Alveolar Bone Loss Clinical Trial
Official title:
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures
The evaluation of the clinical data has demonstrated the conformity of the Resorbable
Collagen Membrane (RCM), EZ CureTM, with the relevant essential requirements for its use in
periodontal applications. The RCM is intended for Guided Tissue Regeneration (GTR) and Guided
Bone Regeneration (GBR) procedures. It acts as a barrier against the migration of epithelial
cells within the bone defect (performance) and thus complies with several surgical
indications in the treatment of maxillofacial bone defects. It has been concluded that the
risks associated with the use of this device are acceptable when weighted against the
benefits to the patients.
In order to improve the clinical data on the RCM, the manufacturer, Biomatlante, decided to
assess that the performance and safety of the device are maintained until the reaching of its
intended use. In this objective, the goal of this study will be to observe the following
parameters:
1. Tissue regeneration (mucosa health on the site of implantation)
2. Safety (report of any adverse event)
3. Radiographic analysis of periodontal tissues
n/a
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