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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04283903
Other study ID # Metabol_Proteom_Implants
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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