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

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

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

Study Overview

• Status: Unknown
• Conditions: Periodontal Bone Loss; Alveolar Bone Loss; Oral Bone Defect; Maxillofacial Bone Defect
• Intervention / Treatment: Device: Guided Tissue Regeneration

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

• Study Contact: Name: Laura PAGNUCCO; Phone Number: 0228020009; Email: laurapagnucco@biomatlante.com
• Study Contact Backup: Name: Nancy TRICHEREAU; Phone Number: 0228020009; Email: nancytrichereau@biomatlante.com

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes
    • Contact: Marjorie Cheraud; Phone Number: 0240087383; Email: 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
  • Nantes, France, 44200
    • Recruiting
    • Cabinet privé du Dr. S. Kimakhe
    • Contact: Saïd KIMAKHE, PhD, DDS; Phone Number: 0240897023; Email: s.kimakhe@wanadoo.fr
    • Sub-Investigator: Saïd KIMAKHE, PhD, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The group will be selected in the entire population of the dental care center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 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)

Collaborators and Investigators

• Sponsor: Biomatlante
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2019
• Primary Completion (ANTICIPATED): March 28, 2021
• Study Completion (ANTICIPATED): March 29, 2021

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Collagen membrane; Periodontal defects; Alveolar bone preservation; Mucosa healing
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: RE-DT04-18A; 2018-A03202-53 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No