Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Clinical attachment level
研究概览
简要总结
The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.
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, Outcomes Assessor)
盲法说明
Participants will be masked using a sham laser. Outcomes assessor will be blinded in relation to naming of the experimental groups.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity (grade II and III classified according to Body Mass Index)
- •Periodontitis stage II to IV
- •Presence of at least 20 teeth excluding 3rd molars.
排除标准
- •Alcohol or drugs consumption
- •Kidney disorders
- •Pregnancy or lactation
- •Use of antibiotics at the last 30 days
- •Use of drugs that alter periodontal structures as phenytoin or ciclosporin
- •Periodontal treatment at the last 6 months
研究组 & 干预措施
Control
Treatment of scaling and root planing.
干预措施: Control (Procedure)
Antimicrobial Photodynamic therapy adjunct to scaling and root planing
Treatment of scaling and root planing followed by antimicrobial photodynamic therapy with methylene blue (100 micrograms/ml) and red laser
干预措施: antimicrobial photodynamic therapy (aPDT) (Procedure)
结局指标
主要结局
Clinical attachment level
时间窗: Baseline, 1, 3 and 6 months
Changes in clinical attachment level measured from the cemento-enamel junction to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.
Probing depth
时间窗: Baseline, 1, 3 and 6 months
Changes in probing depth measured from the gingival margin to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.
次要结局
- Changes on bleeding on probing(Baseline, 1,3,and 6 months)
- Differences in proteomics(baseline, 3 and 6 months)
研究者
Carla Andreotti Damante
Associate professor
University of Sao Paulo