Evaluating the Effect of Xylitol Wipes on Cariogenic Bacteria in Infants and Toddlers: A Longitudinal Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in salivary lactic acid level
研究概览
简要总结
This clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral bacteria associated with early childhood caries. A total of 20 healthy children aged 9 to 18 months are enrolled. Mothers are instructed to clean their children's teeth and gums using xylitol dental wipes three times daily after meals for four weeks. Saliva samples are collected at baseline and during weekly follow-up visits to measure lactic acid levels and mutans streptococci counts. A pediatric dentist examines each child at every visit to monitor general oral health and to check for any potential side effects. The study aims to assess the feasibility, safety, and potential preventive value of parent-applied xylitol wipes during early childhood.
详细描述
This longitudinal interventional study is designed to assess the preventive effect of xylitol-containing dental wipes on oral bacteria linked to early childhood caries (ECC). The study enrolls 20 healthy, caries-free infants and toddlers aged 9 to 18 months attending the Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University. After obtaining informed consent, mothers are instructed to use commercially available xylitol dental wipes (Spiffies Baby Tooth Wipes™, Dr. Products Inc., USA) to clean their children's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contains a xylitol-based solution intended to provide mechanical cleaning and daily exposure to approximately 4.2 g of xylitol.
Saliva samples are collected at baseline and at four weekly follow-up visits. Two primary outcome measures are assessed:
Lactic acid levels, using the Clinpro Cario-L-Pop chairside kit (3M ESPE, Germany) Mutans streptococci counts, using the CRT Bacteria Caries Risk Test (Ivoclar Vivadent, Liechtenstein) Participants are monitored weekly to assess compliance, document any dietary changes, and report potential side effects, including mild gastrointestinal symptoms. Children undergo oral examinations by a pediatric dentist at each visit to evaluate oral tissues and overall tolerance of the intervention.
The study protocol focuses on determining whether the regular use of xylitol wipes is feasible, acceptable to parents and children, and potentially useful as a preventive measure against early childhood oral bacterial activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants and toddlers aged 9 months to 18 months
- •Caries-free (no visible dental decay or white spot lesions)
- •Cooperative child and mother willing to participate for 4 weeks
- •Mother able to understand and follow instructions for xylitol wipe use
- •Written informed consent obtained from parent or legal guardian
排除标准
- •Infants or toddlers with systemic diseases or medical conditions affecting saliva
- •Use of antibiotics or antimicrobial mouth products within the past 4 weeks
- •Known allergy or sensitivity to xylitol or product components
- •Existing oral lesions or ongoing dental treatment
- •Non-compliance with study protocol or loss to follow-up
结局指标
主要结局
Change in salivary lactic acid level
时间窗: Baseline; weeks 1, 2, 3, and 4.
Description: Lactic acid level in saliva measured using the Clinpro Cario-L-Pop chairside kit. Unit of Measure: Lactic acid score (1-9 scale).
Change in salivary mutans streptococci (MS) count
时间窗: Baseline; weeks 1, 2, 3, and 4.
Description: Mutans streptococci colony density assessed using the CRT bacteria caries risk test. Unit of Measure: MS score (0-3 scale).
次要结局
- Parental compliance and tolerance to xylitol wipes(Weekly for 4 weeks.)
研究者
Omar Abdelsadek, BDS, MSc, PhD
Professor of Pediatric Dentistry
Alexandria University