Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Phase: NA
Conditions: Pediatric Mandibular Fracture
Sponsor: Cairo University

1 
 
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed 
Acrylic Occlusal Cap Splint: A Case Series 
 
 تقييم اإلطباق في حاالت كسور الفك السفلي في المرضى األطفال المعالجين باستخدام جبيرة إطباقية ثالثية
 األبعاد من األكريليك: سلسلة حاالت 
 
Protocol submitted to 
Faculty of Dentistry, Cairo University, Egypt. 
for partial fulfillment of the requirements for the Master Degree in Oral and 
Maxillofacial Surgery.  
 
By: 
Arsany Hany Fekry Shafik 
B.Sc. in Oral and Dental Medicine, Cairo University, Egypt, 2018 
(2026) 
 
Code: 
 
Supervisors’ signatures                              Head of department’s signature 
1- Assoc. Prof. Dr. Mostafa Talaat 
 
2- Dr. Ahmed Youssef 
 
 
Date 
 

2 
 
Protocol Checklist 
 
Section and topic Item 
no. 
Checked item 
Reported 
on page no. 
Reviewer’s 
check 
I. Administrative Information 
 
1 
Title 
4 
 
2 
Protocol Registration 
4 
 
3 
Protocol Version 
4 
 
4 
Funding 
4 
 
5 
Roles and Responsibilities 
4 
 
II. Introduction 
A) Background 
and Rationale 
6 
Research Question 
6 
 
Statement of the Problem 
6 
 
Rationale for carrying out the trial 
7 
 
Review of Literature 
8 
 
B) Objectives 
7 
Aim of the Study 
11 
 
C) Trial Design 
8 
Trial Design 
11 
 
III. Methods 
A) Participants, 
Interventions 
and Outcomes 
9 
Study Settings 
12 
 
10 
Eligibility Criteria 
12 
 
11 
Interventions 
13 
 
12 
Outcomes 
15 
 
13 
Participants Timeline 
16 
 
14 
Sample Size 
16 
 
15 
Recruitment 
16 
 
B) Data 
Collection, 
Management, 
and Analysis 
16 
Data Collection Methods 
17 
 
17 
Data Management 
17 
 
18 
Statistical Methods 
18 
 
C) Monitoring 
19 
Data Monitoring 
19 
 
20 
Harms 
19 
 
21 
Auditing 
19 
 
IV. Ethics and Dissemination 
 
22 
Research Ethics Approval 
20 
 
23 
Protocol Amendments 
20 
 
24 
Informed Consent 
20 
 
25 
Confidentiality 
20 
 
26 
Declaration of Interests 
21 
 
27 
Access to Data 
21 
 
28 
Ancillary and Post-trial Care 
21 
 
29 
Dissemination Policy 
21 
 
V. Appendices 
 
30 
Informed Consent Materials 
22 
 
31 
Biological Specimens 
22 
 
VI. References 
 
32 
References 
23 
 
 

3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evidence-based Committee (Reviewers) 
Name 
Signature 
Date 
1. 
 
 
2. 
 
 
Research Plan Committee 
Name 
Signature 
Date 
1. 
 
 
2. 
 
 

4 
 
I. Administrative Information: 
 
1. Title: 
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic 
Occlusal Cap Splint: A Case Series 
 
2. Protocol Registration: 
Trial will be registered at clinicaltrials.gov 
 
3. Protocol Version: 
First version (April 2026) 
 
4. Funding: 
Self-funded 
 
5. Roles and Responsibilities: 
• Name: Assoc. Prof. Dr. Mostafa Talaat 
Affiliation: Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo 
University, Egypt. 
Main supervisor. 
Responsible for outcomes assessment, auditing and main surgical supervision. 
• Name: Assoc. Prof. Dr. Ahmed Youssef 
Affiliation: Associate Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, 
Cairo University, Egypt. 
Assistant supervisor. 
Responsible for outcome assessment, supervising all surgical procedures, supervising and 
editing writing the thesis. 
 

5 
 
• Name: Arsany Hany Fekry Shafik 
Affiliation: Resident in Oral and Maxillofacial Surgery department, Faculty of Dentistry, 
Cairo University, Egypt. 
Principle investigator. 
Responsible for recruitment, all surgical procedures, writing protocol and final report of the 
research. 
 
Trail Responsibility: 
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, 
Egypt. 
 
 
 

6 
 
II. Introduction 
 
6. Background 
Research Question: 
Does the 3D-printed acrylic occlusal cap splint is accurate in management of mandibular 
fractures in pediatric patients? 
PIO elements: 
Population (P):  
Pediatric patients with mandibular fracture. 
Intervention (I):  
3D-printed acrylic occlusal cap splint. 
Outcome (O): 
Primary Outcome: Occlusion 
Secondary Outcome: Radiographic evidence of fracture reduction, maximum mouth 
opening, and post-operative pain.  
 
Statement of the Problem 
Pediatric mandibular fractures count for 32.7% of all facial fractures (Luhr, 1998). 
Symphyseal and parasymphyseal fractures account for approximately 2% to 30% of all 
mandible fractures, with higher male predilection (Zimmermann et al., 2005). These 
fractures occur more often in children than in adults, which may be partially explained by 
the presence of developing canine tooth buds resulting in a stress point at the inferior border 
of the mandible (Chacon et al., 2003). It is noteworthy that, one of the most common causes 
of trauma in children is motor vehicle-related accidents followed by falls, sports injuries and 
interpersonal violence (Morris et al., 2012). Moreover, the injury of the mandible has a 
serious impact on the functions of children’s mouth opening, chewing, pronunciation, and 
occlusion.(Yang et al., 2022). Inadequately or incorrectly-treated fractures in growing 
children may lead to serious complications including asymmetric mandibular growth and 
temporomandibular joint (TMJ) ankylosis (Joshi et al., 2015).  

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Rationale for Conducting the Research 
This study is conducted to evaluate the accuracy of 3D-printed acrylic occlusal cap 
splint fabricated by computer-guided software in reduction and fixation of pediatric 
mandibular fractures. There are a wide range of choices in the management of mandibular 
pediatric trauma, ranging from observation and follow-up, conservative treatment, and open 
reduction and internal fixation (ORIF) (Chakravarthy et al., 2019). 
Mandibular growth, with the presence of tooth buds, along with deciduous/ permanent teeth 
eruption (mixed dentition) favor the use of conservative approaches in the management of 
pediatric mandibular fractures, where splints are fixed over the mandible by the use of 
circum-mandibular wiring (non-rigid fixation) (Tandon et al., 2020). The virtual surgical 
planning is increasing in popularity in craniomaxillofacial surgery (Abo Sharkh and 
Makhoul, 2020).  
There are multiple advantages that this study offers. First, it is suitable for the 
patients with a complete primary dentition as well as those in mixed dentition. Second, the 
fracture segments will be reduced accurately during virtual surgical simulation, improving 
the accuracy of the operation. Third, due to the splint is done according to the individual 
dentition of the child, it is more stable than the traditional dental arch splint ligation. Fourth, 
compared with intraoperative impression taking, pouring them into casts, fracturing and 
reattaching them in the correct positions to fabricate the splints, it avoids the contamination 
of the operation area and helps shorten the operation’s time spent, and improves the safety 
and efficiency of the operation (Yang et al., 2022). 
 
 

8 
 
Review of literature 
Hyperactivity, road traffic accidents (RTA), falls, abuses, and assaults make children 
the most unfortunate victims of facial trauma and bone fractures (Kaur et al., 2020). Most 
pediatric mandibular fractures are non-displaced due to the resiliency of the mandible and 
the presence of tooth buds that act as small anchors to keep the fractured segments together 
(Fortunato et al., 1982). 
However, displaced mandibular fractures in children need to be reduced and 
immobilized. Such fixation can be achieved with maxillomandibular fixation (MMF) or 
open reduction and internal fixation (ORIF) or a combination of both. MMF is more 
difficult in children than in adult. This is due to a number of factors, including fewer 
available teeth, resorption in roots of deciduous, non-retentive surfaces of deciduous teeth, 
and the crowns of incisors and canines and partially erupted permanent teeth having 
unfavorable shape for fixation of interdental wires and Erich arch bars (El-Anwar et al., 
2018). 
The objective of any surgical intervention is to restore and maintain a stable 
occlusion. Treatment for children is generally conservative. Reconstruction of pediatric 
facial fractures, mandibular fractures in particular, requires an understanding of craniofacial 
development and the consequences of injury on further growth. Appropriate treatment will 
depend on the age of the patient, the location, and the nature of the fracture (Goth et al., 
2012). 
For the young pediatric patients, with fractures that are not displaced and present 
without malocclusion often only require analgesics, close observation, and a liquid or soft 
diet. These patients should avoid strenuous physical activities for several weeks to avoid 
further accidental trauma to the mandible (Smartt et al., 2005). Spiessl stated in 1988 that 
rigid plate fixation is not indicated in mandible fractures in growing younger children, and it 
is usually reserved for difficult fractures when three-dimensional control is required. When 
ORIF is performed in young patients, minimal periosteal manipulation is desirable. 
Alloplastic materials should be avoided. Because of the changes a child experiences during 
growth, long term follow-up of these patients is required to identify and monitor any 
potential growth disturbance or abnormality (Goth et al., 2012). 
Acrylic splints, which were fabricated intraoperatively, are effective to provide 
stability to the mandible; however, they usually require intraoperative impressions and 
model fabrication. In young patients, it is possible to use a single-arch splint and circum-
mandibular wires to stabilize the lower jaw, while allowing the patient to swing freely and 
thus facilitate nutritional intake with less discomfort and anxiety for the patient. This is an 
attractive option for someone who would otherwise need to be wired closed for several 
weeks. However, these splints can be difficult to fabricate in the operating room, especially 

9 
 
because operating room time is expensive, and the appropriate materials or expertise may 
not be readily available (Zide, 1989). 
An alternative fixation method is carried out by taking alginate impressions and 
pouring them into casts, then fracturing and reattaching them in their correct position to 
fabricate the splints prior surgery (Kaur et al., 2020). Furthermore, in facial fractures trans-
nasal wiring combined with circum-mandibular wiring effectively immobilizes the patient’s 
jaws. Although it presents with a risk of injury to the developing teeth along the piriform 
aperture. The surgeon has to be cautious when using this technique because often times, the 
bone in the piriform rim and paranasal area is not dense enough to secure wires. If treated in 
this manner, children will also generally require another general anesthesia to remove the 
wires (Nishioka et al., 1997). 
Besides, Laster et al., 2008 have described another approach for placing specialized, 
pre-formed nickel titanium staples across a fracture line for minimally invasive ORIF of 
mandible fractures, particularly in younger patients. After intermaxillary fixation, or manual 
stabilization of fracture, a small incision, 10 to 15 mm on average, is made to expose the 
fracture. A small hole is then drilled 3 to 4 mm from the fracture line, 1 on each side. The 2 
holes should be placed at the center, so that the shrinkage of the staple will compress the 
fracture line into place. The staple should be as perpendicular to the fracture line as possible. 
The distance between the 2 holes is measured between the 2 closest points of the holes’ 
edges. The appropriate staple size is then selected and cooled below 0 ºC by using a 
commercial spray coolant. Cooling enables momentary straightening of the staple arms to a 
vertical position to facilitate insertion of the staple into the holes. The body heat warms the 
staple and causes closure of the arms, compressing the fracture segments together. 
Additional staples are placed above and below the first one as needed. Any loose staples are 
then replaced to achieve even stability. This technique allows for easy placement and easy 
retrieval of the metal components, while minimizing the number of foreign bodies placed at 
the fracture site. 
Another useful tool in the management of pediatric mandible fractures is the Risdon 
cable. First described by Risdon (Risdon, 1938), the Risdon cable is made from simply 
twisting together a long circum-dental 24-gauge stainless steel wire. Because full-sized arch 
bars can be too bulky for working around the short bulbous teeth of small patients, the 
Risdon cable offers a more malleable and low-profile substitute for the adult arch bars. The 
cable extends from one side of the dental arch to the opposite side and is secured to each 
tooth with circum-dental 24-gauge wires. Variations on this theme are used to deal with 
specific fracture locations in the mandible (Kushner and Tiwana, 2009). 
 
 

10 
 
Additional technique has been reported by making use of resorbable screws and 
large sutures to stabilize the mandible. One small drill hole is placed in each zygoma after a 
small full thickness mucoperiosteal flap is raised. This hole is tapped, and a custom-
resorbable screw is placed into each zygoma. This custom screw has a special hole in the 
screw head, created during the manufacturing process. An awl is then used to pass a large 0, 
or 2-0, monofilament suture under the mandible. The patient is placed in maximum 
intercuspation using the free-hand stabilization technique with the help of an assistant, and 
the suture is passed through the screw head and tied in a knot. At this point, the suture 
appears as an ellipse, with one end wrapped around the mandible and one end wrapping 
through the hole in the screw head. The knot is placed high in the vestibule, free from the 
screw head, to minimize irritation to the patient. After a period of 3 weeks, the surgeon can 
then cut and remove the suture. The custom screw is then left in the zygoma undisturbed, 
left to resorb on its own with no further invasive procedure required to retrieve it. Although 
the initial procedure to place this maxillomandibular fixation requires a general anesthetic, it 
is rapid, secure, and does not damage the teeth; no further second general anesthetic is 
required. Case selection is important because older children will generate jaw forces too 
strong to be stabilized by this technique (Cole et al., 2009). 
Owing to the mandibular growth restriction associated with the traditional permanent 
plates, various resorbable plates have been developed. Several biodegradable materials have 
been examined during the last 40 years. These systems use high molecular weight poly-
hydroxy acids. Polylactic acid (PLA), polyglycolic acid (PGA), and their copolymers have 
been the most commonly used materials to fabricate plates and screws (Ashammakhi et al., 
2001; Landes and Ballon, 2006). Resorbable plating systems have traditionally been bulkier 
and more difficult to handle when compared to titanium plates and screws. Resorbable 
screws require predrilling and tapping. There have also been published complications 
including infection, plate fracture, and fistula formation. Another major concern with 
resorbable systems has been the ability of the plate to withstand the forces produced by the 
functioning mandible (Bos, 2005). 
 
 
 
 
 
 
 

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7. Objectives 
 
Aim of the Study 
To evaluate the occlusal accuracy of 3D-printed acrylic occlusal cap splint fabricated by 
computer-guided software in reduction and fixation of pediatric mandibular fractures. 
 
8. Trial Design 
Prospective consecutive, single-arm, case series trial. 
 
 
 

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III. Methods 
 
A) Participants, Interventions and Outcomes 
9. Study Settings 
Participants will be recruited from Oral and Maxillofacial department, Faculty of 
Dentistry, Cairo University, Egypt. The study is to be conducted in the same setting. The 
start of the study is expected to be on June 2026, and to extend till June 2027. 
 
10. Eligibility Criteria 
Inclusion criteria: 
• Pediatric patients in the mixed dentition phase, aged from 6 to 12 years, with no gender 
predilection. 
• Recent fracture. 
• Single line of fracture; symphyseal, parasymphyseal or body fracture.  
 
Exclusion criteria: 
• Patients with systemic diseases that may impair bone repair. 
• Patients with more than one line of fracture. 
• Patients with pan-facial, ramus, or condylar fractures. 
• Patients with comminuted mandibular fractures. 
• Patients with infection or pre-existing mandibular pathology at the fracture site. 
• Patients who are unable to tolerate follow-up intervals. 
 
 
 

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11. Intervention 
Pre-operative Procedures 
Firstly, patients will go to the polytrauma center to have physical examination to 
exclude any neurosurgical conditions. CBCT imaging will be done at hospital basis and 
DICOM file will be used on Materialize Mimics software (Mimics Medical 21.0, Belgian) 
to virtually reconstruct the patients’ mandible and maxilla, and reduce the fractured bony 
segments. An occlusal cap splint will be designed with thickness of 3 mm, and will be 
converted to STL file to be 3D-printed. 
 
Procedure: 
All the patients will be treated with circummandibular wiring under GA. Local 
anesthetic solution (4% articaine with 1:100,000 epinephrine) will be administered extra-
orally at the point where the bone awl to be inserted. The bone awl will be then guided 
along the body of the mandible and enter lingually piercing the mucosa. Once the awl tip is 
seen, a 26-gauge wire will be secured to its head. It will then be withdrawn till its tip reach 
the inferior border of the mandible and then pass along the buccal side into the sulcus. Same 
procedure will be repeated on the other side of the mandible and wires held in position. 
Extra-oral sutures can be made if needed. 
 
Post-operative Instructions and Medication: 
• Ice packs will be placed for 15 minutes every 1 hour for the first 12 hours. 
• A liquid diet will be initiated on the first post-operative day, followed by instruction 
for a soft diet for the next 4 weeks. 
• Strict oral hygiene measures including brushing and rinsing. 
• Antibiotic, analgesic, and anti-inflammatory drugs will be prescribed, and doses will 
be calculated according to patients’ age and weight. 
• Occlusal cap splint will be removed after one month, under sedation. 
 
Follow-up: 
• One-week post-operative. 
• Two-week post-operative. 
• One-month post-operative. 
• Three-month post-operative. 

14 
 
Strategies to Improve Adherence to Intervention:  
Prior to the procedure, A.H. will carry out the following: 
• Detailed explanation of the procedure. 
• Settling exact follow-up dates. 
• Obtaining a signed informed consent from the patients’ guardian. 
 
Relevant Concomitant Care: 
A.H. will instruct the patients to strictly maintain good oral hygiene, and to avoid any 
mechanical trauma during the healing period.  
 
Criteria for Discontinuing or Modifying Intervention: 
• None. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

15 
 
12. Outcomes 
 
Primary Outcome: 
• Occlusion 
It will be assessed to be satisfactory or not, according to Angle classification, absence of 
midline shift, cross-bite or open-bite after one month, and three months. 
 
Secondary Outcomes: 
• Radiographic evidence of fracture reduction 
Will be assessed by panoramic radiograph immediate post-operative and after three months. 
• Post-operative pain and discomfort 
Will be measured by visual analogue scale (VAS), on a scale from 1 to 10. 
• Maximum mouth opening 
Will be measured by a ruler in mm. 
 
 
Outcome 
Measuring Device 
Measuring Unit 
Primary 
outcome 
Occlusion 
Binary 
Yes or no 
 
Secondary 
outcomes 
Radiographic evidence 
of fracture reduction 
Panorama 
Yes or no 
Maximum 
mouth 
opening 
Ruler 
Mm 
Post-operative pain 
VAS score 
1-10 
 
 
 
 
 
 
 
 
 
 

16 
 
13. Participant timeline 
 
Visit 
Procedure(s) 
Measuring device 
First visit 
Pre-operative records 
CBCT scan done 
 
Second visit 
Operative procedures of placing 
occlusal 
cap 
splint 
using 
circummandibular wires under GA. 
Immediate post-operative panorama 
to assess fracture reduction. 
 
 
 
-Binary  
Third 
visit 
(one-
week post-operative) 
-Post-operative pain 
-Maximum mouth opening 
-VAS (1-10) 
-Ruler in mm 
Fourth visit (two-
week post-operative) 
Fifth 
visit 
(one-
month 
post-
operative) 
Splint removal under sedation 
-Occlusion 
-Post-operative pain 
-Maximum mouth opening 
 
-Binary  
-VAS (1-10) 
-Ruler in mm 
Sixth visit (three-
month 
post-
operative) 
-Occlusion 
-Radiographic evidence of fracture 
reduction 
-Maximum mouth opening 
-Binary 
-Binary 
 
-Ruler in mm 
 
14. Sample Size 
• This study will be conducted on 10 patients. 
 
15. Recruitment 
• Patients will be recruited and selected by A.H. from the outpatient clinic of Oral and 
Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt. 
• Expected duration of recruitment is one year, from June 2026 to June 2027. 
 
 
 
 

17 
 
B) Data Collection, Management, and Analysis 
 
16. Data Collection Methods 
• Occlusion will be assessed visually by A.H., in the follow-up visits (one-month, and 
three-month post-operative) and given values of either intact or deranged. 
• Radiographic evidence of fracture reduction will be assessed by a panoramic 
radiograph, immediate post-operative and three-month post-operative. 
• Post-operative pain will be assessed using visual analogue scale (VAS), with score 
from 1 to 10, in the follow-up visits (one-week, two-week, and one-month post-
operative). 
• Maximum mouth opening will be assessed by ruler in mm in the follow-up visits 
(one-week, two-week, and one-month and three-month post-operative). 
• Recorded data will be kept in the patients file and as a softcopy in Microsoft Excel 
sheet. 
• Patients’ full name, contacts (home and mobile numbers), and ID number will be 
recorded, so reminder calls can be done prior to follow-up visits. 
 
Plans to promote participant retention and complete follow-up: 
• Prior to the surgery, A.H. will inform the patients about the importance of the 
follow-up visits, and their effects on the outcome of the procedure. 
 
17. Data Management 
• All the data will be saved on a Microsoft Excel sheet, encrypted using a password, 
kept on A.H. laptop, and on an external hard drive. 
• Each patient will be assigned a folder containing all his (her) data, including 
personal data, and the measured outcomes (occlusion, radiographic evidence of 
fracture reduction, maximum mouth opening, and post-operative pain), as well as a 
copy of the signed informed consent. 
 
 
 
 

18 
 
18. Statistical Methods: 
• Categorical data will be presented as frequencies (n) and percentages (%) and will 
be analyzed using chi-square test.  
• Numerical data will be explored for normality by checking the data distribution, 
calculating the mean and median values, and using Kolmogorov-Smirnov and 
Shapiro-Wilk tests.  
• If the data is normally distributed, it will be analyzed using paired t-test. If it is non-
parametric, it will be analyzed using Wilcoxon signed rank test.  
• The significance level will be set at P ≤0.05 for all tests. 
• Statistical analysis will be performed with IBM® SPSS® Statistics Version 25 for 
Windows. 
 
 
 

19 
 
C) Data Monitoring 
 
19. Monitoring 
• Oral and Maxillofacial department council. 
 
20. Harms 
• Any temporary or permanent adverse effects will be recorded, documented and 
treated. 
 
21. Audit 
• The study supervisors; Assoc. Prof. Dr. Mostafa Talaat, and Dr. Ahmed Youssef, 
will regularly assess the trial process and documents. They will be involved in 
participants enrollment, consent, eligibility and allocation to study groups, as well as 
adherence to trial interventions and policies to protect participants, including 
reporting of complications and their treatment. Operative procedures will be 
performed under their supervision. 
 
 
 

20 
 
IV. Ethics and Dissemination 
 
22. Research Ethics Approval 
• This protocol and the template informed consent form will be reviewed by the Ethics 
Committee of Scientific Research, Faculty of Dentistry, Cairo University. 
 
23. Protocol Amendments 
• This protocol will be registered on (clinicaltrials.gov) in its current form. 
• Any modifications to the protocol which may have an impact on the conduct of the 
study, potential benefit of the patient or may affect patient safety, including changes 
of study objectives, study design, sample sizes, study procedures, or significant 
administrative aspects will require a formal amendment to the protocol. Such 
amendment will be agreed upon by the Periodontology department council. 
 
24. Informed Consent 
• Researcher will introduce the trial to patients and provide full explanation of its aim 
and benefits in simple language. Patients will then be able to have an informed 
discussion with the researcher to explain all the procedures, and any complication 
that can be met. Researcher will obtain written consent from all patients willing to 
participate in the trial.  
• All consent forms will be in simple Arabic language. 
 
25. Confidentiality 
• All study-related information will be stored securely. All participant information will 
be stored in locked file cabinets in areas with limited access. All reports, data 
collection, process, and administrative forms will be identified by a coded ID 
[identification] number only to maintain participant confidentiality. All records that 
contain names or other personal identifiers will be stored separately from study 
records identified by code number. All local databases will be secured with 
password-protected access systems. 
• Patients’ personal information will be available to the researcher only, while clinical 
and analytical data will be available to the entire research team. 

21 
 
26. Declaration of Interest  
• This study is a part of a Master’s Degree in Oral and Maxillofacial Surgery, from 
Faculty of Dentistry, Cairo University.  
• No financial conflict of interest, as it is self-funded by main researcher. 
 
27. Access to Data 
• The principal investigator and the supervisors will be given access to the data sets. 
All data sets will be password protected. To ensure confidentiality, data dispersed to 
project team members will be blinded of any identifying participant information. 
• Clinical and analytical data may be made available at a data repository if requested 
by a publishing journal. 
 
28. Ancillary and Post-trial Care 
• All patients will be followed-up until complete healing and satisfactory results occur. 
• Dental and oral treatment will be provided if needed. 
 
29. Dissemination Policy 
• Study results will be published as partial fulfillment of the requirements for Master’s 
Degree in Oral and Maxillofacial Surgery. Topics suggested for presentation or 
publication will be circulated to the authors. Study result will be published in 
international journal. 

22 
 
V. Appendices 
 
30. Informed Consent 
• Informed consent template is attached. 
 
31. Biological Specimen 
• No samples will be collected. 
 
 
 
 

23 
 
VI. References  
Abo Sharkh, H., & Makhoul, N. (2020). In-House Surgeon-Led Virtual Surgical Planning for 
Maxillofacial Reconstruction. Journal of Oral and Maxillofacial Surgery, 78(4), 651–660. 
https://doi.org/10.1016/j.joms.2019.11.013 
Ashammakhi, N., Peltoniemi, H., Waris, E., Suuronen, R., Serlo, W., Kellomäki, M., Törmälä, P., & 
Waris, T. (2001). Developments in Craniomaxillofacial Surgery: Use of Self-Reinforced 
Bioabsorbable Osteofixation Devices. Plastic and Reconstructive Surgery, 108(1), 167–180. 
https://doi.org/10.1097/00006534-200107000-00027 
Bos, R. R. M. (2005). Treatment of pediatric facial fractures: The case for metallic fixation. Journal of 
Oral and Maxillofacial Surgery, 63(3), 382–384. https://doi.org/10.1016/j.joms.2004.11.010 
Chacon, G. E., Dawson, K. H., Myall, R. W. T., & Beirne, O. R. (2003). A comparative study of 2 
imaging techniques for the diagnosis of condylar fractures in children. Journal of Oral and 
Maxillofacial Surgery, 61(6), 668–672. https://doi.org/10.1053/joms.2003.50134 
Chakravarthy, C., Gupta, N. C., & Patil, R. (2019). A Simplified Digital Workflow for the Treatment of 
Pediatric Mandibular Fractures Using Three-Dimensional (3D) Printed Cap Splint: A Case Report. 
Craniomaxillofacial Trauma & Reconstruction Open, 3(1), s-0039-1694765. 
https://doi.org/10.1055/s-0039-1694765 
Cole, P., Kaufman, Y., Izaddoost, S., Hatef, D. A., & Hollier, L. (2009). Principles of Pediatric 
Mandibular Fracture Management. Plastic and Reconstructive Surgery, 123(3), 1022–1024. 
https://doi.org/10.1097/PRS.0b013e318199f695 
El-Anwar, M. W., Salah, M., & Abdulmonaem, G. (2018). C-arm-assisted internal fixation of pediatric 
mandibular fracture. Egyptian Journal of Otolaryngology, 34(2), 122–126. 
https://doi.org/10.4103/ejo.ejo_81_17 
Fortunato, M. A., Fielding, A. F., & Guernsey, L. H. (1982). Facial bone fractures in children. Oral 
Surgery, Oral Medicine, Oral Pathology, 53(3), 225–230. https://doi.org/10.1016/0030-
4220(82)90294-8 
Goth, S., Sawatari, Y., & Peleg, M. (2012). Management of pediatric mandible fractures. In Journal of 
Craniofacial Surgery (Vol. 23, Issue 1, pp. 47–56). https://doi.org/10.1097/SCS.0b013e318240c8ab 
Joshi, S., Kshirsagar, R., Mishra, A., & Shah, R. (2015). Clinical efficacy of open reduction and semirigid 
internal fixation in management of displaced pediatric mandibular fractures: A series of 10 cases 
and surgical guidelines. Journal of Indian Society of Pedodontics and Preventive Dentistry, 33(2), 
161. https://doi.org/10.4103/0970-4388.155135 
Kaur, D., Kaura, S., Suneja, B., Bansal, D., Bahl, D., Jodhka, D., & Singh Saini, D. (2020). Role of Cap 
Splints in the Management of Paediatric Mandibular Fractures- A Case Series. European Journal of 
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