Evaluation of efficacy and acceptability of herbal toothpaste in the reduction of plaque and gingival inflammation in healthy adult population – A Multicentric pilot study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Changes in the Plaque and Gingival scores
研究概览
简要总结
The study is an open-label multi-centric clinical trial conducted across 5 centers across India. Total sample size of the study is 300. The study aims to assess the efficacy and efficiency of the toothpaste in its antiplaque and anti-gingivitis properties and to evaluate the acceptability, tolerability, and safety of the toothpaste among the adult population.
The primary outcome of the study is changes in the plaque and gingival scores and changes in the clinical signs of gingiva inflammation. The secondary outcome is the assessment of its acceptability and tolerability through survey data points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with plaque scores above 1 Subjects with gingival scores between 1 and 2 Subjects showing signs of mild marginal gingival inflammation.
排除标准
- •Subjects with gingival scores more than 2 Subjects with a known history or present condition of hypersensitivity to any toothpaste, The use of antibiotics, antimicrobial, analgesic medications, mouthwash, or desensitizing toothpaste during the previous one month, Any history of periodontal therapy by surgical interventions, History of dentine hypersensitivity treatment History of smoking or smokless tobacco products Subjects who are pregnant, lactating or nursing Subjects with severe calculus or tartar Subjects with uncontrolled medical illness like HIV, hepatitis etc.
结局指标
主要结局
Changes in the Plaque and Gingival scores
时间窗: Plaque and gingival score to be assessed at 1 | monthi.e at 1st followup 2 months i.e at2nd | followup and 3 months i.e at 3rd followup
Changes in the clinical signs of marginal gingival inflammation
时间窗: Plaque and gingival score to be assessed at 1 | monthi.e at 1st followup 2 months i.e at2nd | followup and 3 months i.e at 3rd followup
次要结局
- Understanding of the products acceptability through survey data points(acceptability and tolerability to be assessed after)
研究者
Dr Ashok Dhoble
Indian Dental Association