Inward-Inclined Implant

Platform for the

Amplified Platform-Switching
Concept:
18-Month Follow-up Report of a
Prospective
Randomized Matched-Pair
Controlled Trial
Luigi Canullo, DDS1/Jose Carlo Rosa, DDS2/Vicente Souza Pinto, Dr Med
Dent3/ Carlos Eduardo Francischone, DDS, MS, PhD4/Werner Gtz, MD, PhD5

Purpose: This prospective randomized matched-pair controlled trial aimed to evaluate marginal bone levels
and soft tissue alterations at implants restored according to the platform-switching concept with a new
inward- inclined platform and compare them with external-hexagon implants. Materials and Methods:
Traditional external-hexagon (control group) implants and inward-inclined platform implants (test group), all
with the same implant body geometry and 13 mm in length, were inserted in a standardized manner in the
posterior maxillae of 40 patients. Radiographic bone levels were measured by two independent
examiners after 6, 12, and
18 months of prosthetic loading. Buccal soft tissue height was measured at the time of abutment connection
and 18 months later. Results: After 18 months of loading, all 80 implants were clinically osseointegrated in
the
40 participating patients. Radiographic evaluation showed mean bone losses of 0.5 0.1 mm (range, 0.3 to
0.7 mm) and 1.6 0.3 mm (range, 1.1 to 2.2 mm) for test and control implants, respectively. Soft tissue
height showed a significant mean decrease of 2.4 mm in the control group, compared to 0.6 mm around the
test implants. Conclusions: After 18 months, significantly greater bone loss was observed at implants
restored according to the conventional external-hexagon protocol compared to the platform-switching
concept. In addition, decreased soft tissue height was associated with the external-hexagon implants versus
the platform- switched implants. Int J Oral MaxIllOfac IMplants 2012;27:927934.

Key words: bone resorption, dental implants, follow-up studies, implant connection, implant platform,
platform switching

A
ccording to previous studies, when an
implant is exposed to the oral environment,
a vertical reposi- tioning of hard and soft
tissues takes place.15 The usu- al amount of
this peri-implant bone remodeling over time
in physiologic conditions is 2 to 3 mm,
depending on arch, jaw region, the patients
smoking status, bone quality, and the
implant surface and design.6 Several
factors may afect this postrestorative
biologic process: (1) local and systemic
patient-related factors (eg, smok- ing habits,
systemic disease, soft tissue thickness and
1
PhD student, Department of Orthodontics and Prosthodontics,
University of Bonn, Germany; Private Practice, Rome, Italy.
2
Private Practice, Caxias do Sul, Brazil.
3
Private Practice, So Paulo, Brazil.
4
Professor, Department of Operative Dentistry, Faculty of
Odontology, University of So Paulo, Bauru, Brazil.
5
Professor, Department of Orthodontics and Prosthodontics,
University of Bonn, Germany.
Correspondence to: Dr Luigi Canullo, Via Nizza 46, 00198
Rome, Italy. Email: luigicanullo@ yahoo.com

The International Journal of Oral & Maxillofacial Implants 927

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biotype, individual bone pattern, oral
microbiology); (2) implant and prosthetic
factors (eg, implant mi- cro- and
macrogeometry, prosthetic material and
configuration); (3) surgical factors (eg, flap
design, drill- ing procedure, stage-two
surgery technique), and (4) biologic and/or
biomechanical factors (eg, biologic width
reestablishment, occlusal loading).
Focusing on this last group, bone resorption
may be related to the reestablishment of
biologic width that takes place following
bacterial invasion of the implant/abutment
interface.7 Although controversial, additional
bone re- sorption seems to be related to
occlusal loading, which transfers stresses
along the coronal bone-implant in-
terface.8,9 A diferent theory has been
proposed that is not aligned with the
infection or adverse loading theories; this
has been named the compromised heal-
ing/adaptation theory,10 in which failures
are divided into three groups: preloading,
early loading, and late loading.
Recently, published studies showed a
different con- cept of implant-abutment
connection: the platform- switching concept.
The main characteristic of platform

The International Journal of Oral & Maxillofacial Implants 927

2012 BY QUINTESSENCE PUBLISHING CO, INC. PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY.
NO PART OF MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER.
Canullo et al

switching is the presence of a wider implant tissues more than conventional

compared to the abutment selected. This prosthetic concepts.
configuration results in a mismatch at the
implant/abutment interface, there- by
moving the potentially infected interface Material and
away from the vital bone. Methods
This concept has been investigated with
different models and with implant-abutment study design and Patient
horizontal mis- matches between 0.35 and selection
1.0 mm, and decreased vertical bone loss Between February 2007 and
compared to conventionally re- stored February 2008, patients referred to
implants has been observed.11 Histologic four private clinics in Rome and
analy- sis of platform-switched implants Piacenza,
demonstrated less bone loss in a dog
model12,13 and in humans compared to the
conventional restoration protocol.14,15 The
soft and hard tissue responses around
platform-switched implants have also been
assessed.14,1619
Additionally, a randomized controlled trial
demon- strated a linear inverse correlation
between implant/ abutment mismatching
and bone resorption. The outcome of that
study demonstrated the assumption that a
greater mismatch would be associated
with less bone resorption.20 The
biomechanical rationale for platform
switching has also been analyzed.21 The
platform-switching configuration, in fact,
was demon- strated to shift the stress
concentration away from the peri-implant
bone, reducing the stress exerted on the
abutment-implant interface.
There is evidence of improved bone
preservation around platform-switched
implants compared to the conventional
design. However, a recently published pilot
study with a small sample size highlighted
poorer performance of platform switching
when thin soft tis- sues were present and
conventional healing/loading protocols (2 to
4 months) were followed.22
In the literature, the platform-switching
concept has been performed with horizontal
flat or outward- inclined mismatching.
However, no study has yet test- ed the
benefits of an inward oblique mismatching.
The aim of this multicenter prospective
randomized con- trolled matched-pair trial
was to evaluate the hard and soft tissue
responses around a new implant concept
with an inward inclined platform, which is
believed to amplify the platform-switching
concept, and com- pare them to the tissue
response around an external- hexagon
implant restored according to the traditional
prosthetic concept. The null hypothesis was
that an in- ward-inclined, platform-switched
restoration does not benefit hard and soft

2012 BY QUINTESSENCE PUBLISHING CO, INC. PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY.
NO PART OF MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER.
Italy, and So Paulo and Caxias do Sul, Brazil, were
ex- amined. To be included, a patient had to meet the
fol- lowing criteria:
A need for a fixed implant-supported prosthesis in
the posterior maxilla (from the first premolar to the
second molar)
Age at least 18 years
No relevant medical conditions
Nonsmoking or smoking 10 cigarettes/day
(all pipe or cigar smokers were excluded)
Full-mouth plaque score and full-mouth bleeding
score 25%
Availability for follow-up for 18 months after pros-
thetic loading
Presence of a ridge wide enough to allow the
inser- tion of a 4-mm-diameter implant according to
the Brnemark protocol
Subjects with acute infections at the planned treat-
ment sites, a need for horizontal bone regeneration,
current pregnancy or lactation, or a history of
bisphos- phonate therapy were excluded from
participation.
All patients received two adjacent implants: one
with a traditional external-hexagon configuration (EH,
P-I Branemark Philosophy, control group) and one with
an inward-inclined platform (Amplified, P-I Branemark
Philosophy, test group) (Fig 1). Both implants present-
ed the same implant body and the same neck and
were made of grade IV titanium. A hybrid geometry
that fea- tured a conical apex (with a bone-collecting
928 Volume 27, Number 4, 2012
2012 BY QUINTESSENCE PUBLISHING CO, INC. PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY.
NO PART OF MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER.
chamber) and a parallel body with special
threaded profiles was present. The body was
4.0 mm in diameter, with the platform
opening to a final diameter of 4.3 mm,
result- ing in a conical coronal region. The
surfaces of both implants featured
nanotopographic characteristics. The
semirough surface was obtained after a
subtrac- tion process by mechanical
ultrasonic cleaning. Thus, differences from
the two groups were restricted to the
abutment connection and design.
The mesiodistal positions of the two
implants (con- trol and test) were assigned
randomly according to predefined
randomization tables. A balanced random
permuted block approach was used to
prepare the randomization tables to avoid
unequal balance be- tween the treatment
groups. To reduce the chance of unfavorable
splits between the test and control groups in
terms of key prognostic factors, the
randomization process took into account the
following variables: pres- ence of adjacent
teeth, distal-extension sites, and site
location in dental arch. Assignment was
performed us- ing a sealed envelope.
The present study was performed
following the prin- ciples outlined by the
Declaration of Helsinki on experi- mentation
involving human subjects. All procedures
 Canullo et al

a b c d
Fig 1 Images of (a) control and (b) test group implants, which feature the same macrogeometry. (c) Scanning electron microscopic
and (d) traditional microscopic images showing the inward inclined platform of the test group implant.

and materials in the present prospective Tension-free sutures were placed with a 5.0
study were ap- proved by the local ethical monofilament to prevent any early exposures of
committees, and all patients provided cover screws.
informed consent. Patients were instructed to eat a soft diet and to
avoid chewing in the treated area until the sutures
surgical and Prosthodontic Protocol were removed. Oral hygiene at the surgical site was
Before the surgical procedure, full-mouth lim-
professional prophylaxis was conducted.
Patients received 1 g of amoxicillin
clavulanate 1 hour prior to surgery and
continued with 2 g per day for 6 days. A
crestal incision was performed after
anesthesia had been induced (Fig 2a).
When required, sinus elevation was per-
formed, but the coronal part of all implants
was always placed in at least 4 mm of native
bone.
After the implant site was prepared
(round and
2-mm drills at 1,500 rpm; pilot drill at 1,000
rpm; and surgical site finalization at 1,000
rpm with drills of
2.8 mm for soft bone, 3.0 mm for normal
bone, and
3.3 mm for dense bone, all under abundant
saline ir- rigation), surgeons assistants were
asked to open the sealed envelope
containing the information regarding implant
positions, ie, the surgical site was prepared
by the surgeon without previous knowledge
of the type of implant to be placed.
According to the randomiza- tion, two 13-
mm-long implants (one control and one test)
were inserted at the crestal level (Fig 2b).
Before implant insertion, buccolingual
width of the buccal bone wall was measured
using a surgical probe as the distance from
the implant platform to the most external
bone.
All implants were inserted with the
platform at the bone level (Figs 2c and 2d).
ited to soft brushing for the first 2 abutment was used. In the test group,
weeks postsurgery. Regular according to the platform-switching concept,
brushing in the rest of the mouth the selected abutment resulted in a
and rinsing with 0.12% horizontal mis- match of 0.35 mm
chlorhexidine were prescribed for 2 (corresponding to a total of 0.50 mm
weeks. Thereafter, conventional because of the inward-inclined platform)
brushing and flossing were between the implant and abutment
permitted. After 2 weeks, the diameters (Fig 3).
sutures were removed. Implants To prevent unequal loading of the
were allowed to undergo implants, the test and control implant
submerged healing. restorations were splinted. Cement- ed
Two to 3 months later, the restorations were adopted, and the margins
implants were uncov- ered. The were posi- tioned approximately 1 mm below
cover screws were exposed and the soft tissue margin to ease the removal of
removed via a crestal incision excess cement. The crowns were luted with
placed just over the area temporary cement (Temp Bond, KerrHawe).
correspond- ing to the implant.
Attached keratinized mucosa was radiographic and Clinical assessments
present on both the palatal and An individual customized digital film holder
buccal aspects around all implants. was fabricat- ed for each patient to ensure
Subsequently, the corresponding reproducible radiographic analysis. At the
healing abutment was inserted. time of the connection of the definitive
After 1 week, a corresponding abutment and crown, implant stability and
coping transfer was used and an soft tissue conditions were assessed.
impression was made. Furthermore, digital periapi- cal standardized
For prosthetic restoration, in the radiographs were obtained to ensure perfect
control group, a matching-diameter adaptation of the abutment on the implant.

The International Journal of Oral & Maxillofacial Implants 929

Canullo et al

a b

d
Fig 2 (a) After a crestal incision was
made, (b to d) control (left) and test (right)
implants were inserted adjacent to each
other at the crestal level according to the
randomization
c protocol.

Every 6 months for 18 months after was measured from the mesial
definitive res- toration, clinical examinations and distal margins of the implant
were performed to evaluate peri-implant neck to the most coronal point of
and periodontal parameters at implants bone contact with the im-
and the neighboring (mesial and distal)
teeth, respectively. Every 6 months,
periapical stan- dardized digital radiographs
were also obtained to evaluate changes in
marginal bone levels after loading (Digital
Sensor Schick 1, Schick Technologies).
Digital periapical radiographs were
standardized using the previously
mentioned individualized mouthpiece to
ensure a consistent technique. Exposure
parameters were conducted according to the
manufacturers rec- ommendations and
standard clinical protocols (Fig 4).
A computerized measurement technique
was ap- plied to the digital periapical
radiographs. Evaluation of the marginal bone
level around implants was per- formed using
image analysis software (Autocad 2006,
version Z 54.10, Autodesk) that could
compensate for radiographic distortion.21
The software calculated bone resorption at
the mesial and distal aspects of the
implants. Since each implant was inserted at
the level of the bone crest, the distance
plant. For each implant, separate mesial and distal
val- ues were recorded. All measurements were made
and collected by two calibrated examiners who had
not placed the implants. For each pair of
measurements, mean values were used. Calibration of
the blinded ex- aminers was performed on triplicate
measurements before the study began.
soft tissue Measurements
At the time of abutment connection and after 18
months of prosthetic loading, the buccal soft tissue
height was measured and recorded. A modified perio-
dontal probe, accurate to within 0.5 mm, was selected
for this purpose. The probe was positioned at the mar-
930 Volume 27, Number 4, 2012
gin of the platform. The distance from the
platform to the gingival margin was
recorded. To facilitate mea- surements,
crowns and abutments were removed at the
18-month examination.
statistical analysis
To evaluate the differences in bone height
between the paired control and test
implants, the Wilcoxon sign rank test was
used. The differences in bone height with
respect to implant site and the type of
grafting (or no
 Canullo et al

Fig 3 Reopening procedure 3 months after implant insertion. The definitive abutments Fig 4 Control and test adjacent im-
were inserted, creating a mismatch of 0.85 mm with the test implant and a matching- plants restored with a single splint-
diameter abutment on the control implant. ed restoration to prevent unequal
loading between the implants. Ra-
diograph shows a site at 18 months
after prosthetic loading.

grafting performed) was calculated by the infection. For each time point evaluated (6, 12, and 18
Kruskal- Wallis test. To determine the months), bone loss around the control implants was
degree of association between buccal bone sig-
width and bone loss, the Pear- son
correlation coefficient was selected.
Correlations (r) between 0 and 0.25 were
considered low, those between 0.25 and 0.5
were considered fair, those be- tween 0.5
and 0.75 were considered moderate, and
those greater than 0.75 were considered
strong. The significance level was set at P < .
05.

results

A total of 63 patients presented with the

anatomical conditions required for the
present trial. Of these pa- tients, 23 did not
fulfill the inclusion criteria; thus, 40 patients
were included. Twenty-four patients were
men and 16 were women, and the average
age of the participants was 58.2 years.
A total of 19 patients (38 implants)
required major sinus elevation with a buccal
approach. The implants were placed and the
sinus membrane was elevated during the
same procedure, according to the guide-
lines suggested by Wallace and
Froum.23 Another
10 patients (20 implants) underwent minor
sinus el- evation with a crestal approach
using osteotomes. Nanostructured
hydroxyapatite was used as the only
grafting material (Nanobone, Artoos).
No patients dropped out and all were
followed for a period of 18 months after
prosthetic loading. All im- plants belonging
to the control and test groups were clinically
osseointegrated, stable, and free of signs of
nificantly greater than around the
test implants (Fig 5). At the last
follow-up assessment, control
implants ex- hibited an average of
1.63 mm of bone loss, compared to
0.49 mm for the control implants
(Fig 6).
A total of 11, 29, 33, and 7
implants from both groups were
placed in the first premolar, second
pre- molar, first molar, and second
molar regions, respec- tively. The
bone loss was different around
control implants depending on the
implant location; more bone
resorption was demonstrated at
the first premo- lar compared to
the second premolar and first
molar but was similar to that seen
at second molar sites. No
difference was observed in test
implants with respect to implant
site (Fig 6). A total of 19 implants
in each group was associated with
sinus graft elevation from the
lateral wall (major procedure) and 10
implants from each group were associated
with sinus elevation by a crestal approach
(minor procedure); 11 implants from each
group were placed without any bone aug-
mentation procedure. No difference in
bone height was seen regardless of whether
grafting (major or mi- nor) was performed,
both for control (P = .3) and for test (P = .6)
implants. The buccal bone width was simi-
lar for both control and test implants, and no
correla- tion was found between buccal bone
width measured at surgery and marginal
bone level alterations after
18 months in the control (r = .03, P = .81) or
test (r = .13 and P = .41) groups (Fig 7).
Similar mean buccal soft tissue height
(3.0 mm) was measured at the time of
abutment connection around both types of
implants. However, after 18 months of
loading, significantly lower soft tissue height
was seen around the external-hexagon
implants (0.6 mm) than around the platform-
switched (2.4 mm) implants.
The International Journal of Oral & Maxillofacial Implants 931
Canullo et al

Mean bone loss (mm)

Mean bone loss (mm) 1.8 Control *
1.6 Test 2.0
*
1.4
1.2 1.5
1.0
0.8 1.0
0.6
0.4 0.5
0.2
0.0 0.0
6 mo 12 mo 18 mo 0
Time 1 2 3 4
Implant site

Fig 5 Mean bone loss for the test and control implants at 6,
12, and 18 months after prosthetic loading. *P .05.
Fig 6 Correlation of bone loss versus implant site.
Greater bone loss was observed around control (external-
hexagon) im- plants (gray diamonds) inserted in the first premolar
and second molar areas compared to second premolar and first
molar sites. No difference in bone height was detected in the
test implants (black squares) (*P .05).

r = 0.03, Additionally, many factors associated with

P = .81
Bone loss (mm)

bone loss are patient related, which may

2.0
influence the results of a clinical trial. A
1.5 matched-pair design was therefore selected
to exclude the patient as a variable. Test
1.0 r = 0.13, and control implants were placed adjacent
P = .41
to each other to minimize differences in
0.5 bone site pattern. Moreover, to prevent
variations in occlusal loading, the two im-
0.0 1.5 2.0 2.5
0.5
1.0 plants were restored with a single two-unit
prosthesis.
Additionally, it should be highlighted that,
in fact, the observed differences cannot be
related to soft tis-
Buccal bone width (mm) surface, varying only in the
connection. Thus, the different
Fig 7 No correlation was found between control (gray dia- results would seem to be related to
monds) and test (black squares) implants and buccal bone width. the differ- ences in the design of
the abutment and connection.
disCussion

Over a period of 18 months, the present

study dem- onstrated that implants restored
according to the amplified platform-
switching concept experienced significantly
less marginal bone loss and better soft tis-
sue preservation compared to implants with
matching implant and abutment diameters
and a conventional external-hexagon
configuration.
All patients enrolled in the present study
received the same treatment: one implant
with an external hexagon with a matching-
diameter abutment and one implant with
the amplified platform-switching
configuration. To ensure that the results
would be comparable, both control and test
implants presented the same macroscopic
and microscopic design and the same
sue thickness, since implants were inserted in the control implants exhibited mean marginal
same bone loss of
environment. The most extensive marginal bone level 1.63 mm after 18 months, are in line with
alterations were seen at the first follow-up (6 months these previ- ous findings. Several
after prosthetic loading), whereas during the 1-year explanations for these observed changes in
observation period thereafter, minor bone loss was crestal bone height have been suggested.
observed. Previous experimental and clinical stud- Some authors have discussed the potential
ies in fact observed the most pronounced marginal role of the microgap at the implant-abutment
bone level changes after the surgical trauma resulting interface, which could act as site for
from implant placement and abutment connection, bacterial colonization at the implant
whereas after functional loading, only minor signs of sulcus.4,29,30 Others described the
bone loss occurred.7,24,25 During the first year of load- establishment of an adequate dimension of
ing, two-piece implants in particular have frequently the biologic width associated with marginal
been associated with crestal bone loss of about 1.5 bone resorption at sites with a thin mu-
to cosa25 and in conjunction with abutment
2.0 mm.2628 The result of the present study, in connection.31
which

932 Volume 27, Number 4, 2012

 Canullo et al

Butt-joint connections associated with bacterial flow into and out of the implant-abutment
matching-diam- eter implant-abutment interface during functional loading.42 However, the
configurations have linked in- flammation (an importance of this influence might be minimized by
inflammatory cell infiltrate) to bone loss of the fact that the two implants were restored with a
1.5 to 2.0 mm.7,32 single two-unit prosthesis in the present study.
The reasons for the observed reduced In addition, the concept behind the inward-inclined
bone loss at platform-switched implants in platform could contribute to the reduced bone loss.
the present study can only be speculated From a geometric approach, according to Pitagoras
upon. The horizontal inward repo- sitioning of
the implant-abutment interface has been
suggested to overcome some of the
problems associat- ed with two-piece
implants. The platform switching may
increase the distance between the gap of the
implant- abutment interface (which is
associated with inflam- matory cell infiltrate)
and the marginal bone, thereby decreasing
the potential bone-resorptive effect. Also,
there might be a reduction in the amount of
marginal bone loss necessary to expose a
minimum amount of implant surface to
which the soft tissue can attach.11
These assumptions are supported by recent
animal studies13,26,33 and human histologic
observations.18
Clinical case series of immediate
implants34,35 and prospective controlled
studies have evaluated the bone
responses14,3638 as well as the soft tissue
respons- es16 to platform-switched implants,
although positive outcomes are believed to
be dependent on the soft tissue biotype.22
The magnitude of the observed mar- ginal
bone level alterations varied among the
studies. This may be a result of different
observation periods (6 to 24 months),
implant types, study populations, and
radiographic analysis methods. However,
compared to control implants with matching
abutment-implant di- mensions, these
studies all demonstrated significantly less
marginal bone loss as assessed on
radiographs at implants restored according
to the platform-switching concept.
The differences in bone loss may also be
related to the different mechanics of the
implant-abutment con- nections analyzed. In
fact, the connection type exerts a significant
influence on the stress distribution in bone
because of different load transfer
mechanisms and dif- ferences in the size of
the contact area between the abutment and
the implant; controversially, the stresses
around the peri-implant area was shown to
be higher in an external-hex compared to an
internal-hex con- figuration.3941 Tolerance
between components and a resulting
instability of the connection could also affect
bone resorption because of the bidirectional
theorem, this configuration allows
for an amplified mismatching
compared to a flat implant
platform. In fact, according to
previous results,20 a linear inverse
correlation between implant-
abutment mismatch and bone
resorption was found. Furthermore,
this configu- ration is expected to
provide additional space for the so-
called walling-off function of soft
tissue, which is supposed to
protect the underlying bone from
bac- terial invasion, thereby
preventing epithelial down-
growth.17 Soft tissue behavior, in
fact, seems to reflect this histologic
difference, showing statistically
signifi- cant differences in control
and test groups, according to some
studies.16,38
exhibited bone loss that was more than 1
mm greater than that seen around the
platform-switched implants. This difference
was not related to grafting procedures, and
no correlation with baseline buccal bone
width could be observed. Future
experimental and clinical studies will help to
unravel the biologic processes involved as
well as establish the significance of these
findings for long-term implant success.
aCKnowledgMents
The authors highly appreciate the skills and commitment of
Dr Audrenn Gautier for language suggestions and Dr Henry
Canullo for his effective help in finalization of the protocol.
Furthermore, the authors are particularly grateful to Dr Paola
Cicchese and Dr Giuseppe Goglia for their support in radio-
graphic measurements and patient recruitment and Dr Luiz
Meirellis for supervision of the manuscript. The authors declare
that there are no conflicts of interest. This study was partially
funded by P-I Brnemark Philosophy.

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