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临床试验/NCT04129957
NCT04129957已完成不适用

The Prediction of Failure Rate of Dental Implants

Academic Centre for Dentistry in Amsterdam1 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2018年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
337
试验地点
1
主要终点
Failure of dental implants

研究概览

简要总结

The aim of the study is to identify predictors in patient profiles and implant characteristics and to develop and calibrate a prediction model for failure of implants. Patients' demographic characteristics, lifestyle habits, general health, dental health, and implant characteristics were regarded as potential predictors. The failure of implants and the follow-up time in days of implants were considered the outcome. Multivariate Cox proportional hazards regression analysis is used to find out the important risk factors for failure of dental implants and to develop the model for prediction of failure of dental implants at follow-up. The performance and clinical values of the model is determined.

详细描述

During the past decades, dental implant therapy has developed into a successful treatment option for patients confronted with both partial and complete edentulism. Based on the literature, the survival rate of dental implants, which is defined that the dental implants are still in the mouth after insertion, is around 95% in the 5-year follow-up and around 90% in the 10-year follow-up. The success rate of dental implants, which is defined as dental implants in function, with good hard and soft tissue physiology and user satisfaction ranges from 85.2% to 88.7% in the follow-up of up to 20 years. This indicates that both the success rate and survival rate of dental implants is high. However, both survival rates and success rates vary across patients with different profiles. The expense of dental implant treatment is high and implant placement is a surgical procedure which is invasive and thus risky for the patients' health. Once the failure of dental implants occurs, it may cause some severe negative consequences for patients. For example, the failure will cause a financial loss for patients and a possible shock concerning both mental and physical aspects. To reduce these risks it is important and necessary for clinicians to be able to predict the risk of the failure of dental implants of individual patients before they undergo dental implant treatment.

Aim:

The aim of the project is to find out the possible risk factors for failure of dental implants and to develop a prediction model for the failure of dental implants at follow-up as a tool for clinicians to establish patients individual risk profile.

Methods:

The study is a retrospective design. The clinical data of the adult patients who were referred to the Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA) for placement of dental implants from September 2009 to September 2013 are collected retrospectively from the clinical data management system of ACTA in the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients were over 18 years old at baseline;
  • patients underwent the placement of at least one implant;
  • patients were followed up for the implants at least one time after placement of implants;
  • patients provided their informed consent.

排除标准

  • patients were <18 years old at baseline;
  • patients were not followed up;
  • patients did not provide the informed consent.

结局指标

主要结局

Failure of dental implants

时间窗: up to 5 years follow-up

The failure of implants was defined as the presence of peri-implantitis, presence of mobility of implants, or removal of the implants for any reasons, for instance, unacceptable performance in aspects of function, tissue physiology, esthetics, and patients' satisfaction after placement of suprastructure.

Follow-up time

时间窗: up to 5 years follow-up

The follow-up time is defined as the difference in time between implant placement and implant failure, or the date of the last follow-up time point if the dental implant is in an acceptable state.

次要结局

未报告次要终点

研究者

发起方
Academic Centre for Dentistry in Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naichuan Su

Principal Investigator

Academic Centre for Dentistry in Amsterdam

研究点 (1)

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