NCT07569432 Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis
| NCT ID | NCT07569432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biruni University |
| Condition | Peri-implantitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Burcu Karaduman, PhD
STUDY CHAIR
Biruni University
Frequently Asked Questions
Who can join the NCT07569432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07569432 currently recruiting?
Yes, NCT07569432 is actively recruiting participants. Visit ClinicalTrials.gov or contact Biruni University to inquire about joining.
Where is the NCT07569432 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07569432 clinical trial?
NCT07569432 is sponsored by Biruni University. The principal investigator is Burcu Karaduman, PhD at Biruni University. The trial plans to enroll 120 participants.