Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

NCT04283903 | Unknown

• 1 other identifier: Metabol_Proteom_Implants
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

• Peri-implant diseases presence

  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

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

  1-year after treatment (longitudinal part)

Interventions

PICF DIAGNOSTIC_TEST

PICF collection from 4 sites

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Previously treated implants to be included

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Department of Periodontology, University Complutense Madrid, Spain

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mario Romandini

CONTACT

+393801563046; maromand@ucm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 25, 2020
• Study Start: May 1, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 11, 2023

Record last verified: 2022-12

Locations

ES (1)