The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone regeneration i.e. the amount of new bone that is formed and its suitability for dental implant placement. Part B is designed to evaluate long-term safety and performance of the product, i.e. whether the newly-formed bone is suitable to retain implants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
86
Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt
Erfurt, Germany
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Erlangen-Nürnberg
Erlangen, Germany
Universitätsklinikum Schleswig Holstein, Campus Kiel
Kiel, Germany
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