Periodontal Air-Polishing Device Reduces Tissue Damage and Improves Clinical Outcomes and Exosomal Modulation. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Bleeding on Probing (BOP)
研究概览
简要总结
This study looks at two common ways to perform deep cleaning of the gums in people with periodontitis: Airflow® (a spray system that uses fine powder and water) and hand scaling (cleaning with metal instruments). The investigators want to see how each treatment affects inflammation at the molecular level by measuring exosomes (tiny particles released by cells that carry signals) and cytokines (proteins that help regulate inflammation) in the fluid around the gums.
Participants will receive one of the two standard treatments and will have samples taken from the mouth (saliva and/or gum fluid) at specific times before and after treatment. The authors will also record clinical measurements such as bleeding, gum pocket depth, and attachment loss, as well as simple questionnaires about symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis patients
排除标准
- •Diabetes or other uncontrolled systemic inflammatory diseases
结局指标
主要结局
Bleeding on Probing (BOP)
时间窗: Pre-treatment and Re-Evaluation (4-6 weeks after treatment)
Description: Proportion of sites showing bleeding upon gentle probing. Unit of Measure: Percentage (%)
Periodontal Pocket Depth (PPD)
时间窗: Pre.treatment and 4-6 weeks after treatment
Description: Depth of periodontal pockets measured at six sites per tooth using a PCPUNC-15 probe. Unit of Measure: Millimeters (mm)
Periodontal Inflammation Severity Index (PIRIM, modified)
时间窗: Pre-treatment and 4-6 weeks after treatment.
Description: Calculated as the sum of periodontal pocket depth, normalized by the number of teeth. Unit of Measure: Index score (continuous variable, unitless)
Biochemical variables
时间窗: Pre-treatment and Re-Evaluation (4-6 weeks after treatment).
Concentration of exosomes and cytokines using a commercial kit, measured in pg/mL. Gingival Crevicular Fluid will be obtained using the Mombelli technique (introducing an absorbent paper point inside the periodontal pocket)
Clinical Attachment Loss (CAL)
时间窗: Pre-treatment and 4-6 weeks after treatment.
Description: Distance from the cementoenamel junction to the base of the pocket. Unit of Measure: Millimeters (mm)
Visible Plaque Index (VPI)
时间窗: Pre-treatment and 4-6 weeks after treatment.
Description: Proportion of sites with visible plaque. Unit of Measure: Percentage (%)
次要结局
未报告次要终点
研究者
Marco Bonilla
Research Intern, Dp of Periodontics
Universidad de Granada