Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Recurrence of Black stains
研究概览
简要总结
The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:
Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?
Participants will:
Take chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative child to be able to perform and tolerate different oral hygiene procedures
- •Parents providing informed consent
- •Accept 18 weeks follow up period
- •Teeth showing black stains without calculus.
排除标准
- •Patients with Allergic reactions to food & drugs containing derivatives from crustacean organisms.
- •Taking any antibiotic drugs within 2- week period before sample collection.
- •Taking any dietary supplements containing iron.
- •Teeth selected should be free of caries
- •Free of any developmental defects
研究组 & 干预措施
Pediatric patients before and after using chitosan mouthwash
pediatric patients with black stains will be recruited in the study. Scaling and polishing will be done then followed up for 3 months, then scaling and polishing will be repeated after follow up period and the patient will be given chitosan mouthwash to be used for additional 3 months.
干预措施: Chitosan (Drug)
结局指标
主要结局
Recurrence of Black stains
时间窗: 36 weeks
次要结局
未报告次要终点
研究者
Rawda wagih Mostafa Hassan
Doctorate candidate in faculty of dental medicine Azhar university girls
Al-Azhar University