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The Use of Patient-Specific

I mplants in Or al and
Maxillofacial Surgery
Michael F. Huang, DDS, MDa,b,*, David Alfi, DDS, MDa,b, Jonathan Alfi, MAc,
Andrew T. Huang, MDd

KEYWORDS
 Patient-specific implants  3D printed plates
 Custom temporomandibular joint total joint replacement  Maxillofacial reconstruction
 Orthognathic surgery  Computer-aided design  Computer-aided manufacture

KEY POINTS
 Patient-specific cutting guides and patient-specific implants are becoming increasingly common in
oral and maxillofacial surgery.
 Custom temporomandibular joint (TMJ) total joint prosthesis allows for individualized reconstruc-
tion of the TMJ.
 Computer-aided design and computer-aided manufacturing technology allows for the fabrication
of patient-specific cutting guides and patient-specific reconstruction plates used for accurate
and efficient reconstruction of complex maxillofacial defects with or without vascularized bone
flaps.
 Improved accuracy of patient-specific implants allows for their application in orthognathic surgery,
although their use in mandibular surgery, specifically the bilateral sagittal split osteotomy, has yet to
be proven.

INTRODUCTION design and computer-aided manufacturing (CAD/


CAM) technology, several recent developments
Personalized medicine is a term that has gained mo- have allowed the application of personalized medi-
mentum in the twenty-first century. The National cine to oral and maxillofacial surgery in order to
Cancer Institute defines it as “a form of medicine improve outcomes. The decreasing cost of this
that uses information about a person’s gene, pro- technology has also made it more affordable and
teins, and environment to prevent, diagnose, and accessible to patients. Patient-specific implants
treat disease.”1 It refers to a shift away from the are currently used in multiple areas of oral and maxil-
“one-size-fits-all” approach designed for the lofacial surgery, including temporomandibular joint
average patient toward treatments tailored for the (TMJ) total joint replacement, reconstruction of the
individual. Given the complexity of the facial skel- maxillofacial skeleton, and orthognathic surgery.
eton and the development of computer-aided
oralmaxsurgery.theclinics.com

Disclosure Statement: The authors have nothing to disclose.


a
Department of Oral and Maxillofacial Surgery, Houston Methodist Hospital, 6560 Fannin Street, Suite 1280,
Houston, TX 77030, USA; b Weill Cornell Medical College, New York, NY, USA; c Surgical Planning Laboratory,
Department of Oral and Maxillofacial Surgery, Houston Methodist Research Institute, 6560 Fannin Street, Suite
1280, Houston, TX 77030, USA; d Otolaryngology – Head & Neck Surgery, Baylor College of Medicine, 1977 But-
ler boulevard, Suite E5.200, Houston, TX 77030, USA
* Corresponding author. Department of Oral and Maxillofacial Surgery, Houston Methodist Hospital, 6560
Fannin Street, Suite 1280, Houston, TX 77030, USA
E-mail address: mfhuang@houstonmethodist.org

Oral Maxillofacial Surg Clin N Am 31 (2019) 593–600


https://doi.org/10.1016/j.coms.2019.07.010
1042-3699/19/Ó 2019 Elsevier Inc. All rights reserved.
594 Huang et al

CONTENT chromium-molybdenum alloy and a mandibular


Temporomandibular Joint Total Joint body made from titanium-aluminum-vanadium
Replacement extralow interstitial alloy.10 A third-party virtual
surgical planning software (ie, 3D Systems, Materi-
Alloplastic replacement of the entire TMJ complex,
alise, or Individual Patient Solutions) can be used
including fossa and the condyle-ramus unit, for the
to fabricate intraoperative cutting guides in order
treatment of severe end-stage TMJ disease or
to replicate the planned resection and joint
pathologic condition has been described as early
reconstruction.
as 1970. Several different alloplastic materials
A study involving 45 patients published in 2003
have been used for these devices, including cast
demonstrated better outcomes with custom
Vitallium with a polymethyl methacrylate head,2
TMJ prostheses fabricated by TMJ Concepts
Proplast-Teflon-coated Vitallium,3 and Dacron/
(formerly Techmedica Inc) compared with stock
Proplast-Teflon/ultra-high-molecular-weight poly-
prostheses made by TMJ Inc.11 A recent meta-
ethylene.4 Patient-specific implants using CAD/
analysis did not reveal any relevant differences
CAM technology for TMJ replacement was intro-
between stock and patient-specific prostheses
duced in 1993.5 Since then, several studies have
with respect to increased maximum incisal open-
validated the long-term stability and success rate
ing and decreased pain.12 Although TMJ total
of these devices,6–8 with the longest follow-up
joint replacement can be reliably performed using
being 20 years.9
a stock prosthesis in a more timely fashion
Currently, the only Food and Drug Administration–
because of the longer processing time required
approved custom-made total joint prosthesis in the
for skull models and custom implants, there are
United States is one made by TMJ Concepts (Ven-
many advantages to using custom-made prosthe-
tura, CA, USA). The workflow begins with a
ses, including reconstruction of complex defects
computed tomographic (CT) scan following their
of the skull base and mandible (Fig. 1) as well
protocol in order to fabricate a stereolithic skull
as greater ability to alter the position of the
model from which the mandibular resection and
mandible in relation to the skull base as seen in
fossa preparation can be performed. A minimum
concomitant TMJ reconstruction and orthog-
gap of 13 mm should be present from the skull
nathic surgery.13
base to the mandible after the resection. The postre-
section stereolithic skull model is then shipped to
Reconstruction of the Maxillofacial Skeleton
TMJ Concepts for implant design and fabrication
that is specific to the patient’s anatomic There are many challenges unique to bony
morphology, surgical defect, and jaw relationship. reconstruction of the maxillofacial skeleton,
TMJ Concepts’ fossa component is made from un- including anatomic diversity, complex movement
alloyed titanium mesh bonded to an articulating sur- of the mandible, saliva contamination, and dental
face made of ultra-high-molecular-weight rehabilitation. Internal fixation in maxillofacial
polyethylene. Their mandibular component is surgery gained popularity after the introduction
composed of a condylar head made from cobalt- of antibiotics in the 1940s.14 Christiansen15 is

Fig. 1. Reconstruction of complex sur-


gical defects involving the TMJ, skull
base, and hemimandible using
custom TMJ prostheses. (Courtesy of
TMJ Concepts, Inc., Ventura, CA.)
Use of Patient-Specific Implants in Oral Surgery 595

credited with introducing bone plates to maxillo- the DICOM data of the preoperative CT scan to
facial surgery in 1945, but most surgeons at that the medical engineers at a third-party virtual
time used plates and screws designed for ortho- surgical planning company (ie. 3D Systems [Lit-
pedics (ie, metacarpal plates). Luhr16 was the tleton, CO, USA], Materialise [Leuven, Belgium],
first to study rigid internal fixation for maxillofa- Individual Patient Solutions [Breisgau, Ger-
cial surgery and introduced compression plates many]). The recommended slice thickness of
as well as self-threading screws to the specialty the CT scan is less than 1.0 mm in order to
in the 1960s. Before the development of custom have adequate surface detail on which accurate
implants, mandibular reconstruction was carried surgical guides and implants can be manufac-
out using rigid fixation plates and locking screws tured. A Web meeting then takes place between
designed to fit the “average” mandible, usually at the surgeon and the engineer to plan the resec-
the inferior border away from relevant anatomic tion, design the surgical guides, and design the
structures, such as inferior alveolar neurovascu- reconstruction plate. The surgical guide serves
lar bundle and teeth. The titanium reconstruction as a cutting guide for the resection as well as a
plates were flat and required bending intraoper- drill guide for the screws used to secure the
atively while the patient remained under general reconstruction plate. After the Web meeting, a
anesthesia, after adequate exposure is achieved report is e-mailed to the surgeon for final design
and sometimes after resection had taken place. approval before manufacturing. The cutting
Some prefabricated plates had a built-in angle guides, reconstruction plate, an optional steriliz-
to simulate the in-plane bend at the angle of able stereolithic model, and a detailed report of
the mandible. Despite this, shaping a mandibular the surgical plan are sent to the surgeon before
reconstruction plate to fit a particular patient’s surgery (Fig. 2). A multicenter study of 30 pa-
surgical defect was time consuming and weak- tients in 2015 validated this protocol for recon-
ened the integrity of the plate. struction of mandibular defects using patient-
A major advancement to patient-specific im- specific surgical guides and patient-specific
plants was the rapid prototyping of stereolithic implants.21
models to scale, first described in oral and maxil- Mascha and colleagues22 demonstrated the
lofacial surgery by Brix and Lambrecht17,18 in accuracy of mandibular reconstruction using
1987. The printed models can be used to manu- patient-specific mandibular reconstruction plates
ally bend reconstruction plates fitted for a partic- milled from titanium blocks, with slightly better
ular defect before the day of surgery, a concept results in sole alloplastic reconstruction cases
commonly known as “prebending.” This tech- compared with cases whereby osseous flap
nique allowed for the accurate adaptation of reconstruction was performed. When used in
the reconstruction plate to the patient’s anatomy conjunction with composite flap reconstruction
without the patient being under anesthesia with (ie, fibula, iliac crest, and scapula) of complex
an open wound. As the prices of desktop 3- mandibular defects, patient-specific cutting
dimensional (3D) printers and resins decreased and drilling guides that correspond to patient-
over time, it became feasible and practical for in- specific reconstruction plate allow for accurate
dividual institutions to fabricate stereolithic 3D orientation of the bony flap segments. The
models on their own using in-house CAD soft- accuracy of flap reconstruction compared with
ware (ie, Anatomic Aligner). Improved accuracy the virtual plan in 6 patients was evaluated
of prebent plates compared with the conven- by Schepers and colleagues,23 who found a
tional method of intraoperative bending for mean deviation of 3.0 mm (standard deviation
mandibular reconstruction was demonstrated in 1.8 mm) and a mean angulation of 4.2 (standard
a study of 42 patients in 2015.19 The drawback deviation 3.2 ). One factor that accounts for the
of plate weakness that occurs with bending how- decreased accuracy of fibula reconstruction
ever still remains, although at lesser values compared with virtual plan is the fit of fibula
because of more direct and improved cutting guides over an intact periosteum, which
application. is arbitrarily determined to be 0.4 mm during
The first case report of a patient-specific plate CAD/CAM fabrication of the surgical guide.
used in mandibular reconstruction was in 2012 Although this study had a small sample size, it
by Ciocca and colleagues,20 whereby a titanium likely reflects greater accuracy and precision
alloy plate was manufactured by direct metal compared with conventional techniques of free-
laser sintering using a CAD/CAM protocol to hand reconstruction and intraoperative bending,
reconstruct a mandibular defect from oral can- not to mention decreased surgical times. The
cer. Similar to the fabrication of a custom TMJ same study also evaluated the accuracy of
prosthesis, this protocol begins with sending endosseous implants placed at the time of
596 Huang et al

Fig. 2. Reconstruction of a mandibular ramus-condyle unit using vascularized fibula flap. (A) Custom cutting
guides for the resection and flap harvest. (B) Virtual plan of the flap reconstruction with planned dental implants.
(C) Assembled fibula flap using patient-specific reconstruction plate with dental implants inserted using the
custom drill guides built into the fibula cutting guide. (D) Postoperative CT scan demonstrating the final
reconstruction.

primary reconstruction using patient-specific drill plate allowed for the placement of screws in areas
guides and found deviation of 2.2 mm (standard of native bone with predicable thickness (ie,
deviation 1.1 mm) and 10.7 angular deviation buttresses).
(standard deviation 7.6 ). This deviation again
likely reflects the decreased accuracy of adapta-
Orthognathic Surgery
tion of the fibula drilling guide on the fibula on ac-
count of the periosteum, which is needed to Orthognathic surgery has been revolutionized by
maintain vascularity. Two recent studies advances in 3D imaging and CAD/CAM technol-
compared fibula reconstruction of mandibular ogy. Traditional orthognathic surgery involves
defects using patient-specific implants with the presurgical planning using 2-dimensional cepha-
conventional method of prebending. There was lometric analysis, facebow transfer, plaster
a greater degree of deviation from the virtual models, and an Erickson model table. The model
plan in the conventional method, but this differ- surgery is then transferred to the operating room
ence was not statistically significant.24,25 using occlusal wafers, and surgery is carried out
Reconstruction of the maxilla and orbitozygo- using miniplates that are adapted intraopera-
matic regions is equally challenging given the tively. Thanks to the work by Gateno, Xia, and
complex 3D anatomy as well as its multiple func- other pioneers, this method has been replaced
tions, including separation of the oral and nasal with digital planning using 3D data, but the surgi-
cavities, and support for dentition. Melville and cal plan is still transferred to the patient using
colleagues26 published a case report of fibula occlusal wafers printed based on “intermediate”
reconstruction of a maxillary defect (Brown classi- and “final” occlusions. Although 3D surgical
fication IId) using patient-specific guides and planning provides significant foresight into issues
patient-specific implants. The overall workflow is that can be encountered intraoperatively (ie,
very similar to mandibular reconstruction using a proximal and distal segment collision during
vascularized flap. The patient-specific reconstruc- sagittal split osteotomy and bony interferences
tion plate allowed for accurate orientation of the during Le Fort I impaction), the surgery does
fibula segments in order to reconstruct the alveolar not exactly replicate the surgical plan because
portion of the surgical defect. The customized the osteotomies are still made freehand. In
Use of Patient-Specific Implants in Oral Surgery 597

2013, Li and colleagues27 published a series of 6 occlusion or the position of the mandible; (2)
patients who underwent Le Fort I osteotomy us- elimination of intraoperative plate bending, which
ing 3D printed cutting and repositioning guides is time consuming, weakens the integrity of
whereby the final maxillary position was deter- the bone plates and can introduce errors; (3)
mined using bone-borne guides, independent of elimination of intermaxillary fixation, which is
occlusion or the position of the mandible. This also time consuming and puts personnel at risk
technique eliminated the potential errors caused for penetrating injuries; and (4) precise place-
by autorotation of the mandible, but fixation of ment of screw using patient-specific drill guides
the final maxillary position was achieved using designed to for placement in thick bone and to
the conventional technique of intraoperative avoid key areas such as dental roots. Disadvan-
plate bending, which is technique sensitive and tages of patient-specific implants used in Le Fort
has the ability to introduce errors. I osteotomy for orthognathic surgery include (1)
The first case report of patient-specific implants increased cost, some of which may be offset
used in orthognathic surgery in the English litera- by decreased time in the operating room; (2)
ture was published by Philippe28 in 2013. In this increased processing time for fabrication of the
report, they described a patient who underwent patient-specific guides and implants; (3) inability
segmental Le Fort I osteotomy using bone-borne to change the plan intraoperatively in cases
cutting guides that also served as a drill guide for where the virtual plan is not accurately translated
final fixation. After downfracture and mobilization to the patient; (4) risk of screw placement in thin
of the Le Fort I segments, fixation was performed maxillary bone without the ability to alter screw
using 3 laser-sintered custom implants secured placement; and (5) unpredictability of maxillary
using the predrilled holes. Minimal discrepancy in transverse stability in cases of segmental maxil-
plate position was seen between the virtual surgi- lary surgery.
cal plan and postoperative result. The exclusive Suojanen and colleagues32 evaluated the use
use of bone-borne patient-specific guides and of patient-specific osteotomy and drill guides
patient-specific implants avoided the need for and milled patient-specific implants in 30 pa-
occlusal wafers. Two larger studies published in tients who underwent mandibular advancement
2015 and 2016 described the use of patient- with bilateral sagittal split osteotomy. They found
specific cutting guides and patient-specific accurate fit of the implants in 11 patients,
implants for Le Fort I osteotomy in 10 and 32 pa- acceptable fit after modifications in 17 patients,
tients, respectively.29,30 Precise fit of the 3D and unacceptable fit in 2 patients. This inaccu-
printed plates was seen in most cases. Unaccept- racy is likely due to the unpredictability in seating
able fit of the custom implants was seen in only 1 the proximal segment and imprecise preopera-
case in Suojanen and colleagues30’ study, and tive virtual prediction of the sagittal split. The in-
the remainder of the surgery was carried out using vestigators thus recommended that patient-
a CAD/CAM occlusal wafer and traditional plate specific implants should not be used without
bending. occlusal wafers. Around the same time, a group
In 2017, Heufelder and colleagues31 published a from China published a series of 10 patients
series of 22 patients who underwent bimaxillary who underwent splintless bimaxillary surgery us-
orthognathic surgery. In this series, all patients un- ing patient-specific implants for the maxilla and
derwent maxilla surgery first using patient-specific mandible.33 They noted small differences in posi-
bone-borne guides and patient-specific implants tion and orientation between the planned and
manufactured by selective laser melting. After postoperative outcomes, but stated “all the pa-
repositioning of the maxilla using the waferless tients achieved good final occlusion without
technique, mandibular surgery was carried out in postoperative elastic traction.”
conventional fashion using CAD/CAM occlusal In the series published by Heufelder and col-
wafers in the final position and intraoperative leagues,31 all patients underwent bimaxillary
bending of fixation plates. When postoperative re- surgery with the maxilla-first approach using
sults were compared with the presurgical plan, patient-specific implants followed by mandibular
they found median deviations of 0.3 mm in the surgery using CAD/CAM occlusal wafers and in-
left-right dimension plane, 0.33 mm in the vertical ternal fixation via the conventional approach.
dimension, and 0.7 mm in the anterior-posterior This sequence allowed for accurate 3D posi-
dimension. tioning of the maxillomandibular complex with
There are several advantages to maxillary establishment of appropriate final occlusion,
positioning using patient-specific cutting guides which may not be achieved with fully guided
and patient-specific implants: (1) accurate 3D orthognathic surgery exclusively using bone-
positioning of the maxilla independent of borne guides and patient-specific implants
598 Huang et al

Fig. 3. Orthognathic surgery using


patient-specific cutting guides (A)
and patient-specific implants (B).

(Fig. 3). Because establishment of normal occlu- sole reconstruction using alloplastic materials
sion is a major goal of orthognathic surgery, this has become more popular because of the better
seems to be a prudent approach of incorporating customization of the implants and avoidance of
patient-specific implants into orthognathic donor site morbidity with low rate of complica-
surgery. tions. Ideally, reconstruction using an autogenous
material identical to the surgical defect in size and
shape would be best for restoration of form and
Future Direction function. Advances in tissue engineering using
Autogenous bone grafting remains the gold scaffolds and stem cells will soon allow for recon-
standard for reconstruction of the maxillofacial struction of bony defects using autogenous bone
skeleton because the biomechanical properties without the need for significant donor site
best match that of the missing tissue it is meant morbidity.
to replace. In certain areas of reconstruction, Patient-specific custom implants made with
patient-specific titanium alloy implants are used autogenous, adipose-derived, stem cells (ASCs)
for accurate positioning and fixation of autoge- in custom bioreactors have already proven effi-
nous bone grafts (ie, vascularized fibula and non- cacy and superiority to traditional implants in large
vascularized iliac crest). In other areas, such as animal studies. Bhumiratana and colleagues34
TMJ reconstruction and orbital fracture repair, demonstrated that anatomically correct bone

Fig. 4. Custom shape bovine bone scaffold and custom bioreactor illustrating nutrient flow for stem cell
manipulation.
Use of Patient-Specific Implants in Oral Surgery 599

grafts from ASCs were grown and implanted in 6. Mercuri LG, Wolford LM, Sanders B, et al. Custom
Yucatan mini-pigs to reconstruct the ramus- CAD/CAM total temporomandibular joint reconstruc-
condyle unit (Fig. 4). The custom stem cell grafts tion system: preliminary multicenter report. J Oral
were tested against both no graft and scaffold Maxillofac Surg 1995;53(2):106–15.
only and were found to have superior characteris- 7. Mercuri LG, Giobbie-Hurder A. Long-term outcomes
tics in terms of strength, volume, and shape. The after total alloplastic temporomandibular joint recon-
stem cell grafts were also found to benefit from struction following exposure to failed materials.
antiresorptive properties. J Oral Maxillofac Surg 2004;62(9):1088–96.
The need for reconstruction alternatives with 8. Mercuri LG, Edibam NR, Giobbie-Hurder A. Four-
synthetic availability that allows for single-staged teen-year follow-up of a patient-fitted total temporo-
procedures and avoids donor site morbidity is mandibular joint reconstruction system. J Oral
paramount to the evolution of patient-specific im- Maxillofac Surg 2007;65(6):1140–8.
plants. Fortunately, advances in technology and 9. Wolford LM, Mercuri LG, Schneiderman ED, et al.
biomaterials provide us with a real opportunity to Twenty-year follow-up study on a patient-fitted
introduce regenerative products that can be temporomandibular joint prosthesis: the Techmed-
printed in the desired shape, size, form, and archi- ica/TMJ Concepts device. J Oral Maxillofac Surg
tecture. Tools that are readily printable and have 2015;73(5):952–60.
the advantage of sterility, antimicrobial properties, 10. TMJ Concepts. Material Description. Available at:
and regenerative capability provide for very https://tmjconcepts.com/product-information/material-
exciting possibilities. Years of development have description/. Accessed February 1, 2019.
brought us to this point, where we are ready to 11. Wolford LM, Dingwerth DJ, Talwar RM, et al. Com-
test and develop this technology. parison of 2 temporomandibular joint total joint pros-
thesis systems. J Oral Maxillofac Surg 2003;61:
685–90.
SUMMARY 12. Zou L, He D, Ellis E. A comparison of clinical follow-
up of differential total temporomandibular joint
Patient-specific implants are oral and maxillofacial
replacement prostheses: a systematic review and
surgery’s answer to personalized medicine.
meta-analysis. J Oral Maxillofac Surg 2018;76:
Although this technology has been in use for many
294–303.
years in some areas such as TMJ total joint replace-
13. Movahed R, Teschke M, Wolford LM. Protocol for
ment, it is relatively new in other areas, such as
concomitant temporomandibular joint custom-fitted
reconstruction and orthognathic surgery. Advances
total joint reconstruction and orthognathic surgery
in CAD/CAM technology with decreasing costs will
utilizing computer-assisted surgical simulation.
continue to allow this field to evolve in order to
J Oral Maxillofac Surg 2013;71:2123–9.
improve accuracy, efficiency, and overall outcome.
14. Ellis E. Rigid skeletal fixation of fractures. J Oral
Maxillofac Surg 1993;51:163–73.
15. Christiansen GW. Open operation and tantalum
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