- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00727818
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.
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
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Zurich, Switzerland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R304 - 002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bone Regeneration Following Wisdom Teeth Extraction
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Zoya Haitov Ben ZikriRecruitingWisdom Teeth Extraction or Jaw ImplantIsrael
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Krizaj d.o.o.Completed
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Mohammed Bin Rashid University of Medicine and...Not yet recruitingDental Implants | Bone Regeneration | Tooth Extraction
-
Rui FigueiredoMTS Europe GmbH (sponsor)WithdrawnBone Resorption | Loss of Teeth Due to ExtractionSpain
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PfizerCompletedPost-surgical Pain Following Extraction of Molar TeethUnited States
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Implantology InstituteUnknownBone Resorption | Alveolar Bone Loss | Loss of Teeth Due to ExtractionPortugal
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Universidad Complutense de MadridNORICUM SLRecruitingEdentulous Alveolar Ridge | Alveolar Bone Loss | Loss of Teeth Due to ExtractionSpain
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William GiannobileJohnson & Johnson; OraPharmaCompletedEdentulous Alveolar Ridge | Alveolar Bone Loss | Loss of Teeth Due to ExtractionUnited States
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