Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia (OSSIX)

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson
OraPharma
Information provided by (Responsible Party):
William Giannobile, University of Michigan
ClinicalTrials.gov Identifier:
NCT00639860
First received: March 14, 2008
Last updated: March 1, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.

Condition Intervention Phase
Alveolar Bone Loss
Loss of Teeth Due to Extraction
Edentulous Alveolar Ridge
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:
  • Change in Bone Gain or Loss in Millimeters (Buccopalatal) [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

  • Change in Bone Gain or Loss in Millimeters (Mesiodistal) [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

  • Change in Bone Gain or Loss in Millimeters (Stent to Apex) [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.

  • Radiographic Bone Changes [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).

  • New Bone Formation [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Percentage of new bone formation of the alveolar bone core biopsies.


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: Placing OSSIX-Plus in Extraction Site
Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
Device: OSSIX-Plus
resorbable collagen membrane

Detailed Description:
Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 and compliance with re-evaluation appointments
  • Subjects who read, understand and are 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 or 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, biphosphonatesm, 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
William Giannobile
Johnson & Johnson
OraPharma
Investigators
Principal Investigator: William V Giannobile, DDS, DMedSc Professor
  More Information

Publications:
Responsible Party: William Giannobile, William Giannobile, D.D.S., D.Med.Sc., University of Michigan
ClinicalTrials.gov Identifier: NCT00639860     History of Changes
Other Study ID Numbers: HUM00016574 
Study First Received: March 14, 2008
Results First Received: December 11, 2015
Last Updated: March 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Michigan:
extraction
implant
alveolar ridge preservation

Additional relevant MeSH terms:
Alveolar Bone Loss
Tooth Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on September 29, 2016