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

NCT03978962 | Completed

• 2 other identifiers: RE-DT04-18A2018-A03202-53
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

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. 1.Tissue regeneration (mucosa health on the site of implantation)
2. 2.Safety (report of any adverse event)
3. 3.Radiographic analysis of periodontal tissues

Conditions

Oral Bone Defect; Maxillofacial Bone Defect; Periodontal Bone Loss; Alveolar Bone Loss

Keywords

Periodontal defects; Alveolar bone preservation; Collagen membrane; Mucosa healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number and precise description of any adverse event during the follow-up

  From screening visit through visit at 12 weeks

• Percentage of bone reconstruction in the treated bone defect by a radiographic examination

  Before surgery and 12 weeks post-surgery (+/-1 week)

Study Arms (1)

Study population

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

Device: Guided Tissue Regeneration

Interventions

Guided Tissue Regeneration DEVICE

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.

Also known as: Guided Bone Regeneration

Study population

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomatlante: lead
• Atlanstat: collaborator

Study Sites (2)

Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes

Nantes, 44093, France

Location

Cabinet privé du Dr. S. Kimakhe

Nantes, 44200, France

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Guided Tissue Regeneration

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Saïd Kimakhe, PhD, DDS

  Centre Hospitalo-Universitaire de Nantes

  PRINCIPAL INVESTIGATOR

• Saïd Kimakhe, Phd, DDS

  Cabinet privé

  PRINCIPAL INVESTIGATOR

• Guy Daculsi, PhD

  Biomatlante

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: June 7, 2019
• Study Start: May 28, 2019
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)