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临床试验/NCT03523845
NCT03523845已完成不适用

Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.

University of Valencia0 个研究点目标入组 46 人开始时间: 1996年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
主要终点
Tooth status

研究概览

简要总结

A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.

详细描述

A case-control study was performed following the STROBE statement (17) at the Oral Surgery Department, Faculty of Medicine and Dentistry (University of Valencia, Spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (Figure 1). All patients were informed about the study design and procedures. Prior to participating, they were requested to sign an informed consent document. The study design was approved by the Ethical Committee of the University of Valencia (H1478255958653).

Two groups were established: Test group (patients diagnosed with early apical peri-implantitis diagnosed) and Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

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

  • The following inclusion criteria were applied: patients ≥18 years old and controlled medical conditions who received treatment with implants. Additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically.

排除标准

  • for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.

结局指标

主要结局

Tooth status

时间窗: Intraoperative

apical lesion or endodontic treatment in the tooth being replaced or adjacent tooth endodontically treated

tooth-implant distance

时间窗: Intraoperative

mesial and distal tooth-implant distance measured at the apex

type of surgery

时间窗: Intraoperative

immediate/delayed placement

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel Peñarrocha Diago

Head of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain.

University of Valencia

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