Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Completed · Phase 1/Phase 2
Conditions studied: Alveolar Bone Loss, Loss of Teeth Due to Extraction, Edentulous Alveolar Ridge
In brief
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.
Key facts
- Study ID
- NCT00639860
- Run by
- William Giannobile
- People needed
- 10
- Starts
- 2008-03-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2016-03-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Michigan Center for Oral Health Research — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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