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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978962
• Other study ID #: RE-DT04-18A
• Secondary ID: 2018-A03202-53
• Status: Recruiting
• Start date: June 17, 2019
• Est. completion date: March 29, 2021

Study information

• Verified date: July 2019
• Source: Biomatlante
• Contact: Laura PAGNUCCO
• Phone: 0228020009
• Email: laurapagnucco[@]biomatlante.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: March 29, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Maxillofacial Bone Defect
• Oral Bone Defect
• Periodontal Bone Loss

Intervention

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.

Locations

Country	Name	City	State
France	Cabinet privé du Dr. S. Kimakhe	Nantes
France	Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Biomatlante	ATLANSTAT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)