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

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 May 16, 2013

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