lead to 
poor self-esteem and low quality of life (Dubron et al., 2022). 

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Virtual surgical planning (VSP) is a rapidly advancing technology that has 
revolutionized the field of craniofacial surgery. This technique allows 
surgeons to use advanced computer software to simulate surgical procedures 
and plan the optimal approach for treating complex facial fractures, such as 
those of the zygomaticomaxillary complex (Committeri et al., 2024). 
Currently, the correction of maxillofacial fractures can be simulated virtually 
with surgical repositioning of fracture fragments and complex rotations. This 
virtual approach to surgical planning allows the surgeon to visualize the 
entire facial skeletal deformity and its surrounding structures to manipulate 
the 3D anatomy and plan the desired reductions more precisely. The 
development of virtual surgical planning techniques has led to major 
advances in repair of facial fractures while limiting the size of surgical 
access, thus rendering the surgery less invasive. (Thakker et al., 2019). 
 
Because of the ZMC structure shape, traditional radiographic ways for the 
evaluation of ZMC symmetry are subjected to distortion. On contrary, 3D 
computed tomography (3D-CT) techniques provide accurate measurements 
and provides accurate reads of different anatomical structures. Moreover, the 
3D-CT technique avoids the distortion caused by improper head position. 
Thus, the accurate quantification of ZMC symmetry can be done with 3D-
CT. (Farida et al., 2020). 
 
The need for digital planning before surgery is increasing but there is a 
continuing concern about its accuracy. (Jansen et al., 2018). 
Virtual planning significantly improves the accuracy of zygomaticomaxillary 
complex fracture reduction compared to conventional techniques, resulting in 
better symmetry and anatomical restoration. (Wang et al., 2021). 
Recent studies have demonstrated that this approach can significantly 
improve surgical outcomes. For instance, Longeac et al. (2021) reported that 
VSP and 3D-printed guides allowed for precise reduction and fixation of 
complex ZMC fractures. The use of these technologies enables surgeons to 
preoperatively simulate the reduction, design patient-specific guides, and 
precontour plates, thereby reducing intraoperative decision-making and 
improving efficiency. 

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3. Research Q (RQ): 
Xue et al. (2019) found that this method not only improved accuracy 
but also reduced operative time. Furthermore, Bao et al. (2019) 
quantitatively assessed symmetry recovery in ZMC fracture reduction, 
revealing that computer-assisted techniques resulted in more accurate 
outcomes compared to traditional methods. The integration of VSP, 
3D-printed guides, and prebending of conventional miniplates offers a 
synergistic approach that leverages advanced technology while utilizing 
familiar fixation materials, potentially facilitating wider adoption of 
these precision-enhancing techniques in maxillofacial trauma surgery. 
So the aim of this study is to determine the accuracy of virtual surgical 
planning (VSP) and 3D-printed surgical guides, combined with 
prebending of conventional miniplates, in zygomaticomaxillary 
complex (ZMC) fracture reduction and comparing outcomes clinically 
and radiographically to traditional surgical method. 
In patients with zygomaticomaxillary facture what is the difference 
between virtual planning and traditional surgery clinically regarding 
facial symmetry, presence of intra or postoperative complications and 
bone formation? 

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4.  Research Hypothesis, Aim, Objectives & Expected Outcomes 
a. Hypothesis 
b. Aim 
 
c. Objectives 
 
d. Expected Outcomes 
To investigate the accuracy of virtual surgical planning (VSP) and 
prebending 
of 
conventional 
miniplates 
in 
management 
of 
zygomaticomaxillary complex (ZMC) trauma. 
Clinical Outcomes: 
1- Presence of intra or postoperative complications via clinical 
examination. 
2- Contour and symmetry of the face via measurements of clinical facial 
reference points. 
3- Eye movement through clinical examination of eye movements and 
absence of diplopia in all gazes. 
4- Presence or absence of enophthalmos, diplopia, ectropian and wound 
dehiscence through clinical examination. 
5- Duration of the surgery by recording of start and end time from the 
beginning of incision. 
Radiographic Outcomes: 
1- Healing Process through post-operative CT. 
2- Cost of virtual planning and 3d printed surgical guide. 
Null Hypothesis: there is no significant difference between virtual 
planning and traditional surgery clinically regarding facial symmetry, 
presence of intra or postoperative complications and bone formation. 
Alternative Hypothesis: there is significant difference between virtual 
planning and traditional surgery clinically regarding facial symmetry, 
presence of intra or postoperative complications and bone formation. 
Virtual surgical planning and prebending of miniplates may provide 
more accurate reduction of zygomaticomaxillary fractures and improve 
function and facial esthetics. 

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5.  Research Design and Methods 
1- Materials : 
 
 
 
Brand name 
Composition 
Company 
Miniplates 
Titanium 
Anton Hipp 
Screw 
Titanium 
Anton Hipp 
 Software: Slicer 3D, Blender and Cloud Compare. 
2- Methods: 
 Study Design: 
Randomized clinical study via www.randomizer.org 
 Study Setting: 
This study will be conducted on twenty patients with zygomaticomaxillary 
fracture. 
 Patient Selection and Grouping: 
Patients will be selected from the outpatient clinic of the Oral and Maxillofacial 
Surgery department in the Faculty of Dentistry, Suez Canal University and 
Mataryah Teaching Hospital. All patients will be informed with all the details 
of the surgical procedures, complications and the whole study schedule. Then, 
each patient will sign an informed consent. 
Patients participating in the current study will have to fulfill the 
following eligibility criteria: 
 
 
Inclusion Criteria: 
1. Confirmed ZMC fracture. Patients must have a confirmed diagnosis of a ZMC 
fracture based on clinical and radiological evaluation (e.g., CT or cone-beam 
CT). (Farida et al., 2020) 
2. Age above 18 years. Adult patients are typically selected to avoid the 
variability of growth in pediatric patients. (Dubron et al., 2022) 
3. Ability to undergo pre- and post-operative imaging (Jansen et al., 2018) 

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Exclusion Criteria: 
1. Systemic diseases affecting bone healing (e.g., osteoporosis, cancer, long-term 
corticosteroid use) (Bitter et al., 2021) 
2. Non-compliance or inability to follow-up post-operatively includes patients with 
cognitive impairments, psychiatric illness, or lack of consent. (Dubron et al., 
2022). 
3. ASA IV, V and VI 
 
Grouping: 
Only 20 patients with zygomaticomaxillary fracture the patients will be divided 
into two groups (Group I and Group II): 
Group I: Ten patients with zygomaticomaxillary complex fracture undergo 
open reduction and internal fixation will be managed with virtual planning, 3D 
printed guide and prebending of conventional miniplates. 
Group II: Ten patients with zygomaticomaxillary complex fracture undergo 
open reduction and internal fixation will be managed by traditional surgery 
without virtual planning 3D printed guide and prebending of conventional 
miniplates. 
 
Workflow: 
 
Preoperative CT data will be segmented to generate three-dimensional (3D) 
models of the zygomaticomaxillary complex fracture. Virtual reduction will be 
performed on these models to achieve anatomical alignment, followed by 3D 
printing of the model to facilitate prebending of titanium miniplates. These prebent 
plates will subsequently be used for intraoperative fixation. 
 
Postoperatively, CT scans will be reconstructed into 3D models and superimposed 
onto the preoperative virtually reduced models using specialized alignment 
software. This process will enable quantitative assessment of discrepancies 
between the planned reconstruction 
and 
the 
achieved surgical outcome. 
 

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I. Preoperative evaluation: 
 Clinical examination (check facial symmetry, occlusion, eye movement, 
sensation). 
 Imaging: CT scan (3D preferred) to assess fracture lines and displacement. 
 Virtual surgical planning, 3D printing and preplating of surgical miniplates 
II. Surgical protocol: 
 Anesthesia and Preparation (Dubron, K. et al., 2022) 
1. General anesthesia is the standard. 
2. Prophylactic antibiotics are administered pre-incision. 
3. Patient is draped to allow access to both intraoral and periorbital regions. 
 
 Surgical Approach (Committeri, U. et al., 2024) 
 
1. Lateral eyebrow (zygomaticofrontal suture) 
2. Subciliary or transconjunctival (infraorbital rim/orbital floor) 
3. Intraoral (zygomaticomaxillary buttress) 
4. Optional: Gillies temporal approach (zygomatic arch) 
 
 Fracture Exposure and Reduction (Dubron, K. et al., 2022) 
1. Carefully expose fracture lines through selected approaches. 
2. Reduce displaced zygoma using bone hooks or elevators. 
3. Confirm anatomical repositioning by assessing orbital rim, malar 
projection, and zygomatic arch. 
 
 Fixation 
 
Perform 3-point or 4-point fixation depending on fracture complexity: 
1. Zygomaticofrontal suture 
2. Infraorbital rim 
3. Zygomaticomaxillary buttress 
4. Zygomatic arch (if needed) 
Use titanium mini-plates and screws; optionally, prebent using VSP. 

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Consider orbital floor reconstruction if herniation or displacement is present. 
 
 Orbital Floor Reconstruction (if needed) (Jansen, B. et al., 2018) 
1. If the floor is fractured or herniated, use titanium mesh or resorbable 
materials to reconstruct. 
2. Avoid over- or under-correction to prevent enophthalmos or diplopia. 
 
 Closure 
 
Layered closure of all incisions. 
 
 
III. 
Postoperative evaluation: (Starch-Jensen, T. et al., 2023) 
 
 Medication: Prescribe antibiotics, corticosteroids, and analgesics. 
 Imaging: Postoperative CT scan with the following machine specifications 
(model name: GE optima CT 520, software: GE health care volume viewer, 
power: AC 3-50 Hz, voltage: 75kva) after 24 hours and 3 months to verify 
reduction, presence of infection, hardware failure and facial symmetry. 
 Follow-up: Assess for complications—enophthalmos, diplopia, malunion, 
infraorbital nerve damage. 

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IV. Drug prescription protocol: 
 Broad-spectrum antibiotics, such as amoxicillin-clavulanic acid 
(625 mg orally every 8 hours for 5–7 days), are commonly 
prescribed to reduce the risk of postoperative infections, 
particularly when intraoral incisions are involved (Farida et al., 
2020). 
 In patients with penicillin allergies, clindamycin may be used as an 
alternative (Lalani and Laskin, 2007). 
 To manage inflammation and swelling, a short course of 
dexamethasone (4 mg once daily for 2–3 days) is often 
administered (Anderson et al., 2014). 
 Pain control typically includes a combination of non-steroidal 
anti-inflammatory drugs (NSAIDs) such as ibuprofen (400–600 
mg every 6–8 hours) and paracetamol (acetaminophen) (500–
1000 mg every 6 hours), depending on the patient’s pain levels and 
tolerance (Laskin, 2012). 
 In cases where intraoral incisions are used, chlorhexidine 
mouthwash (0.12%, twice daily for 7–10 days) is recommended to 
maintain oral hygiene and reduce bacterial load (Kumar et al., 
2015). 
 
 
 
 
 
 
 
6. Statistical plan 
A-Sample Size Calculation: 
 
The sample size for this study was calculated according to (Arkin 
1984). 
N =(𝑍𝛼)2 ∗ (𝑆)2 
(𝑑)2 

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N= Total sample size 
S = Standard diversion 
𝒁𝜶= 1.96 at significant level 95% 
d =Different between factors 
This sample size is in agreement with another study that tested in smeller 
subject (Kholaki O., Hammer D. A et al, .2019). 
Sample size calculation was performed using G*Power version 3.1.9.4 Faul et al, 
(2007) University Kiel, Germany. Copyright (c) 1992-2019. 
The effect size f was 5.34 (large) according to the previous studies with alpha 
(a) level of 0.05 and Beta (B) level of 0.05, i.e., power = 95%; the estimated 
sample size (n) should be 20 samples and will be divided as follows. 
Table, shows the samples distribution in each group 
Samples distribution 
Type 
No. of samples 
Group 1 
Control 
10 
Group 2 
Study 
10 
Total samples 
20 

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B-Statistical analysis: 
All data will be assessed by use of Statistical Package for Social Sciences (SPSS) 
system. 
Experimental design and data analysis 
All data will be collected and statistically analyzed using statistical tests as 
follows: 
A normality test will be done to check normal distribution of the sample. 
Statistical analysis will be done using the SPSS software at significant 
levels 0.05 (P- Value ≤0.5 
1) Descriptive data: 
Descriptive statistics will be used to summarize patient demographics, fracture 
characteristics, and surgical parameters. Continuous variables (e.g., age, surgical 
time, 3D discrepancies) will be expressed as means ± standard deviations (SD) or 
medians with interquartile ranges (IQR), depending on the distribution. 
Categorical variables (e.g., complication types) will be presented as counts and 
percentages. 
2) F- test 
One way ANOVA (parametric or non-parametric) will be used to 
compare between the two groups for each parameter under study. P value ≤0.05 
is considered be statistically significant. 
3) T- test 
Independent Student’s T-test data will be performed for comparing the 
mean differences between the two groups for each measurement. 

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To assess the effectiveness of Virtual Surgical Planning (VSP) in the management of 
zygomaticomaxillary complex (ZMC) fractures, a comparative analysis will be 
conducted between two cohorts: one managed with virtual reduction and the other 
with a traditional surgical approach. The statistical analysis will be focused on 
evaluating surgical accuracy, operative time, and postoperative complications. 
The primary outcome will be the mean discrepancy in 3D alignment, as calculated 
through the superimposition of preoperative and postoperative CT models. These 
models will be analyzed using specialized software to quantify the spatial deviation 
(in millimeters) between planned and achieved bone positions. The discrepancy data 
will be exported in STL format and aligned using 3D processing tools such as Cloud 
Compare. 
The mean, standard deviation, minimum and maximum values, and root mean square 
error (RMSE) of discrepancies will be computed for each group. Normality of the 
data will be assessed using classical tests including Shapiro–Wilk, Anderson–
Darling, Lilliefors, and Jarque–Bera, with significance defined at p > 0.05 to support 
the assumption of normal distribution. 
The primary statistical test for comparing surgical accuracy between groups will be 
the independent samples t-test (two-tailed). Where applicable, a Z-test may be used to 
confirm the results, particularly for standardized mean difference comparisons. A 
significance threshold of p < 0.05 will be applied throughout. 
For sample size justification, data were extrapolated from Committeri et al. (2024), in 
which the VSP (virtual reduction) group showed a mean CT discrepancy of 0.175 
mm (SD ± 0.147) compared to 0.875 mm (SD ± 0.112) in the traditional surgery 
group. Based on these parameters, a power analysis was performed using G*Power 
3.1, indicating that a minimum of 1 patient per group would be statistically sufficient 
to detect a difference with an effect size of Cohen’s d = 5.34, assuming α = 0.05 and 
power = 0.95. In the present study, 10 patients per group (total N = 20) will be 
included, resulting in a calculated power > 0.999. 
Facial symmetry will be assessed by measuring distances between anatomical 
reference points (such as the zygomatic prominences and infraorbital rims) on both 
sides of the face, using postoperative clinical photos or 3D facial scans. 

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Differences greater than 2 mm will be considered asymmetrical. The mean inter-side 
difference will be compared between groups using the same tests as above. 
Secondary variables, including operative time and complication rates (e.g., oedema, 
hematoma, bleeding), will be analyzed as follows: 
Operative time: Expressed as means ± SD and compared using t-test or one-way 
ANOVA if multiple subgroups (e.g., different surgeon experience levels) are 
involved. 
Complications: Tabulated as frequencies and compared using Chi-square or Fisher’s 
exact test, depending on distribution requirements. 
Where relevant, correlation between surgical experience level and operative time will 
be analyzed using Pearson’s or Spearman’s correlation coefficient. Data visualization 
will include bar graphs, distribution curves, and superimposition colorimetric maps, 
following the structure of the original study. 
All analyses will be conducted using SPSS, GraphPad Prism, and G*Power 3.1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fig 2, power (1-β err prob) for sample size 

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7.   Ethics consideration: 
The present research will be conducted after the approval of the Research 
Ethics Committee (REC) of the faculty of Dentistry, Suez Canal 
University. It will be conducted on twenty patient suffering from 
zygomaticomaxillary fracture. Ethical considerations regarding patient 
well-being and confidentiality will be undertaken by the researcher and 
an informed written consent will be signed by the subjects/ patients 
before commencing the study explaining all clinical examinations, 
procedures and follow up. 
(Attached appendix) 

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8. Time Plan: 
 
Include Grant Chart as following example: 
Starting after approval of ethical committee and faculty counsel. Ending after 12 months 
Aivity/Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
Patient selection 
☒ ☒☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
Surgical procedure 
☐ ☐☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
Post-operative evaluation 
☐ ☐☐ ☐ ☒ ☐ ☒ ☐ ☐ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
Statistical analysis 
☐ ☐☐ ☐ ☐ ☒ ☐ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
Thesis writing 
☐ ☐☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
Publication 
☐ ☐☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
 
9. Research Estimated Budget in Egyptian pound 
 
Supplementary 
Publications 
Total 
Radiographs 
drugs/ 
Lab chemicals 
Lab- 
investigations 
Materials 
Others 
(Instruments) 
CT 
Antibiotics, 
analgesics, 
anti-
inflammatory 
Drugs 
CBC 
Virology 
(HBV,H 
CV,HIV) 
Titanium 
miniplate 
mesh and 
screw 
Lancet#15 
, Suture 
silk , Local 
Elevators 
Syringes 
Minnesota 
Muco-
periosteal 
elevator 
anesthesia, 
Saline 
Softwares 
3d printed 
model 
10000 
2000 
10000 
35000 
5000 
3000 
65000 

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10.  References 
 
 
Anderson, D.J., Podgorny, K., Berríos-Torres, S.I., Bratzler, D.W., Dellinger, E.P., 
Greene, L., Nyquist, A., Saiman, L., Yokoe, D.S. and Maragakis, L.L., 2014. 
Strategies to prevent surgical site infections in acute care hospitals. Infection 
Control & Hospital Epidemiology, 35(S2), pp.S66–S88. 
Arkin, H. and Colton, R.R., 1984. Tables for Statisticians. 2nd ed. New York: 
Barnes & Noble. 
Bao, T., Yu, D., Luo, Q., Wang, H., Liu, J. and Zhu, H., 2019. Quantitative 
assessment of symmetry recovery in navigation-assisted surgical reduction of 
zygomaticomaxillary complex fractures. Journal of Cranio-Maxillofacial Surgery, 
47(2), pp.311–319. 
Bitter, K., Huber, K. and Schmid, K., 2021. Anatomy and clinical relevance of the 
zygomaticomaxillary complex. Journal of Cranio-Maxillofacial Surgery, 49(3), 
pp.215–222. 
 
Boffano, P., Roccia, F., Zavattero, E., Dediol, E., Uglešić, V., Kovacević, P., 
Vesnaver, A., Konstantinović, V.S. and Petrović, M., 2013. The management of 
zygomatic-maxillary complex fractures: A review of the literature. Annals of 
Maxillofacial Surgery, 3(1), pp.70–73. 
 
Committeri, U., Arena, A., Carraturo, E., Austoni, M., Germano, C., Salzano, G. 
and Piombino, P., 2023. Incidence of orbital side effects in zygomaticomaxillary 
complex and isolated orbital walls fractures: a retrospective study in South Italy 
and a brief review of the literature. Journal of Clinical Medicine, 12(3), p.845. 
Committeri, U., Magliulo, R., Carraturo, E., Arena, A., Abbate, V., Salzano, G., 
Troise, S., Barone, S., Germano, C., Vaira, L.A., Giovacchini, F., Cataldo, R., 
Grassia, M.G., Califano, L. and Piombino, P., 2024. Virtual surgical planning in 
tripod zygomatico-maxillary complex fractures: A prospective comparison 
between two different strategies. Journal of Cranio-Maxillofacial Surgery, 52(12), 
pp.1497–1504. 
Dubron, K., Van Camp, P., Jacobs, R., Politis, C. and Shaheen, E., 2022. Accuracy 
of virtual planning and intraoperative navigation in zygomaticomaxillary complex 
fractures: A systematic review. Journal of Stomatology, Oral and Maxillofacial 
Surgery, 123(6), pp.e841–e848. https://doi.org/10.1016/j.jormas.2022.07.003. 

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20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Farida, M., Bessar, A.A., Ibrahim, A.A. and Dalia, S.A., 2020. Role of 
multidetector computed tomography in assessment of maxillofacial fractures. The 
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M.M., 2019. Virtual surgical planning for zygomaticomaxillary complex fractures: 
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pp.1710.e1–1710.e9. 
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pgs.240089@dent.suez.edu.eg 
Tel: 01145007231 
21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Starch-Jensen, T., Hernández-Alfaro, F., Kesmez, Ö., Gorgis, R. and Valls-
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11.  Appendices 
(Questionnaire / Consent form) 

E-mail: 
pgs.240089@dent.suez.edu.eg 
Tel: 01145007231 
22 
 
 
 
 
 
 
Faculty of Dentistry Research 
Ethics Committee (REC) 
 
 
Investigator Application Form 
 
1- Name of researcher: Hossam Shaban El Fadly Mohamed 
2- Name of Department: Oral and Maxillofacial Surgery 
3- Address of researcher: 6th of October city Giza. 
a- Email: Hossax20@gmail,com 
b- Phone number: +201145007231 
 
4- Name (s) of Co-investigator (s): 
Prof. Dr. Mohamed Ahmed Elsholkamy 
Prof. Dr. Morres Fekry khalil 
Dr. Mohamed Nageh 
 
 
5- Grade of protocol: 
*M.D.Sc. (*) *Ph.D. ( ) *Doctorate degree (D.D.Sc) ( ) 
*Other ( ) 
*Domestic ( ) *Multi-Centre within Egypt ( ) 
*International ( ) 
 
6- Title of the research: Accuracy of Virtual Surgical Planning in 
Reduction of Zygomatico-Maxillary Fractures A Randomized 
Clinical Controlled Study 

E-mail: 
pgs.240089@dent.suez.edu.e 
Tel:01145007231 
3 
 
 
 
 
 
 
 
7- Type of the research: 
 
*Drug trial ( ) *Surgical technique (*) 
*Investigative technique ( ) 
*Devise study ( ) *Survey study ( ) *Blood sampling ( ) 
*Review of old records ( ) 
Subjects of research: 
1- * Children (˂ 18 years): ( ) *Adults (>18 years) : (*) 
*Vulnerable groups 
(yes) or no (*) 
If yes, please describe: