NCT05682833Unknown不适用
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
General Objective :
To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning
Specific Objective :
To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age : 20-60 years old
- •At least 20 remaining teeth
- •Periodontitis stage III and IV ,Grade A, B and C
排除标准
- •Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory
- •Previous periodontal therapy in the past 3-6 months.
- •Immunocompromised patients
- •Systemically diseased patients: Diabetes ,osteoporosis etc
- •History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid
- •Pregnant or lactating women.
- •Heavy Smokers (more than 20/day)
研究组 & 干预措施
Test
Experimental
NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application
干预措施: Non surgical periodontal therapy (Procedure)
Control
Placebo Comparator
NS therapy + Placebo gel subgingival application
干预措施: Non surgical periodontal therapy (Procedure)
结局指标
主要结局
Clinical attachment level
时间窗: 2 months
Bleeding on Probing
时间窗: 2 months
pocket depth
时间窗: 2 months
次要结局
- Plaque index(2 months)
研究者
Zahi BADRAN
Professor
University of Sharjah
研究点 (1)
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