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

Sponsor

Biomatlante (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03978962

Collaborator

Atlanstat (Industry)

Enrollment

Locations

21.4

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oral Bone Defect Maxillofacial Bone Defect Periodontal Bone Loss Alveolar Bone Loss	Device: Guided Tissue Regeneration

Study Design

Study Type:

Observational

Anticipated Enrollment :

56 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 17, 2019

Anticipated Primary Completion Date :

Mar 28, 2021

Anticipated Study Completion Date :

Mar 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Study population Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure	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. Other Names: Guided Bone Regeneration

Arm

Intervention/Treatment

Study population

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

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.

Other Names:

Guided Bone Regeneration

Outcome Measures

Primary Outcome Measures

Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection) [1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week)]
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

Secondary Outcome Measures

Number and precise description of any adverse event during the follow-up [From screening visit through visit at 12 weeks]
Record and description of any adverse event during the follow-up that reflects the safety of the Resorbable Collagen Membrane
Percentage of bone reconstruction in the treated bone defect by a radiographic examination [Before surgery and 12 weeks post-surgery (+/-1 week)]
Comparison of the radiographies recorded before surgery and at the last follow-up visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes	Nantes		France	44093
2	Cabinet privé du Dr. S. Kimakhe	Nantes		France	44200

Sponsors and Collaborators

Biomatlante
Atlanstat

Investigators

Principal Investigator: Saïd Kimakhe, PhD, DDS, Centre Hospitalo-Universitaire de Nantes
Principal Investigator: Saïd Kimakhe, Phd, DDS, Cabinet privé
Study Director: Guy Daculsi, PhD, Biomatlante