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

NCT03978962 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2025-02-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Atlanstat

    collaborator INDUSTRY

  • Biomatlante

    lead INDUSTRY

Principal Investigators

  • Saïd Kimakhe, PhD, DDS · Centre Hospitalo-Universitaire de Nantes

  • Saïd Kimakhe, Phd, DDS · Cabinet privé

  • Guy Daculsi, PhD · Biomatlante

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2020-08-26
Completion
2020-08-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978962 on ClinicalTrials.gov