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A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.

This study has been completed.
Sponsor:
Collaborator:
Inion OY Tampere Finland
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00727818
First received: July 31, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted

July 31, 2008
July 31, 2008
May 2006
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No Changes Posted
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A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.
Not Provided

The purpose of this study was to evaluate by histology and histomorphometry, thirty human osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of implantation. This study is part of a splitting-blind clinical investigation to compare the performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of wisdom teeth.

The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson & Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer Bio-Gide®-membrane.

This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation.

This study was conducted in accordance with the requirements of the FDA (Department of health and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.

  • Trial with medical device
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Bone Regeneration Following Wisdom Teeth Extraction
Device: guided bone regeneration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2007
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Inclusion criteria: Females or males between the age of 18 to 30 Subject for extraction of both lower fully impacted wisdom teeth Signed informed consent Able and willing to comply with all study procedures

Exclusion criteria: Heavy smoker (>20/day) Insulin dependant diabetes Pregnant or nursing

Both
18 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00727818
R304 - 002
Not Provided
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University of Zurich
Inion OY Tampere Finland
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP