Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia - Full Text View

Sponsors and Collaborators:	University of Michigan Johnson & Johnson OraPharma
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00639860

Purpose

The purpose of this study is to document and evaluate how protective covering materials (a barrier membrane called OSSIX-Plus) can help preserve bone size after a tooth is removed. As you know by now, dental implants can only be placed when enough bone is found and this protective covering may help the healing of your bone after the tooth is removed. For this study, we are asking that records we take during procedures (pictures of teeth only, notes) can be used for publications.

Condition	Intervention	Phase
Tooth Extraction	Device: OSSIX-Plus	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia

Further study details as provided by University of Michigan:

Primary Outcome Measures:

bone gain or loss in millimeters, radiographic bone changes, and percentage of new bone formation in the alveolar bone core biopsies. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

soft tissue wound healing. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: OSSIX-Plus resorbable collagen membrane

Detailed Description:

The purpose of this study is to document and evaluate how protective covering materials (a barrier membrane called OSSIX-Plus) can help preserve bone size after a tooth is removed. Dental implants can only be placed when enough bone is found and this protective covering may help the healing of bone after the tooth is removed. For this study, we are asking that records we take during procedures (pictures of teeth only, notes) can be used for publications.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
Residual extraction sockets must have <80% bone loss in all dimensions (3 or 4-walled bony defects)
Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)
Subjects willing and able to comply with all study-related procedures
Including maintenance of good oral hygiene
Compliance with re-evaluation appointments
Subjects who read
Understand
Willing to sign an informed consent statement

Exclusion Criteria:

Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site
Presence of acute infections at the time of tooth extraction
Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth
Other renal
Hepatic
Cardiac
Endocrine
Hematological
Autoimmune or acute infectious diseases that makes interpretation of the data more difficult
History of head & neck radiation therapy
Subjects taking steroids
Tetracycline or tetracycline analogs
Bone therapeutic levels of fluorides
Biphosphonates
Medications affecting bone turnover
Antibiotics for >7 days or any investigational drug
Patients who are or become pregnant during the length of the study
Sites in which one or both adjacent teeth are missing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639860

Contacts

Contact: Anna M Galloro, BS	734-998-6721	ashafto@umich.edu
Contact: Lana R Huffman	734-998-6721	lanahuff@umich.edu

Locations

United States, Michigan
Michigan Center for Oral Health Research	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Anna M Galloro, BS 734-998-6721 ashafto@umich.edu
Contact: Lana Huffman 734-998-6721 lanahuff@umich.edu

Sponsors and Collaborators

University of Michigan

Johnson & Johnson

OraPharma

Investigators

Principal Investigator:

William V Giannobile, DDS, DMedSc

Professor

More Information

Responsible Party:	University of Michigan ( William Giannobile )
Study ID Numbers:	2008-01
Study First Received:	March 14, 2008
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00639860
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

extraction
implant

ClinicalTrials.gov processed this record on January 16, 2009