Trabecular Implant Poster Studies

Trabecular Implant Poster Studies, geplaatst op de Annual Meeting Academy of Osseointegration 2013

European Multicenter Studies of a Porous Tantalum-Titanium Implant: One-Year Interim Results

Authors: Markus Schlee, Peter van der Schoor, Hai Bo Wen, Shilpa Kottalgi, Martin Dinkel

Background: For almost 50 years numerous attempts have been made to augment osseointegration. This paper reports preliminary 1-year follow-up results from two prospective multicenter clinical studies  on TM implants.

Materials and Methods:

  1. Immediate Loading (IL/PoP) Study – provisionalization out of occlusion within 48 hours with definitive abutments, final restorations within 2 weeks of implant placement; a 3-year evaluation
  2. Longitudinal Data Collection Program (LDCP) – investigators in 23 clinical sites were required to follow the IFU only; evaluation of clinical outcomes in an uncontrolled population

Results:

  1. In the IL (PoP) study:
  • The survival rate was 97.2%, n=35/36 at 6 months and 28 implants continuing a 3-year evaluation had no additional failures.
  • The mean marginal bone loss was 0.52mm.
  1. In the LDCP study:
  • 141 implants exhibited 97.9% survival at 1 year
    • 100% survival for fresh extraction and type IV bone cases
    • 98.4% survival for bone augmentation cases
    • 41% of the subjects had risk factors.   

Conclusion: in both studies, controlled and semi-controlled with uncontrolled patient population, the TM implant had high survival rate of >97%


Trabecular Metal Implants – from Orthopedics to Dental Implantology (this poster is complementary to the Proof-of-Principle study as a similar protocol was used by a private practice clinician)

Author: Suheil M. Boutros, DDS, MS

Background: Evaluation of effectiveness of immediate loading with the TM Implants

Materials and Methods: 18 implants placed in 14 patients. Immediate provisionalization out of occlusion within 48 hours, definitive loading within 2 weeks post-op.

Results: At 1 year, all implants were clinically osseointegrated and functioning. Bone and soft tissue levels remained stable.

Conclusion: TM Implants exhibited adequate primary stability to enable immediate loading in selected patients, with successful results after 1 year


 Osseoincorporation of Porous Tantalum Cylinders Implanted in Human Subjects: 12-Week Interim Results (the first study to document bone ingrowth in humans)

Authors: Celia Clemente de Arriba, Miguel Angel Alobera Gracia, Mariano Del Canto Pingarron (faculty of the Universities of Madrid and Leon, Spain), Kim Bradbury, Hai Bo Wen

Background: Evaluation of osseoincorporation with TM Implants in humans

Materials and Methods: 24 TM cylinders (3x5 mm) placed in 23 patients. Cylinders were explanted at 2, 3, 6 or 12 weeks and histological evaluation was performed to measure degree of bone ingrowth

Results: New bone formation was observed in the TM pores at 12 weeks. The degree of ingrowth varied by depth, for example, at 0.5mm depth, mean bone fill was 22.7%.

Conclusion: Ingrowth of bone and blood vessels inside porous TM cylinders was observed at 12 weeks.

Merken

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