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临床试验/NCT07750171
NCT07750171招募中不适用

Impact of Smoking on Th1/Th2-M1/M2 Cytokine Balance and B-Cell Immune Responses in Peri-Implant Health and Disease

Gazi University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
216
试验地点
1
主要终点
Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers

研究概览

简要总结

Peri-implant diseases are inflammatory conditions affecting the gums and bone around dental implants. Peri-implant mucositis causes inflammation in the gums, while peri-implantitis can also lead to bone loss and, in severe cases, implant failure. Smoking is an important risk factor for these conditions because it may change how the immune system responds to inflammation and infection.

This study will compare smokers and non-smokers with healthy dental implants, peri-implant mucositis, or peri-implantitis. Fluid samples will be collected from around the implants to measure proteins involved in inflammation, healing, and immune responses. The aim is to better understand how smoking affects the body's response to peri-implant diseases and to identify biological markers that may help assess disease risk and severity in the future.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • willingness to participate in the study;
  • having at least one dental implant that has been in function for at least one year;
  • having an implant diagnosed with peri-implant health, peri-implant mucositis, or initial peri-implantitis according to the study definitions; for the initial peri-implantitis group, having an implant with PD of 6-7 mm.

排除标准

  • having received periodontal therapy, oral decontamination treatment, antibiotics, or steroids within the last six months before study initiation;
  • being pregnant or breastfeeding;
  • having rheumatoid arthritis, lupus erythematosus, or poorly controlled systemic diseases such as diabetes or hypertension;
  • having a history of radiation therapy or cancer therapy.

研究组 & 干预措施

Smokers With Peri-Implantitis

Participants who smoke and have peri-implantitis

Smokers With Peri-Implant Mucositis

Participants who smoke and have peri-implant mucositis.

Non-Smokers With Peri-Implant Health

Participants who do not smoke and have clinically healthy peri-implant tissues.

Non-Smokers With Peri-Implant Mucositis

Participants who do not smoke and have peri-implant mucositis.

Non-Smokers With Peri-Implantitis

Participants who do not smoke and have peri-implantitis.

Smokers With Peri-Implant Health

Participants who smoke and have clinically healthy peri-implant tissues.

结局指标

主要结局

Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers

时间窗: At a single study visit

Peri-implant crevicular fluid samples will be analyzed to determine the levels of IFN-γ, IL-12p70, IL-4, IL-13, IL-10, BAFF, and APRIL. These marker levels will be compared among smokers and non-smokers with peri-implant health, peri-implant mucositis, or peri-implantitis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Buse Naz BÜYÜKAKÇALI ALTAY

Research Assistant

Gazi University

研究点 (1)

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