To evaluate the efficacy and acceptability of the fluoridated toothpaste in its anti-plaque and anti-gingivitis properties in a pediatric population in the age group of 6 to 12 years – A non- randomized active controlled clinical trial.
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
T The study is a randomized controlled trial to check for the efficacy and acceptability of fluoridated toothpaste in a pediatric population. This study will be conducted across five centers in India with a total sample size of 300 pediatric patients. The primary outcome of the study is changes in the plaque and gingival scores and changes in the clinical signs of gingival inflammation. The secondary outcome is understanding products acceptability and tolerability through survey data points
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with plaque score 1 Subjects with gingival scores 1 and 2 Subjects showing signs of mild marginal gingival inflammation Subjects parent or guardian who agree to comply with all study requirements and are able to follow the study directions.
排除标准
- •gingival scores more than 2 orthodontic bands and five or more carious lesions History of allergies Subject on antibiotics Subject with five or more carious lesions requiring immediate restorative treatment.
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 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 products acceptability through survey data points(acceptability and tolerability to be assessed after 1 month)
研究者
Dr Ashok Dhoble
Indian Dental Association