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Relationship Between Metrnl Expression, IL-1β, and TNF-α in Patients With Peri-Implantitis

9 luglio 2026 aggiornato da: Pinar Eser Tuna, Ataturk University

Association of Metrnl Expression With IL-1β and TNF-α in Patients With Peri-Implantitis: Potential as a Novel Biomarker

Peri-implantitis is an inflammatory disease affecting the tissues around dental implants and may lead to progressive bone loss and implant failure. Current diagnosis is mainly based on clinical and radiographic findings, which may not fully reflect the underlying inflammatory activity. Therefore, there is a need for biological markers that may provide additional information about disease-related changes.

This observational study aims to compare the levels of Meteorin-like protein (Metrnl) and selected inflammatory cytokines in peri-implant crevicular fluid obtained from individuals with peri-implantitis and individuals with healthy implants. The study will evaluate Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10). It will also examine the relationships between Metrnl and these inflammatory markers.

The study hypothesis is that Metrnl levels differ between healthy peri-implant tissues and peri-implantitis and are associated with pro-inflammatory and anti-inflammatory cytokine levels. The findings may help clarify the possible role of Metrnl in peri-implant inflammation and its potential as a biomarker for distinguishing peri-implant health from peri-implantitis.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

Peri-implantitis is a biofilm-associated inflammatory disease characterized by inflammation of the peri-implant mucosa and progressive loss of supporting bone. Although clinical and radiographic parameters, including probing depth, bleeding on probing, suppuration, and radiographic bone loss, are central to diagnosis, these measures primarily reflect established tissue changes and may not fully characterize the underlying local immune-inflammatory response. Analysis of biomarkers in peri-implant crevicular fluid may therefore provide complementary information about the biological processes associated with peri-implant health and disease.

Meteorin-like protein (Metrnl) is an immunoregulatory protein involved in inflammatory regulation, macrophage polarization, and tissue repair. Experimental and clinical evidence suggests that Metrnl may interact with both pro-inflammatory and anti-inflammatory pathways. However, its possible role in peri-implantitis has not been sufficiently investigated.

This observational study will include individuals with peri-implantitis and individuals with healthy peri-implant tissues. Participants will be classified according to clinical and radiographic findings. Clinical periodontal and peri-implant parameters will be recorded to characterize the study groups. Peri-implant crevicular fluid samples will be collected from selected implant sites, and the concentrations of Metrnl, interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10) will be analyzed.

The primary objective is to compare Metrnl levels between the peri-implantitis and peri-implant health groups. Secondary objectives are to compare IL-1β, TNF-α, and IL-10 levels between the groups and to evaluate the relationships between Metrnl and these pro-inflammatory and anti-inflammatory cytokines. The study will also explore the ability of Metrnl and the evaluated cytokines to distinguish peri-implant health from peri-implantitis.

The study hypothesis is that Metrnl levels differ between peri-implant health and peri-implantitis and are associated with the local inflammatory cytokine profile. Evaluation of these relationships may provide new information about the role of Metrnl in the immunoinflammatory mechanisms of peri-implantitis and its potential value as a biomarker.

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population will consist of adults with at least one functioning dental implant who are evaluated at the Department of Periodontology, Faculty of Dentistry, Atatürk University. Participants will be classified into two groups according to clinical and radiographic findings: individuals with peri-implantitis and individuals with peri-implant health. Peri-implant clinical parameters and peri-implant crevicular fluid biomarker levels will be evaluated and compared between the groups.

Descrizione

Inclusion Criteria:

  • Individuals aged 18 years or older
  • Individuals without systemic disease
  • Individuals with at least one healthy implant or one implant affected by peri-implantitis
  • At least 1 year having elapsed since placement of the prosthetic restoration on the relevant implant

Exclusion Criteria:

  • Pregnant or lactating individuals.
  • Current smokers.
  • Use of antibiotics or corticosteroids within the previous 6 months.
  • Presence of an implant-supported removable prosthesis.
  • Periodontal or peri-implant treatment within the previous 6 months.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Peri-Implantitis Group
Individuals diagnosed with peri-implantitis based on clinical and radiographic criteria. Peri-implant crevicular fluid samples will be collected, and Metrnl, IL-1β, TNF-α, and IL-10 levels will be evaluated.
Peri-Implant Health Group
Individuals with clinically and radiographically healthy peri-implant tissues. Peri-implant crevicular fluid samples will be collected, and Metrnl, IL-1β, TNF-α, and IL-10 levels will be evaluated.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Metrnl Concentration in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
Meteorin-like protein (Metrnl) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in ng/mL. Metrnl concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
At enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
IL-1β Concentration in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
Interleukin-1 beta (IL-1β) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. IL-1β concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
At enrollment
TNF-α Concentration in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
Tumor necrosis factor-alpha (TNF-α) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. TNF-α concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
At enrollment
IL-10 Concentration in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
Interleukin-10 (IL-10) concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China), according to the manufacturer's instructions, and expressed in pg/mL. IL-10 concentrations will be compared between the peri-implantitis and peri-implant health groups using an independent-samples t test for normally distributed data or a Mann-Whitney U test for non-normally distributed data.
At enrollment

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation Between Metrnl and IL-1β Concentrations in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
The correlation between Metrnl concentration (ng/mL) and IL-1β concentration (pg/mL) in peri-implant crevicular fluid will be evaluated. Both biomarkers will be quantified using commercially available enzyme-linked immunosorbent assay (ELISA) kits (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) according to the manufacturer's instructions. The correlation will be quantified using a Pearson or Spearman correlation coefficient, as appropriate based on data distribution.
At enrollment
Area Under the ROC Curve for Metrnl in Distinguishing Peri-Implantitis From Peri-Implant Health
Lasso di tempo: At enrollment
Metrnl concentration in peri-implant crevicular fluid will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) and expressed in ng/mL. Its diagnostic ability to distinguish peri-implantitis from peri-implant health will be evaluated using receiver operating characteristic (ROC) curve analysis. Diagnostic performance will be quantified by the area under the ROC curve (AUC), a unitless measure ranging from 0 to 1.
At enrollment
Correlation Between Metrnl and TNF-α Concentrations in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
The correlation between Metrnl concentration (ng/mL) and TNF-α concentration (pg/mL) in peri-implant crevicular fluid will be evaluated. Both biomarkers will be quantified using commercially available enzyme-linked immunosorbent assay (ELISA) kits (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) according to the manufacturer's instructions. The correlation will be quantified using a Pearson or Spearman correlation coefficient, as appropriate based on data distribution.
At enrollment
Correlation Between Metrnl and IL-10 Concentrations in Peri-Implant Crevicular Fluid
Lasso di tempo: At enrollment
The correlation between Metrnl concentration (ng/mL) and IL-10 concentration (pg/mL) in peri-implant crevicular fluid will be evaluated. Both biomarkers will be quantified using commercially available enzyme-linked immunosorbent assay (ELISA) kits (Shanghai Sunred Biological Technology Co., Ltd., Shanghai, China) according to the manufacturer's instructions. The correlation will be quantified using a Pearson or Spearman correlation coefficient, as appropriate based on data distribution.
At enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ataturk University

Investigatori

  • Direttore dello studio: Recep Orbak, DDS, PhD, Ataturk University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

7 luglio 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

2 agosto 2026

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 758 (Chinese clinical trial registry)
  • 15367 (Altro numero di sovvenzione/finanziamento: Atatürk University Scientific Research Projects Coordination Unit)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The plan to share individual participant data has not yet been determined and will be considered after study completion and publication of the main results.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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