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

Completed

• Conditions: Oral Bone Defect; Maxillofacial Bone Defect; Periodontal Bone Loss; Alveolar Bone Loss
• Interventions: Device: Guided Tissue Regeneration

• Registration Number: NCT03978962
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-07
• Study Start: 2019-05-28
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Guided Tissue Regeneration	Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes; 🇫🇷 Nantes, France

Cabinet privé du Dr. S. Kimakhe; 🇫🇷 Nantes, France