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临床试验/NCT07323277
NCT07323277已完成不适用

The Effect of Smoking on Macrophage Polarization in the Pathogenesis of Periodontitis

Suleyman Demirel University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Gingival iNOS Level

研究概览

简要总结

This observational case-control study investigates the effect of smoking on macrophage polarization in the pathogenesis of periodontitis. Adult participants who were either systemically healthy smokers or non-smokers, and who met the clinical criteria for periodontal health or periodontitis, were included. Gingival tissue samples were collected during periodontal procedures performed after completion of Phase I periodontal therapy, and the expression levels of macrophage polarization markers (iNOS and Arginase-1) were analyzed using ELISA. In addition, comprehensive clinical periodontal measurements-including probing pocket depth, clinical attachment level, bleeding on probing, Plaque Index, and Gingival Index-were recorded to evaluate the relationship between smoking status, inflammatory burden, and macrophage phenotype. The study aims to clarify how smoking modulates the balance between M1 and M2 macrophage responses in periodontal tissues.

详细描述

Periodontitis is a chronic inflammatory disease in which macrophage polarization plays a key regulatory role in the host immune response. Smoking is a well-established risk factor that alters inflammatory pathways and immune cell behavior. This study was designed to examine how smoking influences macrophage polarization-specifically the balance between M1 (iNOS-mediated) and M2 (Arginase-1-mediated) phenotypes-in periodontal tissues.

Systemically healthy adult participants were recruited and categorized into four groups based on smoking status and periodontal condition: (1) healthy non-smokers, (2) periodontitis non-smokers, (3) healthy smokers, and (4) periodontitis smokers. Gingival tissue samples (approximately 2×2 mm) were collected during periodontal surgical procedures performed after completion of Phase I periodontal therapy, immediately stored at -80 °C, and processed for biochemical analysis. Comprehensive clinical periodontal measurements-including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), Plaque Index (PI), and Gingival Index (GI)-were recorded on the same day to evaluate periodontal status and inflammatory burden. ELISA was used to quantify iNOS and Arginase-1 levels in gingival tissues.

The primary objective of this study is to determine whether smoking shifts the macrophage phenotype toward a more pro-inflammatory M1 profile or suppresses M2-associated regulatory pathways in the context of periodontitis. The findings are expected to contribute to a better understanding of smoking-related alterations in periodontal immune mechanisms.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study population consisted of volunteer participants aged 18-65 years who were referred to the Department of Periodontology at Süleyman Demirel University Faculty of Dentistry for periodontal treatment and who met the inclusion criteria without violating any

排除标准

  • Exclusion Criteria:
  • Individuals who did not consent to participate in the study
  • History of any periodontal treatment within the past 6 months
  • Use of systemic antibiotics within the past 3 months
  • Pregnancy or lactation
  • Psychological or physical conditions that may interfere with cooperation during clinical examination
  • History of substance or alcohol abuse
  • Presence of severe malocclusion or ongoing orthodontic treatment
  • Acute dental pain due to caries, abscess, or other odontogenic infections
  • Presence of systemic diseases with oral manifestations or any systemic condition known to affect periodontal tissues
  • History of malignancy
  • Use of medications that can influence periodontal parameters (e.g., anti-inflammatory drugs) within the past 3 months
  • Participation in another scientific or clinical research study within the past 3 months

研究组 & 干预措施

Healthy Non-Smokers

Systemically healthy individuals who do not smoke and present with clinically healthy periodontal status. Gingival tissue samples were collected after completion of Phase I periodontal therapy during routine periodontal procedures.

Periodontitis Non-Smokers

Systemically healthy individuals diagnosed with periodontitis who do not smoke. Gingival tissue biopsies were obtained after completion of Phase I periodontal therapy during periodontal surgical procedures.

Healthy Smokers

Systemically healthy individuals who smoke (≥10 cigarettes/day) and exhibit clinically healthy periodontal status. Gingival tissue samples were collected after completion of Phase I periodontal therapy during periodontal procedures.

干预措施: Smoking Exposure (Other)

Periodontitis Smokers

Systemically healthy individuals who smoke (≥10 cigarettes/day) and are clinically diagnosed with periodontitis. Gingival tissue samples were collected after completion of Phase I periodontal therapy during periodontal surgical procedures.

干预措施: Smoking Exposure (Other)

结局指标

主要结局

Gingival iNOS Level

时间窗: At the time of periodontal surgery following completion of Phase I periodontal therapy.

Concentration of inducible nitric oxide synthase (iNOS) in gingival tissue biopsies measured by ELISA (ng/mg tissue).

Gingival Arginase-1 Level

时间窗: At the time of periodontal surgery following completion of Phase I periodontal therapy.

Concentration of Arginase-1 in gingival tissue biopsies measured by ELISA (ng/mg tissue).

次要结局

  • Probing Pocket Depth (PPD)(Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.)
  • Clinical Attachment Level (CAL)(Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.)
  • Bleeding on Probing (BOP)(Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.)
  • Plaque Index (PI)(Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.)
  • Gingival Index (GI)(Immediately prior to periodontal surgery, following completion of Phase I periodontal therapy.)

研究者

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

Asli Ege Ozdamar

PhD Candidate / Principal Investigator

Suleyman Demirel University

研究点 (1)

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