Skip to content

Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis

Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07569432
Enrollment
120
Registered
2026-05-06
Start date
2026-04-01
Completion date
2028-09-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implantitis

Keywords

peri-implantitis, smoking, macrophage

Brief summary

Peri-implantitis is a chronic inflammatory disease characterized by plaque-associated inflammation of the peri-implant mucosa and progressive loss of supporting bone around dental implants, which may ultimately lead to implant failure if left untreated. It has been demonstrated that cellular and molecular responses of the host immune defense system play a critical role in the pathogenesis of peri-implantitis. Macrophages are key cells in the host immune response and are generally classified into two phenotypes: pro-inflammatory (M1) and anti-inflammatory (M2). While M1 macrophages are actively involved in the early defense response, a shift toward the M2 phenotype is required for the resolution of inflammation and tissue repair. Smoking has been shown to adversely affect macrophage polarization and function, thereby exacerbating inflammatory responses. Therefore, in the present study, levels of soluable CD163 (sCD163), B cell activating factor (BAFF), tumor necrosis factor-like weak inducer of apoptosis (TWEAK), a proliferation-inducing ligand (APRIL), interferon-gamma (IFN-γ), interleukin-10 (IL-10), interleukin-34 (IL-34), interleukin-35 (IL-35), and arginase activity (ornithine levels) will be evaluated in peri-implant health and peri-implantitis patients with varying disease severity and different smoking statuses. In addition, a comprehensive proteomic analysis will be performed to investigate the relationships among peri-implantitis severity, smoking, and macrophage polarization-related molecules. Baseline periodontal and peri-implant parameters will be recorded for all participants. In the peri-implant health group, tissue samples will be collected during exposure surgery performed for submerged implants, after which participants will be enrolled in supportive peri-implant care. Participants diagnosed with peri-implantitis will receive non-surgical therapy, during which tissue samples will be collected. Periodontal and peri-implant parameters will be reassessed for all participants at baseline, and at 6 and 12 weeks. Healthy peri-implant samples will be collected from submerged implants during exposure surgery. Peri-implantitis samples (probable pocket depth ≥ 6 mm with bleeding on probing) will be obtained during non-surgical therapy using a single stroke along the pocket wall.

Interventions

None listed

Sponsors

Biruni University
Lead SponsorOTHER
University of Turku
CollaboratorOTHER
The Scientific and Technological Research Council of Turkey
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals who is suitable for the peri-implantitis diagnosis according to the classifications of periodontal and peri-implant diseases and conditions established in 2017. * Individuals with at least one bone-level dental implant and scheduled to undergo exposure surgery.

Exclusion criteria

* prior peri-implantitis surgery * being diagnosed with autoimmune disease, genetic disorders, bone metabolism disorders, poorly controlled systemic diseases (such as diabetes or hypertension) * pregnancy or lactation * having a history of oral malignancy, chemotherapy or radiotherapy * use of anti-inflammatory drugs within 2 weeks, antibiotics within 3 months, * need for prophylactic antibiotics * contraindications for dental/surgical procedures.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of interleukin-34 (IL-34) LevelsBaselineIL-34 levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.
Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levelsBaselineTWEAK levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.
Evaluotion of interleukin-10 (IL-10) levelsBaselineIL-10 levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.
Evaluation of arginase activityBaselineArginase activity in tissue samples collected from the participants will be evaluated using Chinard's method by determined ornithine levels. The results of the biochemical analyses will be reported as pg/ng.
Evaluation of interleukin-35 (IL-35) levelsBaselineIL-35 levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.
Evaluation of soluable CD163 (sCD163) levelsBaselinesCD163 levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.
Evaluation of a proliferation-inducing ligand (APRIL) levelsBaselineAPRIL levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.
Evaluation of B-cell activating factor (BAFF) levelsBaselineBAFF levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.

Secondary

MeasureTime frameDescription
Probable pocket depth (PPD)Baseline and 6th week.Probable pocket depth wiil be measured using a periodontal probe
Bleeding on probing (BoP)Baseline and 6th week.The presence of visible bleeding following periodontal probing will be assessed by visual inspection (+/-). The total bleeding score will be expressed as a percentage.
Plaque indexBaseline and 6th week.The presence of visible plaque will be evaluated with a periodontal probe (+/-). The total plaque score will be expressed as a percentage.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRBurcu Karaduman, PhD

Biruni University

STUDY_CHAIRUlvi K Gursoy, PhD

University of Turku

STUDY_CHAIRMustafa Yilmaz, PhD

Istanbul University

PRINCIPAL_INVESTIGATORAyse Kaban

Biruni University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026