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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03202-53 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Atlanstat | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The group will be selected in the entire population of the dental care center
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes | Nantes | 44093 | France | |||
| Cabinet privé du Dr. S. Kimakhe |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2019 | Jun 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D048091 | Guided Tissue Regeneration |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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Comparison of the radiographies recorded before surgery and at the last follow-up visit |
| Before surgery and 12 weeks post-surgery (+/-1 week) |
| Nantes |
| 44200 |
| France |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |