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

2026年5月10日 更新者: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.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluation of soluable CD163 (sCD163) levels
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Probable pocket depth (PPD)
大体时间:Baseline and 6th week.
Probable pocket depth wiil be measured using a periodontal probe
Baseline and 6th week.
Bleeding on probing (BoP)
大体时间: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
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Burcu Karaduman, PhD、Biruni University
  • 学习椅:Ulvi K Gursoy, PhD、University of Turku
  • 学习椅:Mustafa Yilmaz, PhD、Istanbul University
  • 首席研究员:Ayse Kaban、Biruni University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年4月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月10日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2024-BIAEK/16-60

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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