Interim Analysis of Certain® PREVAIL® Implant Clinical

Trial Outcomes

Prevail Observational Multicenter Study: total of 264 implants OsseoTite® Certain PREVAIL implants were placed in 162 patients in 12 centers, Single Units and Short Bridges, in all areas early loaded in 2 months.

Results: Up to 3-years of observation, a total of 6 implants have failed, giving a (Cumulative Survival Rate) CSR of 97.3%

Single-tooth (63.8%)., short-span and long-span restorations, evenly in both the maxilla and mandible but primarily located inposterior regions (73.5%)A total of only 6 implant failuresTwo implant failures in the same restoration failed within the first month of function and five were observed within six months of implant placement prior to permanent prostheses insertion.

Interim Analysis of Certain® PREVAIL® Implant Clinical Trial Outcomes

Preservation Of Hard And Soft Tissues: The Effect Of The PREVAIL® Implant OnCrestal Bone Regressive ModelingJames Kenealy, PharmD. and Renee M Stach, DDS.

Cliffhanger (2301) RadioCity (2302) Studies: Prospective, randomized-controlled multi-center clinical studies: Certain PREVAIL Expanded Collar Implants (with 0.35mm of lateralization) vs. Full Ossotite XP implants (non-platform switched) as control in short span bridges. To asses the effect of lateralization in crestal bone preservation.

13 centers, 124 patients, 331 implants. Enrollment began January 2005, finished Jan 2006. Three year- Interim results Jan 2008.

Test: Osseotite Certain PREVAIL Expanded

Collar

Control: Full Osseotite XPNo Platform Switching

Interim 2-year post-loading results presented as poster at the Chicago 2008 Biomet 3i Global Symposium

Interim Analysis of Certain® PREVAIL® Implant Clinical Trial Outcomes

13 centers, 124 patients, 331 implants. Three-year results.

 Results: Certain PREVAIL Implants have demonstrated a mean 0.65mm of bone remodeling by the time of permanent prosthesis insertion. This is less than one-half the bone remodeling exhibited in previous studies with traditional OSSEOTITE Implants with matched Implant-Abutment Junctions (1.6mm).

 

Test: Osseotite Certain PREVAIL Expanded

Collar0.65mm

Test: Osseotite XPNo Platform Switching

Osseotite Certain Hybrid:1.6mm

No Platform Switching

Interim Analysis of Certain® PREVAIL® Implant Clinical Trial Outcomes

• Bone Regression is limited to about 0.65 mm for Prevail implants

• Some difference between Prevail and Controls emerging after permanent

prosthesis insertion

• Expanded platform & FOSS surface appears to have a possitive effect on

bone regression

Prevail implant bone preservation results compared with typical outcomes from

standard Osseotite non-platform-switched implants show a different pattern

suggesting the overall design of PREVAIL implants features reduce regressive

modeling.

Interim Conclusions:

Interim Analysis of Certain® PREVAIL® Implant Clinical Trial Outcomes