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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Load-bearing capacity of screw-retained CAD/CAM-produced titanium implant
frameworks (I-Bridge<sup>®</sup>
2) before and after cyclic mechanical
loading</title>
<author><name sortKey="Dittmer, Marc Philipp" sort="Dittmer, Marc Philipp" uniqKey="Dittmer M" first="Marc Philipp" last="Dittmer">Marc Philipp Dittmer</name>
<affiliation><nlm:aff id="aff01"> PD Dr, Private Practice, Hannover, Germany.</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Nensa, Moritz" sort="Nensa, Moritz" uniqKey="Nensa M" first="Moritz" last="Nensa">Moritz Nensa</name>
<affiliation><nlm:aff id="aff02"> Clinic for Maxillofacial Surgery, Plastic Surgery, Implant Center, Stuttgart, Germany.</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Stiesch, Meike" sort="Stiesch, Meike" uniqKey="Stiesch M" first="Meike" last="Stiesch">Meike Stiesch</name>
<affiliation><nlm:aff id="aff03"> Professor Dr., Head of the Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kohorst, Philipp" sort="Kohorst, Philipp" uniqKey="Kohorst P" first="Philipp" last="Kohorst">Philipp Kohorst</name>
<affiliation><nlm:aff id="aff04"> PD Dr., Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.</nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">24037068</idno>
<idno type="pmc">3881892</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3881892</idno>
<idno type="RBID">PMC:3881892</idno>
<idno type="doi">10.1590/1679-775720130077</idno>
<date when="2013">2013</date>
<idno type="wicri:Area/Pmc/Corpus">000612</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000612</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Load-bearing capacity of screw-retained CAD/CAM-produced titanium implant
frameworks (I-Bridge<sup>®</sup>
2) before and after cyclic mechanical
loading</title>
<author><name sortKey="Dittmer, Marc Philipp" sort="Dittmer, Marc Philipp" uniqKey="Dittmer M" first="Marc Philipp" last="Dittmer">Marc Philipp Dittmer</name>
<affiliation><nlm:aff id="aff01"> PD Dr, Private Practice, Hannover, Germany.</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Nensa, Moritz" sort="Nensa, Moritz" uniqKey="Nensa M" first="Moritz" last="Nensa">Moritz Nensa</name>
<affiliation><nlm:aff id="aff02"> Clinic for Maxillofacial Surgery, Plastic Surgery, Implant Center, Stuttgart, Germany.</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Stiesch, Meike" sort="Stiesch, Meike" uniqKey="Stiesch M" first="Meike" last="Stiesch">Meike Stiesch</name>
<affiliation><nlm:aff id="aff03"> Professor Dr., Head of the Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kohorst, Philipp" sort="Kohorst, Philipp" uniqKey="Kohorst P" first="Philipp" last="Kohorst">Philipp Kohorst</name>
<affiliation><nlm:aff id="aff04"> PD Dr., Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">Journal of Applied Oral Science</title>
<idno type="ISSN">1678-7757</idno>
<idno type="eISSN">1678-7765</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p>Implant-supported screw-retained fixed dental prostheses (FDPs) produced by CAD/ CAM
have been introduced in recent years for the rehabilitation of partial or total
endentulous jaws. However, there is a lack of data about the long-term mechanical
characteristics.</p>
<sec><title>Objective</title>
<p>The aim of this study was to investigate the failure mode and the influence of
extended cyclic mechanical loading on the load-bearing capacity of these
frameworks.</p>
</sec>
<sec><title>Material and Methods</title>
<p>Ten five-unit FDP frameworks simulating a free-end situation in the mandibular jaw
were manufactured according to the I-Bridge<sup>®</sup>
2-concept
(I-Bridge<sup>®</sup>
2, Biomain AB, Helsingborg, Sweden) and each was
screw-retained on three differently angulated Astra Tech implants (30º buccal
angulation/0º angulation/30º lingual angulation). One half of the specimens was
tested for static load-bearing capacity without any further treatment (control),
whereas the other half underwent five million cycles of mechanical loading with
100 N as the upper load limit (test). All specimens were loaded until failure in a
universal testing machine with an occlusal force applied at the pontics.
Load-displacement curves were recorded and the failure mode was macro- and
microscopically analyzed. The statistical analysis was performed using a t-test
(p=0.05). </p>
</sec>
<sec><title>Results</title>
<p>All the specimens survived cyclic mechanical loading and no obvious failure could
be observed. Due to the cyclic mechanical loading, the load-bearing capacity
decreased from 8,496 N±196 N (control) to 7,592 N±901 N (test). The cyclic
mechanical loading did not significantly influence the load-bearing capacity
(p=0.060). The failure mode was almost identical in all specimens: large
deformations of the framework at the implant connection area were obvious. </p>
</sec>
<sec><title>Conclusion</title>
<p>The load-bearing capacity of the I-Bridge<sup>®</sup>
2 frameworks is much higher
than the clinically relevant occlusal forces, even with considerably angulated
implants. However, the performance under functional loading <italic>in
vivo</italic>
depends on additional aspects. Further studies are needed to
address these aspects.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Appl Oral Sci</journal-id>
<journal-id journal-id-type="iso-abbrev">J Appl Oral Sci</journal-id>
<journal-id journal-id-type="publisher-id">J. Appl. Oral. Sci.</journal-id>
<journal-title-group><journal-title>Journal of Applied Oral Science</journal-title>
</journal-title-group>
<issn pub-type="ppub">1678-7757</issn>
<issn pub-type="epub">1678-7765</issn>
<publisher><publisher-name>Faculdade de Odontologia de Bauru da Universidade de São
Paulo</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">24037068</article-id>
<article-id pub-id-type="pmc">3881892</article-id>
<article-id pub-id-type="doi">10.1590/1679-775720130077</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject>
</subj-group>
</article-categories>
<title-group><article-title>Load-bearing capacity of screw-retained CAD/CAM-produced titanium implant
frameworks (I-Bridge<sup>®</sup>
2) before and after cyclic mechanical
loading</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>DITTMER</surname>
<given-names>Marc Philipp</given-names>
</name>
<xref ref-type="aff" rid="aff01">1</xref>
<xref ref-type="corresp" rid="c01"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>NENSA</surname>
<given-names>Moritz</given-names>
</name>
<xref ref-type="aff" rid="aff02">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>STIESCH</surname>
<given-names>Meike</given-names>
</name>
<xref ref-type="aff" rid="aff03">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>KOHORST</surname>
<given-names>Philipp</given-names>
</name>
<xref ref-type="aff" rid="aff04">4</xref>
</contrib>
</contrib-group>
<aff id="aff01"><label>1</label>
PD Dr, Private Practice, Hannover, Germany.</aff>
<aff id="aff02"><label>2</label>
Clinic for Maxillofacial Surgery, Plastic Surgery, Implant Center, Stuttgart, Germany.</aff>
<aff id="aff03"><label>3</label>
Professor Dr., Head of the Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.</aff>
<aff id="aff04"><label>4</label>
PD Dr., Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.</aff>
<author-notes><corresp id="c01"><bold>Corresponding address:</bold>
Marc Philipp Dittmer - Kleinertstr. 9 - 30627 -
Hannover - Germany - Phone: +49 (0) 511 7602151 - e-mail:
<email>marc@drdittmer.de</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><season>Jul-Aug</season>
<year>2013</year>
</pub-date>
<volume>21</volume>
<issue>4</issue>
<fpage>307</fpage>
<lpage>313</lpage>
<history><date date-type="received"><day>16</day>
<month>1</month>
<year>2013</year>
</date>
<date date-type="rev-recd"><day>26</day>
<month>3</month>
<year>2013</year>
</date>
<date date-type="accepted"><day>10</day>
<month>5</month>
<year>2013</year>
</date>
</history>
<permissions><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/"><license-p>This is an Open Access article distributed under the terms of the Creative
Commons Attribution Non-Commercial License which permits unrestricted
non-commercial use, distribution, and reproduction in any medium, provided the
original work is properly cited. </license-p>
</license>
</permissions>
<abstract><p>Implant-supported screw-retained fixed dental prostheses (FDPs) produced by CAD/ CAM
have been introduced in recent years for the rehabilitation of partial or total
endentulous jaws. However, there is a lack of data about the long-term mechanical
characteristics.</p>
<sec><title>Objective</title>
<p>The aim of this study was to investigate the failure mode and the influence of
extended cyclic mechanical loading on the load-bearing capacity of these
frameworks.</p>
</sec>
<sec><title>Material and Methods</title>
<p>Ten five-unit FDP frameworks simulating a free-end situation in the mandibular jaw
were manufactured according to the I-Bridge<sup>®</sup>
2-concept
(I-Bridge<sup>®</sup>
2, Biomain AB, Helsingborg, Sweden) and each was
screw-retained on three differently angulated Astra Tech implants (30º buccal
angulation/0º angulation/30º lingual angulation). One half of the specimens was
tested for static load-bearing capacity without any further treatment (control),
whereas the other half underwent five million cycles of mechanical loading with
100 N as the upper load limit (test). All specimens were loaded until failure in a
universal testing machine with an occlusal force applied at the pontics.
Load-displacement curves were recorded and the failure mode was macro- and
microscopically analyzed. The statistical analysis was performed using a t-test
(p=0.05). </p>
</sec>
<sec><title>Results</title>
<p>All the specimens survived cyclic mechanical loading and no obvious failure could
be observed. Due to the cyclic mechanical loading, the load-bearing capacity
decreased from 8,496 N±196 N (control) to 7,592 N±901 N (test). The cyclic
mechanical loading did not significantly influence the load-bearing capacity
(p=0.060). The failure mode was almost identical in all specimens: large
deformations of the framework at the implant connection area were obvious. </p>
</sec>
<sec><title>Conclusion</title>
<p>The load-bearing capacity of the I-Bridge<sup>®</sup>
2 frameworks is much higher
than the clinically relevant occlusal forces, even with considerably angulated
implants. However, the performance under functional loading <italic>in
vivo</italic>
depends on additional aspects. Further studies are needed to
address these aspects.</p>
</sec>
</abstract>
<kwd-group><kwd>Dental implants</kwd>
<kwd>Implant-supported dental prosthesis</kwd>
<kwd>Dental implant-abutment connection</kwd>
</kwd-group>
<funding-group><award-group><funding-source>Biomain</funding-source>
</award-group>
</funding-group>
</article-meta>
</front>
<body><sec><title>INTRODUCTION</title>
<p>Since the long-term success rates of osseointegrated dental implants may be as high as
99%<sup><xref ref-type="bibr" rid="r20">20</xref>
</sup>
, this treatment option has
become increasingly important in the field of oral rehabilitation. Besides single tooth
replacement<sup><xref ref-type="bibr" rid="r08">8</xref>
</sup>
, oral implants
offer the possibility of rehabilitating partial and total edentulous jaws with fixed
(FDPs) or removable dental prostheses (RDPs)<sup><xref ref-type="bibr" rid="r16">16</xref>
</sup>
. However, meta-analyses have shown that there is insufficient
evidence to establish clinical guidelines for either FDPs or RDPs in partially
edentulous jaws<sup><xref ref-type="bibr" rid="r02">2</xref>
,<xref ref-type="bibr" rid="r30">30</xref>
</sup>
. Notwithstanding, most patients prefer implant-supported
FDPs, since this kind of prosthesis replaces the tooth under as natural conditions as
possible.</p>
<p>Implant-supported FDPs can be connected to the implant fixture in two ways. The first
option is to place a screw-retained abutment onto the endosseal implant and to fix the
FDP by conventional cementation; with the second option, the superstructure is directly
connected with the implant by a screw. There have been no consistent conclusions about
the long-term success of the two connection types: Nissan, et al.<sup><xref ref-type="bibr" rid="r21">21</xref>
</sup>
(2011) reported that the long-term
outcome of cemented implant-supported FDPs was superior to that of screw-retained
FDPs<sup><xref ref-type="bibr" rid="r21">21</xref>
</sup>
. In contrast, the results
of Sherif, et al.<sup><xref ref-type="bibr" rid="r29">29</xref>
</sup>
(2011) indicate
that screw and cement-retained restorations are equivalent with respect to most success
parameters as assessed by the clinician or patient<sup><xref ref-type="bibr" rid="r29">29</xref>
</sup>
. A major problem with all implant-supported FDPs was identified
in a systematic review: technical complications related to implant components and
suprastructures were reported in 60-80% of the studies included, whereas the fixture
failed in less than 1% of the cases <italic>in vivo</italic>
<sup><xref ref-type="bibr" rid="r05">5</xref>
</sup>
. Implant overload was thought to be responsible for
cracks developing in the material, leading to catastrophic failure even after short
periods of function<sup><xref ref-type="bibr" rid="r22">22</xref>
</sup>
.</p>
<p>Cemented FDPs are aesthetically superior, since they have no screw channel and
angulations of the implant can be compensated by the abutment. Furthermore, fabrication
tolerances are adjusted by the cement layer and bacterial microleakage is less,
especially in combination with a conical implant-abutment connection<sup><xref ref-type="bibr" rid="r04">4</xref>
</sup>
. However, removal of the superstructure
for maintenance or hygienic reasons is very demanding or even impossible. In contrast,
with screw-retained FDPs, these procedures can be handled easily, for example if a
fixation screw has become loose or has failed, or another technical or biological
maintenance is needed. A further advantage of these FDPs is that they are less expensive
due to minor complexity of the manufacturing process if CAD/CAM technology is applied.
Nevertheless, screw-retained FDPs require a passive fit and some studies have reported
that CAD/CAM produced frameworks may exhibit misfits and deformation stresses<sup><xref ref-type="bibr" rid="r11">11</xref>
,<xref ref-type="bibr" rid="r18">18</xref>
</sup>
.</p>
<p>One example of a screw-retained FDP is the I-Bridge<sup>®</sup>
2, introduced in 2005 by
Biomain (Biomain AB, Helsingborg, Sweden). This kind of restoration is a CAD/CAM-milled
implant bridge of either titanium or cobalt chromium alloy with the possibility of
angling the screw channels by up to 20º. Due to this angulation, the screw channels can
be placed at the oral side of the FDP, especially in the anterior region, thus making it
possible to build FDPs with larger spans with satisfactory aesthetics. Furthermore, this
system is compatible with most established implant systems, since the FDP can be
directly connected to the fixture or with a special abutment between the implant and
framework, e.g. with Astra Tech (see <xref ref-type="fig" rid="f01">Figure
1</xref>
).</p>
<fig id="f01" orientation="portrait" position="float"><label>Figure 1</label>
<caption><p>Schematic cross-section of the I-Bridge<sup>®</sup>
2 system</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g01"></graphic>
</fig>
<p>There is a lack of information about the mechanical characteristics of screw-retained
FDPs, especially when these are connected directly with the implant fixture. The authors
expect major stresses and distortions within the connection area and the screw which may
affect the mechanical characteristics of these restorations. The aim of the present
study was therefore to evaluate the load-bearing capacity of a five-unit milled titanium
implant framework (I-Bridge<sup>®</sup>
2, Biomain AB, Helsingborg, Sweden) supported by
three implants and to test the influence of artificial aging from cyclic mechanical
loading on the load-bearing capacity. Additionally, failed specimens were micro- and
macroscopically analyzed to identify the failure modes.</p>
<p>The hypotheses to be tested within the present study were: 1) Load-bearing capacity of
screw-retained, five-unit milled titanium implant frameworks supported by considerably
angulated implants is higher than static functional forces occurring in the posterior
region. 2) Even after extended cyclic mechanical loading specimens show a stable
implant-framework connection and a sufficient load-bearing capacity for use in the
posterior area.</p>
</sec>
<sec sec-type="materials|methods"><title>MATERIAL AND METHODS</title>
<sec><title>Fabrication of the master model and framework pattern</title>
<p>For each test specimen, three implants had to be reproducibly placed into a
bone-simulating socket. A master model was prepared for this purpose: a silicone
negative (Optosil<sup>®</sup>
, Heraeus Kulzer, Hanau, Germany) of a block - 55 mm in
length, 25 mm in height and 25 mm in depth - served as the parent for all sockets.
The silicone form was cast once with polyurethane (AlphaDie Top<sup>®</sup>
, Schütz
Dental GmbH, Rosbach, Germany) to generate a master socket for the implants in order
to simulate placement in the right mandibular canine (43), the right mandibular
second premolar (45) and the right mandibular second molar (47) region. To mimic a
realistic clinical worst-case scenario with respect to the shape of the mandibular
jaw, the implants were angulated as follows: 43: 30º buccal angulation, 45: no
angulation, 47: 30º lingual angulation. Drilling holes for implant analogues were
prepared with a device for the manufacturing of surgical templates
(gonyX<sup>®</sup>
, Straumann GmbH, Freiburg, Germany), thus guaranteeing the
predefined angulation and drilling hole depth. Implant analogues were placed into the
drilling holes and fixed with acrylic resin (Palavit<sup>®</sup>
G, Heraeus Kulzer,
Hanau, Germany) in such a manner that a simulated bone loss of 3 mm from the implant
shoulder was considered in accordance with ISO 14801<sup><xref ref-type="bibr" rid="r15">15</xref>
</sup>
. The distances between the center points of the
implants were 14 mm (43-45) and 19 mm (45-47). In the next step, the implant
analogues were prepared for modelling an I-Bridge<sup>®</sup>
2 master framework by
adding viscous acrylic resin (Pattern Resin LS, GC International Corp., Tokyo, Japan)
(see <xref ref-type="fig" rid="f02">Figure 2</xref>
). For this purpose, special
components of the I-Bridge<sup>®</sup>
2 system, called the I-Flex<sup>TM</sup>
(see
<xref ref-type="fig" rid="f03">Figure 3</xref>
), were fixed at the implant
analogues. The I-Flex<sup>TM</sup>
is a screw with a spherical head that serves as a
substructure for the modelling and is used to define the angling of the screws
connecting the implant and the framework. Modelling caps were then placed onto the
substructure and the FDP was modelled in such a manner that the occlusal surfaces
were planar, except for both pontics, where small cavities were included for the
exact load application. The distance between the shoulder of the middle implant and
the occlusal surface was 12 mm (<xref ref-type="fig" rid="f02">Figure 2</xref>
).
Finally, the whole model was sent to the manufacturer (Biomain<sup>®</sup>
), for
scanning of the implant situation and the master framework and for milling 10
identical titanium frameworks according to the I-Bridge<sup>®</sup>
2 system.</p>
<fig id="f02" orientation="portrait" position="float"><label>Figure 2</label>
<caption><p> I-Bridge®2 master framework made of acrylic resin</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g02"></graphic>
</fig>
<fig id="f03" orientation="portrait" position="float"><label>Figure 3</label>
<caption><p>Special components of the I-Bridge®2 system, called the I-Flex™, placed on the
implants prior to master framework modelling</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g03"></graphic>
</fig>
</sec>
<sec><title>Fabrication of specimens</title>
<p>Using the special abutment (Biomain<sup>®</sup>
) as interconnecting components (see
also <xref ref-type="fig" rid="f01">Figure 1</xref>
), original implants
(OsseoSpeed<sup>TM</sup>
4.0 S, 13 mm length, Astra Tech, Mölndal, Sweden) were
fixed to the frameworks with the corresponding screws. The framework-implant
assemblies were then consecutively placed in the above mentioned silicone negative
which was afterwards poured out with polyurethane (AlphaDie Top<sup>®</sup>
, Schütz
Dental GmbH, Rosbach, Germany). After the curing process was finished, all
implant-framework connections were removed. To assure reproducible assemblies, the
abutment and the frameworks were reconnected to the implants with the corresponding
screws and the torque given by the manufacturer (implant-abutment 15 Ncm,
abutment-framework 20 Ncm). Five specimens were randomly selected for cyclic
mechanical loading and prepared with a resilient silicone bearing at the socket
(Mollosil Plus, DETAX, Ettlingen, Germany), in order to prevent socket fracture due
to non-planar contact during cyclic loading.</p>
</sec>
<sec><title>Cyclic mechanical loading</title>
<p>Specimens of the test group underwent five million cycles of mechanical loading in a
chewing simulator (machine shop, Hannover Medical School, Hannover, Germany), with
100 N as the upper load limit at a frequency of 2.5 Hz prior to final testing. After
every 250,000 load cycles, the specimens were macroscopically checked to see whether
the screws had loosened or failed. For this purpose, the mechanical loading was
stopped and the specimens were macroscopically evaluated by visual inspection
regarding the potential changes in the construction. Furthermore, the stiffness of
the screw connection was tested by use of the recommended screw driver without
applying an additional force to the complex. As <xref ref-type="fig" rid="f04">Figure
4</xref>
shows, the load was applied onto the pontics at two points 16.5 mm apart
via two tungsten carbide balls (diameter 6.0 mm) on interposed tin foils (thickness
0.2 mm) to ensure an equally distributed load application. The loading piston was
mounted using an intermediate silicone layer (Mollosil Plus, DETAX, Ettlingen,
Germany) to prevent point-wise overload and to guarantee a homogeneous load
application (see <xref ref-type="fig" rid="f04">Figure 4</xref>
). Since a survey has
revealed that the average number of chewing cycles is about 800,000
<italic>per</italic>
year<sup><xref ref-type="bibr" rid="r25">25</xref>
</sup>
, the
five million cycles applied in this study corresponded to an <italic>in-vivo</italic>
service period of approximately 75 months (6 years, 3 months).</p>
<fig id="f04" orientation="portrait" position="float"><label>Figure 4</label>
<caption><p>I-Bridge<sup>®</sup>
2 in the universal test instrument prior to cyclic
mechanical loading. The force was transferred to the pontics via two tungsten
carbide balls</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g04"></graphic>
</fig>
</sec>
<sec><title>Load until failure testing</title>
<p>After cyclic mechanical loading, the resilient silicone socket bearing and the tin
foils were removed and the test and control specimens were loaded in a universal
testing machine (Type 20K, UTS Testsysteme, Ulm-Einsingen, Germany).
Load-displacement curves were recorded until failure (defined as a drop in load of
more than 500 N, see <xref ref-type="fig" rid="f05">Figure 5</xref>
). The load piston
was the same as that used for the cyclic mechanical loading; the crosshead speed was
1 mm/min. The statistical analysis was performed using the t-test for independent
groups, with the level of significance set at p=0.05.</p>
<fig id="f05" orientation="portrait" position="float"><label>Figure 5</label>
<caption><p>Exemplarily chosen load-displacement curve of a test specimen</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g05"></graphic>
</fig>
</sec>
<sec><title>Failure analysis</title>
<p>Before and after testing, all specimens were macro- and microscopically analyzed at
the interface of the implant and superstructure, using a reflected light microscope
(M3Z, Wild, Heerbrugg, Switzerland). Failure modes were documented via a digital
camera (ProgRes C12 plus, Jenoptik, Jena, Germany) with all pictures including a
scale bar. Changes in the frameworks' geometry due to load testing were evaluated by
comparing pictures of the specimens before and after the testing procedure.</p>
<p>Additionally, one specimen from each test group was selected for cross-sectional
analysis. For this purpose, the specimens were embedded in clear methylmethacrylate
(Acryfix, Struers GmbH, Willich, Germany) and mid-sectioned along the longitudinal
axis of each implant in the bucco-lingual direction using a diamond saw (IsoMet 4000,
Buehler, Illinois, USA). After polishing the cross-sectional surface to a roughness
depth of less than 9 µm, the internal configuration was visually inspected and
photographed under a reflected-light microscope (M3Z, Wild, Heerbrugg, Switzerland)
at tenfold magnification to evaluate the failure mode.</p>
</sec>
</sec>
<sec sec-type="results"><title>RESULTS</title>
<p>All specimens survived cyclic mechanical loading and no obvious failure or screw
loosening could be observed. Load-displacement curves showed a more or less steep
increase until a maximum force was reached, followed by a gradually decreasing force
and, finally, failure.</p>
<p><xref ref-type="table" rid="t01">Table 1</xref>
and <xref ref-type="fig" rid="f06">Figure 6</xref>
show the results of the load-bearing capacity testing. In comparison
to the control group with a load-bearing capacity of 8,496 N±196 N, the aged specimens
exhibited a broad decrease in load-bearing capacity to 7,592 N±901 N. However, the
cyclic mechanical loading did not significantly influence the load-bearing capacity
(p=0.060).</p>
<table-wrap id="t01" orientation="portrait" position="float"><label>Table 1</label>
<caption><p>Mean values (MV), standard deviations (SD), medians (MD), maximum (Max) and
minimum (Min) are given</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
<td colspan="3" align="center" valign="top" style="background-color:#CCCCCC" rowspan="1"><bold>Load-bearing capacity in Newton (N)</bold>
</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
</tr>
<tr><td align="center" rowspan="1" colspan="1"></td>
<td align="center" rowspan="1" colspan="1"><bold>MV</bold>
</td>
<td align="center" rowspan="1" colspan="1"><bold>SD</bold>
</td>
<td align="center" rowspan="1" colspan="1"><bold>MD</bold>
</td>
<td align="center" rowspan="1" colspan="1"><bold>Max</bold>
</td>
<td align="center" rowspan="1" colspan="1"><bold>Min</bold>
</td>
</tr>
</thead>
<tbody><tr><td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">Control</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">8,495.9</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">196.3</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">8,434.8</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">8,723.6</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">8,294.2</td>
</tr>
<tr><td align="center" rowspan="1" colspan="1">Test</td>
<td align="center" rowspan="1" colspan="1">7,591.6</td>
<td align="center" rowspan="1" colspan="1">901.3</td>
<td align="center" rowspan="1" colspan="1">7,850.6</td>
<td align="center" rowspan="1" colspan="1">8,448.0</td>
<td align="center" rowspan="1" colspan="1">6,159.8</td>
</tr>
<tr><td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">p</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1">0.060</td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
<td align="center" style="background-color:#CCCCCC" rowspan="1" colspan="1"></td>
</tr>
</tbody>
</table>
</table-wrap>
<fig id="f06" orientation="portrait" position="float"><label>Figure 6</label>
<caption><p>Box chart representing load-bearing capacity for both test groups. Medians and
quartiles are given</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g06"></graphic>
</fig>
<p>External inspection of the specimens revealed an identical failure mode for all
specimens. Large deformations of the titanium framework in the abutment area accompanied
by a loss of vertical dimension were obvious. Nevertheless, all FDPs were still fixed on
the implants and no screw fracture could be detected.</p>
<p>Analyses of cross-sections showed framework fractures near the abutment in both the
control and test group (see <xref ref-type="fig" rid="f07">Figure 7A-C</xref>
).
Furthermore, the screw threads of the abutment and the implant were deformed. In one
case, the implant head even fractured in the middle of the thread.</p>
<fig id="f07" orientation="portrait" position="float"><label>Figure 7 A-C</label>
<caption><p>Polished cross-sections of embedded failed specimens of the differently angulated
implants (a: +30°, b: 0°, c: -30°). Large deformations of the framework at the
implant connection area are obvious</p>
</caption>
<graphic xlink:href="jaos-21-04-0307-g07"></graphic>
</fig>
</sec>
<sec sec-type="discussion"><title>DISCUSSION</title>
<p>Dental implants are subjected to functional loading during their period of wear
<italic>in vivo</italic>
. Hence, it is of crucial importance to consider cyclic
mechanical loading when evaluating the long-term behaviour of implant-supported
restorations <italic>in vitro</italic>
. Fatigue testing until failure is accepted as a
method to generate data on the fracture strength and implant longevity<sup><xref ref-type="bibr" rid="r23">23</xref>
,<xref ref-type="bibr" rid="r26">26</xref>
</sup>
. A standardized guideline (ISO 14801) for the dynamic fatigue
testing of single implants has been established by the International Organization for
Standardization<sup><xref ref-type="bibr" rid="r15">15</xref>
</sup>
. In contrast
to single implant testing, testing of multi-implant supported FDPs is not yet
standardized, but the experimental setup of the present study was carefully chosen to be
in accordance with ISO 14801. Furthermore, an unfavourable clinical situation was
imitated as best as possible: the distance between the implant shoulder and crestal bone
level was adjusted to 3 mm in order to represent a typical reduction in the bone
support, as recommended in ISO 14801<sup><xref ref-type="bibr" rid="r15">15</xref>
</sup>
. To mimic natural bone, the implants were embedded in reinforced
polyurethane with an elastic modulus similar to that of bone<sup><xref ref-type="bibr" rid="r27">27</xref>
</sup>
. Moreover, since in numerous clinical situations
implants are angulated to the restoration's axis, in particular in the vestibulo-oral
direction<sup><xref ref-type="bibr" rid="r03">3</xref>
</sup>
, in the current test
scenario the anterior (43 region) and the posterior implant (47 region) were angulated
30º off-axis in the buccal and lingual directions, respectively. Cyclic mechanical
loading was performed with a chewing simulator and an upper load limit of 100 N, which
is in accordance with the average bite forces of between 20 N and 120 N, depending on
the nutrition's hardness<sup><xref ref-type="bibr" rid="r28">28</xref>
</sup>
. However, a
fixed number of mechanical cycles (five million) was applied, representing an <italic>in
vivo</italic>
service period of approximately 75 months (6 years, 3 months)<sup><xref ref-type="bibr" rid="r25">25</xref>
</sup>
. This period of wear makes it possible
to draw conclusions on the long-term behaviour of the implant components<sup><xref ref-type="bibr" rid="r07">7</xref>
</sup>
. Even though tests were performed under
highly realistic conditions, the significance of the present study may be limited due to
the sample size of only five specimens <italic>per</italic>
group. Notwithstanding this,
the number of test samples seems to be adequate, since several other authors have
conducted studies on implant connection stability with the same sample size<sup><xref ref-type="bibr" rid="r09">9</xref>
,<xref ref-type="bibr" rid="r10">10</xref>
,<xref ref-type="bibr" rid="r23">23</xref>
</sup>
.</p>
<p>In a systematic review, Berglundh, et al.<sup><xref ref-type="bibr" rid="r05">5</xref>
</sup>
(2002) showed that technical complications related to implant
components and superstructures were reported in 60-80% of the studies included, in
contrast to biological complications in only 40-60% of the studies<sup><xref ref-type="bibr" rid="r05">5</xref>
</sup>
. Screw loosening and joint failure are
major problems<sup><xref ref-type="bibr" rid="r06">6</xref>
,<xref ref-type="bibr" rid="r19">19</xref>
</sup>
. In the present study, no screw loosened or failed
during the cyclic mechanical loading. The locking of multiple implants seems to
stabilize the whole implant-framework assembly<sup><xref ref-type="bibr" rid="r11">11</xref>
</sup>
. Furthermore, this may be due to the passive fit of the
CAD/CAM-milled I-Bridge<sup>®</sup>
2. Abduo, et al.<sup><xref ref-type="bibr" rid="r01">1</xref>
</sup>
(2011) considered that the CAD/CAM is the most consistent method
for screw-retained implant frameworks, potentially giving an excellent fit<sup><xref ref-type="bibr" rid="r01">1</xref>
</sup>
. In contrast, Eliasson, et al.<sup><xref ref-type="bibr" rid="r11">11</xref>
</sup>
(2010) reported clinically acceptable
I-Bridges<sup>®</sup>
without passive fitting<sup><xref ref-type="bibr" rid="r11">11</xref>
</sup>
.</p>
<p>The load-bearing capacity of the I-Bridge<sup>®</sup>
2 even after cyclic mechanical
loading was 7,592 N, which is much higher than maximum bite forces. These range
approximately between 150 N and 880 N in the posterior region, depending on experimental
conditions and the individual<sup><xref ref-type="bibr" rid="r12">12</xref>
,<xref ref-type="bibr" rid="r13">13</xref>
,<xref ref-type="bibr" rid="r17">17</xref>
</sup>
. Nevertheless, large deformations of the framework were obvious in
the connection area of the implant. The onset of plastic deformation typically appears
earlier than the load drop which defined failure. Hence, it is possible that some of the
veneering layer may delaminate in clinical practice before failure sets in. As the
load-bearing capacity of the I-Bridge<sup>®</sup>
2 achieves approximately tenfold the
maximum bite forces, it can be assumed that this phenomenon may be quite rare. As a
limitation of the present study, it has to be mentioned that the frameworks fabricated
were a little bulkier than many actual clinical frameworks, thus resulting in a higher
load-bearing capacity.</p>
<p>The present results suggest that screw-retained implant bridges are sufficient to
rehabilitate partial and total edentulous jaws. A recently published long-term
evaluation of full-arch implant bridges is in accordance with these findings<sup><xref ref-type="bibr" rid="r24">24</xref>
</sup>
. However, it has to be emphasized that
just one specific implant system was included in this study, so that conclusions for
other systems are hard to draw. Furthermore, long-term success depends on additional
aspects, e. g. peri-implant soft tissue complications<sup><xref ref-type="bibr" rid="r14">14</xref>
</sup>
.</p>
</sec>
<sec sec-type="conclusions"><title>CONCLUSION</title>
<p>The load-bearing capacity of the I-Bridge<sup>®</sup>
2 frameworks is much higher than
the clinical relevant occlusal forces, even with non-optimally placed implants, so that
there is a huge safety margin. The cyclic mechanical loading did not significantly
influence the load-bearing capacity, but <italic>in vivo</italic>
long-term stability
depends on additional aspects, e. g. bacterial microleakage.</p>
</sec>
</body>
<back><ack><sec><title>ACKNOWLEDGEMENT</title>
<p>This study was supported by Biomain, Sweden, whose support is gratefully
acknowledged.</p>
</sec>
</ack>
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