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
  Purpose

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

Condition Intervention Phase
Bone Regeneration Following Wisdom Teeth Extraction
Device: guided bone regeneration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by University of Zurich:

Study Start Date: May 2006
Estimated Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727818

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Inion OY Tampere Finland
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00727818     History of Changes
Other Study ID Numbers: R304 - 002
Study First Received: July 31, 2008
Last Updated: July 31, 2008
Health Authority: Switzerland: UZurich

ClinicalTrials.gov processed this record on July 22, 2014