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临床试验/NCT06150066
NCT06150066进行中(未招募)不适用

Evaluation of the Role of Smoking in the Peri-implantitis Pathogenesis

Mustafa Kemal University2 个研究点 分布在 2 个国家目标入组 96 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
96
试验地点
2
主要终点
The evaluation of the abundance of Prevotella intermedia in plaque samples

研究概览

简要总结

the primary aim of this project is to evaluate the microbiological and inflammatory effect of smoking status and smoking severity on periimplantitis lesions. The secondary aim is to compare the effect of smoking on periimplantitis and periodontal microbiota and inflammation in the same individuals.

There will include 96 patients, equally divided into four groups: Smokers with peri-implantitis (n=24), non-smoker individuals with peri-implantitis (n=24), smokers with healthy peri-implant tissues (n=24), non-smoker individuals with healthy peri-implant tissues (n=24).

Microbiological and biochemical analyses will be performed on the samples taken.

详细描述

The cross-sectional study will be carried out in collaboration with the Departments of Periodontology in the Faculty of Dentistry at Bern University, Switzerland, Hatay Mustafa Kemal University, Dokuz Eylul University, Gazi University, and Ege University, Turkey. The first step of the study will be carried out in Turkey, and the second step in Switzerland. Since Hatay is one of the three provinces most affected by the 2023 earthquake in Turkey and Hatay Mustafa Kemal University Dental School was severely damaged, it is impossible to recruit samples from the patients in Hatay. Therefore, this project has been planned as a multicenter, and patient samples will be recruited from the Dokuz Eylül, Gazi University, and Ege University, Department of Periodontology, Faculty of Dentistry. The samples will be analyzed in the Laboratory of Oral Microbiology, Department of Periodontology, University of Bern, Switzerland. The study protocol was approved by the Ethics Committee for the Use of Human Subjects in Research of Dokuz Eylul University (Protocol No: 2023/GOA-8246).

This study will include 96 patients, equally divided into four groups:

  • Smokers with peri-implantitis
  • Non-smoker individuals with peri-implantitis
  • Smokers with healthy peri-implant tissues
  • Non-smoker individuals with healthy peri-implant tissues

Smoking status will be categorized into two groups: smoker and non-smoker (never smoker). The non-smoker group will include former smokers who stopped smoking at least 6 years ago.

The cigarettes smoked per day, smoking index (self-reported average cigarettes per day x years of tobacco use), and smoking pocket year will be calculated (self-reported average cigarettes per day x years of tobacco use / the number of cigarettes in a pocket). Smoking status will be detected according to self-report. Smoking status will be later validated by saliva cotinine levels. Salivary cotinine concentration for smoking will be accepted at 5-7 ng/ml. Smoking severity will be determined by higher concentrations.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The evaluation of the abundance of Prevotella intermedia in plaque samples

时间窗: 2 months

The presence and abundance of Prevotella intermedia will be analysed by real-time Q-PCR in plaque samplse

The evaluation of the abundance of Tannerella forsythia in plaque samples

时间窗: 2 months

The presence and abundance of Tannerella forsythia will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Treponema denticola in plaque samples

时间窗: 2 months

The presence and abundance of Treponema denticola will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Saccharibacteria (TM7) in plaque samples

时间窗: 2 months

The presence and abundance of Saccharibacteria (TM7) will be analyzed by real-time Q-PCR in plaque samplse

The evaluation of the abundance of Streptococcus aureus in plaque samples

时间窗: 2 months

The presence and abundance of Streptococcus aureus will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Fusobacterium nucleatum

时间窗: 2 months

The presence and abundance of Fusobacterium nucleatum will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Actinomyces oris in plaque samples

时间窗: 2 months

The presence and abundance of Actinomyces oris will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Campylobacter rectus in plaque samples

时间窗: 2 months

The presence and abundance of Campylobacter rectus will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Aggregatinacter actinomycetemcomitans in plaque samples

时间窗: 2 months

The presence and abundance of Aggregatinacter actinomycetemcomitans will be analysed by real-time Q-PCR in plaque samples

The evaluation of the abundance of Porphyromonas gingivalis in plaque samples

时间窗: 2 months

The presence and abundance of Porphyromonas gingivalis will be analysed by real-time Q-PCR in plaque samples

次要结局

  • The evaluation of 8-OHdG, PARK7/DJ-1, and NADPH oxidase levels in GCF and saliva samples(2 months)
  • The evaluation of IL-1beta, IL-17A/E, and osteoprotegerin (OPG) levels in GCF and saliva samples(2 months)
  • The evaluation of MMP-8 and MMP-3 levels in GCF and saliva samples(2 months)
  • The evaluation of bone morphogenic protein (BMP)-2, epidermal growth factor (EGF), and vascular endothelial growth factor (VEGF) levels in GCF and saliva samples(2 months)

研究者

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

Aysegul SARI

PhD, Assistant professor

Mustafa Kemal University

研究点 (2)

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