Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
Phase: NA
Conditions: Mandibular Fractures
Sponsor: The University of Texas Health Science Center, Houston

IRB APPROVAL DATE: 02/10/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Comparison of Operating Room Time Length with the Use of Virtual Surgical Planning Versus 
Conventional Treatment of Mandible Fractures 
 
NCT04283981 
 
Version Date: 02/10/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB APPROVAL DATE: 02/10/2021 
 
 
 
 
Protocol Title: 
Comparison of Operating Room Time Length with the Use of Virtual Surgical 
Planning Versus Conventional Treatment of Mandible Fractures 
 
Principal Investigator: 
Timothy C. Woernley III, DDS 
 
UTHealth Co-Investigators: 
Nagi Demian DDS MD FACS; Simon Young DDS MD PhD FACS; Craig Pearl 
DDS; Ronald Bilow MD; Arsalan Bhatti DDS; Viet Lam DDS 
 
Study Coordinators: 
Auco Dang; Georgiann Brown APRN FNP; Audrena Hankins 
 
Population: 
All patients presenting with diagnosed mandible fracture at Memorial 
Hermann Hospital 
 
Number of Sites: 
Memorial Hermann Hospital 
 
Study Duration: 
Between November 2019 and November 2021 (until adequate data is 
obtained for significant statistical analysis) 
 
Subject Duration: 
From the initial preoperative evaluation to end of treatment which is 2 months 
 
 
General Information 
Patients at Memorial Hermann Hospital who have an isolated mandibular fracture and who are appropriately 
consented will partake in this study. They will be split evenly into 2 groups which are virtual surgical planning (VSP) 
and the conventional surgery. The conventional surgery involves having medical grade CT in order to assess the 
mandible fracture and having an open reduction and internal fixation of the fracture. The reconstruction plate will be 
bent intra-operatively. VSP patients will also receive the medical grade CT and also receive intraoral scans for aid in 
assessing occlusion. 3D models of the patient’s jaws will be made and set into the proper occlusion. A reconstruction 
plate will be bent before the surgery using these models to be used at the time of surgery. Advancements in VSP 
technology increasingly demonstrate improvements in operative efficiency and reduce operating time. Pre-surgical 
planning and fabricated guides can potentially improve intraoperative efficiency, postoperative outcomes, and minimize 
complications. Additionally, use of this technology may permit a reduction of operating costs associated with longer 
operating room and anesthesia times in conventional treatments. Another challenge presented with VSP is turn over 
time from the actual planning and fabrication of splints or anatomical models to having them ready for surgery. This 
can take between one to two weeks and delay treatment for acute trauma cases. 
 
Objectives 
Objective of this randomized controlled study is to compare operating room time between conventional treatment 
techniques (without VSP) versus use of VSP and surgically-guided techniques. Surgically-guided techniques will 
include use of an occlusal splint (from digital intraoral scanner), and a 3D printed anatomical model for adaptation of 
pre-bent titanium plates. Additionally we will determine if remotely printing anatomical guides and splints is feasible and 
can decrease turn over time for VSP. 
 
 
 
 
 
 
 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
To compare OR time between 
conventional treatment techniques 
(without VSP) vs use of VSP and 
surgically guided techniques 
ORIF time, which is defined as 
starting after the dissection is 
complete and fractures are reduced 
until final screws are placed. Ideally 
the dissection, reduction, closure 
To compare whether 
or not the 
intervention (VSP) 
yielded decrease OR 
time 

IRB NUMBER: HSC-DB-19-1074 
IRB APPROVAL DATE: 02/10/2021 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
should not change from the control to 
the treatment 
Secondary 
To compare and contrast the effect 
of any other variables that might 
have an effect on the overall result 
Age, gender, fracture pattern, Type of 
archbars, fit guides, type of approach, 
Surgical revisions, infections, mouth 
opening, Hardware failure defined as 
plate fracture or screw loosening 
Age, gender, and 
fracture pattern is 
basic data needed to 
analyze results. The 
rest of the endpoints 
are important because 
they might possibly 
have an effect on the 
primary objective. 
 
Background Information 
Mandibular fractures are the second most common facial bone fracture [1] due to its prominent position in the 
maxillofacial region and the mandible’s relative lack of structural support. The most common cause of injury is low 
impact blunt trauma, including motor vehicle accidents (MVCs), physical assault, and sports injuries [1, 2]. 
Advancement in mandibular reconstruction increasingly allow for interventions that result in reduction of facial 
deformities [3]. With the application of virtual surgical planning (VSP), the planning process has become more precise, 
reducing the number of intra- and postoperative complications [4-16]. 
 
Complex mandibular fractures often require open treatment with internal fixation of the mandibular segments, and 
maxillomandibular fixation for proper healing. Treatment and surgical approaches vary with fracture patterns, location, 
degree of bony displacement, and involvement of dental structures. Greatly displaced fractures, fractures in difficult 
anatomical locations, and loss of dental landmarks (occlusion) can pose a challenge for the reconstructing surgeon. [1, 
3, 4]. Successful management of these complex fractures requires careful consideration of these factors. Such 
challenges may include achieving an accurate reduction of the fragments and placing a stable reconstruction plate for 
the purpose of re-establishing the original shape of the mandible. In order to help overcome these challenges, VSP has 
been utilized for the reconstruction of traumatic facial injuries, including the repair of complex mandible fractures. 
Three-dimensional modeling of maxillofacial injuries facilitates precise intraoperative reduction of displaced bone 
fragments, while CAD/CAM technology produces occlusal splints that allow superior restoration of facial symmetry, 
appearance, and function to those fitted intra-operatively [5]. 
 
The advent of VSP allows surgeons to increase surgical precision while reducing operating time. In addition to 
shortening OR time, surgical reconstruction of the mandible using VSP and pre-bent hardware demonstrates 
successful restoration of orofacial contour and function [4, 7, 8, 10, 14]. Today, there are numerous publications on the 
use of VSP and 3D imaging methods to fabricate occlusal splints and anatomical models to facilitate adaptation of a 
pre-bent reconstruction plate for mandibular reconstruction [4-23]. Furthermore, these studies have demonstrated 
reduction in operating time and had minimal intraoperative plate manipulation [4-16]. 
 
Excellent results have been shown for VSP on mandibular reconstruction with assistance from an intraoral scanner for 
modeling generated occlusal splints and pre-bent fixation plates. This randomized control study will attempt to 
determine whether there is reduction in operating time, costs, and post-operative complications. This treatment 
modality may potentially allow for increased accuracy, efficiency, and outcome in this surgical setting. A reduced time 
in the operating room could potentially lead to better outcomes for the patient while decreasing overall treatment cost. 
Hence, a decreased operating time, anesthesia time, and hospitalization could thereby, potentially, justify the additional 
preoperative costs that come with computer assisted surgical planning. Furthermore we will determine the 
effectiveness of remote 3D printing guides and models to decrease the turn over time of VSP. 
 
Study Design 
● 
In this randomized controlled study, we will evaluate patients from the University of Texas Health Science 
Center at Houston, Department of Oral & Maxillofacial Surgery treatment facility at Memorial Hermann Hospital 

IRB NUMBER: HSC-DB-19-1074 
IRB APPROVAL DATE: 02/10/2021 
 
- from a patient population that undergoes mandibular trauma via open reduction internal fixation (ORIF) via 
intraoral or extraoral approach, using an intra-oral scanner, VSP® 3D Systems, and Stryker Anatomical 
Models. 
● 
The study population will be composed of patients presenting with mandible fractures to Memorial Hermann 
Texas Medical Center in Houston, Texas from November 2019 to November 2021 (until adequate data is 
obtained for significant statistical analysis). 
● 
Recruited and consented patients will be asked to attend the follow up appointments, for permission to review 
their records, to answer additional questionnaires, and have additional measurements/formal exam taken. 
● 
Subjects will be re-evaluated at 3 within 6 weeks to assess the patient’s mandible fracture healing via panorex 
or maxillofacial CT (follow ups: 1 week, 3 weeks +/- 1 week, 6 weeks +/- 1 week) 
● 
Patients will be recruited from the Memorial Hermann Hospital when assessed and scheduled for mandibular 
reconstruction via open reduction internal fixation with VSP, fabrication of occlusal splint (from intraoral 
scanner), and 3D printed anatomical model for adaptation of pre-bent reconstruction plate. 
● 
The study design would implement a randomized non-blinded clinical trial. Randomization will be performed 
by having sealed envelopes at the time of enrollment with either “original” or “VSP” written on cards. 
● 
Both groups of patients will be treated by a team of oral and maxillofacial surgery residents and attending 
surgeons. 
● 
The patients will be divided into two groups, the treatment group and control group. Records for both groups 
will be evaluated by the investigators and the patients will be asked to follow up in the OMFS Clinic at 
Memorial Hermann and treated by the Oral & Maxillofacial Surgery service. 
o 
The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction 
internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite 
registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware 
o 
The control group will include patients that undergo mandibular reconstruction via open reduction 
internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning 
assistance and occlusal splint) 
 
 
Study Population 
Our study population consists of all patients with complex mandible fractures presenting to the University of Texas 
Health Science Center at Houston, Department of Oral & Maxillofacial Surgery facility at Memorial Hermann Hospital 
between October 2019 and October 2021 (until adequate data is obtained for significant statistical analysis). 
● 
We anticipate recruitment of approximately 50 patients (25 patients for each control and treatment group) from 
Memorial Hermann Hospital. The control group will undergo mandibular fixation via standard open reduction 
internal fixation techniques. The VSP group will undergo mandibular fixation with standard open reduction 
internal fixation techniques and utilization of intraoperative occlusal splint, Virtual Surgical Planning via 3D 
Systems, and Stryker Anatomical Models. 
● 
Inclusion criteria: 
o 
Patient consent 
o 
Male or female; 18 years or older 
o 
Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. 
● 
Exclusion criteria: 
o 
Patient refusal to participate in study 
o 
Infected mandible fracture 
o 
Closed reduction treatment of mandible fracture 
o 
Fractures older than 2-3 weeks at the time of treatment 
o 
o 
Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or 
malignant pathology that may require resection 
o 
Pregnant patients will NOT be excluded from the study 
o 
Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes 
(A1c greater than 8) 
 
Patient would be enrolled upon evaluation and consent for mandibular reconstruction at the University of Texas Health 
Science Center at Houston, Department of Oral & Maxillofacial Surgery treatment facility at Memorial Hermann 
Hospital - Texas Medical Center 

IRB NUMBER: HSC-DB-19-1074 
IRB APPROVAL DATE: 02/10/2021 
 
Study Procedures 
● 
No additional time will be required from participants than the time required for the normal care, treatments, or 
management. Patients will not be charged anything additional to participate in the study and will also not 
receive any compensation. 
● 
Patients will have post-operative CT scan to ensure adequate reduction and fixation of fractures 
● 
Patients will be re-evaluated at 3 follow up visits within 6 weeks to determine mandible fracture healing. 
o 
Post-op (prior to discharge), 1 week, 3 weeks +/- 1 week, 6 weeks +/- 1 week 
● 
Collected data will include: 
o 
Age, gender, operating time (ORIF time, total operating time), fracture pattern 
▪ 
ORIF time will be defined as starting after the dissection is complete and fractures are 
reduced until final screws are placed. 
▪ 
Ideally the dissection, reduction, closure should not change from the control to the treatment 
o 
Accuracy of fracture reduction 
o 
Type of archbars, fit of guides, type of approach 
o 
Surgical revisions, infections, mouth opening 
o 
Hardware failure defined as plate fracture or screw loosening 
● 
Once data is collected, variability will be calculated within individual test results. 
 
Data & Safety Monitoring 
● 
Adverse events 
o 
Expected adverse events: pain, infection, bleeding, swelling, trismus, possible nerve damage, damage 
to adjacent structures 
o 
Unexpected adverse events: repeat fractures, trauma post-surgery, plate fractures, loose screws, mal- 
unions, non-unions, poor cosmetic outcome, delayed healing 
o 
Potential serious adverse events: sepsis from infection, osteomyelitis 
● 
Unanticipated problems will be discussed amongst investigators. 
● 
Methods of measuring results will be discussed amongst investigators and standardized so that measurements 
remain consistent from investigator to investigator. 
● 
The research team will periodically review its protocols to ensure maximal patient safety and data validity. 
 
Statistics 
● 
Generalized linear model will be used to identify data distribution differences between the two study groups. 
● 
This data will be recorded using a standardized data sheet to be shared within the department. 
● 
Power analysis was performed for an f-test, and to show a large effect size (f=0.4) between the groups will 
require: 
o 
n = 25 patients/group to achieve a power of 0.8 and a significant level of 0.05. 
● 
ANOVA-based power analysis figures require: 
o 
n = 26 patients/group for a large effect size 
o 
n = 64 patients/group for a medium effect size 
o 
n = 393 patients/group for a small effect size 
 
Ethics 
● 
A written informed consent will be obtained from the adult subject. This site has submitted the consent 
documents for CPHS review. 
● 
IRB approval will be sought from CPHS (Committee for the Protection of Human Subjects). 
● 
Treatment and clinical management will not be affected by this study. The surgical procedure investigated in 
this study is considered standard of care. 
● 
Informed consent for the review of records and permission to conduct additional questionnaires and 
measurements at each follow up appointment will be obtained from each patient prior to commencing the 
study. 
● 
To protect the privacy of subjects, only members of the research staff including the attending doctors, 
residents, will have access to patient health information 
 
Data Handling & Record Keeping 

IRB NUMBER: HSC-DB-19-1074 
IRB APPROVAL DATE: 02/10/2021 
 
● 
Data collected electronically through the medical record system and recorded on the data sheets attached to 
this protocol. Access to source documents will be per respective EHR guidelines on computers that are 
encrypted, and password protected. The data sheets, including consents, will be kept with the principal 
investigator in a locked cabinet. The patients will also receive a copy of their consent forms. HIPAA compliance 
guidelines will always be used. 
● 
Human subjects will not be directly identifiable, but only identifiable in the study database through identifying 
information (Hospital MRN) 
● 
Age of patient will be recorded to replace birth date. Only specific disease information, sex, and age as 
potential identifier will be used. No identifiable patient name, number or birth date will be used in this study and 
subsequent publications. 
● 
The study data will be saved on the HIPAA compliant University of Texas Secured Cloud Service (Secure 
Share). 
 
Quality Control & Assurance 
● 
The investigators will use the same methods and supplies in completing physical examinations, including 
inspection, palpation, sensation, and range of motion, and post-operative complications and to record data 
consistently. 
● 
The investigators will record the ORIF time (defined above) and total operating time 
● 
Results will be verified against known sample for testing validity. 
● 
There are no plans for third party monitoring. 
 
Publication Plan 
● 
Research will be submitted to multiple scientific, medical, dental, and OMFS journals for publication 
consideration. 
● 
The results will not be returned to research subjects. 
 
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