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临床试验/NCT06178081
NCT06178081已完成不适用

Effect of Non-Surgical Periodontal Treatment on Biomarker Levels in Smoker and Non-Smoker Periodontitis Patients

Biruni University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1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
发起方
入组人数
100
试验地点
1
主要终点
Examination of IL-39 levels of periodontal disease and clinically healthy

研究概览

简要总结

Periodontitis is a destructive disease that follows untreated gingivitis and is characterized by gingival inflammation, clinical attachment loss, alveolar bone loss and periodontal pocket formation, increased tooth mobility and tooth loss. Although the primary etiological factor is microbial dental plaque, the host response plays an important role in the transition from periodontal health to disease. Smoking is a major risk factor for periodontitis and affects the formation and severity of the disease and healing after periodontal treatment by changing the host response to plaque. Proinflammatory and antiinflammatory cytokines have an important role in the pathogenesis of periodontal disease. Among these cytokines, interleukin (IL)-1β, IL-10 and currently IL-39 have been associated with periodontal disease. Further studies with post-treatment longitudinal evaluation are needed to elucidate the functions of IL-39 and its possible role in the pathogenesis of periodontal diseases. In this study, it was aimed to investigate the effects of non-surgical periodontal treatment on salivary and gingival crevicular fluid (GCF) IL-39, IL-1β and IL-10 levels in smokers and non-smokers with Stage 3 Grade B periodontitis and periodontally healthy individuals, both smokers and non-smokers. To the best of our knowledge, there is no study investigating the effects of non-surgical periodontal treatment and smoking on IL-39.

50 individuals with periodontitis and 50 periodontally healthy individuals (total 100 individuals) will be included in our study, and these two groups will be divided into two sub-groups as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), saliva and GCF samples will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be performed in individuals with periodontitis. Saliva and GCF samples will be collected before treatment. The clinical measurements, saliva and GCF collection will be repeated 12 weeks after the treatment. The saliva and GCF levels of IL-39, IL-1β and IL-10 will be analyzed by ELISA. Cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.

With this study, we aimed to develop IL-39 diagnostic kits for the diagnosis of periodontal diseases, detection of disease activity, follow-up of response to treatment and healing.

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

入选标准

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

排除标准

  • •Chronic alcohol use,
  • •Oral contraceptive use, pregnancy, pregnant,
  • •Last 6 months antibiotic or anti-inflammatory drug use,
  • •To have periodontal therapy in the last 6 months

研究组 & 干预措施

Clinical Healthy

Active Comparator

Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and gingival crevicular fluid will be taken from all individuals at the beginning of the study. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and gingival crevicular fluid will be collected from the clinically healthy group.

干预措施: Periodontal Healthy (Other)

Periodontitis

Experimental

Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and gingival crevicular fluid will be repeated 12 weeks after the treatment. IL-39 analysis will be performed by ELISA in saliva and gingival crevicular fluid of individuals. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis. 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.

干预措施: Periodontal Healthy (Other)

结局指标

主要结局

Examination of IL-39 levels of periodontal disease and clinically healthy

时间窗: up to 1 year

Examination of IL-39 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and saliva samples obtained from individuals with periodontitis.

次要结局

  • Evaluation of the effect of non-surgical periodontal treatment on changes in IL-39 level.(up to 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

Proffesor

Biruni University

研究点 (1)

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