Clinical Trial: Localized Alveolar Ridge Augmentation With Space Maintenance Devices

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Space Maintenance Devices for Soft Tissu

Brief Summary: The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant, so that a dental implant can later be inserted.

Detailed Summary:

The INFUSE® Bone Graft is a device approved by the FDA to be used instead of using your own bone (from another site on your body) to replace missing bone in your jaw. INFUSE® Bone Graft is commercially available and is made up of 2 parts - recombinant human Bone Morphogenetic Protein-2 (rhBMP 2) placed on an absorbable collagen sponge (ACS). The rhBMP-2 is a genetically altered protein which recruits bone-forming cells to the surgical area and changes local cells to bone. ACS is made from Type I collagen from bovine (cattle) tendon. It helps to hold the rhBMP-2 in place and acts as a support for the growing bone. The sponge itself will reabsorb in time as the new bone forms.

The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw so that a dental implant can later be inserted. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with space holding devices, in a 2-part procedure. Your dental implants will be placed at approximately 6 months after the INFUSE® Bone Graft implant.

Sponsor: Medtronic Spinal and Biologics

Current Primary Outcome: Alveolar ridge bone formation sufficient to place endosseous implants [ Time Frame: approximately 6 months post-surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans. [ Time Frame: approximately 6 months post-surgery ]

Original Secondary Outcome: Same as current

Information By: Medtronic Spinal and Biologics

Dates:
Date Received: October 6, 2009
Date Started: October 2009
Date Completion:
Last Updated: February 15, 2012
Last Verified: September 2011