An observational study in Peri-implantitis, sponsored by Biruni University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Biruni University · Observational
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.
304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 116 observational studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Biruni University is the lead sponsor of 172 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals who applied to Biruni University Faculty of Dentistry for treatment or oral examination will be included in this study.
Exclusion Criteria:
Individuals with at least one bone-level dental implant, who are current smokers, and are scheduled to undergo exposure surgery.
Individuals with at least one bone-level dental implant, who are non-smokers, and are scheduled to undergo exposure surgery.
Individuals with peri-implantitis (non-smokers) were defined as subjects who were non-smokers and presented with bleeding and/or suppuration on gentle probing, an increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond crestal bone level changes resulting from initial bone remodelling. In cases where previous examination data were not available, peri-implantitis was diagnosed based on the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the implant.
Individuals with peri-implantitis (smokers) were defined as subjects who were current smokers and presented with bleeding and/or suppuration on gentle probing, an increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond crestal bone level changes resulting from initial bone remodelling. In cases where previous examination data were not available, peri-implantitis was diagnosed based on the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the implant.
Evaluation of soluable CD163 (sCD163) levels
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.
Time frame: Baseline
Evaluation of a proliferation-inducing ligand (APRIL) levels
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.
Time frame: Baseline
Evaluation of B-cell activating factor (BAFF) levels
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.
Time frame: Baseline
Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levels
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.
Time frame: Baseline
Evaluotion of interleukin-10 (IL-10) levels
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.
Time frame: Baseline
Evaluation of interleukin-34 (IL-34) Levels
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.
Time frame: Baseline
Evaluation of interleukin-35 (IL-35) levels
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.
Time frame: Baseline
Evaluation of arginase activity
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.
Time frame: Baseline
Probable pocket depth (PPD)
Probable pocket depth wiil be measured using a periodontal probe
Time frame: Baseline and 6th week.
Bleeding on probing (BoP)
The presence of visible bleeding following periodontal probing will be assessed by visual inspection (+/-). The total bleeding score will be expressed as a percentage.
Time frame: Baseline and 6th week.
Plaque index
The presence of visible plaque will be evaluated with a periodontal probe (+/-). The total plaque score will be expressed as a percentage.
Time frame: Baseline and 6th week.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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