Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

NCT ID: NCT04283903

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2025-05-01

Brief Summary

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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

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Conditions

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Peri-implant Mucositis Peri-Implantitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PICF

PICF collection from 4 sites

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previously treated implants to be included
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Periodontology, University Complutense Madrid, Spain

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mario Romandini

Role: CONTACT

+393801563046

Facility Contacts

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Mariano Sanz Alonso

Role: primary

Other Identifiers

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Metabol_Proteom_Implants

Identifier Type: -

Identifier Source: org_study_id

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