OsteoActivator-P for accelerated localized alveolar ridge preservatio
- Conditions
- Healthy patients with a ruinous dentition (including the canines) in the lower jaw in need of extractions of all teeth of the mandible.
- Registration Number
- NL-OMON29312
- Lead Sponsor
- Osteo Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 16
• Males and females, aged =18 years.
• Patient has signed informed consent.
• Patients with a ruinous dentition (including the canines) in the lower jaw in need of extractions of all teeth of the mandible.
• Patients in need of a total dental prosthesis in the lower jaw.
• Patients that want an implant-based denture in the lower jaw.
• Bone width of at least 7mm
• Bone height beneath the root-point of the canines at least 10mm
• Absence of the lower canines
• History of treatment with bisphosphonates or denosumab
• History of radiotherapy in the head/neck region
• Poor oral hygiene
• Women who are pregnant or breastfeeding
• Compromised immune system (e.g. uncontrolled diabetis) or unstable bleeding disorder.
• Patients with ASA classification of III or worse
• Local infection at the site of implantation
• History of previous ridge augmentation/preservation at the site of interest
• History of oral cancer or radiation of the oral cavity.
• Current malignancy
• Unresolved oral pathologies
• Refusing the implantation of porcine material
• Highly atrophic mandible (Cawood classification V or higher)
• Known allergy to collagen.
• Heavy smoking (> 20 cigarettes/day).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • To histologically assess and compare new bone formation and bone quality 8 weeks after socket preservation with OsteoActivator-P porcine pericard membranes containing alendronate and testosterone to Collagen Membrane-P uncoated.<br>• To assess the safety of the use of OsteoActivator-P porcine pericard membranes in the treatment of alveolar ridge preservation.
- Secondary Outcome Measures
Name Time Method • To assess and compare new bone formation and bone quality by computed tomography 8 weeks after socket preservation with OsteoActivator-P porcine pericard membranes containing alendronate and testosterone to Collagen Membrane-P uncoated.<br>• To determine the ease of use of OsteoActivator-P porcine pericard membranes for alveolar ridge preservation.<br>• Implant site inspection<br>• To assess reliable implant placement at 8 weeks with application of OsteoActivator-P porcine pericard membranes containing alendronate and testosterone as compared to standard of care (Collagen Membrane-P uncoated).<br>• Implant Stability Quotient (ISQ) at implantation and after 12 weeks.<br>• Patient satisfaction