Status:
COMPLETED
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Lead Sponsor:
William Giannobile
Collaborating Sponsors:
Johnson & Johnson
OraPharma
Conditions:
Alveolar Bone Loss
Loss of Teeth Due to Extraction
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 e...
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00639860
Start Date
March 1 2008
End Date
March 1 2009
Last Update
March 31 2016
Active Locations (1)
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1
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106