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

NCT07697729 | Not Yet Recruiting

• 2 other identifiers: 75815367
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implantitis

Keywords

Meteorin-Like Protein; Metrnl; Peri-Implant Crevicular Fluid; Interleukin-1 Beta; Tumor Necrosis Factor-Alpha; Interleukin-10; Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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.

  At enrollment

Secondary Outcomes (3)

• IL-1β Concentration in Peri-Implant Crevicular Fluid

  At enrollment

• TNF-α Concentration in Peri-Implant Crevicular Fluid

  At enrollment

• IL-10 Concentration in Peri-Implant Crevicular Fluid

  At enrollment

Other Outcomes (4)

• Correlation Between Metrnl and IL-1β Concentrations in Peri-Implant Crevicular Fluid

  At enrollment

• Area Under the ROC Curve for Metrnl in Distinguishing Peri-Implantitis From Peri-Implant Health

  At enrollment

• Correlation Between Metrnl and TNF-α Concentrations in Peri-Implant Crevicular Fluid

  At enrollment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, Erzurum, 25080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Recep Orbak, DDS, PhD

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

Pınar Eser Tuna, DDS

CONTACT

+905063372525; pnareser@yandex.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Student

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: July 7, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

TU (1)