Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biomatlante
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)
时间窗: 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
次要结局
- 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))