Evaluation of Clinical and Anti-Inflammatory efficacy of Berberine HCI Containing Mouth wash on Dental Plaque Induced Gingivitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- The Berberine HCl containing mouthwash has a significant anti-inflammatory and anti-plaque effect on the clinical
研究概览
简要总结
The study titled “Evaluation of Clinical and Anti-Inflammatory Efficacy of Berberine HCl Containing Mouthwash on Plaque-Induced Gingivitis” aims to assess the potential of Berberine HCl mouthwash as a natural alternative to chlorhexidine in managing plaque-induced gingivitis. Ninety-three patients with gingivitis will be divided into three groups using Berberine HCl mouthwash, 0.2% chlorhexidine, or saline rinse for 15 days. Clinical parameters—Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS)—and salivary levels of interleukin-4 (IL-4) and interleukin-6 (IL-6) will be evaluated at baseline, day 15, and day 21. Statistical analysis will compare the anti-plaque and anti-inflammatory effects among the groups. The study is expected to demonstrate that Berberine mouthwash offers comparable or superior clinical and biochemical benefits to chlorhexidine, making it an effective, herbal, and side effect–free alternative for gingivitis management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •18-40 years of age
- •Patients with moderate to severe gingivitis with a minimum of 20 permanent with gingival inflammation.
- •No previous history of periodontal surgery or consumption of antibiotics/anti-inflammatory medications in the past 6 months.
- •Systemically healthy.
排除标准
- •Patients suffering from systemic diseases, which may have an impact on the periodontium, such as diabetes mellitus and osteoporosis.
- •Uncooperative patients.
- •Patients on antibiotics and/or anti-inflammatory drugs.
- •Patients with a history of drug allergy or hypersensitivity reactions.
结局指标
主要结局
The Berberine HCl containing mouthwash has a significant anti-inflammatory and anti-plaque effect on the clinical
时间窗: Baseline, day 7, day 15, day 21
signs and biochemical levels of dental plaque-induced gingival inflammation.
时间窗: Baseline, day 7, day 15, day 21
次要结局
未报告次要终点
研究者
Dr Bhaskarya Bhaskar Bora
AB Shetty Dental College