Clinical trial NCT03978962: Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
Official title: Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Bone Defect
Maxillofacial Bone Defect
Periodontal Bone Loss
Alveolar Bone Loss
Keywords: Periodontal defects
Alveolar bone preservation
Collagen membrane
Mucosa healing
Lead sponsor: Biomatlante
Sponsor class: INDUSTRY
Collaborators: name: Atlanstat
First posted: 2019-06-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group will be selected in the entire population of the dental care center

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:

1. Tissue regeneration (mucosa health on the site of implantation)
2. Safety (report of any adverse event)
3. Radiographic analysis of periodontal tissues


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

Primary outcomes:
measure: Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)
timeFrame: 1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week)
Secondary outcomes:
measure: Number and precise description of any adverse event during the follow-up
timeFrame: From screening visit through visit at 12 weeks
measure: Percentage of bone reconstruction in the treated bone defect by a radiographic examination
timeFrame: Before surgery and 12 weeks post-surgery (+/-1 week)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes
city: Nantes
country: France
facility: Cabinet privé du Dr. S. Kimakhe
Study officials:
affiliation: Centre Hospitalo-Universitaire de Nantes
name: Saïd Kimakhe, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet privé
name: Saïd Kimakhe, Phd, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomatlante
name: Guy Daculsi, PhD
role: STUDY_DIRECTOR
References: