A Prospective Analysis of Failures/Complications With Oral Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Survival of implants
研究概览
简要总结
The purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).
详细描述
The treatment begins with screening against inclusion and exclusion criteria. The patients will then be informed of the design of the study through the reading of the Form for Patient Information and the Informed Consent in Swedish and verbally.
All dental implants to be inserted will be included in the study. Some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions.
Data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications.
Besides descriptive statistics, Kaplan-Meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate Cox proportional hazards models will be used to identify prognostic variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a minimum age of 18 years;
- •Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
排除标准
- •Age less than 18 years;
- •General contraindications for implant surgery;
- •Subjects with an untreated systemic disease. A complete medical report will permit the disqualification of subjects with an untreated systemic disease. Patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.
研究组 & 干预措施
Dental implants
Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017
干预措施: Insertion of dental implants (Procedure)
结局指标
主要结局
Survival of implants
时间窗: Up to 3 years
Time from the surgical placement of implants until the last follow-up visit or until its failure
次要结局
- Dental prosthesis complications(Up to 3 years)
- Marginal bone loss(Up to 3 years)
研究者
Bruno Ramos Chrcanovic
DDS, MSc, PhD student
Malmö University