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临床试验/NCT06809439
NCT06809439已完成不适用

Comparison of Salivary RANKL, OPG, IL-10, IL-1β and Cortisol Levels with Non-surgical Periodontal Treatment in Periodontitis Patients Living in Two Different Geographical Regions in Turkey

Karabuk University4 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2023年1月2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
77
试验地点
4
主要终点
Study population, pre-treatment and post-treatment periodontal clinical parameters

研究概览

简要总结

Periodontitis is a multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. Immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of inflammatory mediators such as IL-1β. It is thought that IL-10 has a regulatory role by limiting the initiation and progression of the acute inflammatory response with its anti-inflammatory effect. The high detection of RANKL and RANKL/OPG ratios in periodontitis indicates that these markers play a role in bone destruction. Elucidating the connections between the immune system and bone-related cytokines will contribute significantly to the resolution of these complex mechanisms underlying periodontal diseases. Risk factors for periodontal diseases include gender, age, smoking and some hereditary factors. Cortisol is an important marker of psychological stress. It is emphasized that stress and depression reduce immune system function and cause chronic inflammation. Thus, it indirectly provokes periodontal tissue destruction.

详细描述

This study consists of patients and healthy volunteers. Saliva will be collected only once from healthy volunteers; from patients at the beginning and after non-surgical periodontal treatments are performed by the researchers. In the collected saliva; clinical parameters and salivary RANKL, OPG, IL-10, IL-1β, cortisol levels will be determined in periodontitis and periodontally healthy individuals living in two different geographical regions in Turkey (Ankara -Erzurum); it will be determined whether non-surgical periodontal treatment has an effect on cytokines determined in saliva and clinical status at the end of 1-month follow-up period; periodontal pathogenesis and host response will be evaluated in smoker and non-smoker groups. Analyses will be performed by ELISA method.

The study is based on the hypothesis that "different regional and geographical conditions determining climate, culture, environment, life, stress situations affect the course of periodontitis disease and host response". A regional comparison will be made between markers that affect the course of periodontitis disease and play a role in its pathogenesis in patients with different climate, living and cultural conditions, according to location.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 35-60 years of age
  • good cooperation
  • a minimum of 20 permanent teeth, excluding third molars

排除标准

  • systemic diseases
  • taking any medications
  • received antibiotic treatment in the last three months
  • those who had undergone periodontal treatment six months ago
  • pregnant or breastfeeding patients
  • prosthetic restorations
  • undergoing orthodontic treatment

结局指标

主要结局

Study population, pre-treatment and post-treatment periodontal clinical parameters

时间窗: up to 4 weeks

This study included 10 systemically healthy non-smokers from Ankara with stage III, grade B generalized periodontitis, 8 smokers with stage III, grade C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers. In Erzurum, systemically healthy, 9 non-smokers, stage III B generalized periodontitis , 6 smokers (≥10/day), stage III C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers were included. Clinical parameters of probing depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP) were recorded . All clinical measurements were made after saliva samples were taken and recorded as initial values. The periodontal index form was used for this purpose. (https://www.periodontalchart-online.com/uk/) Nonsurgical periodontal treatments lasted 4 weeks. Baseline and post-treatment periodontal parameters were compared.

次要结局

  • Salivary biomarkers(up to 2 months)

研究者

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

Sevilay Yeğinoğlu

Asst Prof Dr

Karabuk University

研究点 (4)

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