NCT00889265

CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation

Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft for Localized Alveolar Ridge Augmentation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.

Detailed description

The study will evaluate the use of CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft, with the use of Puros Cancellous Particulate Allograft (Puros Cancellous), a mineralized allograft, for the augmentation of localized alveolar ridge defects in edentulous sites. The purpose of the study will be to determine placement time, ease of use, stability, esthetics and to clinically evaluate the efficacy of the list products. A biopsy will be taken from a subset of the patient population, at one investigational site, to evaluate the grafted site's formation of new bone. The study hypothesis is that if CopiOs Pericardium and Puros Cancellous are used, the a single, localized alveolar ridge defect will clinically improve at an edentulous site.

Conditions

• Alveolar Ridge Defect

Interventions

Type	Name	Description
DEVICE	CopiOs Pericardium Membrane	CopiOs Pericardium, Puros Cancellous

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-04-28
• Last updated: 2014-08-11
• Results posted: 2014-08-07

Locations

4 sites across 1 country: United States