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临床试验/NCT06523205
NCT06523205尚未招募不适用

Evaluation of the Relationships Between Salivary Tenascin C ,IL-4, IL-6, and IL-1β Levels, Smoking and Periodontal Status

Necmettin Erbakan University0 个研究点目标入组 100 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Periodontal clinical parameters (percentage bleeding on probing (BOP))

研究概览

简要总结

The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are:

Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease?

Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will:

Provide saliva samples. Be categorized based on their smoking status and periodontal condition.

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 periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Agreeing to participate in the study

排除标准

  • use of oral contraceptive drugs
  • use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study;
  • history of excessive alcohol use;
  • pregnancy or breastfeeding status;
  • periodontal treatment during the last 6 months before the study.
  • Not agreeing to participate in the study
  • Not meeting the inclusion criteria

结局指标

主要结局

Periodontal clinical parameters (percentage bleeding on probing (BOP))

时间窗: baseline

The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include percentage bleeding on probing (BOP) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth. Percentage Bleeding on Probing (BOP) Unit: Percentage (%)

Periodontal clinical parameters (Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD))

时间窗: baseline

The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include probing pocket depth (PPD) and clinical attachment level (CAL) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth. Clinical Attachment Level (CAL) Unit: Millimeters (mm) Probing Pocket Depth (PPD) Unit: Millimeters (mm)

1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI))

时间窗: baseline

The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include plaque index (PI) and gingival index (GI) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth. Gingival Index (GI) Unit: Numerical score Plaque Index (PI) Unit: Numerical score

Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples

时间窗: baseline

Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples (ng/L) Unit: Picograms per milliliter (pg/mL) Tenascin C, IL-1β, IL-4 and IL-6 levels will be assayed with commercially available kits using the enzyme-linked immunosorbent assay (ELISA) method.

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

Osman Babayigit

Assistant Professor

Necmettin Erbakan University

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