Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

May 9, 2023 updated by: Universidad Complutense de Madrid

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Department of Periodontology, University Complutense Madrid, Spain
        • Principal Investigator:
          • Mariano Sanz Alonso
        • Contact:
          • Mariano Sanz Alonso
        • Principal Investigator:
          • Mario Romandini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

According to a study with a similar design on periodontitis (Barnes et al. 2009), twenty-five patients with at least one implant with peri-implantitis and one implant with peri-implant mucositis (Berglundh et al. 2018) will be selected in Complutense University of Madrid for PICF collection, before any treatment is provided. This will be done with the aim of excluding potential inter-individual variability in the metabolomic and proteomic profile of PICF.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previously treated implants to be included

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

Eklund Foundation
SEPA (Sociedad Española de Periodoncia)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metabol_Proteom_Implants

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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