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

NCT01541345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-02

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Daniel S Thoma, Prof. Dr. · Clinic of Reconstructive Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-04-25
Completion
2019-06-04

Countries

  • Austria
  • Switzerland

Study Locations

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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 NCT01541345 on ClinicalTrials.gov