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Received: 6 December 2018 Revised: 7 February 2019 Accepted: 16 February 2019

DOI: 10.1111/cid.12748

ORIGINAL ARTICLE

Assessment of three dimensional bone augmentation


of severely atrophied maxillary alveolar ridges using prebent
titanium mesh vs customized poly-ether-ether-ketone (PEEK)
mesh: A randomized clinical trial
Mohamed Mounir BDS, MSc, PhD1 | Mahmoud Shalash BDS, MSc, PhD2 |
Samy Mounir BDS, MSc, PhD3 | Yasmine Nassar BDS, MSc, PhD4 | Omar El Khatib BDS4

1
Oral and Maxillofacial Surgery, Faculty of
Dentistry, Cairo University and New Giza Abstract
University, Cairo, Egypt Background: Alveolar bone grafting techniques and dental rehabilitation of patients with maxil-
2
Surgery and Oral Medicine Department, lary alveolar defects is a very challenging and costly procedure. Various methods have been
National Research Centre, Cairo, Egypt
described to reconstruct these defects in order to facilitate the placement of dental implants.
3
Oral and Maxillofacial Surgery, Faculty of
The aim of this study was to assess three dimensional (3D) maxillary ridge augmentation using
Dentistry, MSA University, 6th of October
City, Egypt two innovative, accurate, and time saving protocols.
4
Oral and Maxillofacial Surgery, Faculty of Materials and Methods: Sixteen patients (32 implants) with vertically and horizontally deficient
Dentistry, Cairo University, Cairo, Egypt maxillary alveolar ridges, were equally allocated into 2 groups; a mix of particulate autogenous
Correspondence and xenogenic bone grafts loaded in a prebent titanium mesh (Control group) vs patient specific
Mohamed Mounir, Oral and Maxillofacial poly-ether-ether ketone meshes (Study group). Radiographic assessment was performed preop-
Surgery, Faculty of Dentistry, Cairo University,
Cairo, Egypt.
eratively, 1 week and 6 months postoperatively. Assessment included measurements of linear
Email: [email protected] changes in the vertical and horizontal dimensions on cross sectional cuts of cone beam com-
puted tomography using special software. Finally; the percentage of 3D bone gain in each group
was compared to that of the other.
Results: Wound healing was uneventful for all cases except one patient in each group were the
meshes were exposed 2 weeks' postsurgery. There was no statistical significance between both
groups (P value = 0.2).
Conclusion: Within the limitations of the sample size of this study, both techniques could be
used as a successful method of ridge augmentation with no statistical significance
between them.

KEYWORDS

bone augmentation, CAD-CAM, patient specific, PEEK, titanium, mesh

1 | I N T RO D UC T I O N time patients present with alveolar ridge defects that does not allow
for a prosthetically driven implant placement. These defects can result
The use of dental implants for oral rehabilitation has become a routine from periodontal disease, dental trauma, traumatic extraction or a
procedure with predictable outcomes in modern dentistry.1 For ideal genetic anomaly such as complete or partial anadontia. These cases
functional, esthetic and phonetic outcomes, dental implants must be are usually associated with 3D alveolar ridge atrophy.3–5
2
placed in the correct three dimensional (3D) position. Most of the Various strategies have been described to reconstruct these
defects and facilitate the placement of dental implants. These tech-
Approved by the ethical committee of Cairo University. niques include inlay and onlay block bone grafts, bone splitting,

Clin Implant Dent Relat Res. 2019;1–8. wileyonlinelibrary.com/journal/cid © 2019 Wiley Periodicals, Inc. 1
2 MOUNIR ET AL.

distraction osteogensis, and guided bone regeneration (GBR) using defect site in both the horizontal and vertical dimensions to allow the
6
resorbable and nonresorbable barrier membranes. GBR has been placement of implants with proper dimensions, taking into account
shown to improve the predictability of bone augmentation and pro- the thickness of the mesh and the soft tissue volume available that
7–9
vides long-term stability to the newly augmented site. would not hinder a tension free primary closure. An increase in inter-
The basic principle of GBR involves placing a mechanical barrier arch space while it may allow for placement of implants of sufficient
to protect the blood clot and isolating the bony defect from the sur- height present, will result in less than ideal prosthetic outcome since
rounding connective tissue. This allows for the osteoblasts an access this would result in improper crown to implant ratio.
to an isolated space intended for bone regeneration. Accordingly, the
use of a barrier membrane has the advantage of facilitating the aug-
mentation of alveolar ridge defects, inducing bone regeneration and 4 | PATIENT GROUPING AND
improving bone grafting results.10 RANDOMIZATION
Titanium meshes have a long track record in achieving predictable
Patients were randomly divided into two equal groups (eight patients
bone regeneration, owing to their rigidity, ability to conform to the
11 each) who underwent 3D ridge augmentation using either a prebent
shape of the defect and maintenance of their shape overtime. To
titanium mesh (control group) or a patient specific milled peek mesh
overcome one of its main draw backs which is the increased surgical
(study group) utilizing a 50:50 mixture of autogenous bone harvested
time required for their shaping and fitting onto the defect, preshaping
from the iliac crest of each individual patient and xenogenic bone
of the mesh on a stereolithographic model (STL) of the patient's jaw
(Bio-Oss, Geistlich Pharma, Switzerland). All patients received a total
has been shown to significantly shorten the intraoperative time.12-
of 32 dental implant in a second stage surgery.
More recently, 3D printed custom made titanium devices have been
13 Randomization was carried out using special computer software.
introduced for the same purpose.
Patients took a certain number and placed in concealed closed
Poly-ether-ether-keton (PEEK) is a poly aromatic semi-crystalline
envelopes.
thermoplastic polymer with mechanical properties and biocompatibil-
14
ity, that makes it favorable for use in the medical field. The use of
patient specific peek implants for reconstruction of maxillofacial
5 | PREOPERATIVE PREPARATION
defects following oncologic resections and/or maxillofacial trauma,
has been in practice for several years with very predictable
• A brief medical and dental history, followed by clinical examina-
outcomes.15
tion was carried out for all patients. Clinical measurements were
To the best of our knowledge, there has been no reports docu-
done visually and then using caliper to ensure the patient adher-
menting the use of patient specific peek meshes for GBR and hence
ence to the initial inclusion criteria prior to further investigations.
the aim of this study was to compare the outcomes following GBR of
• Periapical radiographs were done for primary investigation to
3D bone defects in the maxilla using prebent titanium mesh vs patient
exclude the presence of any lesion at the area of interest. A CBCT
specific, milled peek meshes.
scan was done as a final investigation for the assessment of the
alveolar ridge volume.

2 | MATERIALS AND METHODS


6 | V I RT U A L P L A N NI N G A N D
The investigators designed a single institutional randomized clinical
MANUFACTURING TECHNIQUES
comparative study. The inclusion criteria were patients who had a par-
tial or completely edentulous maxillary alveolar ridge with apparent
• DICOM files of both groups were imported in a specialized soft-
3D defect following teeth loss. After gaining the approval of the ethics
ware (mimics 19, Materialize NV, Belgium). In the control group,
and research committee at Cairo University. All patients were con-
designing process started with virtual 3D (vertical &horizontal)
sented and informed about the procedures to be followed throughout
incremental increase for the deficient ridge till acquiring the
the study. All patients were free from any local or general disease that
required dimensions (Figure 1); 3D printing technology was used
may interfere with bone healing and had no history of previous graft-
(Envisiontec GMBH, Gladbeck, Germany) to fabricate the virtually
ing procedure at the designated edentulous ridge.
grafted 3D stereo lithographic model that was then used as a
guide for prebending of a readymade titanium mesh to create a
3 | CRITERIA OF THE EDENTULOUS RIDGE space for the particulate graft intraoperatively (Figure 2).
• In the test group, a perforated meshwork was designed with a 2 mm
The ridge had to exhibit severe vertical and horizontal (3D) alveolar thickness covering the buccal, crestal, and palatal surface of the alve-
ridge deficiency with alveolar ridge height less than 6 mm from the olar bone leaving the desired space for the proposed particulate
alveolar crest to the basal bone and a ridge width of less than 2 mm or graft site between the resorbed native bone and the fitting aspect of
a clinically apparent increase in interarch space relative to the adjacent the designed mesh (Figures 3–4). Fabrication method for this group
natural teeth. The alveolar ridge augmentation was carried out at the of patients was done using five axis milling machine from medically
proposed implant sites taking into account the need to over build the grade PEEK blocks to manufacture the final form of the customized
MOUNIR ET AL. 3

FIGURE 1 Three dimensional (3D) bottom view of CBCT scan


showing incremental increase (red color) in the vertical and horizontal
dimension of the alveolar ridge

FIGURE 3 Designing of the PEEK mesh on the cross sectional cut of


a preoperative CBCT scan of the study group

FIGURE 2 Prebending of the titanium mesh preoperatively guided by


3D printed model

mesh (Figure 5). The ti-meshes were steam sterilized using autoclave
while for the test group the peek meshes were cold sterilized prior
to performing surgery by placing it in 2.4% glutaraldehyde (Cidex,
Johnson & Johnson Co., Washington, D.C.) for 20 minutes.

7 | INTRAOPERATIVE SURGICAL
P R OC ED U RE S ( BO TH GR OU P S)
FIGURE 4 3D bottom view of CBCT scan showing the final design of
All surgical procedures were performed under General Anesthesia uti- the peek mesh of the study group
lizing two teams. One team harvesting the autogenous bone from the
iliac crest while the other team working intra-orally. Scrubbing and door technique (Figure 6). The donor site was then closed using
draping of the patients was carried out in a standard fashion using resorbable vicryl suture material in a layered fashion.
Bovidine-Iodine (Betadine, Purdue Products L.P, Washington, D.C.) Intra-orally, local anesthesia was injected at the defect site (arti-
surgical scrub. Autogenous particulate spongy bone was harvested caine 4%, septodont, France) for hemostasis. Full thickness mucoper-
from the anterior iliac crest in a standard layered approach using trap- iosteal flaps were raised to expose the cortical bone, compromising a
4 MOUNIR ET AL.

FIGURE 8 Full thickness reflection of pyramidal flap with paracrestal


incision and two oblique releasing incisionsin the study group
FIGURE 5 3D milled PEEK mesh
For the control group, the prebent titanium mesh was fixed first on
the palatal side, followed by graft application (50:50 mixture of autog-
enous bone harvested from the iliac crest of each individual patient
and xenogenic bone). The mesh was then adapted and fixed in place
using three or four micro titanium screws. (Figure 9). Similar steps
were followed for the study group where the peek mesh was fixed in
place by at least three or four screws. (Figure 10). Collagen membrane
(Bio-Gide, Geistlich Pharma, Switzerland) was then applied on top of
the meshes in both groups (Figure 11). For tension free closure, peri-
osteal releasing incision was done on the underside of the flap using a
sharp 15 C surgical blade. The flap was then closed with single inter-
rupted sutures using prolene 4-0 (Ethicon US LLC, Washington, D.C.;
Figure 12).

FIGURE 6 Anterior iliac crest harvesting using trap door technique 8 | STUDY VARIABLES AND MEASURING
T H E F I N A L B O N E G A I N F O R BO T H GR O U P S
para-crestal incision with one or two vertical releasing incisions
(ST A N D A R DI ZA TI ON O F CA L CU LA T I ON S)
depending on the location and extent of the defect.
A full-thickness reflection of labial and palatal mucoperiosteal flap
• Nasal and maxillary sinus floor were used as a fixed anatomical
was then performed. Reflection was extended to expose the whole
reference. This was achieved by adjusting the cross sectional long
length of the facial cortical plate of the alveolar ridge (Figures 7–8).
axis in the center of the region of interest and bisecting it. On the
Bleeding points (decortication) were done using a small rounded surgi-
cross sectional view of CBCT and at each proposed implant site, a
cal bur to expose the underlying marrow for easier graft consolidation, line was drawn from the crest to the apical area and then the
height and the width were estimated preoperatively, immediately
(1 week) and 6 months postoperatively to calculate the net 3D
bone gain in both groups. (Figure 10). As it was not possible to
compare the bone gain in millimeters (as this was case depen-
dent), so the final percentage of bone gain was evaluated. Bone
gain was calculated as a percentage as it was not possible to cal-
culate it in millimeters since all the defects did not have the same
dimensions.16The obtained data were subjected to statistical
analysis.

9 | STATISTICAL ANALYSIS

Statistical analysis was performed using SPSS (Statistical package for


the social sciences, version 20, IBM corp). Data were represented as
FIGURE 7 Full thickness reflection of pyramidal flap with paracrestal mean ± SD. Paired student t-test was used to compare two variables
incision and two oblique releasing incisionsin the the control group within the studied group of patients. Independent sample t-test was
MOUNIR ET AL. 5

FIGURE 12 Suturing of the wound

3D maxillary alveolar ridge augmentation was done for both


groups using prebent titanium mesh (control group) in eight patients
FIGURE 9 Prebended titanium mesh in place fixed with bicortical (six males and two females) with a mean age of 38 years vs custom-
titanium screws ized PEEK mesh (test group) eight patients (four males and four
females) with a mean age of 39 years. Both types of meshes were
loaded with a 50:50 mixtures of xenograft and autogenous bone
grafts.

10.1 | Clinical and Radiographic results of both


groups
10.1.1 | Vertical bone height
1. Six months following graft placement, all cases showed un event-
ful wound healing except one patient in each group showed mesh
exposure 2 weeks post operatively that was treated using normal
saline daily irrigation and ended with healing by secondary inten-
FIGURE 10 PEEK mesh in place fixed withbicortical titanium screws
tion. After obtaining CBCT scans, and verifying the successful
regeneration of the alveolar defect, dental implants were success-
fully placed in all patients of both groups (Screwplant, Implant
Direct LLC, Washington, D.C.)
2. All patients were included for statistical analyses. There was no
statistical significance between the two studied groups regarding
patients' age and gender distribution. There was no significant dif-
ference between the mean percentage of 3D bone gain between
both groups P value (0.2; Table 1). (Figures 13–16).

11 | DISCUSSION

Different protocols for reconstructing alveolar ridge defects have


FIGURE 11 Collagen membrane covering the mesh been described in literature. Each protocol has its own merits and
demerits and will be tailored according to each patient's individual
used to compare variables between the two studied groups. In all needs, operator's skill and preference.
tests, result was considered statistically significant if the P value GBR using different types of barrier membranes has long been
was < 0.05. used as a very successful treatment for the management of alveolar
ridge defects with a large body of evidence demonstrating its success
1 0 | RE SU LT S to regenerate missing bone at potential implant sites with insufficient
bone volume and the long-term success of implants placed simulta-
A total of 32 implants were placed for the 16 patients; where they neously with, or after, GBR.17
were classified randomly into two groups, each included eight patients A large variety of barrier membranes have been used for GBR proce-
who received 16 implants placed in a delayed fashion. dures. The criteria required to select appropriate barrier membranes for
6 MOUNIR ET AL.

TABLE 1 Three dimensional bone gain percentage for both groups

Mean % SD P value
Control group 20.9% 13.3 0.2
Study group 31.8% 22.7

FIGURE 15 Bar chart representing percentage of bone gain for both


groups

FIGURE 13 CBCT 6 months postoperatively of the control group


on an STL model created from the CT data to build a 3D graft matrix
for successful vertical ridge augmentation. De Moraes et al12 showed
that using a similar technique of prebending of the ti-mesh on the STL
model prior to surgery optimizes the surgical outcomes, reduces oper-
ating time and allows achievement of the desired bone volume with
great predictability. In this study, using the same technique has re-
sulted in reducing the overall operating time since we were able to
easily adapt the mesh in place.
One of the main drawbacks of using ti-mesh is the increased inci-
dence of exposure owing to its stiffness.22 this complication was
expected to be found to a lesser extent in the peek group due to its
better tensile strength and resiliency which is closer to human bone
than that of the titanium. This drawback can affect the amount of
bone regeneration at the defect site and will depend on the time of
FIGURE 14 CBCT 6 months postoperatively of the study group exposure. If this occurs after 4 to 6 weeks, the grafted material is suf-
ficiently stabilized by the newly forming bone, so the loss of grafted
GBR include its biocompatibility, integration by the host tissue, cell occlu- material is minimal.23 In our study mesh exposure occurred in one
18
siveness, space-making ability, and ease of clinical application. Ti-mesh case of the control group at 2 weeks and was managed by strict oral
have been shown to be very predictable in increasing the bone volume hygiene instructions to the patient and daily irrigation with saline. This
in large alveolar ridge deficiencies prior to or during implant surgery exposure, however, did not result in a compromised regeneration and
owing to its excellent mechanical properties for the stabilization of bone implants were successfully installed in the newly regenerated bone.
grafts19 Several studies have shown that the ti-mesh can maintain space This conforms with the findings of Her et al24 where they reported
with a high degree of predictably, even in extensive ridge defects. Ikuya that although ti-mesh exposure was observed in their study, the
et al20 showed that autogenous bone grafting with titanium mesh allows amount of regenerated bone was not affected. This finding could be
adequate vertical and horizontal alveolar bone reconstruction both quan-
titatively and qualitatively for implant placement. However, the clinical
outcome of the augmentation is dependent on the type of the defect. in
other words and since we were dealing with defects that were not equal
in size, the amount of bone gain in one case could be found sufficient to
place implants with ideal dimensions while the same bone gain in another
case may not be sufficient to do that and further augmentation would be
needed. This correlates with our findings which has shown that the per-
centage of bone gain is case dependent.
Obtaining an ideal shape of the ti-mesh to conform to the shape
of the defect is usually time consuming and results in increased intra-
operative time. Yong et al21 used a preformed titanium mesh shaped FIGURE 16 Bar chart showing bone gain between both groups
MOUNIR ET AL. 7

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05.002. Nassar Y, El Khatib O. Assessment of three dimensional bone
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