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Documented Clinical Success

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Bone-To-ImplantContact

Demonstrates High Contact OfImplant With New Bone

The OSSEOTITE® Surface Is Designed To Facilitate The Osseointegration Process

One Of The Most Well- Researched Dental Implant

Surfaces On The Market Today

Comprehensive Clinical Research

No IncreasedRisk Of

Peri-implantitisvs. Hybrid Implant

The OSSEOTITE® Implant – Documented Success

• Numerous Studies Report 98% Cumulative Success Rates

• Surface Provides For Effective Implant Attachment

• Human Histology With Demonstrated High Bone-To-Implant Contact1

• Five-Year Study2 Showed No Increased Risk Of Peri-implantitis vs. A BIOMET 3i Hybrid Implant

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The OSSEOTITE® Implant Family

OSSEOTITE®

4.0mmOSSEOTITE®

5.0mm

The OSSEOTITE® Implant features an acid-etched surfacedesigned to facilitate osseointegration by increasing plateletactivation and red blood cell agglomeration.

The OSSEOTITE® Surface has more than 10 years ofdocumentation from numerous global multicenter clinicalevaluations.3-10 Clinical studies on the OSSEOTITE® Surfacecontinue to document the benefits of increased contactosteogenesis, especially in poor-quality bone.11

Image courtesy of Jun Y. Park, The Bone Interface Group.

OSSEOTITE® ImplantsEnhanced Microscopy Image of OSSEOTITE®

Surface Showing Platelet Activation.

Proven Clinical Success

The OSSEOTITE®Implant Surface isDesigned to FacilitateOsseointegration byIncreasing PlateletActivation and Red Blood Cell Agglomeration

The OSSEOTITE® Surface Features Are Optimally Sized To Entangle The Fibrin Strands.

The OSSEOTITE® Surface And The Healing Process

Blood Clotting And Implant Attachment

A blood clot attaches to an implant when its fibrin strandsbecome intertwined in an implant’s micro-surface features.The strength of the clot/implant attachment depends onhow tightly the fibrin strands are entangled in the surface.Fibrin strands are typically submicron in diameter.Therefore, for the strongest bond, the implant surfacefeatures should create a maze of slightly larger spacesthat can tightly capture the fibrin strands. Characterized bya 1 to 3 micron peak-to-peak surface created by a uniqueacid-etched process, the OSSEOTITE® Surface featuresare optimally sized to entangle the fibrin strands of theblood clot.

Platelet Aggregation

Platelet Activation Up-Regulates Healing ResponseOsteogenic cell migration will occur through the blood clotand can be expected to be influenced by the release ofcytokines and other growth factors from activated cellularcomponents of the blood clot. In a study of red blood cell(RBC) and platelet interactions with implant surfaces, theamount of RBC agglomeration on the OSSEOTITE®

Surface was 54% greater than as seen on a smooth-machined surface.12

In addition, platelet adhesion onto the OSSEOTITE®

Surface was enhanced by 110% in comparison to asmooth-machined surface. RBC agglomeration isknown to enhance blood clot permeability, which canlead to enhanced wound healing. Increased plateletactivity can also lead to enhanced wound healing by therelease of cytokines and growth factors.13 Takentogether, both platelet adhesion and RBC agglomerationcan therefore result in increased bone formation on theOSSEOTITE® Surface.

Smooth - Healing ExistingMachined Bone BoneImplant

OSSEOTITE® Healing ExistingImplant Bone Bone

Distance Osteogenesis –A gradual process of bone healinginward from the edge of theosteotomy toward the implant.Bone does not grow directly onthe implant surface.

“At the earliest stages of healing, fibrin in the blood clot binds strongly tothe microtexture of the OSSEOTITE® Surface. This facilitates migration ofbone cells to the implant surface and results in contact osteogenesis.”– J.E. Davies†, BSc, BDS, PhD

Clot Attachment Increases Contact Osteogenesis

Contact Osteogenesis Optimizes Bone Healing

Bone heals around an implant through two distinct and overlapping phenomena: distanceosteogenesis and contact osteogenesis. The rate and extent of healing around an implantis dependent on the degree of contact osteogenesis that occurs at the implant surface. Themigration of osteogenic cells through the clot matrix causes contraction of the fibrin strandsin the clot matrix, which can detach the strands from smooth machined implant surfaces,disrupting or stopping contact osteogenesis and osteoconduction.14

Contact Osteogenesis –The direct migration of bone-building cells through the clotmatrix to the implant surface.Bone is quickly formed directlyon the implant surface.

†J.E. Davies has a financial relationship with BIOMET 3i LLC resulting from speaking engagements, consulting engagements and other retained services.

Human Histologic Data

The OSSEOTITE® Surface And Bone Contact

In a study on the effect of implant surface features on bone healing, human histologic dataconfirmed the increase in osteoconduction and contact osteogenesis with the OSSEOTITE®

Surface as compared to a smooth-machined surface. Two millimeter diameter screws, eachhaving on one side a OSSEOTITE® Surface and on another side a smooth-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 forOSSEOTITE® of 72.96% as compared to 33.98% for the smooth-machined surface.15

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% Bone/Implant Contact (BIC)

Human Histology MatchedSmooth-Machined AndOSSEOTITE® Surface PairsLazarra† et al. A Human Histologic Analysisof OSSEOTITE and Machined SurfacesUsing Implants with 2 Opposing Surfaces.The International Journal of Periodontics AndRestorative Dentistry. 1999:19:117-129.

Considerations for potential benefits of extending the DAEsurface to the seating surface led to this prospectiverandomized-controlled study designed to assess the risk andincidence of peri-implantitis for fully-DAE-surfaced implants (FullOSSEOTITE®/FOSS).

Study implants, fully-DAE-surfaced“test” implants and hybrid-DAE “control”implants, were placed in a single-stageapproach with the seating surface levelwith the crestal margin of the alveolarbone. The implants were allowed to healfor two months and were thenprovisionalized. Final restorations wereplaced at six months and patients werefollowed for five years at annual intervals.Follow-up evaluations included SulcusBleeding Index scores (SBI), probing for

suppuration, assessments for mobility and periapical radiographsto identify radiolucencies and crestal bone levels.

One hundred twelve patients were enrolled and 165 test and139 control implants were placed supporting 127 prostheses.No substantial differences in mucosal health outcomesbetween test and control groups were observed throughoutthe five year follow-up. For both groups, the bleeding-on-

probing scores were no different. There wasone case of peri-implantitis reported overthe five years of observation and this wasfor a hybrid implant.

Radiographic analysis of crestal boneregression demonstrated that the meanchange from baseline (provisionalization) isless for test implants in comparison to controlimplants (P<.01). The results of this five-yearstudy showed no increased risk in soft tissueoutcomes and peri-implantitis for fully-DAE-surfaced implants versus the controlledimplants in this study.

A Five Year Study

A five-year prospective, multicenter, randomized-controlled study of the incidence of periimplantitisfor hybrid-DAE and fully-DAE implants.2

Full OSSEOTITE® Implants And Peri-Implantitis

FullOSSEOTITE®

Surface

Test Implant:

Control Implant:

hybrid-DAE

fully-DAE

References:

†Clinicians have a financial relationship with BIOMET 3i LLC resulting fromspeaking engagements, consulting engagements and other retained services.

1. Lazarra† et al. A Human Histologic Analysis of OSSEOTITE and Machined SurfacesUsing Implants with 2 Opposing Surfaces. The International Journal of Periodontics AndRestorative Dentistry. 1999:19:117-129.

2. Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennström JL, Chierico A†, Stach RM†, KenealyJN†. A Prospective, Multicenter, Randomized-Controlled Five-Year Study of Hybrid andFully-etched Implants for the Incidence of Peri-implantitis. Journal of Periodontology. 2010 Apr;81(4):493-501.

3. Sullivan DY, Sherwood RL, Porter SS. Long-Term Performance of OSSEOTITE® Implants: A6-Year Clinical Follow-up.Compendium.April 2001; Vol. 22, No. 4.

4. Davarpanah M, Martinez H, Etienne D, Zabalegui I, Mattout P, Chiche F†, Michel J. A ProspectiveMulticenter Evaluation of 1,538 3i Implants: 1 to 5-year Data. The International Journal ofOral & Maxillofacial Implants. 2002; Vol. 17, No. 6.

5. Feldman S, Boitel N, Weng D, Kohles SS, Stach RM†. Five-Year Survival Distributions ofShort-Length (10mm or less) Machined-Surfaced and OSSEOTITE Implants.ClinicalImplant Dentistry and Related Research. 2004; Vol. 6, No. 1.

6. Sullivan D, Vincenzi G, Feldman S. Early Loading of OSSEOTITE Implants 2 Months AfterPlacement in the Maxilla and Mandible: A 5-year Report. The International Journal of Oral &Maxillofacial Implants. 2006; Vol. 20, No. 6.

7. Stach RM†, Kohles SS. A Meta-Analysis Examining the Clinical Survivability ofMachined-Surfaced and OSSEOTITE Implants in Poor-Quality Bone. ImplantDentistry. 2003; Vol. 12, No.1.

8. Testori T†, Wiseman L, Woolfe S, Porter SS.A Prospective Multicenter Clinical Study of theOSSEOTITE Implant: Four-Year Interim Report. The International Journal of Oral &Maxillofacial Implants. 2001;16:193-200.

9. Gaucher H, Bentley K, Roy S, Head T, Blomfield J, Blondeau F, Nicholson L, ChehadeA, Tardif N, Emery R†. A Multi-Centre Study of OSSEOTITE Implants SupportingMandibular Restorations: A 3-Year Report. Journal of the Canadian DentalAssociation. October 2001; Vol. 67, No. 9.

10. Testori T†, Fabbro MD, Feldman S, Vincenzi G, Sullivan D, Rossi R, Anitua E, Bianchi F, Francetti L,Weinstein RL. A Multicenter Prospective Evaluation of 2-months Loaded OSSEOTITE®Implants Placed in the Posterior Jaws: 3-year Follow-up Results.Clinical Oral ImplantsResearch. 2002;13:154-161.

11. Stach RM†, Kohles SS. A Meta-Analysis Examining the Clinical Survivability ofMachined-Surfaced and OSSEOTITE® Implants In Poor Quality Bone. Implant Dent2003;12:87-96.

12. Park JY, Davies JE†. Red Blood Cell and Platelet Interactions with Titanium ImplantSurfaces.Clinical Oral Implants Research. 2000:11:530-539.

13. Gemmell CH, Park JY. Initial Blood Interactions with Endosseous Implant Materials.2000;Chapter 9 in Bone Engineering (ed. Davies JE†); Em Squared Inc. Toronto, Canada. pp 108-117.

14. Davies JE†. Mechanisms of Endosseous Integration. The International Journal ofProsthodontics. 1998;11:5:391-401.

15. Lazarra† et al. A Human Histologic Analysis of OSSEOTITE and Machined SurfacesUsing Implants with 2 Opposing Surfaces. The International Journal of Periodontics AndRestorative Dentistry. 1999:19:117-129.

BIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 334101-800-342-5454Outside The U.S.: +1-561-776-6700Fax: +1-561-776-1272www.biomet3i.com

BIOMET 3iEurope, Middle East & AfricaWTC Almeda Park, Ed. 1, Planta 1ªPl. de la Pau, s/n08940, Cornellà de Llobregat(Barcelona) SpainPhone: +34-93-470-55-00Fax: +34-93-371-78-49

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Certain, OSSEOTITE, OSSEOTITE XP and PREVAIL are registered trademarks of BIOMET 3i LLC. Providing Solutions - One Patient At A Time is a trademark of BIOMET 3i LLC. ©2012 BIOMET 3i LLC.

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