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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: OSSIX-Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placing OSSIX-Plus in Extraction Site<br>Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. | Device: OSSIX-Plus<br>* resorbable collagen membrane<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extraction, implant, alveolar ridge preservation