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

Tooth Extractions Clinical Trial

— OSSIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639860
• Other study ID #: 2008-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 14, 2008
• Last updated: May 20, 2009
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Extractions

Intervention

Device:
• OSSIX-Plus
resorbable collagen membrane

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Johnson & Johnson, OraPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone gain or loss in millimeters, radiographic bone changes, and percentage of new bone formation in the alveolar bone core biopsies		12 weeks	No
Secondary	soft tissue wound healing		12 weeks	Yes