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Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants

NCT01012921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2018-01-02

Study results available
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Summary

The aim of the study is to test in a randomized comparative study the performance of Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann® SLActive bone level titanium implants.

Furthermore the clinical evaluation and comparison of complementary parameters describing the bony and soft tissue environments at the surgical sites during the study period to evaluate effectiveness and performance of the membranes.

Conditions

  • Degeneration; Bone

Interventions

DEVICE

barrier membrane

The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).

DEVICE

MembraGel

Device application at surgery

OTHER

Bio-Gide® membrane

Device application at surgery

Sponsors & Collaborators

  • Institut Straumann AG

    lead INDUSTRY

Principal Investigators

  • Christoph Haemmerle, Prof. Dr. · Medical University Zürich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-10-31
Completion
2015-12-31

Countries

  • Belgium
  • Germany
  • Hungary
  • Italy
  • Spain
  • Sweden
  • 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 NCT01012921 on ClinicalTrials.gov