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NCT Number: NCT07569432

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayse Kaban

SUB_INVESTIGATOR

Burcu Karaduman

CONTACT

[email protected]

+905323763366

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation of soluable CD163 (sCD163) levels

    Time frame: Baseline

    sCD163 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.

  2. Evaluation of a proliferation-inducing ligand (APRIL) levels

    Time frame: Baseline

    APRIL 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.

  3. Evaluation of B-cell activating factor (BAFF) levels

    Time frame: Baseline

    BAFF 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.

  4. Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levels

    Time frame: Baseline

    TWEAK 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.

  5. Evaluotion of interleukin-10 (IL-10) levels

    Time frame: Baseline

    IL-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.

  6. Evaluation of interleukin-34 (IL-34) Levels

    Time frame: Baseline

    IL-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.

  7. Evaluation of interleukin-35 (IL-35) levels

    Time frame: Baseline

    IL-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.

  8. Evaluation of arginase activity

    Time frame: Baseline

    Arginase 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.

Secondary outcomes

  1. Probable pocket depth (PPD)

    Time frame: Baseline and 6th week.

    Probable pocket depth wiil be measured using a periodontal probe

  2. Bleeding on probing (BoP)

    Time frame: 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.

  3. Plaque index

    Time frame: Baseline 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.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey
  • University of Turku

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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