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Clinical Trials/NL-OMON51997
NL-OMON51997
Completed
Not Applicable

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

Osteo-Pharma.B.V.0 sites16 target enrollmentTBD
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Conditionsdentaalloss of bone volume

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
dentaal
Sponsor
Osteo-Pharma.B.V.
Enrollment
16
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial ended prematurely

Registry
who.int
Start Date
TBD
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Osteo-Pharma.B.V.

Eligibility 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

  • •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
  • •Patients with ASA classification of III or worse

Outcomes

Primary Outcomes

Not specified

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