NCT00163605

Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 86 (planned)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sinus Implant Reconstruction

Interventions

Type	Name	Description
DEVICE	Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)

Timeline

• Start date: 2004-09-01
• Completion: 2007-11-01
• First posted: 2005-09-14
• Last updated: 2007-11-15

Locations

3 sites across 1 country: Germany