Microbial Testing for Caries Risk Assessment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Count of Strep Mutans bacterial
研究概览
简要总结
Specific Aims
- Assess CG (Cariogenic) Saliva-Check Mutans® saliva testing for identification of high caries risk patients
详细描述
Hypotheses and Specific Aims
Hypotheses CG Saliva-Check Mutans will test positive in children with clinical caries.
Specific Aims
- Assess CG Saliva-Check Mutans saliva testing for identification of high caries risk patients
Background and Significance
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Provider and investigator will know if child has clinical caries or not at the time of saliva sample.
入排标准
- 年龄范围
- 24 Months 至 96 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be a patient of record at Children's Hospital Colorado Dental Center
- •Child must fall between 24 and 96 months of age
- •Child must present with full primary dentition
排除标准
- •Patients with a complex medical history classified as being greater than ASA II
- •Patients with recent dose of antibiotics within the previous two weeks or who present with a low caries risk set forth by the AAPD
研究组 & 干预措施
Child with full primary dentition
All children who match inclusion criteria are eligible to have a saliva sample obtained which will act as a proxy for bacterial levels. High bacteria levels are correlated with a higher risk of developing cavities.
干预措施: GC Strep Mutans Saliva Sampling (Device)
结局指标
主要结局
Count of Strep Mutans bacterial
时间窗: 4 weeks
Bacterial (MS) samples resulting in〖5x10〗\^5 colony-forming units per milliliter of saliva (CFU/mL) indicates a low caries risk. In contrast, \>〖5x10〗\^5 CFU/mL of MS in a saliva sample correlates to a moderate or high caries risk. This study is designed to use saliva sampling to determine a non-surgical adjunctive therapy to help lower cavity causing bacteria.
次要结局
- Plaque Index(4 weeks)