Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Difference in percentage change in probing pocket depth
研究概览
简要总结
27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received subgingival instrumentation and rubber cup polishing with pumice. In addition test sites received a single application of PDT using Fotosan® and photosensitizer consisting of toludine blue O solution. The subjects were recalled three and six months later and re-examined. Site level analysis was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health with no systemic diseases causing manifestation of periodontal diseases
- •Age ≥ 21 years
- •History of chronic periodontitis
- •At least two residual PPD ≥ 5 mm with or without bleeding on probing
- •Compliant with recalls, i.e. last SPT visit at most 6 months before start of trial
- •Able to give written informed consent
排除标准
- •Pregnant or lactating females
- •Local or systemic antibiotics intake in the past 3 months
- •Systemic conditions which could affect progression of periodontitis
- •Long term use of NSAIDs or immunosuppressive medications
- •Participation in other clinical trials
研究组 & 干预措施
Photodynamic therapy protocol
In addition to scaling and root debridement, test sites received PDT according to manufacturer's instructions.
干预措施: Fotosan 630, CMS Dental, Copenhagen, Denmark (Device)
SRP
Scaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste.
干预措施: Scaling and root planing (Other)
结局指标
主要结局
Difference in percentage change in probing pocket depth
时间窗: 6 months
次要结局
- Clinical attachment level(6 months)
- Recession(6 months)
- Bleeding on probing(6 months)
- Cytokines level(6 months)
研究者
Goh Xian Jun Edwin
Periodontology Resident
National University of Singapore