Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases
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
- 否
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
