An observational study in Peri-implantitis, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Ataturk University · Observational
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.
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.
304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.
This study's enrollment of 68 is below the median of 80 across 116 observational studies indexed under Peri-Implantitis.
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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.
Exclusion Criteria:
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.
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.
Metrnl Concentration in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
IL-1β Concentration in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
TNF-α Concentration in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
IL-10 Concentration in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
Correlation Between Metrnl and IL-1β Concentrations in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
Area Under the ROC Curve for Metrnl in Distinguishing Peri-Implantitis From Peri-Implant Health
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.
Time frame: At enrollment
Correlation Between Metrnl and TNF-α Concentrations in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
Correlation Between Metrnl and IL-10 Concentrations in Peri-Implant Crevicular Fluid
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.
Time frame: At enrollment
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Ataturk University