Healthy patients with a ruinous dentition (including the canines) in the lower jaw in need of extractions of all teeth of the mandible.
Conditions
Interventions
This will be a split mouth study design. The alveolar ridge preservation will be applied on the two canine regions of the mandible. The alveolar extraction sockets of the canines will be filled with a
Sponsors
Osteo Pharma
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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. • To assess the safety of the use of OsteoActivator-P porcine pericard membranes in the treatment of alveolar ridge preservation. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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. • To determine the ease of use of OsteoActivator-P porcine pericard membranes for alveolar ridge preservation. • Implant site inspection • 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). • Implant Stability Quotient (ISQ) at implantation and after 12 weeks. • Patient satisfaction | — |
Contacts
Public ContactNynke Lie
Maastricht University Medical Center
Outcome results
None listed