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临床试验/NCT06175624
NCT06175624已完成不适用

Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Biomarker Levels

Biruni University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年12月1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
75
试验地点
2
主要终点
Examination of CTRP-1 levels of periodontal disease and clinically healthy

研究概览

简要总结

Periodontal diseases are one of the most common inflammatory diseases. Periodontitis results from products and antigens of microorganisms, which stimulates the innate immune system and local inflammatory response; characterized by gingival inflammation, attachment loss, and alveolar bone destruction. Molecules that play a role in the pathogenesis of periodontal disease can be used as biomarkers in the early diagnosis of periodontitis, in determining the rate of periodontal destruction, and in evaluating the response to periodontal treatment.

CTRPs (C1q/TNF-related proteins), which are adiponectin paralogs, are involved in inflammation, lipid, and glucose metabolism, as well as physiological and pathological processes like vasodilation. CTRP-1 is a glycoprotein belonging to the CTRP family that can be detected in serum in the presence of certain antibodies. Serum CTRP-1 levels increase in type 2 diabetes, prediabetes, coronary artery diseases, congestive heart failure, and atherosclerosis. Lipopolysaccharides found in Gram-negative bacteria cell walls stimulate the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α and interleukin (IL)-1 β, as well as indirectly increasing the production of CTRP-1. CTRP-1 is a therapeutic target in many inflammatory diseases, including periodontal diseases. However, there are no clinical studies on the role of CTRP-1 in the pathogenesis of periodontal disease. Based on these findings, the goal of our research is to examine the effects of periodontal disease on CTRP-1, IL-10, and TNF-α levels in serum and gingival crevicular fluid samples taken before and after periodontal treatment from periodontally healthy individuals and individuals with gingivitis and periodontitis, and also determine whether CTRP-1 is a potential biomarker that can be used in the diagnosis of periodontal disease.

25 patients with periodontitis, 25 with gingivitis and 25 healthy periodontals (total of 75 individuals) will be included in our study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, and bleeding on probing), serum and gingival crevicular fluid samples will be taken from all individuals. Non-surgical periodontal treatment will be applied in quadrant wise within 2 weeks to individuals with gingivitis and periodontitis. 12 weeks after treatment; the clinical measurements and the collection of serum and gingival crevicular fluid will be repeated. Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.

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

入选标准

  • Periodontal healthy group
  • Stage III Grade B 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 and cigarette use,
  • Oral contraceptive use, pregnancy, pregnant,
  • Use of antibiotics or anti-inflammatory drugs within the last 6 months,
  • Having undergone periodontal treatment in the last 6 months.

结局指标

主要结局

Examination of CTRP-1 levels of periodontal disease and clinically healthy

时间窗: up to 1 year

Examination of CTRP-1 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and serum samples obtained from individuals with periodontitis.

Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.

时间窗: up to 1 year

Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.

Comparison biomarkers of study groups.

时间窗: up to 1 year

Comparison of gingival crevicular fluid and serum samples taken before treatment in individuals with periodontitis in terms of CTRP-1 levels.

次要结局

未报告次要终点

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 (2)

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