Multicenter Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of "Kontact Perio Level" implants in everyday practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Edentulous patient requiring the placement of one (or more) dental implant (s) in the maxilla or mandibular
- •Age ≥ 18 years old
- •Good general health (ASA score between [1-2])
- •Sufficient volume and bone quality (with or without bone graft) to support the implant
- •Non-objection of the patient for the collection of his medical data as part of the study
排除标准
- •Poor oral hygiene
- •Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
- •Infections and oral inflammation such as active periodontitis, active gingivitis
- •Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
- •Heavy smoker (> 10 cigarettes / day)
- •Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
- •Patient on prolonged steroid therapy
- •Titanium / titanium alloy allergy
- •Alcohol or drug abuse
- •Pregnant woman (or likely to be pregnant); or breastfeeding
- •Difficulty of medical follow-up patients with geographical, social or psychological constraints
- •Persons deprived of liberty or guardianship
- •Involuntary / patient refusal to participate in the study
结局指标
主要结局
Success rate
时间窗: 12 months
For an implant to be declared "successful" it must meet the following criteria as defined by Albrektsson et al. 1986 adapted: Lack of mobility ; Absence of pain ; Lack of radiolucency around the implant ; Absence of bleeding and inflammation ; No significant peri-implant periodontal pocket (≤4mm) ; Stability of the peri-implant bone level over time with marginal bone loss ≤1.5 mm the first year and ≤0.2 mm the following years
次要结局
- Bone Level(12 months)
- Prosthetic complications(12 months)
- Primary stability(surgical time)
- Survival rate(12 months)
- Factors that influence the survival and success rate(12 months)
- Quality of Life(12 months)
- Peri-implantitis(12 months)