NCT06523244尚未招募不适用
Comparison of Photo Disinfection With Chitosan Nanoparticles Enriched ICG Over ICG as an Adjunct to Open Flap Debridement in Stage II/III Grade B/C Periodontitis. RCT
Krishnadevaraya College of Dental Sciences & Hospital0 个研究点目标入组 24 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- MICROBIAL ANALYSIS
研究概览
简要总结
The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis.
详细描述
A total of 24 patients fulfilling inclusion criteria will be randomly assigned into two treatment groups (Test and Control). Open flap debridement followed by photodynamic therapy using dyes is carried out.
Test group (n=12) - PDT with Chitosan nanoparticles enriched ICG Control group(n=12) - PDT with ICG Microbial levels of P.gingivalis is analysed with PCR analysis on baseline and 3 months after intervention.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy subjects
- •Age group 30-55yrs.
- •Diagnosed with Stages II/III grade B/C periodontitis.
- •Presenting with persistent pocket depth ≥5mm after initial non-surgical therapy.
- •Optimal plaque control
- •Good compliance
排除标准
- •Subjects on antibiotic therapy within last six months of enrollment
- •Previous history of periodontal surgery
- •Allergy to drugs and materials used in this study
- •Pregnant woman
- •Subjects with deleterious habits like smoking, tobacco chewing.
结局指标
主要结局
MICROBIAL ANALYSIS
时间窗: 3 MONTHS
LEVELS OF P. GINGIVALIS
次要结局
未报告次要终点
研究者
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