Evaluation of Anti plaque effect of a novel herbal chewable tablet containing orange peel and syzygium cumini extract in patients undergoing orthodontic therapy : A Randomised controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Reduction in plaque index scores (Silness and Löe plaque index), Changes in gingival index (Löe and Silness), The Orthodontic Plaque Index(OPI) An oral hygiene index for patients with multibracket appliances.
研究概览
简要总结
The herbal dispersible chewable tablet is expected to demonstrate a significant reduction in plaque accumulation compared to chlorhexidine mouthwash. Improved patient compliance due to the palatability and ease of use of the chewable tablet. Minimal to no side effects compared to chlorhexidine. The study will provide evidence supporting a natural and effective alternative for plaque control in orthodontic patients, filling the existing gap in herbal oral care research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 17.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 17-25 years undergoing fixed orthodontic therapy.
- •Patients with no history of systemic diseases affecting oral health.
- •Willingness to comply with study protocol.
- •Patients undergoing fixed orthoodntics.
排除标准
- •History of periodontal therapy in the past 6 months.
- •Known allergies to Citrus or Herbal extracts.
- •Use of antibiotics or anti-inflammatory medications in the past month.
结局指标
主要结局
Reduction in plaque index scores (Silness and Löe plaque index), Changes in gingival index (Löe and Silness), The Orthodontic Plaque Index(OPI) An oral hygiene index for patients with multibracket appliances.
时间窗: 0,3,5,12 days
次要结局
- reported acceptability and compliance, and any adverse effects.(12 days)
研究者
Dr. Surekha Rathod
Rnajeet Deshmukh Dental College, Nagpur