Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Peri-implantitis rate
研究概览
简要总结
A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.
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
- •Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular
- •Age ≥ 18 years
- •Good general health (ASA score between [1-2])
- •Sufficient bone volume and quality (with or without bone graft) to support the implant
- •Non-opposition of the patient for the collection of his medical data as part of the study (delivery of a patient's sheet)
排除标准
- •Poor oral hygiene
- •Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
- •Infections and oral inflammation such as periodontitis, 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
Peri-implantitis rate
时间窗: 12 months post-implantation
Peri-implantitis is an inflammatory process affecting the tissues around the implant and causing loss of bone support (diagnosed by radiographic and clinical assessment).
Mean osseointegration period
时间窗: From the implantation up to 12 months
Period from which a direct structural and functional junction can be observed between the remodeled living bone and the implant surface (by clinical and radiographic assessment).
Implant success rate
时间窗: up to 12 months post-implantation
Rate of implants still in function up to 12 months post-implantation and which fulfill all the predefined success criteria in the protocol.
次要结局
未报告次要终点