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

9. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Metrnl Concentration in Peri-Implant Crevicular Fluid
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
IL-1β Concentration in Peri-Implant Crevicular Fluid
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between Metrnl and IL-1β Concentrations in Peri-Implant Crevicular Fluid
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ataturk University

Efterforskere

  • Studieleder: Recep Orbak, DDS, PhD, Ataturk University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

7. juli 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

2. august 2026

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 758 (Chinese clinical trial registry)
  • 15367 (Andet bevillings-/finansieringsnummer: Atatürk University Scientific Research Projects Coordination Unit)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

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