Effect of a PDT Protocol With Multiple Applications as an Adjuvant on the Non Surgical Treatment of Periodontal Disease in Patients With Type 2 Diabetes. A Clinical and Laboratorial Study in Humans
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level
研究概览
简要总结
The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will be selected and divided in two groups. On the treatment stage, the control group (Group C) will receive standard non surgical periodontal treatment. The Test Group (Group T) will be treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish 3 months. The follow-up will be done for 6 months. The clinical parameters measured will be: plaque index, pocket depth, bleeding on probing, relative clinical insertion level and suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1, TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The investigators expect to find identical or better results for the test group.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Poorly Controlled Type 2 Diabetes (HbA1c > 7%)
- •Advanced Chronic Periodontitis
- •Presence of 15 teeth
排除标准
- •Use on antiinflammatory drugs
- •Use of antibiotics less then 6 months before therapy
- •Positive for HIV
- •Periodontal treatment less then 6 months before therapy
- •Advanced complications of Diabetes
研究组 & 干预措施
Systemic Doxycycline
干预措施: Systemic Doxycycline and Sham aPDT (Drug)
aPDT+ Placebo
干预措施: aPDT + Doxycycline Placebo (Drug)
结局指标
主要结局
Clinical Attachment Level
时间窗: 0, 1 month, 3 months and 6 months
There will be analyzed the changes in clinical attachment level at the proposed experimental times. Clinical attatchment level is known as a proper outcome to evaluate periodontal disease progression or regression. It is measured as the distace between the deepet point fo the periodontal pocket and a stabilshed point, on the case of this study, the tooth occlusal surface.
次要结局
- Microbial Load(0, 3 months and 6 months)
研究者
Arthur Belem Novaes Jr
Chairman
University of Sao Paulo