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临床试验/NCT05339789
NCT05339789招募中不适用

Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

Malmö University3 个研究点 分布在 2 个国家目标入组 650 人开始时间: 2020年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
650
试验地点
3
主要终点
Disease resolution (Binary: yes/no)

研究概览

简要总结

The surgical treatment outcome of patients that have been or are consecutively treated at the University of Malmö, at Blekinge hospital, and at the Dental Clinic of the Sigmund Freud University Vienna will be evaluated on an a regular base; specifically all patients treated since 2014 and those receiving treatment in the future, will be regularly assessed, max. once per year after the 1-year control from the surgical intervention for clinical and radiographic assessment of healing. Clinical peri-implant parameters (e.g., probing pocket depth) and peri-implant sulcus fluid (PISF) are collected, and a peri-apical radiographic examination is made. Further, from 200 patients treated in the future, the inflammatory peri-implant lesion will be collected and subjected to histological, microbiological, and molecular analysis. The removal of these lesions is a standard procedure and performed in all patients independent of study participation; i.e., the lesion has anyway to be removed during surgery and if the lesions are not stored, they would be thrown.

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 130 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients being treated since 2014 and continuously being treated will be called in for regular check-ups after the surgical intervention and an examination for study purpose will be performed annually.
  • Exclusion criteria:
  • implant loss

排除标准

  • 未提供

结局指标

主要结局

Disease resolution (Binary: yes/no)

时间窗: 120 months postoperative

Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.

次要结局

未报告次要终点

研究者

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

Kristina Bertl

Principal Investigator

Malmö University

研究点 (3)

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