Performance and Safety of the Resorbable Collagen Membrane Ez Cure

Study Overview
=================
Brief 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: Tissue regeneration (mucosa health on the site of implantation) Safety (report of any adverse event) Radiographic analysis of periodontal tissues

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

Conditions
-----------------
Oral Bone Defect, Maxillofacial Bone Defect, Periodontal Bone Loss, Alveolar Bone Loss

Intervention / Treatment
-----------------
* Device: Guided Tissue Regeneration


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure | Device: Guided Tissue Regeneration<br>* 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.<br>* Other names: Guided Bone Regeneration;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Before surgery and 12 weeks post-surgery (+/-1 week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal defects, Alveolar bone preservation, Collagen membrane, Mucosa healing