|
|
|
|
|
Sponsored by: |
Baxter Healthcare Corporation |
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00163605 |
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.
Condition | Intervention | Phase |
Sinus Implant Reconstruction |
Device: Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) |
Phase II Phase III |
ChemIDplus related topics: | Calcium gluconate Fibrin Beriplast Calcium phosphate |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion Criteria:
Pregnant or lactating, or intending to become pregnant during the study period
Germany | |||||
Universitätsklinikum Schleswig Holstein, Campus Kiel | |||||
Kiel, Germany, 24105 | |||||
Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt | |||||
Erfurt, Germany, 99089 | |||||
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Erlangen-Nürnberg | |||||
Erlangen, Germany, 91054 |
Baxter Healthcare Corporation |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
Study ID Numbers: | 570201 |
First Received: | September 8, 2005 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00163605 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
|
|
|