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临床试验/NCT05372965
NCT05372965已完成不适用

The Effects of Smoking on miRNA-223 Before and After Non-Surgical Periodontal Therapy

Biruni University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2022年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Evaluation of the effect of non-surgical periodontal treatment on changes in miRNA-223 expressions,

研究概览

简要总结

Periodontal diseases are one of the most common inflammatory diseases. Periodontal disease results from a complex interplay between the subgingival biofilm and the host immune-inflammatory events that develop in the gingival and periodontal tissues in response to the challenge presented by the bacteria. The net result of these inflammatory changes is the breakdown of the fibers of the periodontal ligament, resulting in clinical loss of attachment together with resorption of the alveolar bone. It is known that smoking is a major risk factor for periodontitis and affects the occurrence and severity of the disease and recovery after periodontal treatment by changing the host response to plaque. Biomarkers can be used to diagnose periodontitis early, to determine the rate of destruction, and also to evaluate the response to treatment. It has been reported that microRNAs (miRNAs) play an important role in development, homeostasis and immune functions, and abnormal miRNA expression may increase the severity of disease progression. It can be thought that early diagnosis can be achieved with the detection of miRNAs in patients with periodontitis, thus helping to prevent bone and tooth loss. To the best of our knowledge, there is no study in the literature investigating the effects of periodontal treatment and smoking on miRNAs in saliva or gingival samples. From this point of view, the aim of our study is to examine and compare miRNA-223 expressions in saliva and tissue samples before and after non-surgical periodontal treatment in individuals with periodontitis and to investigate the effect of smoking on miRNA-223 levels.

Materials-Methods: Our study will include 42 people with periodontitis and 42 healthy periodontal patients (84 individuals in total), and these two groups will be divided into two as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be applied to individuals with periodontitis, gingival samples will be collected during the treatment, clinical measurements and saliva collection will be repeated 6 weeks after the treatment. MiRNA-223 gene expression analysis will be performed by real-time PCR method in saliva and gingival samples of individuals. MiRNA-223 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.

With our study, it is aimed to better illuminate the role of miRNA-223 in periodontitis and also to determine which sample is more reliable by comparing miRNA-223 levels in saliva and tissue samples. Thus, the first step towards the development of diagnostic kits in the future will be taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

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

  • Periodontal healthy group
  • Stage III Grade B-C Periodontitis Group
  • To meet the above-mentioned periodontal health and disease criteria

排除标准

  • Periodontal tissues, periodontal disease course, periodontal application training and to have,
  • Chronic alcohol use,
  • Oral contraceptive use, pregnancy, pregnant,
  • Last 6 system or anti-inflammatory drug use,
  • To have developed periodontal in the last 6 months.

结局指标

主要结局

Evaluation of the effect of non-surgical periodontal treatment on changes in miRNA-223 expressions,

时间窗: 6 weeks after the non surgical periodontal therapy

Non-surgical periodontal treatment will be applied to individuals with periodontitis, gingival samples will be collected during the treatment, clinical measurements and saliva collection will be repeated 6 weeks after the treatment.

Examining the effect of smoking, which is one of the main risk factors of periodontitis, on miRNA-223 levels and

时间窗: through study completion, an average of 1 year

the aim of our study is to examine and compare miRNA-223 expressions in saliva and tissue samples before and after non-surgical periodontal treatment in individuals with periodontitis and to investigate the effect of smoking on miRNA-223 levels.

Examination of miRNA-223 expressions, which are stated to be associated with periodontal disease, in saliva and gingival samples obtained from individuals with periodontitis,

时间窗: During study (up to 1 year)

With our study, it is aimed to better illuminate the role of miRNA-223 in periodontitis and also to determine which sample is more reliable by comparing miRNA-223 levels in saliva and tissue samples. Thus, the first step towards the development of diagnostic kits in the future will be taken.

次要结局

  • to determine which sample is more reliable by comparing miRNA-223 levels in saliva and tissue samples(through study completion, an average of 1 year)

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu KARADUMAN

Doç. Dr.

Biruni University

研究点 (2)

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