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

9. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

60

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Metrnl Concentration in Peri-Implant Crevicular Fluid
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
IL-1β Concentration in Peri-Implant Crevicular Fluid
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Correlation Between Metrnl and IL-1β Concentrations in Peri-Implant Crevicular Fluid
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ataturk University

Vyšetřovatelé

  • Ředitel studie: Recep Orbak, DDS, PhD, Ataturk University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

7. července 2026

Primární dokončení (Odhadovaný)

1. srpna 2026

Dokončení studie (Odhadovaný)

2. srpna 2026

Termíny zápisu do studia

První předloženo

6. července 2026

První předloženo, které splnilo kritéria kontroly kvality

9. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 758 (Chinese clinical trial registry)
  • 15367 (Jiné číslo grantu/financování: Atatürk University Scientific Research Projects Coordination Unit)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Podmínky

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Drogové intervence

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Sponzor / Spolupracovníci

Místa

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