NCT03978962

Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"

Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Biomatlante · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Oral Bone Defect
• Maxillofacial Bone Defect
• Periodontal Bone Loss
• Alveolar Bone Loss

Interventions

Type	Name	Description
DEVICE	Guided Tissue Regeneration	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.

Timeline

• Start date: 2019-05-28
• Primary completion: 2020-08-26
• Completion: 2020-08-26
• First posted: 2019-06-07
• Last updated: 2025-02-04

Locations

2 sites across 1 country: France