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
Study Type
OBSERVATIONAL
Enrollment
56
Covering oral-maxillofacial or a periodontal defects with the Resorbable Collagen Membrane in order to avoid epithelial cell infiltration and to promote periodontal tissues healing. Covering alveolar bone defects after tooth-teeth extraction.
Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes
Nantes, France
Cabinet privé du Dr. S. Kimakhe
Nantes, France
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)
Observation of the change of the mucosa health in terms of swelling, wound closure and colour of the implantation site. It reflects the performance of the Resorbable Collagen Membrane
Time frame: 1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week)
Number and precise description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the Resorbable Collagen Membrane
Time frame: From screening visit through visit at 12 weeks
Percentage of bone reconstruction in the treated bone defect by a radiographic examination
Comparison of the radiographies recorded before surgery and at the last follow-up visit
Time frame: Before surgery and 12 weeks post-surgery (+/-1 week)
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