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j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / m j a fi

Review Article

The role of patient specific implants in the oral and


maxillofacial region

Indranil Deb Roy a, Ajay Premanand Desai b,*, M. Ramyasri c, K. Mukesh c


a
Professor & Head, Department of Dental Surgery & Oral Health Sciences, Armed Forces Medical College, Pune, India
b
Associate Professor, Department of Dental Surgery & Oral Health Sciences, Armed Forces Medical College, Pune,
India
c
Resident, Department of Dental Surgery & Oral Health Sciences, Armed Forces Medical College, Pune, India

article info abstract

Article history: Reconstructing maxillofacial defects is quiet challenging due to the region’s complex
Received 11 March 2024 anatomy, and cosmetic and functional effects on patients. With the help of developing
Accepted 29 April 2024 technologies, patient-specific implants (PSIs) using virtual surgical planning based on a
Available online 27 May 2024 Computer aided designing (CAD)/Computer aided manufacturing (CAM) platform is an
evolving treatment option. PSIs can be used in patients with maxillofacial defects and
Keywords: reconstruction. PSIs are also being used in the form of preformed plates for virtually
Patient specific implants planned orthognathic surgeries. Customized temporomandibular joint (TMJ) prosthesis is
Maxillofacial region being routinely used in the debilitating/degenerative joint disease as a part of alloplastic
Autogenous Bone grafts joint replacement. The reconstruction of the maxillofacial region using autogenous tissue
will always be gold standard due to near match of the recipient site. However, autogenous
bone grafts positioned using PSIs or in certain areas such as the TMJ complex and the
orbital region the PSIs are being offered with advantage of reduced donor-site morbidity.
The future research is focussed towards the development of PSIs being used as a scaffold
for engineering of the recipient tissue to restore the lost anatomy of specific region. This
article reviews the varied aspects of this new technology of PSI for correction of various
deformities/defects during the maxillofacial reconstruction.
© 2024 Director General, Armed Forces Medical Services. Published by Elsevier, a division of
RELX India Pvt. Ltd. All rights are reserved, including those for text and data mining, AI
training, and similar technologies.

help of developing technology like computer-aided design and


Introduction computer-aided manufacturing (CAD/CAM) technology, it is
now possible to have a treatment tailored to the individual’s
The paradigm shift from the concept of ‘one-size-fits-all’ has needs even in the complex facial skeleton, and thus has
shifted to a personalized approach in recent times. With the improved the surgical outcome. The patient specific implants

* Corresponding author.
E-mail address: drajaydesai@rediffmail.com (A.P. Desai).
https://doi.org/10.1016/j.mjafi.2024.04.022
0377-1237/© 2024 Director General, Armed Forces Medical Services. Published by Elsevier, a division of RELX India Pvt. Ltd. All rights are
reserved, including those for text and data mining, AI training, and similar technologies.
388 m e d i c a l j o u r n a l a r m e d f o r c e s i n d i a 8 0 ( 2 0 2 4 ) 3 8 7 e3 9 1

(PSIs) manufactured using the technique has thus revolu- especially in the mandibular recontruction needs intra-
tionized the treatment strategy for correction of the residual operative bending and contouring which has risk of plate
deformities/defects in the maxillofacial region. PSIs are fracture and memory phenomenon. Prefabricated plates
currently used in the form of temporomandibular joint (TMJ) incorporating the angle contour were also used for recon-
total replacement and/or reconstruction of the cranial, orbital, struction. Subsequently, with the introduction of the rapid
maxillectomy, and mandibulectomy defects, as well as in the prototyping of stereolithographic models to scale in 1987 by
form of prefabricated fixation implants for orthognathic sur- Brix et al. it was possible to prebend the plates preoperatively
gery.1 There is a high level of evidence indicating the using the models with considerable time saving.8 But the risk
increasing usage of these implants preferred over the other of the weakening of the integrity always remained. With
treatment modalities. advent of the CAD/CAM its was possible to fabricate the
custom-made implants specific to each patient in conformity
to the anatomical configuration, especially with titanium al-
Temporomandibular joint reconstruction loys. The first reported patient-specific plate was used for
mandibular reconstruction by Ciocca et al. in a patient of oral
Alloplastic replacement the entire TMJ complex was first cancer with CAD/CAM technology.9 The protocol involved the
described in the 1970 for the treatment of severe end-stage patient undergoing CT scan with the slice thickness of less
TMJ disease or pathologic conditions. A plethora of different than 1.0 mm. The DICOM data obtained were then incorpo-
alloplastic materials such as cast Vitallium, polymethyl rated in a Virtual Surgical Planning using third party software
methacrylate, Dacron, and ultra-high molecular-weight to create the virtual 3D images for intended surgical plan, the
polyethylene have been employed for the fabrication of the surgical guides, as well as the design of the recommended PSI
TMJ prosthesis.2 PSIs, in the form of a custom-made TMJ in consultation with the treating surgeon in real-time online.
prosthesis was introduced in 1993.3 Various longitudinal A prototype of the implant can be printed using a 3D printer
studies have indicated evidence of the long-term stability and with the patient 3D models before finalizing the final design of
success rate of these devices.4 The basic step in fabrication the implant. Various studies have endorsed this protocol for
involves the patient to undergo a computed tomography (CT) the fabrication of the PSIs. In a study by Wilde et al. 30 patients
scan, fabricate the stereolithographic model, also employing where patient-specific mandibular plates were used for cases
software for the planning and fabrication of the protype of the requiring mandibular reconstruction where time for planning,
prosthesis and subsequently the final prosthesis with active fit of surgical guides, and plates, pre-/post-operative occlu-
involvement of the treating surgeon. A study was carried out sion, radiological position of the temporomandibular joint and
on 45 patients and published in 2003, where custom TMJ complications were recorded.10 Promising results were ob-
prostheses manufactured by TMJ concepts were compared tained and recommended for future use. The accurate con-
with stock prostheses made by TMJ Inc. A better outcome was formity of the mandibular reconstruction was exhibited by
observed in terms of postsurgical pain and jaw function in the Mascha et al. in their study in 18 patients where patient-
custom prosthesis5 A meta-analysis carried out in 2018 specific mandibular reconstruction plates were milled from
comparing stock and patient-specific prostheses with respect titanium blocks as compared with osseous flap reconstruction
to increased maximum incisal opening and decreased pain alone.11 In a study by Schepers et al. they compared retro-
did not reveal any noteworthy differences.6 spectively the pre- and post-operative accuracy of the com-
When compared to stock prosthesis, the custom-made posite flap reconstruction using the patient-specific guides
prosthesis can be used in complex defects and tailor-made for and reconstruction plates and found promising results but
a specific individual, although it involves a reasonable amount needed to account for the thickness of the periosteum.12 They
of time especially to fabricate the skull models. There is al- also studied the placement of the endosseous implants for
ways a scope to alter the position of the mandible in relation accuracy using guides with minor deviation pre- and post-
to the skull base, especially in complex reconstruction. operatively.
The reconstruction of the zygomatico-orbito-maxillary
complex is always challenging in terms of the association
Reconstruction of the maxillofacial complex with nasal cavities, maxillary sinuses, and orbital cavities.
Melville et al. showed the reconstruction of the maxillary
The reconstruction of maxillofacial skeleton is always chal- defect using fibula with the help of patient-specific guides
lenging due to the complex anatomical nature housing the with a great amount of accurate surgical planning.13 Similar
airway and oral cavity, and having a movable jaw bone. steps in the fabrication of the implants were followed akin to
Especially performing such procedures where potential sali- the mandibular reconstruction.
vary contamination is always a possibility. With the advent of In a case series of six patients by Alasseri et al. in which
antibiotics in 1940, internal fixation became popular subse- different types of defects have been reconstructed using
quently, especially in the field of orthopaedics. Initial usage of PSIs with satisfactory results.14 The cases included
the fixation devices in the maxillofacial region was with ParryeRomberg syndrome, hemifacial microsomia, mandibular
the help of the orthopaedic plates. However, Luhr in 1960 deformity post orthognathic surgery, post-craniectomy defect,
introduced the compression plates and screws to be used in and post-traumatic deformity involving the nasal and the
the maxillofacial region.7 The reconstruction plate system, zygomatic region and mandibular continuity defect. All the
m e d i c a l j o u r n a l a r m e d f o r c e s i n d i a 8 0 ( 2 0 2 4 ) 3 8 7 e3 9 1 389

patients showed satisfactory improvement in terms of function toward the development of incorporation of the biocompatible
and cosmesis and eliminated the complications arising due to coatings such as polyvinylpyrrolidone (PVP) hydrogel and poly-
the noncustomized implants. The only drawback was the high meric microspheres.
cost, which was overcome by the enormous advantage of being
specific to each patient.
The PSIs have also been used in patients with maxillofacial Orthognathic surgery
defects arising post-mucormycosis, where a composite defect
had occurred due to the elimination of the affected bones. In a Tremendous advances have taken place in the field of
series of 21 patients of maxillectomy defects post- orthognathic surgery progressively in a sequential manner
mucormycosis a novel design of Zygoma PSIs were used by with the introduction of 3D virtual planning using CAD/CAM
Patel et al.15 They offered advantages in terms of minimal technology.13 Until now, traditional manual methods like 2D
bone augmentation and reduced treatment time to restore cephalometric tracings, facebow transfers model surgery have
function post operatively. It also showed the potential been utilized for planning the surgery by the orthodontists,
advantage of avoiding multiple morbid surgeries for recon- technicians, which often entails intraoperator variability, thus
struction, and thus reducing the overall cost of the treatment. subject to potential errors in planning and subsequent
In another case series by Chowdhury et al. they demon- execution. Subsequently, this data has been replaced with 3D
strated broader scope for PSIs in reconstruction of the maxil- data with the advent of digital planning. However, the surgical
lofacial region.16 They described eight cases of varied nature plan is still based on the occlusal splints fabricated manually.
and aetiology requiring maxillofacial rehabilitation. All the 3D planning has been a boon in terms of the prediction of the
designs of the implants underwent finite element analysis intraoperative osteotomy sites and potential interferences
(FEA) and GOM analysis for standardization and achieving during the bony movements. However, reproducibility on the
optimal functionality. The component of dental implants was ground wasn't possible since the surgery is performed by the
also incorporated in the designing of the PSIs for future hand.14
prosthetic rehabilitation and thus improving the overall pa- Li et al. in a case series of six patients who underwent
tient satisfaction. The study further extended the horizon of Lefort I osteotomy utilised 3D surgical templates determining
reconstruction of the maxillofacial stomatognathic system the final position of the maxilla independent of the occlusion
using PSIs. and the movement of the mandible and found accuracy of
within 1 mm, demonstrating the reliability of the procedure,
eliminating potential errors caused by the autorotation of the
Reconstruction of defects arising due to post mandible.18
oncologic resection Philippe et al. in their case, reported the use of the PSI for
segmental Lefort I Osteotomy using surgical guides placed
There are instances where mild to moderate-sized oncologic during surgery with drill guides with predrilled holes in the
resections cause conspicuous defects in the maxillofacial region. guide.19 The postoperative results showed minimal variations
Performing reconstruction in these cases is often challenging from the presurgical plan. This method also avoided the use of
especially using the autogenous options of vascularized bone the occlusal splints, thus minimizing the error in the bony
grafts. Though they have been the golden standard for recon- apposition. A study by Mazzoni et al. in a larger number of
struction, but there is always a limitation in terms of the bone patients demonstrated the use of patient-specific surgical
available, and there is always a risk of developing tissue necrosis guides via virtual surgical planning and customized plates
post-high-dose anticancer chemo/ radiotherapy. Research by achieved encouraging results in terms of accuracy and pre-
Roman et al. focuses on the development of patient-specifically dictable postoperative outcome.20 Further, in a series of 32
manufactured maxillofacial implant that stimulates bone tis- patients undergoing Lefort I osteotomy by Suojanen et al.
sue growth for such post-ablation defects.17 Herein, the demonstrated the use of the virtual surgical planning along
designing of the metallic substrate of the implant is performed with 3D printed fixation devices with promising results.21
using CT and 3D printing from the Ti6Al7Nb powder, which Heufelder et al. in their study of 22 patients operated on for
could be implanted for reconstruction of these defects. The bijaw surgery, underwent maxillary surgery without
metal core was then evaluated in terms of structural character- using occlusal splints and fixation using customized plates
istic, cytotoxicity, and gene expression through the in vitro tests. followed by the mandibular surgery using the conventional
Their further research was directed toward fabrication of the method with 3D planning using surgical splint with minimal
biocompatible coating for the outer surface of the bone implant variation postoperatively vis-a-vis the presurgical planning.22
that would enhance the healing process and accelerate tissue The use of the patient-specific guides and patient-specific
growth. Another modality of research is also being aimed implants for the maxillary orthognathic procedures have
toward developing a novice approach in including the coating for demonstrated several pros, viz., accuracy in the positioning
the implant surface with two-phase biocompatible layer, independent of the surgical splints, elimination of the errors
including polymeric microspheres and hydrogel carriers, which in adapting the implants, avoidance of the intermaxillary
would provide long-time release of bone and cartilage growth fixation, thus eliminating the risk of needle-stick injuries to
factors around the implant being employed for reconstruction of the operator, decreased intraoperative time, and avoidance of
the ablative defects. Further, research is also being done damage to the adjacent vital tooth roots, etc.23
390 m e d i c a l j o u r n a l a r m e d f o r c e s i n d i a 8 0 ( 2 0 2 4 ) 3 8 7 e3 9 1

Cons of using the patient-specific implants for the maxil- ever-developing technique along with the tissue engineering
lary surgery include the economic burden, increased time for methods will prove as turning point in absolutely
fabrication of the implants, thus the overall treatment time, eliminating human error while performing complex maxillo-
no option of variation in the intraoperative plan where virtual facial reconstruction. Newer methods are being researched in
planning has not been accurate and inability to predict the terms of improving and development of the biocompatible
stability of the osteotomized segments in the transverse materials, which would themselves act as a scaffold for
dimension. Management of soft tissue around the PSI can be growth on which the natural tissues native to the site of being
challenging at times especially when the soft tissue drape is reconstructed would grow and thus eliminate the need for
compromised due to a debilitating surgery, extensive scarring, multiple surgeries that would further decrease the psycho-
or fibrosis in long-standing nonreconstructed defects. The soft logical and economic burden to the patients. Further, the
tissue around the struts for the prosthetic rehabilitation is current strategies in tissue engineering in the form of a scaf-
also prone to injury and subsequent exposure of the implants. fold matrix where impregnation of the stem cells will enable
The role of tissue expanders to achieve adequate coverage of reconstruction of complex maxillofacial bony defects. Patient-
the PSIs can be an additional intervention to counter such specific custom implants derived from the autogenous,
potential problems. ASCs with the help of custom bioreactors have proven to be
Wound dehiscence postreconstruction with PSIs poses a efficient and superior to traditional implants in large animal
serious complication that has been difficult to manage and studies.
causes significant morbidity in such patients. Therefore, it is
of utmost importance when planning the PSI to map the soft
tissues preoperatively to avoid such complications rather
Disclosure of competing interest
than manage them. The patient’s ablative surgery has been
carried out for the oncologic resection or postmucormycosis
The authors have none to declare.
are difficult cases to manage where there are deficient hard
and soft tissues. The hard tissue can be effectively replaced
with the PSIs with meticulous planning. However, the man-
references
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