The Effect of Non-surgical Periodontal Treatment on Serum and Gingival Crevicular Fluid Periostin Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Evaluation of Periostin levels in non-surgical periodontal treatment
研究概览
简要总结
Two different studies were planned from the recruited samples. The aim of these studies was to investigate the effect of non-surgical periodontal treatment on the inflammatory markers levels in serum and gingival crevicular fluid (GCF) in patients with periodontitis.
There were two groups consisting of individuals who had periodontitis and those who were healthy, with 24 individuals in each group.
Periostin levels were assessed at baseline, at the 24th h, 48th h, 14th day 1st month, 3rd month after non-surgical periodontal treatment in serum and GCF samples by the Elisa method in the first study. In parallel, interleukin 1 (IL)-beta and fibroblast growth factor levels were measured.
Progranulin levels were assessed at baseline, at the 24th h, 48th h, 14th day 1st month, 3rd month after non-surgical periodontal treatment in serum and GCF samples by the Luminex method in the second study. In parallel, vascular endothelial growth factor, IL-1 beta, tumor necrosis factor-alpha, and IL-10 levels were measured.
详细描述
The First Study
The observational prospective study was designed to characterize periostin changes over time after non-surgical periodontal treatment in serum and GCF in the Department of Periodontology in the Faculty of Dentistry at Hatay Mustafa Kemal University, Hatay, Turkey. The study protocol was approved by the Ethics Committee for the Use of Human Subjects in Research of Hatay Mustafa Kemal University (Protocol No: 2019/118). The study was carried out in accordance with the tenets of the Declaration of Helsinki and conducted in CONSORT guidelines (Schulz, Altman, & Moher, 2010). This study project was financially supported by Hatay Mustafa Kemal University Scientific Research Projects Coordinator (19M051).
Individuals were included in the study from December 2019 through August 2021. Written informed consent was obtained from each participant before the clinical periodontal examination.
Study Population
Forty-eight adult individuals were enrolled in the study. Participants were recruited into 2 sex matched groups with 24 participants in each: periodontally healthy (PH) and periodontitis (P) groups. In accordance with the demographic variables of the patients included in the P group, the patients in the PH groups were included.
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
- Single (Participant)
入排标准
- 年龄范围
- 24 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals who had never smoked;
- •individuals who had no history of periodontal treatment in the past 6 months;
- •individuals who had had no antibiotic therapy in the past 3 months;
- •individuals who had more than 18 teeth.
排除标准
- •individuals who were pregnant;
- •individuals were current or former smokers;
- •individuals who had any self-reported systemic condition or disease, which are confounding factors e.g. AIDS, rheumatoid arthritis, cardiovascular diseases, diabetes.
结局指标
主要结局
Evaluation of Periostin levels in non-surgical periodontal treatment
时间窗: 0-3 month
The effect of non-surgical periodontal treatment on serum and gingival crevicular fluid periostin levels
次要结局
- Evaluation of IL-1B and FGF levels in non-surgical periodontal treatment(0-3 month)
研究者
Aysegul SARI
Scientific research projects
Mustafa Kemal University