跳至主要内容
临床试验/NCT05395455
NCT05395455已完成不适用

Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid, Salivary and Serum Interleukin-26 Levels in Stage III Grade B and C Periodontitis

Marmara University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
GCF IL-6 level (ng/ml)

研究概览

简要总结

The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF), saliva, and serum IL-26, IL-6, and IL-10 levels in stage III grade B periodontitis (SIII-GB-P) and C periodontitis (SIII-GC-P) patients. 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P participants were enrolled. At baseline, GCF, saliva, and serum samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment (NSPT). Clinical parameters and samples were re-collected at 1 and 3 months after NSPT. GCF, saliva, and serum IL-26, IL-6, and IL-10 were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

详细描述

Periodontitis is an inflammatory process that can result in tooth loss by destroying teeth-supporting tissues. Interleukin (IL) 26, is one of the recent members of the IL-10 cytokine family. The elevated level of IL-26 expression is associated with inflammatory disorders.

IL-6, a pro-inflammatory cytokine and is one of the important molecules in the regulation of inflammatory immune responses in periodontitis. IL-10, an anti-inflammatory cytokine, affects monocytes and macrophages and their immune mediator release.

This study is the first controlled clinical study that examines the levels of IL-26 in GCF, saliva, and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study GCF, salivary, and serum IL-26 and IL-6 levels will be high and GCF, salivary and serum IL-10 will be low in periodontitis groups, in contrast to the periodontal health the second hypothesis of this study is that after periodontal treatment, GCF, saliva, and serum IL-26 and IL-6 will decrease and GCF, saliva, and serum IL-10 will increase.

Based on these hypotheses, the aim of the study is; to compare the levels of IL-26, IL-6, and IL-10 in GCF, saliva, and serum of healthy controls, SIII-GB-P, and SIII-GC-P subjects and to evaluate the effect of periodontal treatment.

A total of 75 systemically healthy patients; 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P were included in this study. The clinical periodontal examination, including measurement of probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI) was performed at 6 sites per tooth, except the third molars. The presence of alveolar bone loss was assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.

研究设计

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

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy and non-smoker individuals
  • having ≥20 teeth present (except third molars)
  • individuals with periodontally healthy, stage III grade B and C periodontitis diagnoses

排除标准

  • having any diagnosed medical disorders
  • usage of antibiotics, non-steroidal anti-inflammatory drugs, and immunosuppressive agents within the past 6 months
  • having any non-inflammatory destructive periodontal disease
  • non-surgical/surgical periodontal therapy received in the past year
  • pregnant/ lactating/ postmenopausal females

结局指标

主要结局

GCF IL-6 level (ng/ml)

时间窗: Baseline to 1 month and 3 months after treatment

Change in GCF IL-6 levels from baseline to 1 month and 3 months after treatment

GCF IL-26 level (ng/ml)

时间窗: Baseline to 1 month and 3 months after treatment

Change in GCF IL-26 levels from baseline to 1 month and 3 months after treatment

GCF IL-10 level (ng/ml)

时间窗: Baseline to 1 month and 3 months after treatment

Change in GCF IL-10 levels from baseline to 1 month and 3 months after treatment

次要结局

  • Serum IL-6 level (ng/ml)(Baseline to 1 month and 3 months after treatment)
  • Saliva IL-6 level (ng/ml)(Baseline to 1 month and 3 months after treatment)
  • Serum IL-26 level (ng/ml)(Baseline to 1 month and 3 months after treatment)
  • Serum IL-10 level (ng/ml)(Baseline to 1 month and 3 months after treatment)
  • Saliva IL-26 level (ng/ml)(Baseline to 1 month and 3 months after treatment)
  • Saliva IL-10 level (ng/ml)(Baseline to 1 month and 3 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验