Bone Regeneration Following Wisdom Teeth Extraction Clinical Trial
| Verified date | July 2008 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: UZurich |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | February 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 30 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich | Inion Oy |
Switzerland,