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

Baxter Healthcare Corporation3 sites in 1 country86 target enrollmentSeptember 2004

ConditionsSinus Implant Reconstruction

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Sinus Implant Reconstruction
Sponsor: Baxter Healthcare Corporation
Enrollment: 86
Locations: 3
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

November 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Previous or coeval major surgical intervention in the targeted area, or major surgical intervention in the targeted area planned within the next 18 months (like Caldwell Luc) (minor interventions like surgical tooth extraction or root tip resections are allowed)
•Surgical tooth extraction in the targeted area less than three months before the SLP
•Maxillary and sinus disorders including: acute sinusitis, chronic sinus pathology, retained root tips, polyps, tumors, and cysts in antral cavity or odontogenic cysts, alveolar scar ablation
•Major occlusal disturbance, like severe bruxism
•Uncontrolled\* periodontal disease
•An inadequate interarch distance requiring an oppositional graft
•Immune system disorders, immunodeficiency or immunosuppression
•Known coagulation disorder
•Uncontrolled\* diabetes mellitus
•Severe hyperparathyroidism