Diapositiva 1

1
Interim Analysis of Certain PREVAIL Implant
Clinical Trial Outcomes
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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
failures Two 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.
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Interim Analysis of Certain PREVAIL Implant
Clinical Trial Outcomes

• 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.

Preservation Of Hard And Soft Tissues The Effect
Of The PREVAIL Implant On Crestal Bone
Regressive Modeling James Kenealy, PharmD. and
Renee M Stach, DDS.
Test Osseotite Certain PREVAIL Expanded Collar
Control Full Osseotite XP No Platform Switching
Interim 2-year post-loading results presented as
poster at the Chicago 2008 Biomet 3i Global
Symposium
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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
Collar 0.65mm
Test Osseotite XP No Platform Switching
Osseotite Certain Hybrid 1.6mm No Platform
Switching
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Interim Analysis of Certain PREVAIL Implant
Clinical Trial Outcomes
Interim Conclusions

• 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.