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临床试验/NCT02369562
NCT02369562已完成不适用

A Retrospective Analysis of Failures/Complications With Oral Implants

Malmö University1 个研究点 分布在 1 个国家目标入组 2,670 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,670
试验地点
1
主要终点
Survival of implants

研究概览

简要总结

The purpose of this retrospective study 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

This is a retrospective study that involves collecting information about the past and comparing that with contemporary information collected from the same cases. The patients' dental records' archive and the digital dental records of the Folktandvården Specialistklinik in Malmö will be scrutinized. The patients will be retraced in the Swedish Personal Data System and will be invited for a recall visit with a clinical and radiographic examination. 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. In case the patient is not willing to pay a recall visit, only the data of the patient's records will be used, under the patients' approval.

The data from the patients' records will be directly inserted to a computer file of the statistical software Statistical Package for the Social Sciences (SPSS Inc., Chicago, USA). The additional follow-up information from the patients' recall visit will be collected in specific forms and then inserted to the previously mentioned computer file. All dental implants inserted will be included in the study. Data will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and trans- and postoperative complications.

Periapical radiographies of the patients' digital record will be neatly filed in a computer file. Periapical radiographies that could possibly exist in celluloid film will be digitalized. From each patient, additional radiographs will be selected from the patient's record, based on availability in several time intervals. At the recall consultation, new periapical radiographies will be taken. The reference point will be established at the implants-abutment junction, and the marginal bone level measurement will be performed by using the Image J software.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All treated patients with dental implants placed and restored at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö with an available dental record;
  • Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.

排除标准

  • Patients not willing to give their permission to scrutinize their records;
  • Lack of enough data in the patients' dental records.

结局指标

主要结局

Survival of implants

时间窗: Including implants placed from 1980 until August 31st 2014

Time from the surgical placement of implants until the last follow-up or until its failure

次要结局

  • Marginal bone loss(Including implants placed from 1980 until August 31st 2014)

研究者

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Ramos Chrcanovic

DDS, MSc, PhD student

Malmö University

研究点 (1)

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