Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" (NCT03978962) | Clinical Trial Compass
CompletedNot Applicable
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
France56 participantsStarted 2019-05-28
Plain-language 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
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)