Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
Summary
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 Design
Allocation: Non-Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
Sinus Implant Reconstruction
Intervention
Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)
Location
Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt
Erfurt
Germany
99089
Status
Completed
Source
Baxter Healthcare Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00163605
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Factor Xiii
A fibrin-stabilizing plasma enzyme (TRANSGLUTAMINASES) that is activated by THROMBIN and CALCIUM to form FACTOR XIIIA. It is important for stabilizing the formation of the fibrin polymer (clot) which culminates the coagulation cascade.
Calcium Carbonate
Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
Bone Cements
Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Synthetic resins are commonly used as cements. A mixture of monocalcium phosphate, monohydrate, alpha-tricalcium phosphate, and calcium carbonate with a sodium phosphate solution is also a useful bone paste.
Propiolactone
Disinfectant used in vapor form to sterilize vaccines, grafts, etc. The vapor is very irritating and the liquid form is carcinogenic.
Fibrin Tissue Adhesive
An autologous or commercial tissue adhesive containing FIBRINOGEN and THROMBIN. The commercial product is a two component system from human plasma that contains more than fibrinogen and thrombin. The first component contains highly concentrated fibrinogen, FACTOR VIII, fibronectin, and traces of other plasma proteins. The second component contains thrombin, calcium chloride, and antifibrinolytic agents such as APROTININ. Mixing of the two components promotes BLOOD CLOTTING and the formation and cross-linking of fibrin. The tissue adhesive is used for tissue sealing, HEMOSTASIS, and WOUND HEALING.
Clinical Trials
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring car...
The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip repl...
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standa...
Fibrin Sealant Vascular Surgery Study
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s...
The aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.
PubMed Articles
Alloplastic Cancellous Bone Replacement and Fibrin Glue in Hand Surgery.
INTRODUCTION: Alloplastic replacement of cancellous bone is being increasingly used in the clinical setting. The use in hand surgery, however, is only sparsely documented. MATERIALS AND METHODS: We re...
Systematic review of the use of fibrin sealant in abdominal-wall repair surgery.
PURPOSE: Our objective was to analyze the advantages and inconveniences associated with the use of fibrin sealant compared with mechanical means for mesh fixation following abdominal-wall surgery. MET...
BACKGROUND:: This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL() Fibrin Sealant (Human)) during vascular surgery. METHODS:: This prospective randomized controll...
Park J-C, So S-S, Jung I-H, Yun J-H, Choi S-H, Cho K-S, Kim C-S. Induction of bone formation by Escherichia coli-expressed recombinant human bone morphogenetic protein-2 using block-type macroporous b...
BACKGROUND: To minimize bleeding and biliary leakage after open hepatectomy, fibrin sealing is undertaken at the transaction plane of the liver. Recently, clinicians have begun using polyglycolic acid...
