Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Peri-Implantitis Clinical Trial

Official title:

Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283903
• Other study ID #: Metabol_Proteom_Implants
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: May 1, 2025

Study information

• Verified date: December 2022
• Source: Universidad Complutense de Madrid
• Contact: Mario Romandini
• Phone: +393801563046
• Email: maromand[@]ucm.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previously treated implants to be included

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

Intervention

Diagnostic Test:
• PICF
PICF collection from 4 sites

Locations

Country	Name	City	State
Spain	Department of Periodontology, University Complutense Madrid, Spain	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Disease resolution of peri-implantitis	According to the criteria proposed by Sanz & Chapple (2012)	1-year after treatment (longitudinal part)