Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Halitosis
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health.
- Participants will be asked to visit the clinic once a week for exam and treatment during 1 month.
- After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.
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, Investigator, Outcomes Assessor)
盲法说明
Simulation of laser treatment
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
- •Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria
- •Stage 3 or 4 periodontitis
- •No periodontal treatment in the previous 12 months
- •a minimum of 20 remaining teeth.
排除标准
- •Alcohol-dependent individuals
- •Pregnant or lactating women
- •Patients with renal disorders
- •Patients using medications that affect the periodontium
研究组 & 干预措施
aPDT - antimicrobial photodynamic therapy
Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.
干预措施: Photodynamic Therapy with Conventional Methylene Blue (Procedure)
Control
Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper
干预措施: Scaling and root planing (Procedure)
结局指标
主要结局
Halitosis
时间窗: From enrollment to the end of treatment at 6 months
Measurement of oral volatile compounds by gas chromatography
次要结局
- Probing depth(From enrollment to the end of treatment at 6 months)
- Clinical Attachment level(From enrollment to the end of treatment at 6 months)
研究者
Carla Andreotti Damante
Clinical Professor - Principal investigator
University of Sao Paulo