Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Peri implant bone level
研究概览
简要总结
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.
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
- •Given a writing consent 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 implant bone level
时间窗: up to 36 months
Bone level evolution compare to the bone level at implantation day
Keratinized tissues level
时间窗: up to 36 months
Assessment of keratinized tissues
Gingival index
时间窗: up to 36 months
Gingival index assess with Loë and Silness Score
Implant survival rate
时间窗: up to 36 months
Number of implants still in function up to 36 months post implantation
Bleeding index
时间窗: up to 36 months
Bleeding index on probing following the Mombelli score
次要结局
未报告次要终点