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Ciocca 2018
Ciocca 2018
Ciocca 2018
Full Title: Prosthetically CAD-CAM guided bone augmentation of atrophic jaws using customized
titanium mesh: preliminary results of an open prospective study.
Abstract: This study evaluated the outcomes of CAD-CAM customized titanium mesh used for
prosthetically guided bone augmentation related to the occlusion driven implant
position; to the vertical bone volume gain of mandible and maxilla; and to
complications, like mesh exposure.. Nine patients scheduled for bone augmentation of
atrophic sites were treated with custom titanium mesh and particulate bone grafts with
autologous bone and anorganic bovine bone in a 1:1 ratio prior to implant surgery.
The bone volume needed to augment was virtually projected based on implants
position, width and length, and the mesh design was programmed for the necessary
retaining screws. After 6-8 months, bone augmentations of 1.72 to 4.1 mm (mean: 3,83
mm) for the mandibular arch and 2.14 to 6.88 mm (mean: 3,95 mm) for the maxilla
were registered on cone beam CT. Mesh premature (within 4 to 6 weeks) exposure
was observed in three cases and delayed (after 4 to 6 weeks) in three other cases.
One titanium mesh was removed before the programmed time, but in all augmented
sites was possible implant insertion. No complication occurred during prosthetic follow-
up. CAD-CAM technology used for prosthetically guided bone augmentation showed
important post-operative morbidity of mesh exposure (66%). Due to this high number of
mesh exposure and the potential infection that could affect the expected bone
augmentation, this study suggests a cautious approach to this procedure when
designing the Ti-mesh, to avoid flap tension that may cause mucosal rupture.
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1 Title:
2 Prosthetically CAD-CAM guided bone augmentation of atrophic jaws using customized titanium
3 mesh: preliminary results of an open prospective study.
4 Leonardo Cioccaa, Giuseppe Liziob, Paolo Baldissarac, Alessandro Sambucod, Roberto Scottie, Giuseppe
5 Corinaldesif
6 a
DDS, PhD, Professor of Maxillo-Facial Prosthodontics, Section of Prosthodontics, Department of Biomedical and Neuromotor Science,
7 Alma Mater Studiorum University of Bologna
8 Via S. Vitale 59
9 40125 Bologna Italy
10 Fax: +39 051 225208
11 E-mail: leonardo.ciocca@unibo.it
12
13 b
DDS, PhD, Research Assistant. Section of Oral Surgery, Department of Biomedical and Neuromotor Science, Alma Mater Studiorum
14 University of Bologna
15 Via S. Vitale 59
16 40125 Bologna Italy
17 Fax: +39 051 225208
18 E-mail: giuseppelizio@libero.it
19
20 c
DDS, PhD, Aggregate Professor, Section of Prosthodontics, Department of Biomedical and Neuromotor Science, Alma Mater
21 Studiorum University of Bologna
22 Via S. Vitale 59
23 40125 Bologna Italy
24 Fax: +39 051 225208
25 E-mail: paolo.baldissara@unibo.it
26
27 d
DDS, Private practice, Bologna, Italy
28
29 e
MD, DDS, Professor and Dean of Oral and Maxillo-Facial Rehabilitation, Section of Prosthodontics, Department of Biomedical and
30 Neuromotor Sciences, Alma Mater Studiorum University of Bologna
31 Via S. Vitale 59
32 40125 Bologna Italy
33 Fax: +39 051 225208
34 E-mail: roberto.scotti@unibo.it
35
36 f
DDS, PhD, Aggregate Professor, Section of Oral and Maxillofacial surgery, Department of Biomedical and Neuromotor Science, Alma
37 Mater Studiorum University of Bologna
38 Via S. Vitale 59
39 40125 Bologna – Italy
40 Fax: 0039 051 225208
41 E-mail: giuseppe.corinaldesi@unibo.it
42
43 Correspondence address:
44 Dr. Leonardo Ciocca
45 Via S. Vitale 59
46 40125 Bologna Italy
47 Fax: +39 051 225208 E-mail: leonardo.ciocca@unibo.it
48
60 This study evaluated the outcomes of CAD-CAM customized titanium mesh used for
61 prosthetically guided bone augmentation related to the occlusion driven implant position;
62 to the vertical bone volume gain of mandible and maxilla; and to complications, like mesh
63 exposure.. Nine patients scheduled for bone augmentation of atrophic sites were treated
64 with custom titanium mesh and particulate bone grafts with autologous bone and
65 anorganic bovine bone in a 1:1 ratio prior to implant surgery. The bone volume needed to
66 augment was virtually projected based on implants position, width and length, and the
67 mesh design was programmed for the necessary retaining screws. After 6-8 months, bone
68 augmentations of 1.72 to 4.1 mm (mean: 3,83 mm) for the mandibular arch and 2.14 to
69 6.88 mm (mean: 3,95 mm) for the maxilla were registered on cone beam CT. Mesh
70 premature (within 4 to 6 weeks) exposure was observed in three cases and delayed (after
71 4 to 6 weeks) in three other cases. One titanium mesh was removed before the
72 programmed time, but in all augmented sites was possible implant insertion. No
75 mesh exposure (66%). Due to this high number of mesh exposure and the potential
76 infection that could affect the expected bone augmentation, this study suggests a cautious
77 approach to this procedure when designing the Ti-mesh, to avoid flap tension that may
79
80 Keywords:
82
83
84 Introduction
85 Since the 1990s, several studies have described the use of titanium mesh for regeneration
86 of the atrophic maxilla and mandible bones.1-15 Clinical studies of titanium mesh1-16 have
88 ranged between 0%14 and 52.7%7, and the number of early removals was between
91 prosthetically guided bone regeneration (PGBR), describing the step-by-step digital design
92 and rapid prototyping (RP) procedures required to obtain custom-made mesh for minimal
95 the bone augmentation of atrophic maxillary arches. The operation time and the number
96 of retaining screws were significantly lower than those in the conventional group (both p <
97 0.01); the incidence of mucosal rupture with mesh exposure and the number of infections
98 were not significantly different between groups (p = 0.27 for both variables).
99 This study presents preliminary data on nine patients undergoing bone augmentation of
100 partially or totally atrophic maxillary arches using customized titanium mesh prior to
101 implant surgery. The aims of this pilot study were to evaluate the outcomes of customized
102 titanium mesh loaded with autologous bone chips and anorganic bovine bone (Bio-Oss;
103 Geistlich Pharma, Wolhusen, Switzerland) in a 1:1 ratio and used for prosthetically guided
104 bone augmentation; to calculate the vertical bone volume gain of the mandible and
109 (approval no. 121/2013/O/Disp). Nine healthy patients, six women and three men with a
110 mean age of 50 years (range: 25 to 68 years), with no systemic contraindications for
111 treatment (diabetes mellitus or heavy smoking, > 10 cigarettes a day) were included in this
113
115 Each implant site was evaluated in either the mandible and/or the maxilla by positioning an
116 at least 8-mm long implant (WinSix; Biosafin Srl, Ancona, Italy; Keystone Dental,
117 Burlington, MA, USA) and observing the required bone regeneration, via data obtained
118 with CBCT (NewTom; Cefla, Verona, Italy). Using NobelClinician software (Nobel Biocare,
119 Kloten, Switzerland), each dental element was positioned as a function of the occlusion in
120 relation to the bucco–palatal/lingual position of the opposite masticatory arch, according to
121 the concept of prosthetically guided bone regeneration.(Fig. 1). Because NobelClinician
122 does not include volume calculation for grafting procedures, the two-dimensional (2D)
123 project screenshots (upper, frontal, and lateral views) were imported into the Mimics
124 Innovation Suite software (ver. 17.0; Materialise, Leuven, Belgium) for conversion into
125 three-dimensional (3D) models. The skull of the maxilla and the mandible was
126 reconstructed by setting the same threshold values used in NobelClinician. Then, the plan
127 was exported into general-purpose CAD software (Freeform Modelling Plus, ver. 13.0; 3D
128 Systems, Rock Hill, SC, USA) to design the bone augmentation, guided by the positions of
130
132 The 1.5-mm safety zone around each implant was virtually modeled to provide the minimal
133 bone width/height of available bone to enhance the clinical safety of the implant
134 procedure. (Fig. 2 a,b) Over this augmented bone volume, we projected an over-
135 contouring of 1.5 mm thickness to compensate for the biological formation of the pseudo-
136 periosteum (connective tissue)21 that typically develops between the titanium mesh and
137 the bone. (Fig. 2c) The mesh was calibrated at a 0.3-mm thickness, and holes in the mesh
138 were calibrated at 1-mm diameter for printing with the direct metal laser sintering (DMLS)
140
142 After completing the CAD design, the Standard Tesselation Language (STL) file was 3D-
143 printed using an EOSINT M270 (Electro Optical Systems, Munich, Germany), a DMLS
144 machine. The metal powder used for RP was Titanium Ti64, a pre-alloyed Ti6AIV4 alloy in
145 fine powder form with excellent mechanical properties and corrosion resistance, low
146 specific weight, and high biocompatibility. The thickness of the mesh was reduced up to
147 0.1 mm by laminating the metal after printing without increasing its fragility.
150 (according to a planned minimal intervention), and its influence on the final outcome
154 The observation period ranged from 6 to 18 months after implant placement. Patients were
155 scheduled to undergo the bone augmentation procedure under general or local
156 anesthesia, depending on whether the autologous bone graft was harvested from the iliac
157 crest or the mandibular ramus. A midcrestal incision was made, maximizing the keratinized
158 mucosa on each side of the incision over the atrophic edentulous ridge. Perforations into
159 the marrow space were produced using a round bur to improve vascularization and
160 incorporation of the graft (Fig. 3a). The mesh was loaded with autologous bone chips
161 (harvested from the mandibular ramus or the iliac crest) and anorganic bovine bone (Bio-
162 Oss; Geistlich Pharma, Wolhusen, Switzerland) in a 1:1 ratio and was fixed with one, or at
163 most two, osteo-synthesis screws (Synthes, West Chester, PA, USA) (Fig. 3b). Releasing
164 incisions of the periosteum along the buccal flap allowed extension of the flap coronally
165 over the mesh to enable passive primary closure. The flap was sutured with Vicryl 4-0
166 (Johnson & Johnson Intl, Ethicon GmbH, Norderstedt, Germany). Postoperatively, patients
167 received antibiotic (amoxicillin and clavulanic acid) and analgesic (ibuprofen) and were
168 instructed to rinse twice daily for 2 weeks (digluconate chlorhexidine, 0.12%).
169 After a 6–8-month healing period, a new CT scan dataset was collected to verify the bone
170 augmentation prior to implant surgery. In all patients, the regenerated bone was sufficient
171 to position the planned implants (n = 26). At the time of implant surgery, the titanium mesh
172 was removed, and the implants were inserted using a two-step technique (submerged
173 implants). After 4-month (maxilla) and 3-month (mandible) healing periods, the implants
174 were uncovered, and prosthetic procedures for construction of the prosthesis were
175 performed (Fig. 4). No implant failure was observed after a 2-year follow-up.
176
178 CT data of post-operative results after implant surgery were used to calculate the bone
179 gain obtained with regenerative therapy. The linear vertical bone augmentation was
180 calculated based on superimposition of the pre-op and post-op CT. A virtual calculation of
181 bone augmentation was performed in relation to each planned implant site (Fig. 5, 6).
182 Table 2 shows all results of the pre/post-op bone augmentation, the incidence and timing
184
185 Bone augmentation results
186 The vertical bone augmentation was digitally measured in relation to the long axis of each
187 programmed implant site. The single values of the augmentation are presented in Table 2.
188 Results data were not considered as mean values to compare with other studies because
189 of their individual specific planning for minimal bone augmentation. However, the data
190 showed 1.72 mm to 4.1 mm of bone reconstruction in the mandible and 2.14 to 6.88 mm in
192
194 Table 2 provides data on the exposure and removal time of the mesh: three of nine
195 patients showed premature exposure of the mesh (2 to 4 weeks), and three of nine
196 patients showed a delayed exposure (10–24 weeks). All meshes except one, which was
197 removed at 3 months with evident discharge of purulent exudate, were removed at 6–8
198 months after surgery. The mesh exposures were examined every 2 months for clinical
199 signs of infection, and the patients were instructed to use a soft toothbrush to apply
200 chlorhexidine digluconate gel 1% (Corsodyl gel; GlaxoSmithKline, Baranzate, Italy) twice a
202
203 Discussion
204 Several studies have supported the excellent mechanical properties of commercial (non-
205 customized) titanium mesh: sufficient rigidity, plasticity for manual bending, and elasticity
206 for the prevention of flap compression.4,19-22 Ciocca et al.24 described a further problem
207 with commercial mesh. After superimposition of the mesh post-op CT data on the planned
208 volume of bone to restore, they registered a compression of the mesh in the palatal area
209 that was interpreted as possible being due to wearing the prosthesis (full denture) during
210 follow-up for regenerative surgery, or as a probable further deformation due to screw
212 Other studies reported the results of customized titanium mesh in terms of accuracy when
213 using RP techniques25,26 The CAD-CAM technology used in this study allowed for
214 programming of the ideal position of implants for atrophic maxillary/mandibular total or
215 partial arches, taking into account the occlusal intermaxillary relationship by using CAD
216 software; moreover, this procedure permitted projecting the least bone augmentation
217 required for implant surgery. When designing the mesh, the virtual project must consider,
218 as an over-contouring with respect to the expected bone augmentation, the width (1.2–1.5
219 mm) of the connective tissue that develops between the mesh and the regenerated bone
220 (pseudo-periosteum). Moreover, the time saving afforded by intraoperative mesh cutting,
221 the bending and adaptation, and the post-op site morbidity due to the limited bone harvest
222 (in turn due to the planned augmentation) represent advantages of this protocol.
223 In terms of bone augmentation, two main variables were analyzed: the increase in the
224 vertical bone level, and mesh exposure. For the first variable, the method described by
225 Ciocca et al. (2011)27 was used to calculate the amount of bone (Fig. 6). The premature
226 (within 4–6 weeks) or delayed (after 4–6 weeks) exposure of the mesh did not limit bone
227 augmentation (mean value: 3.83 mm for the mandible and 3.95 mm for the maxilla) for
228 purposes of the implant surgery, as all programmed implants were positioned according to
229 the treatment plan, even after premature mesh exposure. However, in this case series
230 study, the incidence of mesh exposure was important, and consequently there was a
231 possibility of infection that could jeopardize the desired augmentation. In this regard six
232 patients reported mesh exposure (66%), and one needed to remove the mesh early (3
233 months) to prevent infection risks. Although all instances of wound dehiscence were
234 controlled with local antibacterial rinse and gel during the 6–8-month follow-up before
235 mesh removal, the continuous monitoring of these situations is a weakness of this
236 procedure. This rate of mesh exposure might be due to the stiffness of the Ti-mesh, which
237 could cause mechanical irritation to the mucosal flap 24 that may be worsened if a
238 provisional removable prosthesis is used in the edentulous augmented crest during the
239 healing period. Mesh exposure may be also due to the learning curve associated with
240 CAD-CAM mesh projecting: when virtual design of the mesh is performed, the mesiodistal
241 end of the titanium mesh should be separated at least 2 mm from the adjacent tooth, to
242 avoid creating a pathway for the penetration of bacteria. Moreover, the external shape of
243 the mesh should be projected as smoothly as possible to avoid flap tension that can lead
244 to mucosal rupture. However, no flap re-suturing was required, and even if these
245 complications occurred, they did not influence implant treatment, and no implant failure or
246 bone loss was noted during the follow-up or after the prosthetic rehabilitation.
247 A disadvantage of this technique may be the cost of the CAD-CAM process needed to
248 prototype the titanium mesh: in comparison with a standard commercially available mesh,
249 the cost was slightly higher (USD $425), but the surgical advantage of operation time
251 No sample sizing or power evaluation was performed in this study due to the limited
252 number of implant sites, which does not permit inferential considerations. Further studies
253 are required to develop new resorbable and sufficiently rigid and smoothed mesh that may
255
256 Conclusions
257 This study suggests a cautious approach to this procedure, because the CAD-CAM
258 technology used for prosthetically guided bone augmentation was less successful than
259 expected, especially in terms of post-operative morbidity due to mesh exposure. However,
260 this protocol allowed positioning of all programmed implants according to the treatment
261 plan and simplified the surgery by reducing the number of retaining screws to one, or at
263
264
265
266
267 ABBREVIATIONS
268 PGBR: prosthetically guided bone regeneration
269 CAD-CAM: computer aided design–computer aided machining
270 CT: computed tomography
271 RP: rapid prototyping
272 USD: United States dollar
273
274
275 References
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356
357
358 Figure legends
359 Fig. 1 Virtual implant positioning.
360
361 Fig. 2 Mesh design. a: frontal view; b: palatal view; c: calculation of the pseudo-periosteum.
362
363 Fig. 3: a: Evidence of maxillary atrophy especially in width; b: Rapid prototyping of the mesh and surgical
364 application with two screws.
365
366 Fig. 4 Prosthetic procedures. a: Digital impression; b: try-in of the prototyped metal framework; c: Prosthetic
367 rehabilitation.
368
369 Fig. 5 Schematic diagram of the bone augmentation pre-op planning in reference to each implant head.
370
371 Fig. 6 Actual calculation by superimposition of pre- (red) and post-operative (B/W) computed tomography
372 (CT) data.
373
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