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

Biomatlante

Status: Completed

Conditions: Alveolar Bone Loss; Maxillofacial Bone Defect; Oral Bone Defect; Periodontal Bone Loss

Treatments: Device: Guided Tissue Regeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT03978962

2018-A03202-53 (Other Identifier)

RE-DT04-18A

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged from 18 to 70
• Periodontal defects (e.g. cyst, bone tumour, crest augmentation...)
• Aleveolar bone defect after tooth (teeth) extraction
• Non opposition form (consent of the patient)
• Patients affiliated to the French social security
• Patients not under guardianship or judicial protection

Exclusion criteria

• Pregnancy of breastfeeding women
• Severe smoker (>10 cigarettes per day)
• Acute infections
• Allergies to the material (if an allergy of any kind is suspected, adequate exams must be carried out in advance)
• Refusal of the patient to adhere to surgical follow-up and to the limit in activity level
• Fever and/or local inflammation
• HIV positive known
• History of uncontrolled diabetes (untreated or not stabilized by treatment)
• History of treatments for previous corticosteroids, long-term (more than 6 months) and interrupted for less than 3 months
• History of chemotherapy in progress or during the last three months
• History of cervico-facial radiotherapy
• History of bone disease with disorders of blood circulation which is defined as Akbers-Schönberg disease or Paget's disease
• Known severe hyperparathyroïdism
• History of severe immune deficiency

Trial design

56 participants in 1 patient group

Study population

Description:

Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure

Treatment:

Device: Guided Tissue Regeneration