A randomized prospective clinical trial comparing OsteoActivator-P coated membranes vs Collagen Membrane-P uncoated for accelerated localized alveolar ridge preservation.

Completed

Conditions: dentaal
loss of bone volume

Registration Number: NL-OMON51997

Lead Sponsor: Osteo-Pharma.B.V.

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

• Absence of the lower canines
• Concomitant Medication: prescription or nonprescription drugs affecting
bone-metabolism, including corticosteroids, gonadotropins, sex steroids (not:
contraceptive medication), bisphosphonates, denosumab, parathyroid hormone and
calcitonin.
• 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
• Patient does not give permission for implantation of porcine membrane.
• 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
<p>• Significant increased bone formation as measured by histology.<br /><br><br /><br>• Occurrence of adverse events and adverse device effects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Bone density and volume on cone beam computed tomography<br /><br>• Investigator evaluation of handling.<br /><br>• Probing depth, recession, bleeding upon probing<br /><br>• Implant survival at 26 weeks and 52 weeks after implantation<br /><br>• VAS scale questionnaire<br /><br>• Implant Stability Quotient (ISQ) at implantation and after 12 weeks.</p><br>