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

Phase 1

Completed

Conditions: Loss of Teeth Due to Extraction
Edentulous Alveolar Ridge
Alveolar Bone Loss

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 exodontia.

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.

Recruitment & 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 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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
New Bone Formation	From Baseline to 12 weeks	Percentage of new bone formation of the alveolar bone core biopsies.
Change in Bone Gain or Loss in Millimeters (Mesiodistal)	From Baseline to 12 weeks	Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Radiographic Bone Changes	From Baseline to 12 weeks	Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).
Change in Bone Gain or Loss in Millimeters (Buccopalatal)	From Baseline to 12 weeks	Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Change in Bone Gain or Loss in Millimeters (Stent to Apex)	From Baseline to 12 weeks	Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.