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

NCT01308996 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Averion International Corporation

    collaborator INDUSTRY

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2017-07-31
Completion
2017-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308996 on ClinicalTrials.gov