Comparative Evaluation of Two Different Formulations of Xylitol on Streptococcus mutans and Candida albicans in Children with Early Childhood Caries: A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To check the reduction in colony counts of Streptococcus Mutans and Candida Albicans
研究概览
简要总结
Enrollment of children of the age group 3-6 with early childhood caries will be done using the inclusion and exclusion criteria at the time of their first dental visit to the department. A total sample size of 44 (11 per group) isfound to be sufficient for this Randomised Control Trial.
Group Allocation:
Group 1: Fluoridated Toothpaste (FT) [Morning]
- Xylitol Wipes (XW) [Before Sleeping]
Group 2: Fluoridated Toothpaste (FT) [Morning]
- Placebo Wipes (PW) [Before Sleeping]
Group 3: Xylitol Toothpaste (XT) [Morning] + Placebo Wipes (PW) [Before Sleeping]
Group 4: Xylitol Toothpaste (XT) [Morning] + Xylitol Wipes (XW) [Before Sleeping]
Salivary sample collection will be done at baseline, at 1 month and at 2 months to check the reduction in Streptococcus Mutans and Candida Albicans colony counts.
Plaque accumulation will be assessed at baseline which is pre-intervention and at 1 month which is post-intervention.
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, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3-6 years.
- •Children with ECC, as per AAPD criteria
- •Frankl Rating 3 & 4
- •Subjects willing to comply with the study protocol.
排除标准
- •Children with systemic diseases or history of recent hospitalization
- •Consumption of antibiotics in the last 3 months.
- •Children who have previously used xylitol products regularly within the last 3 months.
- •Children lacking cooperative ability.
结局指标
主要结局
To check the reduction in colony counts of Streptococcus Mutans and Candida Albicans
时间窗: The outcome will be assessed at baseline, at 1 month and 2 months
次要结局
- To check the reduction in plaque accumulation(It will be assessed at baseline and at 1 month)
研究者
Dr Simran Singh
ITS Dental College, Hospital and Research Centre,47 Knowledge Park, Greater Noida