Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peri-implantitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Evaluation of soluable CD163 (sCD163) levels [Time frame: Baseline]
- Evaluation of a proliferation-inducing ligand (APRIL) levels [Time frame: Baseline]
- Evaluation of B-cell activating factor (BAFF) levels [Time frame: Baseline]
- Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levels [Time frame: Baseline]
- Evaluotion of interleukin-10 (IL-10) levels [Time frame: Baseline]
- Evaluation of interleukin-34 (IL-34) Levels [Time frame: Baseline]
- Evaluation of interleukin-35 (IL-35) levels [Time frame: Baseline]
- Evaluation of arginase activity [Time frame: Baseline]
Secondary outcome measures (3)
- Probable pocket depth (PPD) [Time frame: Baseline and 6th week.]
- Bleeding on probing (BoP) [Time frame: Baseline and 6th week.]
- Plaque index [Time frame: Baseline and 6th week.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Biruni University — Istanbul
Identifiers
NCT: NCT07569432 · 2024-BIAEK/16-60