跳至主要内容
临床试验/NCT04283903
NCT04283903招募中不适用

Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Disease resolution of peri-implantitis

研究概览

简要总结

Due to the limited efficacy of its treatment modalities, there is a stringent need to improve the prevention and early diagnosis of peri-implantitis. In fact, to date clinical and radiographic tools are not able to discern which patients are going to develop peri-implantitis and, among the ones already with peri-implantitis, which ones are currently loosing bone and which ones are going to progress.

This project aims to analyze for the first time the whole large scale proteome and metabolome of peri-implant crevicular fluid (PICF) with an integrated approach from implants with peri-implant diseases.

Twenty-five patients with at least one implant with peri-implant mucositis and one implant with peri-implantitis will be selected. For each of the selected participants, the PICF from an implant with peri-implant mucositis and from an implant with peri-implantitis will be sampled two different times before treatment. One year after the corresponding treatment is provided, the PICF of the treated implants with peri-implantitis will be sampled again.

Both proteomic and metabolomic profiling of the samples will be carried out. The most important strength of this project will be the ability to evaluate together the whole proteome and the whole metabolome and to integrate them in the same framework.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • At least one implant with peri-implant mucositis and one with peri-implantitis

排除标准

  • Previously treated implants to be included

结局指标

主要结局

Disease resolution of peri-implantitis

时间窗: 1-year after treatment (longitudinal part)

According to the criteria proposed by Sanz \& Chapple (2012)

Peri-implant diseases presence

时间窗: Baseline (cross-sectional part)

Presence or absence of peri-implant mucositis or peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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