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出境医 / 临床实验 / Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
Study Description
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:
- Tissue regeneration (mucosa health on the site of implantation)
- Safety (report of any adverse event)
- Radiographic analysis of periodontal tissues
| Condition or disease | Intervention/treatment |
|---|---|
| Oral Bone Defect Maxillofacial Bone Defect Periodontal Bone Loss Alveolar Bone Loss | Device: Guided Tissue Regeneration |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 56 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures |
| Actual Study Start Date : | June 17, 2019 |
| Estimated Primary Completion Date : | March 28, 2021 |
| Estimated Study Completion Date : | March 29, 2021 |
Arms 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 Name: Guided Bone Regeneration
|
Outcome Measures
Primary Outcome Measures :
- Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection) [ Time Frame: 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 :
- Number and precise description of any adverse event during the follow-up [ Time Frame: 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 [ Time Frame: Before surgery and 12 weeks post-surgery (+/-1 week) ]Comparison of the radiographies recorded before surgery and at the last follow-up visit
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The group will be selected in the entire population of the dental care center
Criteria
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
Contacts and Locations
Contacts
| Contact: Laura PAGNUCCO | 0228020009 | laurapagnucco@biomatlante.com | |
| Contact: Nancy TRICHEREAU | 0228020009 | nancytrichereau@biomatlante.com |
Locations
| France | |
| Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes | Recruiting |
| Nantes, France, 44093 | |
| Contact: Marjorie Cheraud 0240087383 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 | |
| Cabinet privé du Dr. S. Kimakhe | Recruiting |
| Nantes, France, 44200 | |
| Contact: Saïd KIMAKHE, PhD, DDS 0240897023 s.kimakhe@wanadoo.fr | |
| Sub-Investigator: Saïd KIMAKHE, PhD, DDS | |
Sponsors and Collaborators
Biomatlante
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 |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 7, 2019 | |||||||||
| First Posted Date | June 7, 2019 | |||||||||
| Last Update Posted Date | July 12, 2019 | |||||||||
| Actual Study Start Date | June 17, 2019 | |||||||||
| Estimated Primary Completion Date | March 28, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection) [ Time Frame: 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
|
|||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
|
|||||||||
| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" | |||||||||
| Official Title | Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures | |||||||||
| 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:
|
|||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | The group will be selected in the entire population of the dental care center | |||||||||
| Condition |
|
|||||||||
| 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. Other Name: Guided Bone Regeneration
|
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| Study Groups/Cohorts | Study population
Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure
Intervention: Device: Guided Tissue Regeneration
|
|||||||||
| Publications * | Not Provided | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
56 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | March 29, 2021 | |||||||||
| Estimated Primary Completion Date | March 28, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
|
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| Listed Location Countries | France | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03978962 | |||||||||
| Other Study ID Numbers | RE-DT04-18A 2018-A03202-53 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Biomatlante | |||||||||
| Study Sponsor | Biomatlante | |||||||||
| Collaborators | Atlanstat | |||||||||
| Investigators |
|
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| PRS Account | Biomatlante | |||||||||
| Verification Date | July 2019 | |||||||||
