Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163605
Status:
COMPLETED
Last Update Posted:
2007-11-15
First Post:
2005-09-08
Brief Title:
Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SolventDetergent Treated 4 IUML 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 ie 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 ie whether the newly-formed bone is suitable to retain implants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None