NCT01541345

Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

A Phase III, Randomized, Controlled Clinical Trial of Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed. The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects. The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.

Conditions

• Missing Teeth

Interventions

Type	Name	Description
DEVICE	Autogenous bone graft	Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland)
DRUG	InductOs	CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery.
PROCEDURE	Augmentation surgery	CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane)

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-04-25
• Completion: 2019-06-04
• First posted: 2012-02-29
• Last updated: 2021-12-02

Locations

2 sites across 2 countries: Austria, Switzerland