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

10. Mai 2026 aktualisiert von: Burcu KARADUMAN, Biruni University

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Individuals who applied to Biruni University Faculty of Dentistry for treatment or oral examination will be included in this study.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Peri-implant health - smokers
Individuals with at least one bone-level dental implant, who are current smokers, and are scheduled to undergo exposure surgery.
Peri-implant health - non-smokers
Individuals with at least one bone-level dental implant, who are non-smokers, and are scheduled to undergo exposure surgery.
Peri-implantitis - non-smokers
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.
Peri-implantitis - smokers
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of soluable CD163 (sCD163) levels
Zeitfenster: 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.
Baseline
Evaluation of a proliferation-inducing ligand (APRIL) levels
Zeitfenster: 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.
Baseline
Evaluation of B-cell activating factor (BAFF) levels
Zeitfenster: 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.
Baseline
Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levels
Zeitfenster: 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.
Baseline
Evaluotion of interleukin-10 (IL-10) levels
Zeitfenster: 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.
Baseline
Evaluation of interleukin-34 (IL-34) Levels
Zeitfenster: 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.
Baseline
Evaluation of interleukin-35 (IL-35) levels
Zeitfenster: 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.
Baseline
Evaluation of arginase activity
Zeitfenster: 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.
Baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Probable pocket depth (PPD)
Zeitfenster: Baseline and 6th week.
Probable pocket depth wiil be measured using a periodontal probe
Baseline and 6th week.
Bleeding on probing (BoP)
Zeitfenster: 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.
Baseline and 6th week.
Plaque index
Zeitfenster: 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.
Baseline and 6th week.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: Burcu Karaduman, PhD, Biruni University
  • Studienstuhl: Ulvi K Gursoy, PhD, University of Turku
  • Studienstuhl: Mustafa Yilmaz, PhD, Istanbul University
  • Hauptermittler: Ayse Kaban, Biruni University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. April 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. September 2028

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2024-BIAEK/16-60

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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