Impact of Periodontitis on Metabolomics in Gingival Crevicular Fluid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Probing pocket depth
研究概览
简要总结
This cross-sectional observational study will compare the gingival crevicular fluid metabolomic profile of 30 adults with periodontitis and 30 periodontally healthy adults. Participants will undergo a periodontal examination and gingival crevicular fluid collection during a single study visit. Targeted metabolomic analysis will be used to identify differences between the two groups and associations with periodontal clinical parameters.
详细描述
Sixty adults will be enrolled: 30 with periodontitis and 30 with periodontal health. Gingival crevicular fluid will be collected using four sterile absorbent paper strips inserted sequentially into the deepest eligible periodontal site or gingival sulcus. The strips will be pooled in a coded tube and stored immediately at -20 °C. Blood-contaminated samples will be discarded. Laboratory personnel will be blinded to group allocation. Targeted metabolomic findings will be compared between groups and correlated with periodontal clinical parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years.
- •Ability to understand the study procedures and provide written informed consent.
- •For the periodontitis group: diagnosis of periodontitis according to the 2018 classification of periodontal diseases.
- •For the healthy control group: periodontal health according to the 2018 classification, with no current diagnosis or history of periodontitis.
排除标准
- •Periodontal treatment during the previous 6 months.
- •Use of antibiotics, non-steroidal anti-inflammatory drugs, or immunosuppressive agents during the previous 6 months.
结局指标
主要结局
Probing pocket depth
时间窗: Baseline
次要结局
未报告次要终点
研究者
Gaetano Isola
Prof.
University of Catania