Comparative Evaluation of the Effectiveness of Two Sugar-Free Herbal Lollipops in Promoting Oral Hygiene Among Children Aged 8–12 Years: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- improvement in oral hygiene
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of two sugar-free herbal lollipops containing moringa with natural sweeteners stevia and xylitol in promoting oral hygiene among children aged 8–12 years. The study evaluates their impact on plaque accumulation, and salivary pH levels over 30 day intervention period. Children will be randomly allocated to receive either stevia-moringa or xylitol-moringa lollipops, consumed twice daily. Clinical and microbiological parameters will be assessed at baseline and follow-up visits. The study seeks to explore a novel, child-friendly, non-invasive preventive approach for improving oral health and reducing cariogenic microbial load.
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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children, whose parents or caretakers provide consent to participate.
- •Children whose DMF less than two and caries risk assessment of the child is mild to moderate.
排除标准
- •Children reporting allergy to the plant or any of its constituents.
- •Children with a history of severe debilitating diseases.
- •Children with a history of antibiotics for the past 3-4 weeks.
结局指标
主要结局
improvement in oral hygiene
时间窗: Baseline, day 15, day 30
次要结局
- Improvement in oral hygiene(Baseline, day 15, day 30)
研究者
Lakshika sree K V
Chettinad Dental College and Research Institute