5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CeraRoot SL
- 入组人数
- 652
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question[s] it aims to answer are:
- Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
- What are the complications associated to the procedure and differences between the two groups.
详细描述
The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).
The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of partial or total edentulism.
- •Specially indicated for patients with metal allergies and chronic illness due to metal allergies.
排除标准
- •General Contraindications:
- •Local and Systemic contraindications for surgery.
- •Poor oral hygiene
- •Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.
- •Relative Contraindications:
- •Previously irradiated bone
- •anticoagulant medication
- •hemodynamic problems
- •Para functional habits
- •bad bone anatomy
- •none controlled periodontitis
- •malocclusions
- •TMJ problems
- •diseases in the oral cavity
- •insufficient oral hygiene for adequate health.
- •Local contraindications
- •insufficient bone quantity or quality
- •remaining of roots
- •localized periodontal disease
- •Any pathology in the neighboring teeth.
结局指标
主要结局
Survival rate
时间窗: From enrolment to the end of treatment 12 months or more.
The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.
次要结局
- Complications(1 year after treatment)