OsseoTite Surface - Biomet 3i

The Surface That Succeeds.
Proven Performance. Superior Outcomes.
OSSEOTITE ®
I M P L A N T S Y S T E M
Proven To Promote
Contact Osteogenesis
Optimizes The
Healing Process

1
Biologically Driven Design - Proven Clinical Success
• 97.2% 5-Year Success
• 99.4% 5-Year Success Post-Loading*
• 98.6% 4-Year Success Placement
In Poor-Quality Bone*
• 97.8% 3-Year Success Following
A Two-Month Loading Protocol
Impressive success proven by impressive numbers
compiled from numerous on-going clinical studies.
But the story behind the success is equally
compelling. It is a story of intensive research that
yields a clear understanding of the healing process
and the patented design driving OSSEOTITE’s
incredible clinical performance.
Enhanced OSSEOTITE SEM showing platelet activation
courtesy of Jun Y Park, The Bone Interface Group,
University of Toronto
* These studies were performed with OSSEOTITE, OSSEOTITE XP ® and TG OSSEOTITE Implants.
OSSEOTITE ® Certain ®
Internal Connection System
OSSEOTITE Certain Tapered
Internal Connection System
OSSEOTITE
External Connection System

2
OSSEOTITE ® Optimizes The Healing Process
The OSSEOTITE Surface features our patented
1 to 3 micron peak-to-peak and 5 to 10 micron
peak-to-valley characteristics, proven to be
optimal for:
• Strengthening The Clot/Implant Attachment
• Increasing Platelet Activation And Red
Blood Cell (RBC) Agglomeration
The OSSEOTITE Surface
Strengthens The
Clot/Implant Attachment
A blood clot attaches to an implant when its fibrin
strands become intertwined in an implant’s
micro-surface features. The strength of the
clot/implant attachment depends on how tightly
the fibrin strands are entangled in the surface.
Fibrin strands are typically submicron in diameter.
For the strongest bond, therefore, the implant
surface features should create a maze of slightly
larger spaces that can tightly capture the fibrin
strands.
“At the earliest stages of healing, fibrin in the
blood clot binds strongly to the microtexture of
the OSSEOTITE Surface. This facilitates migration
of bone cells to the implant surface and results
in Contact Osteogenesis.”
J.E. Davies, BSc, BDS, PhD
The Result: Increased Rate
And Extent Of Bone Healing
OSSEOTITE Features are optimally sized
to entangle the fibrin strands.
Other “rougher” implant surfaces fit
loosely with fibrin strands, which may produce
a weaker clot attachment.

3
Stronger Clot Attachment Increases Contact Osteogenesis ...
Contact Osteogenesis
Optimizes Bone Healing –
Bone heals around an implant through two distinct
and overlapping phenomena: Distance Osteogenesis
and Contact Osteogenesis. The rate and extent of
healing around an implant is dependent on the
degree of Contact Osteogenesis that occurs at the
implant surface. The migration of osteogenic cells
through the clot matrix causes contraction of the
fibrin strands in the clot matrix, which can detach
the strands from the implant, disrupting or stopping
Contact Osteogenesis and Osteoconduction. 1
The Stronger The Clot Is Connected To The Implant Surface,
The Higher Degree Of Contact Osteogenesis
Distance Osteogenesis –
A gradual process of bone healing inward from
the edge of the osteotomy toward the implant.
Bone does not grow directly on the implant surface.
Contact Osteogenesis –
The direct migration of bone-building cells through
the clot matrix to the implant surface. Bone is
quickly formed directly on the implant surface.
1 Davies, J.E., “Mechanisms of Endosseous Integration”,
International Journal of Prosthodontics, 1998: 11:5:391-401.
Implant Healing Existing
bone bone
OSSEOTITE ® Healing Existing
Implant bone bone

4
... And Platelet Aggregation
Platelet Activation
Up-Regulates Healing Response
Osteogenic cell migration will occur through
the blood clot and can be expected to be
influenced by the release of cytokines and
other growth factors from activated cellular
components of the blood clot.
In a groundbreaking study of red blood cell
(RBC) and platelet interactions with implant
surfaces, the amount of RBC agglomeration
on the OSSEOTITE ® Surface was 54%
greater than that seen on a machined
surface. 2 In addition, platelet adhesion onto
the OSSEOTITE Surface was enhanced by
110%in comparison to a machined surface.
RBC agglomeration is known to enhance
blood clot permeability, which can lead to
enhanced wound healing. Increased platelet
activity can also lead to enhanced wound
healing by the release of cytokines and
growth factors 3 . Taken together, both platelet
adhesion and RBC agglomeration
can therefore result in increased bone
formation on the OSSEOTITE Surface.
OSSEOTITE Yields 110%
Increase In Platelet
Adhesion And 54%
Increase In RBC
Agglomeration
2. Park JY and Davies JE, “Red Blood Cell and Platelet Interactions With Titanium Implant Surfaces”
Clinical Oral Implants Research, 2000:11:530-539.
3. Gemmell CH and Park JY (2000) “Initial Blood Interactions with Endosseous Implant Materials”,Chapter 9
in Bone Engineering (ed. Davies JE); em squared Inc. Toronto, Canada. pp 108-117.

5
Greater Bone Healing Confirmed
Rate: Early Loading Clinical Studies
Historically, the recommended time between
placement and functional loading of dental implants
has been four months for the mandible and six
months for the maxilla. With the development of
the OSSEOTITE ® Implant, patients are now being
restored and returned to function sooner than
previously thought possible.
In an ongoing multicenter clinical investigation,
a total of 429 OSSEOTITE Implants were placed in
155 patients at 10 study centers and subsequently
loaded two months following placement. 4 The
cumulative implant survival rate was 98.5% at
12.6 months.
OSSEOTITE Provides
2-Month Loading And
A 215% Increase In Mean
Bone Contact.
Extent: Increased Bone/Implant
Contact Human Histology
In a study of the effect of implant surface
features on bone healing, human histologic
data confirmed the increase in Osteoconduction
and Contact Osteogenesis the OSSEOTITE
Surface provides. 2mm diameter screws,
each having one side OSSEOTITE and
one side machined surface, were placed in
the posterior maxilla and removed after
six months of healing. The thirty-nine histologic
sections prepared showed a mean percent
bone/implant contact for OSSEOTITE of 72.96%
compared to 33.98% for the machined surface. 5
Equally impressive was the fact that in thirteen
of the histologic sections the machined surface
showed no bone/implant contact while the
OSSEOTITE Surface on the same implants
had up to 92% bone contact.
% Bone/Implant Contact (BIC)
100
90
80
70
60
50
40
30
20
10
0
Stuart L. Graves, D.D.S., M.S. comments,
“With 98% success rate following a 2 month
loading protocol, you can almost guarantee your
implant is going to work better than other
conventional dental procedures.”
In a follow up analysis recently submitted for
publication, cumulative implant survival rate was
98% at up to 43 months of observation.
Human Histology
Matched Machined and OSSEOTITE Surface Pairs
OSSEOTITE Surface
Machine Surface
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39
Dense Specimens Soft
4. Lazarra et al “A Prospective Multicenter Study Evaluating Loading Of OSSEOTITE Implants 2 Months After Placement: One Year Results”,
Journal Of Esthetic Dentistry:, 1998:6:280-289.
5. Lazarra et al “A Human Histologic Analysis Of OSSEOTITE And Machined Surfaces Using Implants With 2 Opposing Surfaces”, International
Journal Of Periodontics And Restorative Dentistry:, 1999:19:117-129.

6
Demonstrated Long-Term Predictability
Hybrid Surface:
Promotes Soft-Tissue Health
“OSSEOTITE’s ® Hybrid Surface Design minimizes
the possibility of soft tissue infection or
peri-implantitis by maintaining a proven
‘soft-tissue-friendly’ machined surface in
contact with soft tissue.”
Dennis Tarnow, D.D.S.
In a 1999 survey in “Dental Products Report”, 83%
of oral surgeons and 84% of periodontists attributed
implant failure to peri-implantitis. Obviously,
maintaining soft-tissue health is critically important
to long-term implant survival.
The Surface Of Choice For
High-Risk Factor Cases
The OSSEOTITE Surface performance in high-risk
factor cases 6 has been subjected to a comprehensive
evaluation involving 2,814 implants. This analysis
looked specifically at the contributions of various
baseline variables that are associated with an
increased risk of implant failure. These include,
poor-quality bone, implant dimensions
(short ≤10mm lengths and wide diameters) and
implants placed using abbreviated healing periods.
Results: High Post-Loading Success Rate
The success of an implant restoration is not
determined merely by achieving initial integration,
but by the continued integration of the implant after
it has been restored and in function. Post-loading
implant failures are the most challenging because
of the time and expense required to recover from
the loss of the implant as well as the prosthetic
investment. By maintaining soft-tissue health and
evenly distributing mastication forces over a greater
bone/implant interface, OSSEOTITE has achieved
an extremely high post-loading success rate
of 99.4% at 5-years. 7
6 Data on file.
7 Compiled results from OSSEOTITE Sudies in progress.
The hybrid surface of OSSEOTITE
Implants is designed to optimize soft
and hard tissue health.
The findings demonstrate that in many high-risk
factor cases in which OSSEOTITE Implants are
used, clinicians can expect results similar to
those cases without risk factors. This, of course,
offers the opportunity to increase the number of
patients accepted for treatment. Clinicans are also
able to simplify their surgical protocols, minimize
potential complications and reduce important
waiting periods.
Superior Load Distribution
And Soft-Tissue Health
Provide A 99.4%
Post-Loading Success Rate

If You’re Not Using OSSEOTITE ® Implants, You’re Not Using One Of The Most Predictable And Proven
Implants Made. Documented In 6 Years Of Clinical Studies.
Global multicenter clinical evaluations with close to 3,000 implants under study demonstrate a 98.3% success rate at up to six years
post-loading. These clinical studies continue to document the benefits of increased Contact Osteogenesis, especially in poor-quality bone.
Study Purpose/Objective
Dr. Sullivan and Sherwood (J. Prosth Dent 1997 78:379-386)
(Compendium 2001 4:326-334)
No. of Study
Centers
No. of
Patients
No. of
Cases
No. of OSSEOTITE
Implants
3 75 90 147
OSSEOTITE Long Term Performance (JOMI 2001 16:193 - 200) 4 181 210 485
OSSEOTITE Long Term Performance in Posterior Maxillary and
Mandibular Cases (Compendiuming) 1999 7:628 - 640)
OSSEOTITE Success When Used to Support Single Tooth Restorations
(J. Periodontol 2002 73:687 - 693)
OSSEOTITE Performance in Mandibular Restorations 99.3%
(J. Can Dent Assoc 2001 67:528-533)
OSSEOTITE Performance Compared with ST and ICE TM Implants
(J. Periodontol 2001 72:1384-1390)
OSSEOTITE Success in Cases Loaded After a Short Healing Time
(J. Esth Dent 1998 6:280-289)
(A Multicenter Prospective Evaluation Of 2-Month-Loaded OSSEOTITE Implants
Placed In Posterior Jaws: 3 year follow-up results Clin. Oral Imp. Research 2002,
April 154-161)
OSSEOTITE Performance Compared with ICE Implants in the Same
Prostheses (J. Periodontol 2001 72:1384-1390)
4 74 99 219
1 59 71 71
4 172 191 688
14 229 270 543
10 195 268 526
2 97 137 247
Totals 38 1082 1336 2926
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Certain, OSSEOTITE and OSSEOTITE XP are registered trademarks and ICE is a trademark of BIOMET 3i, Inc. BIOMET is a registered trademark
and BIOMET 3i and design are trademarks of BIOMET, Inc. ©2008 BIOMET 3i, Inc. All rights reserved.
Success Rate
96.6%
(6 years post loading)
98.7%
(4 years post loading)
98.6%
(3 years post loading)
99.6%
(3 years post loading)
99.3%
(3 years post loading)
98.7%
(3 years post loading)
97.9%
(4 years post loading)
95.0% vs 86.6%
3 years post loading
98.3%
(Weighted Average)
REV B 02/08