Effect of Photodynamic Therapy on Gingival Crevicular Cytokines in Periodontitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Changes from baseline clinical attachment level at 3rd month and 6th month
研究概览
简要总结
Systemically healthy periodontitis patients were recruited in this single-blind, split-mouth, randomized controlled clinical trial. After SRP, PDT was applied at probing depth (PD) ≥ 4 mm at test quadrant. At baseline, 3rd month and 6th month, clinical parameters and cytokine pattern in gingival crevicular fluids (GCFs) were analysed.
详细描述
Periodontal parameters and cytokine IL-1β, IL-6, IL-8, TNF-α, MMP-8 levels were analysed.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Allocation of test and control quadrants were done randomly by asking each study participant to choose either numbers "1" or "2". Number "1" defined quadrants 1 and 3 as the test quadrants while number "2" referred to quadrants 2 and 4 as the test quadrants. The remaining quadrants served as the control quadrants.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults who were medically fit or have medical condition that did not alter the outcome of periodontal treatment.
- •Females who were not pregnant or nursing.
- •Controlled diabetes mellitus with HbA1c < 7.5 mmol/L.
- •Not on any antibiotics or steroids 3 months prior to periodontal treatment.
- •Diagnosed to have either localized or generalized chronic or aggressive periodontitis (Armitage, 1999) with all 4 quadrants having at least 2 sites with probing depth ≥ 4 mm.
- •Consented to follow the non-surgical periodontal treatment (scaling and root planing) with PDT throughout the period of study, i.e. approximately 6 months.
排除标准
- •Allergic to photosensitizer or dye
- •Pregnant lady and nursing mothers
- •Uncontrolled diabetes
研究组 & 干预措施
SRP and Fotosan 630
Scaling and root planing, photodynamic therapy using Fotosan 630
干预措施: SRP and Fotosan 630 (Device)
Control
Scaling and root planing only
结局指标
主要结局
Changes from baseline clinical attachment level at 3rd month and 6th month
时间窗: 3 months and 6 months
Clinical attachment level in mm
Changes from baseline Interleukin-8 level at 3rd month and 6th month
时间窗: 3 months and 6 months
Interleukin-8 level in gingival crevicular fluid
Changes from baseline Matrix metalloproteinase-8 level at 3rd month and 6th month
时间窗: 3 months and 6 months
Matrix metalloproteinase-8 level in gingival crevicular fluid
Changes from baseline bleeding score at 3rd month and 6th month
时间窗: 3 months and 6 months
Bleeding score in percentage
Changes from baseline Interleukin-6 level at 3rd month and 6th month
时间窗: 3 months and 6 months
Interlekin-6 level in gingival crevicular fluid
Changes from baseline Tumour necrosis factor-alpha level at 3rd month and 6th month
时间窗: 3 months and 6 months
Tumour necrosis factor-alpha level in gingival crevicular fluid
Changes from baseline probing depth at 3rd month and 6th month
时间窗: 3 months and 6 months
Clinical probing depth in mm
Changes from baseline gingival recession level at 3rd month and 6th month
时间窗: 3 months and 6 months
Gingival recession level in mm
Changes from baseline Interleukin-1 level at 3rd month and 6th month
时间窗: 3 months and 6 months
Interleukin-1 level in gingival crevicular fluid
次要结局
未报告次要终点
研究者
Foo Lean Heong
Periodontic Resident, Faculty of Dentistry
National University of Singapore