Jaw Edentulous Clinical Trial
Official title:
Clinical Performance of 4 mm Short Distal Implants in Fixed Cross-Arch Prostheses - An Open, Randomized, Controlled Study
This study aims to compare the clinical performance of 4 mm short implants supporting cross-arch fixed reconstructions in the edentulous mandible either with a combination of two short implants as distal support and two implants of conventional length placed in the interforaminal region, or with a combination of four short implants as distal support and two interforaminal implants of conventional length.
This is a post-market, multi-center, prospective, open, randomized controlled clinical study. The total study duration for each patient should be 36 ± 2 months. Roxolid Standard Plus Implants, 4 mm, Ø 4.1 mm, SLActive will be placed in positions 36/46 or 35/45, 36/46. Roxolid Standard Plus Implants, Ø 4.1 mm, SLActive, in lengths of 10, 12 and 14 mm will be placed in positions 33/43. In total 10 visits per patient are scheduled in this study. Implant survival, implant success, prosthetic survival and success, and adverse events (AEs) will be assessed. All products are CE-(Conformité Européenne, meaning European Conformity) marked and used within its intended use. Two centers in Switzerland and Northern Ireland will participate. The study and any amendments will be performed according to International Organization for Standardization (ISO) 14155:2011, local legal and regulatory requirements and conform to the Declaration of Helsinki (last revision Fortaleza 2013) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02911038 -
Stereolithographic Technique for Dentures
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N/A |