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

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson
OraPharma
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00639860
First received: March 14, 2008
Last updated: May 20, 2009
Last verified: May 2009
  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, the investigators are asking that records taken during procedures (pictures of teeth only, notes) can be used for publications.


Condition Intervention Phase
Tooth Extractions
Device: OSSIX-Plus
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: OSSIX-Plus
resorbable collagen membrane

  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
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: NCT00639860

Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Johnson & Johnson
OraPharma
Investigators
Principal Investigator: William V Giannobile, DDS, DMedSc Professor
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Giannobile, University of Michigan
ClinicalTrials.gov Identifier: NCT00639860     History of Changes
Other Study ID Numbers: 2008-01
Study First Received: March 14, 2008
Last Updated: May 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
extraction
implant

ClinicalTrials.gov processed this record on September 11, 2014