Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair
Phase: NA
Conditions: Mandible Fracture, Maxillofacial Trauma
Sponsor: University of Cincinnati

 
 
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Instructions:  
1. Complete all sections of the protocol template. By clicking on headers in the Table of Contents below, 
the form will navigate you directly to that section. 
2. If a section does not apply, list Not Applicable as advised. 
3. Refer to documents, templates, checklists, SOPs, and worksheets as advised throughout the protocol in 
Blue. Each document referred to in blue contains a hyperlink to the RAP library to obtain the 
documents (CONTROL + CLICK) 
4. Please ensure that your RAP Profile is up to date with your correct email address, phone number, and a 
current CV/Resume. 
5. Upload this completed document into a New Study Submission in RAP (https://rap.irb.uc.edu/irb), on 
the Basic Information Page under “Protocol”.   
TABLE OF CONTENTS 
1.0 OBJECTIVES ....................................................................................................................................................................... 3 
2.0 BACKGROUND .................................................................................................................................................................. 4 
3.0 RESOURCES AVAILABLE .................................................................................................................................................... 5 
4.0 INVESTIGATOR EXPERIENCE ............................................................................................................................................. 6 
5.0 STUDY ENDPOINTS ........................................................................................................................................................... 7 
6.0 PROCEDURES INVOLVED .................................................................................................................................................. 7 
7.0 DATA AND SPECIMEN BANKING .................................................................................................................................... 10 
8.0 SHARING OF RESULTS WITH SUBJECTS .......................................................................................................................... 10 
9.0 STUDY TIMELINES ........................................................................................................................................................... 10 
10.0 INCLUSION AND EXCLUSION CRITERIA & VULNERABLE POPULATIONS ..................................................................... 11 
11.0 NUMBER OF SUBJECTS ................................................................................................................................................. 12 
12.0 RECRUITMENT METHODS ............................................................................................................................................ 12 
13.0 COMPENSATION FOR SUBJECTS .................................................................................................................................. 13 
14.0 WITHDRAWAL OF SUBJECTS ........................................................................................................................................ 13 
15.0 RISKS TO SUBJECTS ....................................................................................................................................................... 13 
16.0 POTENTIAL BENEFITS TO SUBJECTS ............................................................................................................................. 14 
17.0 DATA MANAGEMENT AND CONFIDENTIALITY ............................................................................................................ 15 
18.0 PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS ........................................................... 18 
19.0 PARTICIPANT PRIVACY ................................................................................................................................................. 19 

 
 
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20.0 COMPENSATION FOR RESEARCH RELATED INJURY .................................................................................................... 20 
21.0 ECONOMIC BURDEN TO SUBJECTS .............................................................................................................................. 20 
22.0 CONSENT ....................................................................................................................................................................... 21 
23.0 CONSENT PROCESS ....................................................................................................................................................... 22 
24.0 WAIVER OF DOCUMENTATION OF CONSENT .............................................................................................................. 25 
25.0 WAIVER OR ALTERATION OF CONSENT PROCESS ....................................................................................................... 26 
26.0 CONSENT OF NON-ENGLISH-SPEAKING SUBJECTS ...................................................................................................... 26 
27.0 CONSENT OF SUBJECTS WHO ARE NOT YET ADULTS (infants, children, adolescents) .............................................. 27 
28.0 CONSENT/ASSENT OF COGNITIVELY IMPAIRED ADULTS ............................................................................................ 28 
29.0 HIPAA ............................................................................................................................................................................ 28 
30.0 STUDY INTERVENTION/ INVESTIGATIONAL AGENT .................................................................................................... 28 
31.0 ADDITIONAL REVIEWS AND CONSIDERATIONS .......................................................................................................... 29 
32.0 REGULATORY OVERSIGHT ............................................................................................................................................ 31 
33.0 SETTING ........................................................................................................................................................................ 31 
34.0 EXTERNAL LOCATIONS ................................................................................................................................................. 32 
35.0 REFERENCE LIST ............................................................................................................................................................ 34 
 
STUDY SUMMARY: 
PROTOCOL TITLE: 
Determining the ease of utilizing 3D Printed Models to aide in Isolated Mandibular 
Fracture Repair 
PRINCIPAL 
INVESTIGATOR: 
Deepak G Krishnan, DDS, FACS 
Associate Professor of Surgery  
Chief, Oral & Maxillofacial Surgery 
 
VERSION 
NUMBER/DATE: 
Version 1.3- November 1st, 2022 
SHORT TITLE: 
3D Printed Models for Mandibular Fracture Repair  
RESEARCH 
INTERVENTION(S)/ 
INVESTIGATIONAL 
AGENT(S): 
N/A 
IND/IDE #: 
N/A 

 
 
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STUDY SPECIFIC 
ABBREVIATIONS/ 
DEFINITIONS: 
UCMC is University of Cincinnati Medical Center 
HH is Holmes Hospital 
OMS is Oral and Maxillofacial Surgery 
OR Operating Room 
ORIF Open Reduction and Internal Fixation 
AMUPs Anatomic Model Utility Points 
MVCs motor vehicle collisions 
CPT The Current Procedural Terminology 
SSI Surgical site infection  
VTE Venous thromboembolism 
 
FUNDING SOURCE 
N/A 
FUNDING LOCATION 
☐ 
Funds are held in Sponsored Research Services for a Grant or Contract 
(funds are held internally at UC) 
☐ 
Funds are from a department account (held internally at UC) 
☐ 
Funds held in a corporate account from a Contract (funds held externally 
from UC) 
☒ 
No funding 
 
PROTOCOL: 
1.0 OBJECTIVES 
1.1 Describe the purpose, specific aims, or objectives. 
The goal of treatment is to re-establish the patient's preinjury dental occlusion and facial 
harmony. Fractures that are nondisplaced and exhibit no occlusal changes may be amenable 
to nonsurgical management, but most mandible fractures will require stabilization for 
satisfactory healing and to restore pretraumatic maxillomandibular orientation. Various 
treatment strategies have been described and vary widely depending on the fracture location 
and surgeon's preference. The patient's demographics, comorbidities, dentition, and fracture 
characterization will all influence the choice of fixation by the treating surgeon. [4] 
 
There are very few randomized control trials that show outcomes when 3D printing is used 
for intervention planning and performing a procedure. These data are essential to establish 
value of 3D printing as a clinical service.  There is also anecdotal evidence that a 3D printed 
model of a mandible fracture can be useful for pre-operative planning because the oral and 
maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend 
fixation plates before the procedure. This hypothetically decreases the amount of time in the 
operating room. 
 
The investigators propose a parallel design randomized control trial to study the value of 3D 
printing for preoperative planning in patients with a fracture of the mandible who require 
open reduction, internal fixation. The study will be split into two arms: 1) Patients that will 

 
 
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have a 3D model generated for the surgical procedure 2) The control group who will follow 
normal standards of care as outlined above and won't have the additional 3D model created 
pre-operatively.  
1.2 Describe the hypotheses to be tested. 
The investigators will test the hypothesis that patients randomized to the intervention (3D 
printing with pre-bent plate) arm have less operative room time and less time for the critical 
part of the procedure than patients in the control arm (no 3D printing, current standards of 
care). Personalized medicine and care for fracture treatment. 
 
 
2.0 BACKGROUND 
2.1 Describe the relevant prior experience and gaps in the current knowledge. 
Currently, several corporations are contracted with maxillofacial plating companies to 
provide 3D planning and printing of surgical models, stents, and guides to facilitate surgery. 
However, these services can be cost prohibitive and can require a considerable lead 
time. The typical minimum required time of 1 to 2 weeks for the planning and manufacturing 
process can be limiting when attempting to treat acute injuries in a timely fashion. On-site, or 
in-house, 3D model fabrication with preoperative plate bending is a cost- and time-effective 
option to provide predictable reconstructive solutions with an associated decrease in 
operative time and cost. An inexpensive on-site option mitigates the cost of an outside 
contracted biomedical engineering service, which has a typical per-case cost of $1,000 to 
$2,000, and decreases the time needed to deliver a patient-specific implant to the OR. [10] 
  
Numerous types of 3D printers are currently commercially available, ranging from industrial 
machines costing more than $100,000 to consumer-level products that yield nearly 
industrial-level results with start-up costs of under $3,000. [10] The purpose of this study is 
to evaluate the feasibility, accuracy, and compatibility with current surgical approaches to re-
work the current standards of care to include the use of on-site 3D model creation and 
preoperative plate bending for mandibular fractures.  
2.2 Describe any relevant preliminary data.  
Recent advances in imaging modalities, software technology and 3D printing have allowed 
for increased accuracy, ability to troubleshoot prior to surgery, and decrease operative time. 
Virtual surgical planning (VSP) is routinely utilized in maxillofacial surgery for orthognathic 
surgery, complex craniomaxillofacial trauma, resection and free flap reconstruction of benign 
and malignant pathology. Typical input is radiographic imaging (CT, CT Angio, MRI, etc.), 
intraoral scans, 3D facial scans. With the end goal in sight, through virtual surgical planning, 
cutting guides can be fabricated for accurate osteotomies, intermediate and final dental 
splints can be created to ensure proper placement of osteotomized segments and custom 
plates can be fabricated to fixate the bony segments in a predictable fashion.  
2.3 Provide the scientific or scholarly background for, rationale for, and significance 
of the research based on the existing literature and how it will add to existing 
knowledge.  

 
 
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3D printing is a technology that allows for physical creation of a 3D model (usually made of 
plastic) based on computer generated 3D images from CT scans. The 3D images of 
craniofacial skeleton using computer software are routinely generated and, in turn, these 3D 
images can be used to create a plastic 3D model using a 3D printer. Unstable or comminuted 
facial fractures need to be reduced and rigidly fixated using titanium plates and screws. 
Bending and shaping of the plates is usually performed by free hand based on the surgeon's 
estimation of what best fits the fracture. Often, bending the titanium plates to the shape of 
pre-injury skeletal contour is difficult when the bone is fractured into many pieces or is 
unstable, or when the patient is edentulous (missing several teeth). The process can increase 
the time spent in surgery and the bent plates may not snugly fit the fracture. For these 
difficult cases, one option is to use commercially manufactured 3D printed patient-specific 
models. The patient-specific models provide the benefit of correct shape/form for increased 
surgical accuracy and decreased intra-operative time. Thus, redefining standards of care 
increasing surgical satisfaction from the surgeon and patient, while decreasing the time in 
the OR.  
 
3.0 RESOURCES 
AVAILABLE 
3.1 Describe the resources available to conduct the research. Justify the feasibility 
of recruiting the required number of suitable subjects within the agreed 
recruitment period, e.g. how many potential subjects do you have access to? What 
percentage of those potential subjects do you need to recruit? 
The study will be conducted at University of Cincinnati Medical Center which is designated as 
the region’s only Level I trauma center by the American College of Surgeons. This will be a 
joint study with the divisions of Oral and Maxillofacial surgery, Plastics and Reconstructive 
surgery and Otolaryngology who are designated as the primary teams for management of all 
facial trauma at the institution. Thousands of consults are requested annually through UCMC 
ED and neighboring hospital systems for these specific injuries.  
 
3.2 Describe the time that you will devote to conducting and completing the 
research, i.e. percent effort.  
The staff involved with conducting this research project have clinical and didactic 
responsibilities outside of their research work. The supervisors of this study tend to dedicate 
one academic day a week for research and other administrative needs, realistically yielding 
10-15% of effort on the part of supervisors. However, the main research coordinator and 
main facilitator of the project has a full-time research position at the division of oral and 
maxillofacial surgery, where 100% of effort is dedicated towards the research effort. 
 
3.3 Describe the availability of medical of psychological resources that subjects 
might need as a result of an anticipated consequences of the human research.  
The study will be based out of Holmes Hospital Oral and Maxillofacial Surgery clinic and 
UCMC. In the event of an emergency (which would be extremely unlikely to be because of 
the medications used for this study), quick transportation to the emergency department can 
be arranged. Additionally, a crash cart and complete rescue airway carts are in the clinic, 

 
 
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which always have direct UC always attending coverage. All residents and attendings are 
ACLS/BLS/PALS trained, and all staff at the clinic are BLS trained. Additionally, the clinic is 
located directly adjacent to the ambulatory operating rooms and facilities, which are staffed 
by anesthesiologists, various other surgical specialists, nurses, nurse anesthetists, anesthesia 
technologists, whose resources and help are readily available if needed. Psychological 
outcomes do not pertain to the study. However, standard psychological resources at UC are 
available to any patient who receives their care at UC 
3.4 Describe your process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their duties 
and functions. 
A formal orientation will be held for any member involved with this study conducted by the 
division's research coordinator. Given that this is a blinded study certain pieces of 
information will be withheld from certain individuals, particularly the surgical providers, for 
the integrity of the research. The orientation will include presentations, and one-on-one 
informative meetings, as well as question and answer sessions. All members involved in the 
research study will be carefully monitored by the principal investigator and research 
coordinator for appropriate conduct and compliance with the research protocol and specific 
responsibilities 
3.5 Describe the facilities you have access to that will allow you to conduct the 
research.  
As discussed earlier, the facility that will host the research study is Holmes Hospital Oral and 
Maxillofacial Surgery clinic affiliated with University of Cincinnati Medical Center and the 
Department of Surgery 
 
4.0 INVESTIGATOR 
EXPERIENCE 
4.1 Detail the investigators’ experience as it pertains to the study.  
 Dr. Krishnan has been a member of the UC Surgery faculty since 2008. He is currently 
associate professor of surgery and is serving as the chief of OMS at UC Medical Center and 
Cincinnati Children’s Hospital. Dr. Krishnan obtained his dental degree from Bangalore 
University, India, and trained in Oral and Maxillofacial Surgery at Emory University’s College 
of Medicine in Atlanta, Georgia. Upon completion of residency, Dr. Krishnan pursued further 
fellowship training in Oral & Maxillofacial Surgery focusing on orthognathic surgery at 
Dalhousie University, Halifax, Canada. He currently serves on the Committee of 
Education and Training (CET) of the AAOMS and is the chair of the special committee on 
Emerging leaders in OMS. He is also a consultant to the AAOMS Committee on Anesthesia 
(CAN) on Simulation in Anesthesia. Dr. Krishnan was in the first class of single degree oral and 
maxillofacial surgeons that were recognized as Fellows of the American College of Surgeons. 
 
Dr. Rybicki is Vice Chair of Operations & Quality at the University of Cincinnati Department of 
Radiology, and he is the clinical lead for the 3D printing section at UCH. HI is the past-Chair of 
the American College of Radiology Appropriateness Criteria, and the Founding Chair of the 
Radiological Society of North America 3D Printing Special Interest Group. He also is currently 
the Editor-in-Chief of the journal 3D Printing in Medicine. Dr. Rybicki obtained his medical 

 
 
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degree through the physician scientist program at Harvard -MIT (Medicine and Medical 
Engineering), and he completed his residency in Diagnostic Radiology at the Brigham and 
Women's Hospital and Harvard Medical School, Boston, MA. 
 
 
5.0 STUDY ENDPOINTS 
5.1 Describe any primary and secondary study endpoints. 
Outcome 1: Noninferiority of the clinical outcome (defined by OMS on the post-op, follow up 
exam approx. 6 weeks out) Based on physical exam 
 
Outcome 2: 
a. Total time in the OR 
b. Time in the OR considered critical part of the procedure by the OMS Staff 
 
Outcome 3 
a. Subjective outcome to surgeon Likert scale 
 
5.2 Describe any primary and secondary safety endpoints. 
Not Applicable. 
 
6.0 PROCEDURES 
INVOLVED 
6.1 Thoroughly describe the study design.  
We plan to conduct a randomized controlled trial on trauma patients brought to either 
UCMC or UC HH OMS for treatment of isolated mandibular fractures. This study plans to 
elucidate whether the utilization of 3D models during operations where effective in 
minimizing both OR time and operational costs. Subjects will be identified based off the 
initial physical assessments made by surgical specialists from OMS, Plastic Surgery, and 
otolaryngology. Once the subjects are identified the research coordinator will conduct a 
screening of the patient to ensure they meet the inclusion/ exclusion criteria for the study 
and then randomize the patient into either normal standard of care for surgical repair of the 
fractured mandible or normal standard of care for surgical repair of the fractured mandible 
aided by a 3D printed model of the patient's jaw. Any chart reviewing will be conducted from 
existing electronic medical records maintained by UC Health EPIC and OMS Vision. All the 
following data would be based on the patient’s condition at the time of surgery. 
 
Following completion of the procedure, for the surgeons who received aide via the 3D model 
they will be asked to answer a brief Likert Scale survey outlining their thoughts how 
effectively or ineffectively the model assisted them. In addition to this information, if they 
feel the model increased efficiency saving time, they will be asked to state how much time 
they felt was saved. This time differential will be compared to current CPT codes for OR time 
to understand how much in operational costs were saved by utilizing the models.        
6.2 Detail the procedures being performed, specifically the interaction or 
intervention with human subjects and/or their identifiable information. Please be 
clear and concise and provide information relevant to the current study. For 

 
 
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example, please be sure that what will be done for this research is explained and 
differentiated from activities that have already taken place or will be submitted for 
future review. Please note that details about recruitment and consent are asked in 
later questions. 
The primary goals in the management of mandibular fractures are restoration of functional 
occlusion and facial form. There are frequently several appropriate techniques available for 
the definitive management of a given mandible fracture. In general, mandible fractures are 
treated either closed (maxillomandibular fixation, splinting, modified diet) or open (plates 
and screws, interosseous wiring, lag screws). The technique chosen depends on several 
variables including, dental status, fracture characteristics (open, closed, favorable, 
unfavorable, comminution, bone lose, mechanism of injury, contamination, or frank infection 
etc.), fracture location, associated injuries, patient mental status and patient desires. The 
most important considerations are the dental status, fracture characteristics and fracture 
location. 
 
The main surgical techniques that will be performed will be as follows:  
 
Open reduction and internal fixation of mandible fractures is an evolving science. There are 
several different techniques used to internally fixate mandible fractures. Simple interosseous 
wiring to supplement intermaxillary fixation is a form of open reduction and internal fixation. 
There are a variety of plate and screw systems available for the repair of mandible fractures. 
Compression plating of mandibles has become popular over the last 10 years. Compression 
plate fixation allows direct bone healing and, in most cases, eliminates the need for 4 to 6 
weeks of maxillomandibular fixation needed with closed reduction techniques. Compression 
plates used on the inferior cortex must always be used with some form of tension band as 
discussed above. A special type of compression plate called an eccentric dynamic 
compression plate can be used without a tension band. This plate has sliding ramp holes 
which allow compression of the fracture not only in the plate but also at the tension side of 
the mandible. In general, the application of compression plates requires that the angle of the 
fracture be no more than 30 degrees from a line perpendicular to the long axis of the plate. If 
an angle greater than this exists, the compression plate will cause the fragments to slide 
against one another rendering the reduction nonanatomic and not in compression. 
If internal fixation is desired and compression plating cannot be performed due to an oblique 
fracture or significant comminution of fragments, several other options exist. Reconstruction 
plates are large plates which use at least three screws on each side of the fracture. They hold 
the bone in absolute stability and because of their large size and stability, they do not require 
a tension band. Reconstruction plates are useful in cases of severely comminuted mandible 
fractures such as those resulting from gunshot injuries. If correctly placed small, no 
compression plates (called adaptation plates) may be used to repair mandible fractures. The 
most well-known of these systems is the Champy system. One final method of internal 
fixation of mandible fractures is with lag screws. A lag screw can compress two bone 
fragments and therefore permits direct bone healing. The number of fracture cases suitable 

 
 
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for lag screw repair is relatively small and this technique requires considerable experience 
and skill. 
 
Fractures of the mandible can be approached either trans orally or through the neck. In 
closed fractures one advantage of approaching the fracture through the neck is the absence 
of salivary contamination of the wound. The obvious drawback in an external approach is a 
scar. Most symphyseal and body fractures can be easily plated through the mouth. Angle and 
ramus fractures are difficult to approach through the mouth and if an intraoral approach is 
performed special instruments for the transcutaneous placement of screws must be 
available. Patients with open mandible fractures should be on antibiotics active against oral 
cavity organisms including anaerobes. Perioperative antibiotics have been shown to decrease 
the rate of wound infections. 
 
6.3 Describe procedures being performed to monitor subjects for safety or 
minimize risks. 
Several steps are taken to assure patient safety for surgical procedures. Prior to the 
procedure, their vitals are taken, including their blood pressure, heart rate, respiratory rate, 
and oxygen saturation. Depending on the patient, especially those with history of 
cardiopulmonary disease, monitors are kept cycling every five minutes during the procedure. 
A thorough history and physical is performed before any procedure to assure appropriate 
patient selection and to rule out more emergent issues. During the procedure, patients are 
continuously monitored with active physical examinations by the provider. There is always a 
certified oral and maxillofacial assistant with the patient in the room, especially during the 
procedure. For urgent-add on, a registered nurse is normally present as well to monitor the 
patient. The patient is treated via standard protocol of the oral and maxillofacial clinic at 
Holmes Hospital, which treats thousands of patients annually through safe, effective, and 
efficient measures. As explained earlier, emergency crash carts, including rescue airway 
carts, are present at the facility, as well as dozens of trained personnel promptly available if 
needed.  
6.5 Where applicable, list and describe the data collection tools such as surveys, 
data collection forms, etc. All tools described should be uploaded in the RAP Smart 
Form on the Local Site Documents page unless they are standardized, validated 
tools.  
Data collection will only be stored and collected on REDCap, which is a server software 
maintained by Cincinnati Children's Hospital Medical Center (CCHMC) informational 
technology team. The surgeon assigned to the case will fill out the questionnaire outlining 
the how effective using the 3D model was during the procedure. The outcome data will then 
be collected on the same secured software.   
6.6 Describe all data that will be accessed and collected during the study and how 
that data will be obtained (how it will be accessed). 
Description – Distinguish between data accessed and data collected if applicable. 

 
 
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6.7 If there is a long-term follow-up plan (once all research related procedures are 
completed), what data will be collected during this period.  
No Long-Term Follow-Up 
 
 
7.0 DATA AND 
SPECIMEN BANKING 
7.1 If data or specimens will be banked for future use, describe where the data or 
specimens will be stored, how the data or specimens will be accessed, and who will 
have access to the data or specimens.  
Data collected from this study will be destroyed/deleted after the study's conclusion. No 
specimens will be collected. 
7.2 If specimens are being stored, list the data to be stored or associated with each 
specimen. 
Not Applicable 
7.3 Describe the procedures to release data or specimens, including: (the process to 
request a data/specimen release, approvals required for release, who can obtain 
data or specimens, and the data to be provided with the specimens. 
Not Applicable 
 
8.0 SHARING OF 
RESULTS WITH 
SUBJECTS 
8.1 Describe whether results (study results or individual subject results, such as 
results of investigational diagnostic tests, genetic tests, or incidental findings) will 
be shared with subjects or others (e.g., the subject’s primary care physician) and if 
so, describe the process for sharing. If you do not intend to share any results, 
please state that here. 
The results of the study are obtained directly from the questionnaire and involvement. Thus, 
there is no process to share or release results with patients. Patients will not be sought to 
discuss the particulars of study results. Study results will be shared via peer-reviewed 
journals. This section is not pertinent to the study. 
 
9.0 STUDY TIMELINES 
9.1 Describe the duration of an individual subject’s participation in the study. List 
the number of study visits or frequency of study visits. 
The subject's participation is limited to a one-time appointment.    
9.2 Describe the timeline allotted for the enrollment of subjects. 
Prospective subjects would be triaged during their admissions to UCHMC. If the subject 
meets the study criteria, the research coordinator would enter the evaluation room after the 
surgical provider has completed their history and physical, at which point involvement will be 
established and randomization will be conducted. Thus, based on study design, there is not 
specific timeline of enrollment since the decision is made same day. 
9.3 Describe the estimated date for the investigators to complete this study 
(complete primary analysis). 
Primary analysis is estimated to be complete in January 2024. 
 

 
 
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10.0 INCLUSION AND 
EXCLUSION CRITERIA 
& VULNERABLE 
POPULATIONS 
10.1 Describe how subjects will be screened for eligibility.  
The screening of potential participants will be performed by the providers of University of 
Cincinnati Medical Center’s Department of Oral and Maxillofacial Surgery clinic located at 
Holmes Hospital (UCMC OMS HH clinic), or surgical providers from plastic surgery and 
otolaryngology located in UCMC including resident physicians, attending physicians, research 
staff, and clinic staff. Surgical team members from the division of plastic and otolaryngology 
will be consented and recruited to participate in this study by providing their feedback post 
operatively. The diagnosis and treatment planning will strictly be made by a resident or 
attending surgeon. However, an elected research coordinator will complete a standardized 
eligibility form on REDCap based on the study’s inclusion/exclusion criteria to finalize 
participant selection 
10.2 Describe/list the inclusion/exclusion criteria for the study. 
Inclusion Criteria: 
Patient ≥ 18 years of age 
Patients who have received either a cone beam or conventional CT 
Admitted through UCHMC emergency department 
All isolated mandible fractures referred to UCH OMS 
Surgical team members from the division of plastic and otolaryngology 
 
Exclusion Criteria: 
Patient < 18 years of age   
Patients who have neither cone beam nor conventional CT 
Patients requiring a repeat procedure 
Unexpected exposure of hardware 
 
 
10.3 Indicate specifically whether you will include each of the following vulnerable 
populations. Check all that apply. (You may not include members of the below 
populations as subjects in your research unless you indicate this in your inclusion 
criteria and are approved by the IRB to include them in your research) The member 
checklists are for reference only to ensure you provide appropriate safeguards and 
justification. The checklists do not need to be completed.  
☐ 
Adults unable to consent (cognitively impaired individuals) (HRP-417 – 
MEMBER CHECKLIST Cognitively Impaired) 
☐ 
Individuals who are not yet adults (infants, children, teenagers) (HRP-416 – 
MEMBER CHECKLIST Children) 
☐ Individuals who are not yet adults and are, or may become, wards of the 
state.  
☐ 
Pregnant women (a woman shall be assumed pregnant if she exhibits and of 
the presumptive signs of pregnancy, such as a missed menses, until the results 

 
 
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of a pregnancy test are negative or until delivery.) (HRP-412 MEMBER 
CHECKLIST Pregnant Women) 
☐ 
Non-Viable Neonates (HRP-413 – MEMBER CHECKLIST Non-Viable Neonates) 
☐ 
Uncertain Viability Neonates (HRP-414 – MEMBER CHECKLIST Uncertain 
Viability Neonates) 
☐ 
Prisoners (HRP-415 – MEMBER CHECKLIST Prisoners) 
10.4 If the research involves individuals listed in 10.3 or other individuals who are 
vulnerable to coercion or undue influence, please justify based on the applicable 
checklist and describe additional safeguards included to protect their rights and 
welfare.  
N/A 
10.5 If the research involves or may involve individuals who are students or 
employees where the research is taking place, please describe additional 
safeguards included to protect their rights and welfare. 
Not Applicable 
 
11.0 NUMBER OF 
SUBJECTS 
11.1 Indicate the total number of subjects to be accrued. 
We aim to obtain 50 procedures for each arm of the study (100 in total) 
50: standard surgical procedures aided by use of 3D Printed model  
50: procedures carried out by standard surgical repair for isolated mandibular fractures (No 
model)  
11.2 If applicable, distinguish between the number of subjects who are expected to 
be enrolled and screened, and the number of subjects needed to complete the 
research procedures. 
N/A 
 
12.0 RECRUITMENT 
METHODS 
12.1 Describe when, where, and how potential subjects will be recruited. 
Subjects of this study are those that require emergent medical attention and are referred to 
either UCHMS Emergency Department or to UC OMS for treatment. Subjects will be triaged 
by the clinical providers, and the research coordinator will then complete a standardized 
informative process. Regardless of involvement, the subject will undergo the same treatment 
course as any other patient presenting with an isolated mandibular fracture. For the 
consenting of the surgical team members, they will undergo a research presentation given by 
the research coordinator in which they have an adequate amount of time to ask any 
questions or concerns before deciding to be a part of the study.  
12.2 Describe the source of the subjects. 
Subjects for the study are any patient are referred to HH OMS for treatment of isolated 
mandibular fracture. The referral arrives will need emergent medical treatment arriving from 
the emergency department. No subject will be sought after for the purposes of the study 
since the population will be emergent cases admit to UCHMC. Surgical team members will be 

 
 
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identified by both the PI and research coordinator for recruitment based off of past surgical 
collaboration on routine procedures at UCMC.  
12.3 Describe the materials that will be used to recruit subjects. (Attach copies of 
these documents in the Recruitment section on the local site documents page in 
RAP. For advertisements, attach the final copy of printed advertisements (avoid 
making copies until approved in case modifications are required). When 
advertisements are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude re-taping 
because of inappropriate wording, provided the IRB reviews the final audio/video 
tape) 
N/A 
 
13.0 COMPENSATION 
FOR SUBJECTS 
13.1 Describe the amount, method, and timing of payments to subjects.  
N/A 
 
14.0 WITHDRAWAL OF 
SUBJECTS 
14.1 Describe the anticipated circumstances under which subjects will be 
withdrawn by the study team from the research without their consent. 
Given the strict inclusion and exclusion criteria of the study, we anticipate very few 
circumstances in which patients will need to withdraw by the study team without their 
consent. 
14.2 Describe any procedures for orderly termination. 
Patients will be withdrawn from the study if they unfortunately succumb to their injuries 
related to any polytrauma that caused the underlying mandibular fracture before any 
procedures can be completed. Surgeons who no longer wish to provide feedback via the 
Likert scale questions will also no longer be associated with the study.  
14.3 Describe procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with continued data 
collection, withdrawal of previously collected data upon request, etc. 
Patients and surgeons who are withdrawn from the study for the purposes listed earlier will 
be excluded from all study results. 
 
15.0 RISKS TO 
SUBJECTS 
15.1 Describe the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to the subjects’ participation in the research. 
It may be useful to include: a description of the probability, magnitude, duration, 
and reversibility of the risks. Consider the physical, psychological, social, legal, and 
economic risks. 
There are no risks related to the 3D printing. The physical model is generated from the 
CT images that have already been acquired, and the addition of the 3D printed model 
for those patients randomized to the 3D printing arm will be completely transparent. 

 
 
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The following risks as described are general risks that the patient would assume with 
the study. 
Confidentiality of the data 
Electronic data will contain a de-identified patient ID number, which will be used to 
link back to the identifier. The key linking identifier to subject number will not be 
stored with the electronic data. Electronic data will be managed using an excel sheet 
stored on a secure computer. Analytical datasets will be stored on secure servers that 
also limit access to the investigator team. Should results of the study be published or 
reported, individual names or other identifying information will not be used. 
 
15.2 If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable.  
All procedures and medications used have known risks and are discussed above. Thus, there 
are no unforeseeable risks to discuss. 
15.3 If applicable, indicate which procedures may have risks to an embryo or fetus 
should the subject or the subject’s partner be or become pregnant. 
Not Applicable 
15.4 If applicable, describe risks to those who are not subjects.  
Not Applicable 
15.5 Describe the procedures and actions taken to mitigate the risks to subjects and 
others.  
See section 15.1. Each specific risk listed includes a description on mitigation. Since risk and 
mitigation are synonymous, they have been discussed in the same section. 
 
16.0 POTENTIAL 
BENEFITS TO 
SUBJECTS 
16.1 Describe the potential benefits that individual subjects may experience from 
taking part in the research. It may be useful to include: the probability, magnitude, 
and duration of the potential benefits. Indicate if there is no direct benefit to 
subjects. Do not include benefits to society or to others. 
N/A 
 

 
 
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17.0 DATA 
MANAGEMENT AND 
CONFIDENTIALITY 
17.1 Describe the data analysis plan, including any statistical procedures or power 
analyses. 
We are going to use the Likert questions to develop a numerical scoring system and report 
that data as “raw” Likert scores. Likert questions and conversion of specialists’ responses to 
Anatomic Model Utility Points (AMUPs). Responses of “strongly disagree”, “disagree”, and 
“neutral” were assigned 0 AMUP points. Responses to preprocedural confidence are assigned 
negative points, to effectively subtract the impact of the anatomic model post- versus pre-
procedure. The maximum AMUP for each patient was 500. 
17.2 Describe the steps that will be taken to secure the data. 
All data will be stored on REDCap. During data collection, the research coordinator 
will record the data directly into REDCap. REDCap which is a server software 
maintained by Cincinnati Children's Hospital Medical Center (CCHMC) informational 
technology team. REDCap must be installed on a local web server by CCHMC’s 
internal IT staff. CCHMC’s server environment is physical/on-premises. CCHMC’s 
internal IT staff must handle all aspects of REDCap installation, maintenance, and 
support. The REDCap license is required to install the software. Note, it must be 
pointed out that much of the security surrounding REDCap has nothing to do with the 
REDCap software itself but rather is dependent upon the IT infrastructure and 
environment in which REDCap has been installed. This includes the webserver and 
database server, the communication between those two servers, and the 
communication of the web server with the REDCap end-user. REDCap is easily 
configurable for use and requires minimal infrastructure and setup.  
REDCap can run on several different operating systems (Linux, Unix, Windows, 
Mac). To ensure that REDCap users have access only to data and information that they 
are supposed to have access to within the application, user privileges are utilized 
within the software. REDCap implements authentication to validate the identity of 
end-users that log in to the system. CCHMC’s utilizes Shibboleth authentication to 
provide a single sign-on, external method of authentication.  User’s username and 
password are controlled in CCHMC’s OIM.  Users in REDCap are redirected to 
another webpage to log in, and then are redirected back to REDCap if they 
authenticated successfully.  
REDCap contains an auto-logout setting, which is customizable (default auto-logout 
time is 30 minutes) and will automatically log a user out of the system if they have not 
had any activity (e.g., clicking, typing, moving the mouse) on their current web page 
for the set amount of time. This prevents someone else from accessing their account 
and their project data if they leave a workstation without properly logging out or 
closing their browser window. CCHMC’s REDCap will store all data captured in 
REDCap on its own servers. Therefore, all project data is stored and hosted at 
CCHMC, and no project data is ever transmitted at any time by REDCap from 
CCHMC to another institution or organization. REDCap does not employ any kind of 

 
 
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encryption of data (i.e., encryption “at rest”) on its database server. (This is not to be 
confused with encryption of data “in transit” (i.e., via SSL) to the database, which 
should always be done.) The encryption of database data is not necessary if the 
database server is properly secured. All documents that are uploaded and/or stored in 
REDCap will be stored on the local REDCap web server in a secure directory. To help 
protect and secure the data stored in Redcap's back-end database, the software 
application employs various methods to protect against malicious users who may 
attempt to identify and exploit any security vulnerabilities in the system. Such 
methods will be described here in technical detail: 
In REDCap, all incoming data gets intentionally filtered, sanitized, and escaped. This 
includes all data submitted in an HTTP Post request and all query string data found in 
every URL when users access REDCap, among other modes through which user-
defined data gets submitted in the application. Server environment variables that are 
vulnerable to forgery by end-users are also checked and sanitized. All user-submitted 
data is properly filtered for any possibly harmful markup tags (e.g., <script>) and is 
then escaped before ever being displayed on a web page within the application. SQL 
queries sent to the database server from REDCap are all properly escaped before being 
sent. If any values used in an SQL query originated from user-defined values, they 
would also have already been sanitized beforehand, as described above. User-defined 
data used within SQL queries have their data type-checked to prevent any 
mismatching of data types (e.g., making sure a number is really a number). These 
processes of sanitization, filtering, data type checking, and escaping all help to protect 
against methods of attack, such as Cross-Site Scripting (XSS) and SQL Injection. To 
specifically protect against Cross-Site Request Forgery (CSRF), which is another 
method of attack, REDCap utilizes a “nonce” (a secret, user-specific token) on every 
web form used in the application. The nonce is generated as a unique value for each 
new HTTP request in every REDCap session. 
Additionally, REDCap employs “rate-limiting” on its web pages, in which there is a 
set maximum number of web requests per minute that are allowed from a single IP 
address, and after that maximum is hit, the IP address of that user is permanently 
banned from REDCap. The rate-limiting value of requests per minute per IP is 
customizable and can be modified within Redcap's Control Center. Rate limiting 
prevents denial of service attacks by bots as well as preventing other types of hacker 
attacks that require making many requests to the server in a short amount of time, such 
as with a BREACH attack. Regarding the prevention of BREACH attacks specifically, 
in addition to using rate limiting, REDCap always outputs an invisible string of 
random text of random length on every web page (to conceal the page’s true length) as 
an effective technique for mitigating such an attack. Redcap's use of a unique nonce 
token on every web form also greatly diminishes the possibility of a BREACH attack. 

 
 
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About the security of cookies used by REDCap, all session cookies and other cookies 
related to authentication that are created by REDCap will automatically have the 
“HTTP Only” attribute set to TRUE. By default, the “Secure” cookie flag will be set 
to FALSE. while this is slightly more insecure, setting its value as TRUE can 
sometimes cause login issues with certain server configurations, such as reverse 
proxies. So, for compatibility reasons, it is set as FALSE by default. However, 
CCHMC administrators can enable the “Secure” flag of session cookies to improve 
security by setting session. cookie secure=On in the REDCap web server’s PHP.INI 
configuration file. 
Administrative controls  
University of Cincinnati Medical Center Division of Oral and Maxillofacial Surgery 
Research Coordinator, Reese Triana, has complete administrative control over the 
individuals involved with the research project. Any research members involved must 
formally apply to University of Cincinnati Health Office of Clinical Research. This 
application entails a confidentiality and data security agreement which must be signed 
and approved, which holds the employee liable for violating HIPAA policies and 
patient confidentially. Otherwise, the process of gaining access to the UC charting 
systems is rigorous and extensive, including drug screening, badge identification 
application, IT registration, etc. The research member has an orientation overseen by 
the Research Coordinator, to adjust them to the project, including the rules and 
regulation of maintaining patient confidentiality. CITI training is required of all 
participants, including annual confidentially agreements.  
On REDCap, the Research Coordinator is given full rights to everything within the project, 
after which they may grant other users access to the project and limit those users’ privileges 
as desired. Within each project, there are user controls to limit access to various functionality 
and modules, such as being able to export data, to enter data, to add or modify database 
fields or survey questions, to build or run reports, to modify user privileges, to view the 
logging records, and so on.  
17.3 Describe any procedures that will be used for quality control of data collection.  
REDCap has a built-in audit trail that automatically logs all user activity and logs all 
pages viewed by every user, including contextual information (e.g., the project or 
record being accessed). Whether the activity be entering data, exporting data, 
modifying a field, running a report, or add/modifying a user, among a plethora of other 
activities, REDCap logs all actions. The logging record can itself be viewed within a 
project by users that have been given privileges to view the Logging page. The 
Logging page allows such users to view or export the entire audit trail for that project, 
and to filter the audit trail in various ways based upon the type of activity and/or user. 
The built-in audit trail in REDCap allows administrators to be able to determine all the 
activity and all the data viewed or modified by any given user. This structural aspect 

 
 
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of REDCap allows for close monitoring of data from the study supervisors. 
Additionally, only the research coordinator will have capability to add or remove data. 
REDCap allows the coordinator to designate or prevent specific rights to be assigned 
from team members. 
17.4 Describe how data or specimens will be handled study wide as outlined below. 
17.5 What information will be included in the data or associated with the 
specimens? 
No specimens will be collected. The information collected will be as follows: 
Procedural Time 
Cost differential via model utilization 
3D Printing Likert scale Questions answered by specialist post operatively 
 
 
 
17.6 Who will have access to the data or specimens? 
No specimens will be collected. Data access will be restricted to the research coordinator, the 
principal investigator, and co-investigators 
17.7 Where and how data or specimens will be stored? 
No specimens will be collected. As discussed earlier, all the data will be stored on REDCap. 
17.8 How long the data or specimens will be stored? 
No specimens will be collected. The data will be stored for the duration of the study, which is 
expected to take approximately two years, and for the duration of data analysis and peer-
reviewed publication, which is expected to take another year. Realistically, the data will be 
stored for three years. 
17.9 If applicable, how data or specimens will be transported? 
Not Applicable. 
17.10 Who is responsible for receipt or transmission of the data or specimens? 
Not Applicable. 
 
18.0 PROVISIONS TO 
MONITOR THE DATA 
TO ENSURE THE 
SAFETY OF SUBJECTS 
18.1 For more than minimal risk research, describe the plan to periodically evaluate 
the data collected regarding both harms and benefits to determine whether the 
subjects remain safe.  
The participants will be undergoing surgical repair at UCMC for a mandible fracture. The 
participants participation in the study only lasts for the duration of the procedure. The 
evaluation of the data will be assessed following the completion of the procedure by the 
surgeon consented for participation in answering the Likert Scale questions. Routine surgical 
monitoring associated with current standards of care will be conducted by the surgical staff 
in the procedure room as assigned on the patients care team.  
18.2 What data are reviewed, including safety data, untoward events, and efficacy 
data? 

 
 
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Clinician Monitoring and Respiratory System Monitoring typically conducted by various 
surgical team members assigned for the patient's surgical procedure.  
18.3 How will the safety information will be collected? 
Safety information will be collected by the patient's surgical team in the charting conducted 
both pre and post operatively to coincide with UCMC's current standards of care for surgical 
procedures. 
18.4 The frequency or periodicity of review of cumulative data.  
The review will follow the duration of the surgical procedure and standard six-week follow-
up provided by the patients care team.  
18.5 Who will review the data? 
Data will be reviewed by the surgical team members. 
18.6 The statistical tests for analyzing the safety data to determine whether harm is 
occurring.  
Statistical testing will follow the outlined analysis for this current study as stated in the 
protocol. 
18.7 Any conditions that trigger an immediate suspension of research. 
The standard procedure is to not use a model, and thus we believe that looking at the model 
before the procedure is genuinely minimal risk. The surgeon will have already performed the 
review of the imaging (that forms the basis of the physical model), and therefore there is no 
risk of increased OR time for any patient.  As we stated in the second to last paragraph of 
Page 3 in the initial submission, we are looking at potentially less time in the OR, as there will 
not be more time spent in the OR for any patient. This is looking to redefine the current 
standards of care minimizing the OR time already expected under the normal standards of 
care. No conditions would trigger immediate suspension as current standards of care will be 
utilized throughout surgery. 
 
19.0 PARTICIPANT 
PRIVACY 
19.1 Describe the provisions to protect participants’ privacy and to minimize the 
intrusiveness of the study questions or procedures.  
Subject confidentiality will be protected to the extent permitted by law. Electronic databases 
with subject identifier will also be user-access protected. Subject identifiers will not be used, 
since medical record numbers will be replaced by de-identified patient ID numbers. The 
research data will be periodically reviewed by study team members to ensure that patient 
information and privacy is not at risk of being compromised. Patient privacy during 
evaluations and procedures will be maintained via standard-of-care HIPAA protocols. 
 

 
 
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20.0 COMPENSATION 
FOR RESEARCH 
RELATED INJURY 
20.1 For more than minimal risk research, describe the available compensation in 
the event of research-related injury. 
Not Applicable- even though the research is labeled as more than minimal risk, the same 
standard surgical procedure will be carried out regardless of the use of the 3D model. Any 
complications that arise unexpectedly will be covered under UCMC surgical consent the 
patient signs before surgery that is routine for all surgical procedures conducted in the 
hospital. 
20.2 Provide a copy of contract language relevant to compensation for research-
related injury. 
Not Applicable- even though the research is labeled as more than minimal risk, the standard 
surgical procedure will be carried out regardless of the use of the 3D model. Any 
complications that arise unexpectedly will be covered under UCMC surgical consent the 
patient signs before surgery that is routine for all surgical procedures conducted in the 
hospital. 
 
21.0 ECONOMIC 
BURDEN TO SUBJECTS 
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research.  
There is no additional cost for the subjects for participation in the study 
 

 
 
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22.0 CONSENT  
22.1 Obtaining consent – Check applicable and complete the corresponding 
section(s). Please note, sections 23-28 each apply under different circumstances. 
Please complete the correct sections as checked in this section (e.g. if you do not 
request a waiver of documentation of consent, do not complete section 24) 
☒ 
The research team will obtain written consent from all subjects. (Complete 
section 23) (HRP-502M TEMPLATE Medical Informed Consent or HRP-502S 
TEMPLATE SBER Informed Consent or HRP-502V TEMPLATE VA Informed 
Consent) 
☐ 
The research team will obtain consent from all subjects but is requesting a 
waiver of documentation (signature) of consent. (Complete sections 23 and 
24) (HRP-502I TEMPLATE Information Sheet) 
☒ 
The research team is requesting a waiver or alteration of the consent process. 
(Complete section 25) 
☐ 
The research team is requesting Exception from Informed Consent for 
emergency research. (Please complete the EFIC supplement document and 
upload under number 3 on the local site documents page in RAP) 
☐ 
The research team will enroll Non-English-speaking subjects and obtain 
consent (written or otherwise). (Complete sections 23 and 26) 
☐ 
The research team will enroll subjects who are not yet adults (infants, 
children, teenagers) and will obtain written consent from the subject’s 
parent(s) or guardian(s). (Complete sections 22 and 27) (Parent Permission 
Template) 
☐ 
The research team will enroll adult subjects unable to provide consent 
(cognitively impaired individuals) and will obtain written consent from the 
subject’s Legally Authorized Representative. (Complete sections 23 and 28) 
 

 
 
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23.0 CONSENT 
PROCESS 
23.1 Where will the consent process take place? 
For patients: 
A research team member will go over the consent form with potential subjects in a private 
area and will answer any questions subject may have. Subject will be given a copy of the 
consent and time as needed to consider enrolling in the study. A phone number will be given 
in case the subject has additional questions. All subjects are to receive copies of their signed 
consent form. The date the subject signs the consent form is to be recorded on CRF. 
 
For surgeons: 
The research coordinator will go over the consent form with the surgical team members in a 
private area and will answer any questions subject may have. The surgeons will be given a 
copy of the consent and time as needed to consider enrolling in the study. A phone number 
will be given in case the subject has additional questions. All subjects are to receive copies of 
their signed consent form. The date the subject signs the consent form is to be recorded on 
CRF. 
23.2 Is there a waiting period available between informing the prospective subject 
and obtaining the consent? 
There will be a minimal waiting period, (< 60 minutes) between informing prospective 
patients of interest in study involvement and obtaining consent. 
23.3 Describe: 
• The role of the individuals listed in the application as being involved in the 
consent process.  
• The time that will be devoted to the consent discussion. 
• Steps that will be taken to ensure the subjects’ understanding.  
• Steps that will be taken to minimize the possibility of coercion or undue 
influence.  

 
 
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For patients: 
A research team member will accompany a surgical team member to the pre-operative 
consultation appointment for a prospective study patient about to undergo treatment for a 
mandible fracture. The team member will bring the necessary consent forms.  
 
During this appointment the surgeon will introduce the research team member first so they 
can introduce the study to determine patients' willingness to participate. That way if the 
patient isn't interested in participating minimum time out of the visit has been spent 
discussing study. If subject agrees, the study team member will begin the consenting process.  
 
During the consenting process the research team member will go over all the details and 
timelines for the study. Contact information will also be provided so if any questions or 
concerns arise, they can contact the study team.  
 
The study team will ensure that the patient is by no way obligated to participate in this study. 
The procedure and normal post operative standards of care will be provided if the patient 
participates or not. There will be adequate time for the patient to ask any question or discuss 
any concerns. 
 
Participants will be provided a consent for both to review and take with them during their 
appointment visit. The one copy the research team will obtain the signature of the 
participant and the research team member that obtained the consent. This form will be kept 
in the regulatory binder in the research coordinators office in a locked filing cabinet in a 
personal office where only the study team members have access to. 
 
For surgeons: 
 The research coordinator will establish a private meeting with each surgical team member 
involved in the study who will be preforming the surgical repair for a mandible fracture. The 
research coordinator will bring the necessary consent forms for the surgeon's review.  
 
During this appointment the study coordinator will introduce the Likert scale questions that 
the surgeon will be responsible for answering post- operatively if they are selected to use the 
3D model for that procedure. That way if the surgeon elects to remove themselves from the 
study, they may do so at that present time. If the surgeon agrees to the Likert scale 
questions, the study coordinator will begin the consenting process.  
 
During the consenting process the research team member will go over all the details and 
timelines for the study. Contact information will also be provided so if any questions or 
concerns arise, they can contact the study team.  
 
The study team will ensure that the surgeon is by no way obligated to participate in this 
study. The procedure and normal post operative standards of care will be provided if the 

 
 
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patient participates or not. There will be adequate time for the surgeon to ask any question 
or discuss any concerns. 
 
Participants will be provided a consent for both to review and take with them during the 
meeting. The one copy the research team will obtain the signature of the participant and the 
research team member that obtained the consent. This form will be kept in the regulatory 
binder in the research coordinators office in a locked filing cabinet in a personal office where 
only the study team members have access to.  
23.4 Describe how consent of the subject will be documented in writing.  
Both the patients and surgeons will be provided a consent for both to review and take with 
them. The one copy the research team will obtain the signature of the participant and the 
research team member that obtained the consent. This form will be kept in the regulatory 
binder in the research coordinators office in a locked filing cabinet in a personal office where 
only the study team members have access to.   
23.5 Describe the conditions under which you believe it would be appropriate to 
obtain ongoing consent from the subjects.  
Ongoing consent and communication will be important throughout the study. The subject 
has the right to be removed from the study at any point in time. It is crucial that the subject's 
recovery and well-being be placed above determining effectiveness of the device. Subjects 
will be provided the research coordinators phone number and IRB contact information so 
they can report any issues if need be or any issues directly to the IRB if worried about 
notifying the study team directly. 
 

 
 
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24.0 WAIVER OF 
DOCUMENTATION OF 
CONSENT 
24.1 Justification for waiver of consent documentation. Check all that apply and 
provide rationale for all checked items. Please note that certain combinations of 
the selections below may justify a waiver of documentation. Please refer to HRP-
411 – MEMBER CHECKLIST Waiver of IC Documentation to determine if your study 
qualifies for a waiver of documentation, and which boxes to check to justify the 
waiver. 
☒ 
N/A not requesting a waiver of documentation of consent.  
☐ 
The research presents no more than minimal risk to subjects. 
Rationale/Explanation 
☐ 
Written information describing the research is to be provided to the subject, 
subject parent(s) or guardian(s), or subject Legally Authorized Representative. 
Rationale/Explanation 
☐ 
Written information describing the research does not need to be provided to 
the subject, subject parent(s) or guardian(s), or subject Legally Authorized 
Representative. Rationale/Explanation 
☐ 
The research involves no procedures for which written consent is normally 
required outside of the research context. Rationale/Explanation 
☐ 
The only record linking the subject and the research would be the consent 
documentation. Rationale/Explanation 
☐ 
The principal risk of a signed consent document would be the potential harm 
resulting from a breach of confidentiality. Rationale/Explanation 
☐ 
The subjects are members of a distinct cultural group or community in which 
signing forms is not the norm. Rationale/Explanation 
☐ 
There is an appropriate alternative mechanism for documenting that informed 
consent was obtained. Rationale/Explanation 
☐ 
The research is not FDA-Regulated. Rationale/Explanation 
☐ 
The written script of the information to be provided orally, electronically, or 
on paper (information sheet) includes all required and appropriate additional 
elements of consent disclosure. When requesting a waiver of documentation, 
an information sheet is required. This box should always be checked for a 
waiver of documentation. (Follow HRP-502I TEMPLATE Information Sheet) 
Rationale/Explanation 
☐ 
Other Describe any other reasons/explanations for request of waiver/alteration 
 

 
 
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25.0 WAIVER OR 
ALTERATION OF 
CONSENT PROCESS 
25.1 Justification for waiver or alteration of the consent process. Check all that 
apply and provide a rationale/explanation for all checked statements. Please note 
that certain combinations of the selections below may justify a waiver of or 
alteration of consent. Refer to HRP-410 – MEMBER CHECKLIST Waiver of IC Process 
to determine if your study qualifies for a waiver or alteration of consent, and which 
boxes to check to justify the waiver or alteration. 
☒ 
N/A Not requesting a waiver or alteration of consent process. 
Rationale/Explanation 
☐ 
The research does NOT involve non-viable neonates. Rationale/Explanation. 
☐ 
The research involves no more than Minimal Risk to subjects. 
Rationale/Explanation. 
☐ 
The research could NOT practicably be carried out without the waiver or 
alteration. Rationale/Explanation 
☐ 
The waiver or alteration will NOT adversely affect the rights and welfare of 
the subjects. Rationale/Explanation 
 
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation. Rationale/Explanation 
☐ 
The research is NOT FDA regulated. Rationale/Explanation 
☐ 
Other Describe any other reasons/explanations for request of waiver/alteration 
 
26.0 CONSENT OF 
NON-ENGLISH-
SPEAKING SUBJECTS 
26.1 Indicate what language(s) other than English are understood by prospective 
subjects or representatives. (Please note that if non-English speaking subjects will 
be consented, translated consent forms must be uploaded into the consent section 
of the RAP Smart Form.  For Greater than minimal risk studies, a third-party 
translation certificate is also required. For minimal risk studies, the consent must 
be translated by someone independent of the study team and their credentials 
should be provided.) 
Not Applicable  
26.2 If subjects who do not speak English will be enrolled, describe the process to 
ensure that the oral and written information provided to those subjects will be in 
that language. Indicate that language that will be used by those obtaining consent.  
Not Applicable 
 

 
 
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27.0 CONSENT OF 
SUBJECTS WHO ARE 
NOT YET ADULTS 
(infants, children, 
adolescents) 
27.1 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or procedures 
involved in the research under the applicable law of the jurisdiction in which the 
research will be conducted (e.g. individuals under the age of 18 years (Ohio)) 
 Subjects will receive an ID check during the screening process, to ensure no patients under 
the age of 18 are included in the study. 
27.2 Describe whether parental permission will be obtained. (Parent Permission 
Template) 
• 
Parental permission for inclusion in this study will be determined by the parents 
and/or legal guardians that accompany the patient to the surgical consult. A research 
team member will go over the consent form with potential subjects and 
accompanying parents and/or guardians in a private area and will answer any 
questions subject may have. Subject will be given a copy of the consent and time as 
needed to consider enrolling in the study. A phone number will be given in case the 
subject has additional questions. All subjects are to receive copies of their signed 
consent form. The date the subject signs the consent form is to be recorded on CRF 
27.3 Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission. Describe the process 
used to determine these individuals’ authority to consent to each child’s general 
medical care. 
Not Applicable 
27.4 Indicate whether assent will be obtained from all, some, or none of the 
children. If assent will be obtained from some children, indicate which children will 
be required to assent. (HRP-502Y Youth Assent or Medical Assent Template) 
N/A 
27.5 When assent is obtained, describe whether, and how, it will be documented.  
N/A 
 

 
 
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28.0 
CONSENT/ASSENT OF 
COGNITIVELY 
IMPAIRED ADULTS 
28.1 For potentially cognitively impaired adults, describe the process to determine 
whether an individual is capable of consent. 
N/A 
28.2 List the individuals from whom permission will be obtained in order of priority. 
(Please note that the consent form will require revision to add a signature line for 
LAR and authority of LAR). 
(N/A 
28.3 Describe the process for assent of the subjects. Indicate whether assent will be 
required for all, some, or none of the subjects. If some, indicate which subjects will 
be required to assent and which will not.  
N/A 
28.4 If assent will not be obtained from some or all subjects, explain why. 
N/A 
28.5 Describe whether assent of the subjects will be documented and the process 
to document assent. 
N/A 
 
29.0 HIPAA 
29.1 If you will use hospital or other healthcare provider records, data from a 
research data repository or any other information maintained by a hospital, 
academic medical center, or another healthcare entity, how will you gain access to 
the information? (check all that apply, i.e. if you will request a waiver for screening 
and obtain a signed authorization upon enrollment, check both). 
☐ 
Not using HIPAA-protected information for any research activities 
☒ 
Through a HIPAA Authorization signed by the participant (or their legally 
authorized representative).  
☐ 
Requesting that the IRB approve a waiver of authorization in this application. 
Submit HRP-209 – FORM – UC Waiver of HIPAA Authorization 
☐ 
As a limited data set under a data use agreement. 
 
30.0 STUDY 
INTERVENTION/ 
INVESTIGATIONAL 
AGENT 
30.1 FDA – Select all that apply. 
☐ Drugs/Biologics 
The proposed research involves the administration of an article 
(e.g. drug, biologic, herbal preparation, dietary supplement, 
etc.) to a human where the article is intended for use in the 
diagnosis, cure, mitigation, treatment, or prevention of disease 
or is intended to affect the structure or any function of the 
body. For both FDA and non-FDA approved article. Include 
HRP-306 – WORKSHEET Drugs and Biologics in the submission 
in RAP. 
☐ Devices 
Any research that involves the use of a device (medical or 
other devices, approved or investigational) to test the safety or 

 
 
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effectiveness of the device or the device is the focus of the 
research. Note: This includes research that will use human 
samples to test the safety or effectiveness of a device. Include 
HRP-307 – WORKSHEET Devices in the submission in RAP. 
☐ Data Collection 
Any research that involves the collection of data or other 
results from individuals that will be submitted to, OR held for 
inspection by, the FDA. In general, this would include research 
that involves any data that will be provided (in any form) to a 
pharmaceutical, medical device or biotech company. 
☐ 
Specimens 
Any research activity where specimens (of any type) from 
individuals, regardless of whether the specimens are 
identifiable, are used to test the safety or effectiveness of any 
device (medical or other devices, approved or investigational) 
and the information will be submitted to, or held for inspection 
by, the FDA. 
☒ Not Applicable 
None of the above describes my research.  
30.2 Describe the study intervention and/or investigational agent (e.g. drug, device) 
that is being evaluated.  
Not Applicable 
30.3 Drug/Device Handling: Describe plans to store, handle, and administer those 
drugs or devices so that they will be used only on subjects and be used only by 
authorized investigators. 
Not Applicable 
30.4 If the drug is investigational and has an IND or if the device has an IDE, or claim 
of an abbreviated IDE (non-significant risk device) include the information below: 
• Identify the holder of the IND/IDE/Abbreviated IDE 
• Explain the procedures followed to comply with the sponsor requirements 
for FDA regulated research (as applicable, 21 CFR 11, 21 CFR 54, 21 CFR 210, 
21 CFR 211, 21 CFR 312, 21 CFR 812, 21 CFR 820) 
• If the PI holds the IND/IDE, please include the FDA Application and the FDA 
Letter of Acknowledgement on the Drugs/Devices page of the RAP Smart 
Form. Please also note that a Safety Monitoring Plan will be required if the 
PI holds the IND/IDE. 
Not Applicable 
 
31.0 ADDITIONAL 
REVIEWS AND 
CONSIDERATIONS 
31.1 Check all that apply.  
☐ 
The proposed research meets the definition of a clinical trial, is regulated by 
HHS, and requires that the consent form is posted to a federal website within 
60 days of completion 
Clinical Trial: A research study in which one or more human participants are 
prospectively assigned to one or more interventions (which may include 

 
 
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placebo or control) to evaluate the effects of those interventions on health-
related or behavioral outcomes.  
☐ 
The proposed research involves embryonic stem cells or xenotransplantation. 
☐ 
The PI is responsible for registration of this study on www.clinicaltrials.gov. 
(Please contact the Human Research Protection Program with questions about 
clinicaltrials.gov) 
☐ 
The proposed research requires review by the Institutional Biosafety 
Committee (IBC). IBC review is required for research that will utilize infectious 
agents, select agents, recombinant DNA or viral gene transfer vectors, toxins 
for human gene transfer or genetically modified agent. 
☐ 
The proposed research requires Radiation Safety Committee (RSC) review. RSC 
review is required if the research involves participants being exposed to 
radiation for research purposes or an increase in frequency or duration of 
radiological imaging procedures.  
☐ 
UC Student is serving as Principal Investigator (Add the Faculty Advisor to the 
Study Team Members page in the RAP Smart Form and ensure that their CV is 
included in their RAP profile.) 
☐ 
UC study team members will be conducting research activities at international 
location(s).  
If the research involves international locations, describe additional safeguards 
included to protect the rights and welfare of subjects recruited in these 
locations. Refer to HRP-399 – MEMBER WORKSHEET International Research 
for more information on the information required for review for international 
studies. 
Description, e.g. information about local research oversight, local context, etc. 
☐ 
Collection of information that may include incriminating activities (e.g. illicit 
drug use, illicit sexual behaviors, fraudulent behaviors, theft, abortion or 
other related activities that may be illegal in some states, assault) 
☐ 
Review of UC Student records without obtaining consent. If so, a FERPA 
waiver is required. (Please reach out to Lorre Ratley with UC Office of General 
Counsel.) 
☐ 
Sharing of genomic information generated from NIH-funded research 
☐ 
 
UC Health services will be utilized (check applicable). 
☐ Investigational Drug 
Services 
☐ Imaging Services 
☐ Lab Services 
☐ 
CCHMC Services will be utilized (check applicable). 
☐ 
CICRL 
☐ IRC 
☐ SRC 

 
 
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☐ 
Acute Care Research (Research that occurs within 24 hours of a visit to an 
emergency department or unscheduled admission, or within 24 hours of 
identification of a new or worsening condition – characterized by sudden 
onset requiring immediate care) 
☐ 
The research team will send data FROM the United States TO another country: 
if so, list the country or countries here 
☐ 
The research team will send data FROM another country TO the United States: 
if so, list the country or countries here 
 
32.0 REGULATORY 
OVERSIGHT 
32.1 Check the applicable federal oversite and/or funding.  
☐ 
Environmental Protections Agency 
☐ 
Department of Energy 
☐ 
Tribal Law 
☐ 
Department of Defense 
☐ 
Department of Justice 
☐ 
Department of Education 
☐ 
Food and Drug Administration 
☐ 
Health and Human Services 
(NIH) 
☐ 
Office of Civil Rights 
☐ 
National Science Foundation 
☐ 
Veterans Affairs *See Below 
☐ 
Other Federal Agency  
☐ 
*Check if you will enroll non-veterans 
☐ 
ICH-GCP (E6)  
☐ 
Specify other federal agency/oversight 
Name 
 
33.0 SETTING 
33.1 Where will research activities take place, including where data will be 
stored/accessed (check all that apply). 
☐ 
Barrett Cancer Center 
☐ 
Infectious Disease Clinic 
(Holmes-UC Health) 
☐ 
Blue Ash Campus 
☐ 
Kettering Laboratory 
☐ 
Cincinnati State Technical and 
Community College 
☐ 
Linder Center of Hope 
☐ 
Clermont College 
☐ 
Liver Transplant Clinic (Medical 
Arts Building) 
☐ 
College of Allied Health Sciences 
☒ 
Medical Sciences Building 
☐ 
College of Arts & Sciences 
☐ 
Shriners Hospital 
☐ 
College of Business 
☐ 
Talbert House 
☐ 
College Conservatory of Music 
☐ 
UC Gardner Neuroscience 
Institute 
☐ 
College of Design, Art, Architecture & 
Planning 
☒ 
UCMC (Emergency 
Department, Inpatient and 
Outpatient Units) 

 
 
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☐ 
College of Education 
☐ 
UCMC NICU 
☐ 
College of Nursing 
☐ 
University of Cincinnati 
Physicians (UCP) 
☐ 
College of Pharmacy 
☐ 
University Pointe Surgical 
Hospital 
☐ 
Crossroads Center 
☐ 
VA – Cincinnati Medical Center 
☐ 
Drake Center 
☐ 
VA – Chillicothe Medical Center  
☐ 
Genome Research Institute (Reading 
Campus) 
☐ 
VA – Columbus Medical Center 
☐ 
Hoxworth: Inpatient Unit 
☐ 
West Chester Hospital 
☐ 
Hoxworth: Outpatient Clinics 
☒ 
Other UC/UC Health Affiliated 
location/clinic: Holmes Hospital 
Oral and Maxillofacial Surgery 
Outpatient Clinic 
 
34.0 EXTERNAL 
LOCATIONS 
34.1 List any external locations to UC or its affiliates. 
N/A  
 

 
 
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35.1 List any references sited throughout the protocol below. 

 
 
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35.0 REFERENCE LIST 
1. T.G. Weiser, S.E. Regenbogen, K.D. Thompson, et al. An estimation of the global volume of 
surgery: a modelling strategy based on available data Lancet, 372 (2008), pp. 139-144 
 
2. E.N. de Vries, M.A. Ramrattan, S.M. Smorenburg, et al. The incidence and nature of in-
hospital adverse events: a systematic review Qual Saf Health Care, 17 (2008), pp. 216-223 
 
3. A. Visser, B. Geboers, D.J. Gouma, et al. Predictors of surgical complications: a systematic 
review Surgery, 158 (2015), pp. 58-65 
 
4. Hang Cheng, Jeffrey W. Clymer, Brian Po-Han Chen, Behnam Sadeghirad, Nicole C. Ferko, 
Chris G. Cameron, Piet Hinoul, Prolonged operative duration is associated with 
complications: a systematic review and meta-analysis, Journal of Surgical Research, 
Volume 229, 2018, Pages 134-144, ISSN 0022-4804, 
https://doi.org/10.1016/j.jss.2018.03.022. 
(https://www.sciencedirect.com/science/article/pii/S0022480418301872) 
 
5. Adi M, Ogden GR, Chisholm DM: An analysis of mandibular fractures in Dundee, Scotland 
(1977 to 1985). Br J Oral Maxillofac Surg 1990; 28: pp. 194-199. 
 
6. Telfer MR, Jones GM, Shepherd JP: Trends in the etiology of maxillofacial fractures in the 
United Kingdom (1977–1987). Br J Oral Maxillofac Surg 1991; 29: pp. 250-255. 
 
7. Chrcanovic BR, Abreu MH, Freire-Maia B, Souza LN: 1,454 mandibular fractures: a 3-year 
study in a hospital in Belo Horizonte, Brazil. J Craniomaxillofacial Surg 2012; 40: pp. 116-123. 
 
8. Pickrell BB, Serebrakian AT, Maricevich RS. Mandible Fractures. Semin Plast Surg. 
2017;31(2):100-107. doi:10.1055/s-0037-1601374 
 
9.  AO Foundation. AO Surgery reference. Available at: https://www2.aofoundation.org/.  
 
10. Ellis E III, Miles B A. Fractures of the mandible: a technical perspective. Plast Reconstr 
Surg. 2007;120(7) 02:76S–89S. 
 
11. Nishioka G J, Van Sickels J E. Transoral plating of mandibular angle fractures: a 
technique. Oral Surg Oral Med Oral Pathol. 1988;66(5):531–535. 
 
12. Ellis E III. A study of 2 bone plating methods for fractures of the mandibular 
symphysis/body. J Oral Maxillofac Surg. 2011;69(7):1978–1987. 
 
13. Agnihotri A, Prabhu S, Thomas S. A comparative analysis of the efficacy of cortical screws 
as lag screws and miniplates for internal fixation of mandibular symphyseal region fractures: 
a randomized prospective study. Int J Oral Maxillofac Surg. 2014;43(1):22–28. 
 

 
 
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14. King, Brett J., et al. "On-site 3-dimensional printing and preoperative adaptation decrease 
operative time for mandibular fracture repair." Journal of Oral and Maxillofacial Surgery 76.9 
(2018): 1950-e1. 
 
15.  Furr AM, Schweinfurth JM, May WL: Factors associated with long-term complications 
after repair of mandibular fractures. Laryngoscope 2006; 116: pp. 427-430. 
 
16. Senel FC, Jessen GS, Melo MD, Obeid G: Infection following treatment of mandible 
fractures: the role of immunosuppression and polysubstance abuse. Oral Surg Oral Med Oral 
Pathol Oral Radiol Endod 2007; 103: pp. 38-42. 
 
17. Odono, Lauren, et al. “Mandible Fractures.” Facial Trauma Surgery, 14th ed., vol. 1, 
Elsevier, Amsterdam, Netherlands, 2020, pp. 168–185. 
 
18. Bochlogyros PN: Non-union of fractures of the mandible. J Maxillofac Surg 1985; 13: pp. 
189-193. 
15. Melmed EP, Koonin AJ: Fractures of the mandible. A review of 909 cases. Plast Reconstr 
Surg 1975; 56: pp. 323-327. 
 
19. Ogasawara T, Sano K, Hatsusegawa C, et. al.: Pathological fracture of the mandible 
resulting from osteomyelitis successfully treated with only intermaxillary elastic guiding. Int J 
Oral Maxillofac Surg 2008; 37: pp. 581-583. 
 
20. Quadu G, Miotti A, Rubini L: [Chronic osteomyelitis of the mandible with pathologic 
fracture. Case report]. G Stomatol Ortognatodonzia 1983; 2: pp. 99-100. 
 
21. Jauhar P, Handley T, Hammersley N: A pathological fracture of the mandible due to 
osteomyelitis following a full dental clearance. Dent Update 2016; 43: pp. 168-170.  
 
22. Wagner WF, Neal DC, Alpert B: Morbidity associated with extraoral open reduction of 
mandibular fractures. J Oral Surg 1979; 37: pp. 97-100. 
 
23. Mehra P, Murad H: Internal fixation of mandibular angle fractures: a comparison of 2 
techniques. J Oral Maxillofac Surg 2008; 66: pp. 2254-2260. 
 
24. Ravi P, Burch MB, Farahani S, Chepelev LL, Yang D, Ali A, Joyce JR, Lawera N, Stringer J, 
Morris JM, Ballard DH, Wang KC, Mahoney MC, Kondor S, Rybicki FJ; University of Cincinnati 
3D Printing Clinical Service Participants. Utility and Costs During the Initial Year of 3D Printing 
in an Academic Hospital. Journal of the American College of Radiology. 2022 Aug 18: S1546-
1440(22)00552-X. doi: 10.1016/j.jacr.2022.07.001. Epub ahead of print. PMID: 35988585.