NCT01308996

Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation

A Prospective, Open Label, Randomized, Multicenter, Controlled Clinical Study of INFUSE® Bone Graft Used as an Alternative to Autogenous Bone Graft for Vertical Alveolar Ridge Augmentation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental implants.

Detailed description

The purpose of this study is to evaluate INFUSE® Bone Graft as an alternative to autograft for alveolar ridge bone formation in the posterior mandible prior to dental implants. A subject must have a defect behind the canine of 2-4 teeth for at least 2 months and be a candidate for dental implants.

Conditions

• Alveolar Bone Loss in Mandible
• Edentulous Alveolar Ridge In Mandible

Interventions

Type	Name	Description
DEVICE	INFUSE® Bone Graft	Implantation of INFUSE® Bone Graft \[recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)\] and absorbable collagen sponge (ACS) carrier at 1.50 mg/cc with space maintenance device
PROCEDURE	Autogenous bone graft from tibia or iliac crest	Implantation of autogenous bone graft from iliac crest or tibia with titanium mesh space maintenance device

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2011-03-04
• Last updated: 2018-09-13