Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Probing Depth
研究概览
简要总结
Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease characterized by rapid loss of attachment and alveolar bone occuring in young individuals. Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy, non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival recession, mobility were recorded at baseline and on day 63. Microbiological samples were obtained fom the sites with PD ≥5 mm at the same time points and evaluated for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia and Treponema denticola using micro-IDent test.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy,
- •non-smoker
- •not received any periodontal treatment within the last 6 months
- •no antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months
- •consent to participate in the study
排除标准
- •any systemic disease (i.e. diabetes mellitus, HIV infection) that might influence the prognosis of periodontal disease and outcome of the treatment
- •any medical condition that required antibiotic prophylaxis before the treatment
- •pregnancy and lactation
- •ingestion of antibiotics, anti-inflammatory drugs or any other medication during study period
- •any physical limitations or restrictions that might preclude normal oral hygiene procedures
研究组 & 干预措施
Control Group
NPT including scaling and root planing was applied to 12 subjects with ultrasonic and hand instruments until the operator feels that root surface is clean, hard and smooth.
干预措施: Ultrasonic (Device)
Control Group
NPT including scaling and root planing was applied to 12 subjects with ultrasonic and hand instruments until the operator feels that root surface is clean, hard and smooth.
干预措施: Hand Instruments (Device)
Test Group
Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.
干预措施: LED Source (Device)
Test Group
Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.
干预措施: Ultrasonic (Device)
Test Group
Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.
干预措施: Hand Instruments (Device)
结局指标
主要结局
Probing Depth
时间窗: 63 day
defined as the distance from the free gingival margin to the bottom of the periodontal pocket
次要结局
未报告次要终点