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

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ClinicalTrials.gov Identifier: NCT03978962
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
ATLANSTAT
Information provided by (Responsible Party):
Biomatlante

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

Condition or disease Intervention/treatment
Oral Bone Defect Maxillofacial Bone Defect Periodontal Bone Loss Alveolar Bone Loss Device: Guided Tissue Regeneration

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Study Type : Observational
Estimated 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 : June 17, 2019
Estimated Primary Completion Date : March 28, 2021
Estimated Study Completion Date : March 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Group/Cohort 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 Name: Guided Bone Regeneration




Primary Outcome Measures :
  1. Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection) [ Time Frame: 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 :
  1. Number and precise description of any adverse event during the follow-up [ Time Frame: 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

  2. Percentage of bone reconstruction in the treated bone defect by a radiographic examination [ Time Frame: Before surgery and 12 weeks post-surgery (+/-1 week) ]
    Comparison of the radiographies recorded before surgery and at the last follow-up visit



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The group will be selected in the entire population of the dental care center
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978962


Contacts
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Contact: Laura PAGNUCCO 0228020009 laurapagnucco@biomatlante.com
Contact: Nancy TRICHEREAU 0228020009 nancytrichereau@biomatlante.com

Locations
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France
Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes Recruiting
Nantes, France, 44093
Contact: Marjorie Cheraud    0240087383    Marjorie.CHERAUDCARPENTIER@chu-nantes.fr   
Principal Investigator: Saïd KIMAKHE, PhD, DDS         
Sub-Investigator: Badran ZAHI, PhD, DDS         
Sub-Investigator: Philippe LESCLOUS, PhD, DDS         
Sub-Investigator: Xavier STRUILLOU, PhD, DDS         
Cabinet privé du Dr. S. Kimakhe Recruiting
Nantes, France, 44200
Contact: Saïd KIMAKHE, PhD, DDS    0240897023    s.kimakhe@wanadoo.fr   
Sub-Investigator: Saïd KIMAKHE, PhD, DDS         
Sponsors and Collaborators
Biomatlante
ATLANSTAT
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Biomatlante:

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Responsible Party: Biomatlante
ClinicalTrials.gov Identifier: NCT03978962     History of Changes
Other Study ID Numbers: RE-DT04-18A
2018-A03202-53 ( Other Identifier: ANSM )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biomatlante:
Periodontal defects
Alveolar bone preservation
Collagen membrane
Mucosa healing
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Diseases
Musculoskeletal Diseases
Bone Resorption
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases