The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow treatment of patients with single tooth gaps of small dimensions in the lateral and central incisor positions in the mandible and in the lateral incisor positions in the maxilla. These positions are reduced-load-bearing compared to more posterior positions. During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.
This is a multi-center, prospective, single cohort, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 12 ± 1 months. Straumann BLT implants Ø 2.9 mm will be placed in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement, followed by provisional prosthetic loading after 6 ± 2 weeks and by final prosthetic loading 4 ± 1 months after implant placements. In total 7 visits per patient are scheduled in this study. Implant survival, PES, implant success, bone level changes and adverse events (AEs) will be assessed. The investigational device is a CE-(Conformité Européenne, meaning European Conformity) marked product. Straumann BLT implants Ø 2.9 mm Roxolid SLActive (sand blasted, large grit, acid etched surface) are available in lengths of 10, 12 and 14 mm. Four centers in Germany will participate. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
46
Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen
Düsseldorf, Germany
Medi+
Mainz, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
Mainz, Germany
Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie
Münster, Germany
Implant Survival Rate at 12 Months After Implant Placement
A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.
Time frame: 12 months after implant placement
Pink Esthetic Score (PES) at 6 Months After Implant Placement
The Pink esthetic score allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14. The higher the value, the better the outcome.
Time frame: 6 months after implant placement
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Kieferchirurgische Praxen Hentschel & Herrmann
Zwickau, Germany