Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Recruiting

• Conditions: Peri-Implantitis; Peri-implant Mucositis

• Registration Number: NCT04283903
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Status Verified: 2022-12
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Primary Completion: 2024-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• Previously treated implants to be included

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease resolution of peri-implantitis	1-year after treatment (longitudinal part)	According to the criteria proposed by Sanz \& Chapple (2012)
Peri-implant diseases presence	Baseline (cross-sectional part)	Presence or absence of peri-implant mucositis or peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018)

Trial Locations

Locations (1)

Department of Periodontology, University Complutense Madrid, Spain; 🇪🇸 Madrid, Spain