"Comparative evaluation of efficacy of combination of resveratrol, chitosan, neem and curcumin gel and Chlorhexidine gel as an adjunct to scaling and root planing (SRP) in patients with periodontitis- A randomised controlled clinical trial."
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Relative Attachment Level (RAL)
研究概览
简要总结
There are various local drug delivery systems available, but since long, Chlorhexidine has been one of the most effective topical antimicrobial agent used. However there are some inevitable side effects of chlorhexidine likebrown discoloration of teeth, some restorative materials and also dorsum of tongue , taste disturbances where the salty taste perception is particularly affected, oral mucosal erosion and unilateral or bilateral parotid swelling. Resveratrol has potent antioxidant, antitumor and anti-inflammatory effects that benefit the treatment of some diseases, such as cancer, diabetes, cardiovascular disorders , degenerative diseases, autoimmune diseases and metabolic diseases. The combination of Resveratrol and curcumin have additive or possibly even synergistic effects with respect to host modulation. Hence this study will analyze the efficacy of Resveratrol, Chitosan, Neem & Curcumin (Amfresh) gel and chlorhexidine gel as a local drug delivery in periodontal pocket in chronic periodontitis patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient diagnosed with Generalised periodontitis stage 2 grade 2 currently unstable with no risk factor
- •Patients with persistent pocket depth of minimum 4 -6 mm having minimum of 2-3 sites.
- •Systemically healthy subjects.
排除标准
- •History of any previous periodontal therapy in the last 6 months.
- •2.Use of drugs such as antibiotics, anti-inflammatory, corticosteroids, chemotherapeutics or immunological modulators that might alter the expected response of the oral tissues.
- •Tobacco consumption in any form.
- •Systemic diseases influencing the periodontal disease.
- •Pregnant and lactating women.
- •Allergy to chlorhexidine and Resveratrol, Chitosan, Neem & Curcumin (Amfresh) gel.
结局指标
主要结局
Relative Attachment Level (RAL)
时间窗: Baseline, 1 month and 3 months.
Plaque index (PI) (Silness J, Lo¨e H. 1964)
时间窗: Baseline, 1 month and 3 months.
Probing Pocket Depth (PPD)
时间窗: Baseline, 1 month and 3 months.
次要结局
- Gingival Index (GI) (Loe and Silness, 1963)(Sulcus Bleeding Index.(SBI)(Muhlemann H.R & Son,1971))