Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- clinical attachment level (CAL)
研究概览
简要总结
The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.
详细描述
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.
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)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant
排除标准
- •Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers
研究组 & 干预措施
main treatment group
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
干预措施: Phthalocyanine Dye (Drug)
main treatment group
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
干预措施: LASER assisted SRP (Drug)
control group
LASER assisted SRP
干预措施: LASER assisted SRP (Drug)
结局指标
主要结局
clinical attachment level (CAL)
时间窗: Change from baseline to 6-months.
Assessment of clinical attachment level (CAL, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
Release profile of the drug
时间窗: Change from baseline to 7-days.
Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
probing pocket depths (PPD)
时间窗: Change from baseline to 6-months.
Assessment of probing pocket depths (PPD, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
次要结局
- plaque index (PI)(Change from baseline to 6-months.)
- bleeding on probing (BOP)(Change from baseline to 6-months.)
研究者
Dr R Viswa Chandra
Primary Investigator
SVS Institute of Dental Sciences