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Clinical Trial Summary

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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03978962
Study type Observational
Source Biomatlante
Contact Laura PAGNUCCO
Phone 0228020009
Email laurapagnucco@biomatlante.com
Status Recruiting
Phase
Start date June 17, 2019
Completion date March 29, 2021

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