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:
- 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
- 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
- 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.
- 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.
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