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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Recrutement
- Biruni University
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Contact:
- Burcu Karaduman
- Numéro de téléphone: +905323763366
- E-mail: bkaraduman@biruni.edu.tr
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Sous-enquêteur:
- Ayse Kaban
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Peri-implant health - smokers
Individuals with at least one bone-level dental implant, who are current smokers, and are scheduled to undergo exposure surgery.
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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.
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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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Evaluation of soluable CD163 (sCD163) levels
Délai: Baseline
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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.
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Baseline
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Evaluation of a proliferation-inducing ligand (APRIL) levels
Délai: Baseline
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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.
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Baseline
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Evaluation of B-cell activating factor (BAFF) levels
Délai: Baseline
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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.
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Baseline
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Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levels
Délai: Baseline
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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.
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Baseline
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Evaluotion of interleukin-10 (IL-10) levels
Délai: Baseline
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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.
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Baseline
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Evaluation of interleukin-34 (IL-34) Levels
Délai: Baseline
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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.
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Baseline
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Evaluation of interleukin-35 (IL-35) levels
Délai: Baseline
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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.
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Baseline
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Evaluation of arginase activity
Délai: Baseline
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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.
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Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Probable pocket depth (PPD)
Délai: Baseline and 6th week.
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Probable pocket depth wiil be measured using a periodontal probe
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Baseline and 6th week.
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Bleeding on probing (BoP)
Délai: Baseline and 6th week.
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The presence of visible bleeding following periodontal probing will be assessed by visual inspection (+/-).
The total bleeding score will be expressed as a percentage.
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Baseline and 6th week.
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Plaque index
Délai: Baseline and 6th week.
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The presence of visible plaque will be evaluated with a periodontal probe (+/-).
The total plaque score will be expressed as a percentage.
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Baseline and 6th week.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Burcu Karaduman, PhD, Biruni University
- Chaise d'étude: Ulvi K Gursoy, PhD, University of Turku
- Chaise d'étude: Mustafa Yilmaz, PhD, Istanbul University
- Chercheur principal: Ayse Kaban, Biruni University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024-BIAEK/16-60
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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