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Objective: The
purpose of this paper is to report the use of custom implants as an esthetic
correction method for craniofacial defects.
Materials
and methods: The case series introduced in this paper
corresponds to three patients, which have craniofacial congenital
malformations. The defects were corrected using PoreStar (Anatomics Pvt. Ltd.
Wellington street St. Kilda, Australia) custom implants.
Results: The
craniofacial implants adapted and integrated themselves optimally to the
patients. None of them exhibited failures during the research study and
follow-up period, showing a 100% survival rate. The esthetic results and
acceptance by the patient were very satisfactory.
Conclusion: The
custom implants accomplish optimal esthetic results regarding the handling of
craniofacial defects, facilitating the unique and specific reconstruction of
human characteristics.
Keywords: Implants, Craniofacial defects, Esthetics
INTRODUCTION
The complex esthetic and functional
consequences that craniofacial defects generate require planning reconstruction
and an ideal selection of materials for their restoration [1]. Congenital
malformations, defects due to tumor ablation and sequels of trauma are the main
causes of these defects. The complex anatomy of the malar region turns this
facial region into one of the most vulnerable. Since after altering its natural
position, esthetic deficiencies are produce in its projection and the shape and
function of the eyeball is compromised [2]. Likewise, it produces in the
patient a severe emotional burden that justifies the integral rehabilitation of
these defects [3].
The autologous grafts for the reconstruction
of craniofacial defects are considered as the first option for reconstruction,
however, the need for a donor site and the additional surgical interventions,
limit their use [4]. The extension of the defect, the anatomical
characteristics of the zone that will be operated and the presence of vital structures
near the affected area, highlight the importance of using custom prostheses
that can work with these requirements, restoring the esthetic and function in
accordance with the requirements of each patient [4,5]. Alloplastic implants
are an efficient option for the reconstruction of craniofacial defects, since
their high predictability and surgical stability allows decreasing the
operation times and improves the defect’s reconstruction capacity [5].
The craniofacial implants are medical devices
manufactured to replace/reconstruct an absent biological structure, a damaged
structure or improve an existing structure [6]. These materials must be
compatible, easy to manipulate, resistant to infection and allow an easy
extraction-insertion. Some of the materials used for these implants are
high-density-porous-polyethylene (HDPP), expanded-poli-tetrafluoroethylene
(ePTFE), polyether-ether-ketone (PEEK), methyl-methacrylate, silicone,
bio-ceramic/bio-glass, etc. [6,7].
The purpose of this paper is to report the
use of PoreStar (Anatomics Pvt. Ltd. Wellington street St. Kilda, Australia)
custom implants as an esthetic correction method for cranio-
MATERIALS AND
METHODS
The case series corresponds to patients with
craniofacial defects who were subjected to surgical interventions to place
custom implants (personalized) made with alloplastic materials. The patients
had facial congenital malformations and an acceptable health status. Eight
high-density porous polyethylene (HDPP) PoreStar (Anatomics Pvt. Ltd.
Wellington street St. Kilda, Australia) implants were placed on three patients.
The patients included in the research study
exhibited congenital craniofacial defects and an ASA I or ASA II classification
per the American society of anesthesiologists 2014: physical status
classification system. The patients excluded from the research study were
patients that exhibited craniofacial defects associated to trauma consequences or
tumor ablation. Besides this, they also had an ASA III or higher classification
per the American society of anesthesiologists 2014: physical status
classification system.
This research study was conducted in
accordance with the Declaration of Helsinki and was approved by the researchers
from the ethics committee from the corresponding service. Patient release form
was obtained from all the patients included in this research study.
The initial evaluation was conducted using a
CT scan from the face with high-resolution specifications and minimal distance
cuts between corresponding images at 0.5 mm of spacing, under the strict
imaging calibration from the PoreStar (Anatomics Pvt. Ltd. Wellington street
St. Kilda, Australia) implants protocol. The craniofacial three-dimensional
reconstruction was obtained through stereolithographic models and the
alloplastic implants were custom designed in the models. The virtual assistance
conducted jointly with biomedical engineers from the parent company allowed to
fully comply with the specific technical requirements of each patient. The
three patients were treated at the Simon Bolivar Hospital (Bogota, Colombia).
The surgical bio-model with the custom
implants in place was sterilized. Before placing the implants, they were
submersed in a dilution of 500 ml of SSN 0.9%/2 g cefazolin. Subsequent
conventional approaches were conducted and the implants were placed. The
fixation of the implant had a minimum of two screws (medial and lateral). The
implant considered successful when the 12 months post-implant period ended
without producing associated adverse events.
CASE SERIES
Patient one
Male patient, thirty years old, diagnosed
with Treacher Collins syndrome. Exhibits marked deficiency on the projection
frontal, temporal and bilateral malar (Figures
1A-1C). Additionally, the patient exhibits class II malocclusion with
severe micrognathism and sequels of facial esthetic surgery done to correct
bilateral microtia. For the correction of the craniofacial defects the
following were conducted: osteogenic mandibular distraction, functional
septum-rhinoplasty and camouflage through custom implants in the
frontal-temporal and bilateral malar region. The simultaneous facial-cranial
approach as camouflage for congenital defects is poorly referenced in the
literature.
The planning begins by three-dimensionally
reconstructing the defects that appear in the CT, choosing the ideal position
and contour of the implants (Figure 2).
The stereolithographic model shows the custom implants in the frontal-temporal
region and bilateral malar in place (Figure
3). Subsequently a vestibular approach was made with sub periosteal
exposition of the malar region. The implants were adjusted and fixed in the
ideal position (Figures 4A-4C).
Follow-up of 2 years 3 months without complications (Figures 5A-5C). The esthetic improvement in the frontal, temporal
and malar projection and contour optimally camouflages the defects.
Additionally, the esthetic correction through osteogenic mandibular distraction
and functional septum-rhinoplasty (Figures
6A and 6B) in the patient facilitated the acceptance of the defects,
significantly improving his quality of life.
Patient two
Male patient, nineteen years old, who
exhibits craniofacial defects consistent with microtia and left malar
hypoplasia. To correct the craniofacial defects, the following were conducted:
surgical placing of prosthesis for the auricular left pinna through the
epiplating system (Medicon. Tuttlingen, Germany Company) (Figures 7A and 7B) and camouflage through a custom implant in the
left malar region.
The stereolithographic model shows the custom
implant in the left malar region (Figure
8A). A conventional approach was implemented in the back of the vestibule
with a sub periosteal exposure of the left malar region, the implant was
adjusted and fixed in the ideal position (Figure
8B). Follow-up of 1 year and 8 months without complications (Figures 9A and 9B). The esthetic
improvement in the malar projection and contour camouflages the defect
optimally. Additionally, the esthetic prosthesis complements the integral
handling of the patient.
Patient three
Female patient, thirty-three years old, who
exhibits surgical sequels due to the congenital alteration of cleft palate and
lip. Exhibits marked deficiency in the malar projection and contour bilaterally
(Figures 10A and 10B). Additionally,
the patient exhibits strabismus, class III malocclusion with maxilla
hypoplasia, speech disorder (severe hypernasality) and proportion and volume
nasal defect. The craniofacial defects were corrected through bilateral
sagittal split osteotomy and chin surgery. The camouflage option by means of
the placing of paranasal and malar custom implants was determined through a
consensus with the patient and the surgical team to avoid further disruptions
in speech. Besides, the poor bone quality and the remaining bone defects hampered
the proper completion of the maxilla osteotomy procedure.
RESULTS
The adaptation of the craniofacial implants
significantly improved the esthetic of the operated patients. The eight
adjusted and adapted implants placed to correct the craniofacial defects showed
a success rate of one year over with an implant placing of 100%. The camouflage
obtained in the 3 patients was physically and mentally tolerated in a
satisfactory manner.
DISCUSSION
The reconstruction of the craniofacial
defects represents a great challenge for the physician [8], who must remember
and implement the general facial analysis, and in specific cases, local
specific layouts (for example, the malar zone) [9]. The choice of the ideal
reconstruction material may be confusing, since the range of available
materials is extensive (poli-tetrafluoroethylene, methyl-methacrylate, HDPP, PEEK,
silicone, etc.) [10]. The senior author and other clinicians prefer custom
alloplastic implants made of porous polyethylene [11,12] silicone [13] or PEEK
based on patient specific implants [14]. However, despite the morbidity of the
donor site and rate of resorption, other authors prefer fatty autologous grafts
[15,16] or hyaluronic acid fillers that avoid a donor site and it is analogous
to fat transfer techniques for deeper volumetric adjustment [17].
The HDPP implants (PoreStar, Anatomics Pvt.
Ltd. Wellington street St. Kilda, Australia – Medpor, porex surgical Inc.,
College Park, GA) have the advantage of biological integration to the recipient
site. The collagen deposits form a highly stable compound that will resist
infectious processes, undesired exposures to the material or malformation due
to contractile forces [12]. The preference of different authors [3,9,12,18]
because of their mechanical and biological capacity justifies their use. On the
other hand, silicone implants (Silastic implant Tech, Ventura, CA), have the
advantage of biological encapsulation in the recipient site, facilitating their
adjustment and possibility of easy removal when needed, dissenting on the use
of HDPP implants [13]. Currently, 3D planning facilitates the planning and
execution of reconstructions in a custom manner, allowing obtaining more
predictable results with minimal morbidity [19,20].
Atherton et al. in 2014 [21] describe the
usefulness of malar and paranasal implants related to reconstructions of
midfacial and malar hypoplasia defects in patients with history of cleft lip
and cleft palate, similar to the case introduced in this paper, where the
osteogenic distraction and orthognathic surgery were not viable treatment
options. Likewise, they describe their use in situations, where despite
acceptable esthetic results, the craniofacial contours are compromised.
The handling of craniofacial deformities
through the combination of camouflage techniques and esthetic-functional
procedures allows the appropriate correction and integral rehabilitation of the
different defects found in these patients. Barreto et al. in 2019 [3] conducted
the correction of auricular defects through the auricular epiplating prothesis
system (Medicon. Tuttlingen, Germany Company). Likewise, the authors conducted
osteogenic distraction surgeries and functional septum-rhinoplasty surgeries
using PoreStar implants (Anatomics Pvt. Ltd. Wellington street St. Kilda,
Australia) as a protocol for integral craniofacial rehabilitation with optimal
esthetic results.
In accordance with Robiony et al. in 1998
[9], who simultaneously conducted orthognathic surgeries and implant placing in
the malar region for the correction of craniofacial defects, in our cases we
opted for camouflage interventions that improved the esthetic, without
compromising the function of the patient. In a similar manner as the one
exposed in case three, Robiony et al. [9], specify cases where large maxilla
advances or movements with poor predictability can be replaced by esthetic camouflages
with custom implants.
The complications associated to facial
implants are around 31.5%, mainly related to esthetic (dissatisfaction of 10.1%
due to asymmetry or implant migration) and infection of the operated place
(7.2%) [11]. Other minor complications that may emerge are swelling,
ecchymosis, implant malposition, bone resorption, external implant palpation
and asymmetry [22]. There were not complications in our cases. The intraoral
conventional surgical technique used by the author and in accordance with
Atherton et al. 2014 [21], only exhibits a 0.5% of complications related to
infection. Although the periorbital approaches provide a direct vision, they
also increase the probability of complications (ectropion, epiphora,
infraorbital neurapraxia, etc.) [23].
The greatest questions the surgeon has are,
which implant to use and where to place it. The appropriate implant should be
the one with the correct specifications [13]. The esthetic and functional
rehabilitation of the craniofacial defects represents a great challenge for the
surgeon. The autografts and allografts used for many years implied an increase
in the morbidity of the patients and the completion of an optimal functional
and esthetic rehabilitation was very unpredictable. The rehabilitation through
alloplastic substitutes accomplishes an ideal esthetic camouflage difficult to
obtain through other methods [24]. The use of custom implants not only allows
camouflaging the esthetic defect, but it also facilitates the acceptance due to
psychogenic self-perception, which generates an improvement in the quality of
life of the patient and in their immediate social surroundings [21].
CONCLUSION
The handling of patients with different
craniofacial pathologies (Treacher Collins syndrome, cleft lip and palate,
etc.) who exhibit extreme anatomical conditions can be treated with optimal
esthetic results and minimal morbidity. Custom HDPP implants accomplish optimal
esthetic results in the handling of craniofacial defects, facilitating the
unique and specific reconstruction of human characteristics.
ACKNOWLEDGEMENT
Carlos E Buitrago, DDS, who provided
excellent feedbacks to the article.
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