A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of two caries-detecting devices
研究概览
简要总结
The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and with QLF in determining caries progression. The secondary aim is to compare the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not.
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
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of TUSDM Comprehensive Care Clinic
- •Adult patients over the age of 21
- •Extreme/High Caries Risk classification per TUSDM Caries Management by Risk Assessment (CAMBRA) form
- •Presence of 2 or more initial active primary carious lesions on a free coronal surface of any tooth by visual assessment, QLF, and LumiCare™
- •Presence of at least 1 cavitated lesion
- •Updated (no more than 6 months old) bite wing radiographs available.
- •Patients who responded either yes/no to use of e-cigarettes/vapes
- •1 active caries, 1 inactive caries and 1 sound tooth surface.
排除标准
- •Low or moderate caries risk classification per TUSDM CAMBRA form
- •No clinically detectable carious lesions on free coronal surfaces
- •No cavitated caries lesions
- •Carious teeth with caries lesions concomitant with extrinsic stains, fluorosis, or developmental defects.
- •Patients who responded yes to the use of conventional cigarettes or smokeless tobacco
研究组 & 干预措施
All Participants
All participants enrolled in the study will have the two caries detecting devices used during each research visit.
干预措施: LumiCare rinse (Device)
All Participants
All participants enrolled in the study will have the two caries detecting devices used during each research visit.
干预措施: QLF Inspektor Pro Imaging (Device)
结局指标
主要结局
Comparison of two caries-detecting devices
时间窗: 12 months
Compare the effectiveness of the two caries detecting devices in their ability determining caries progression
次要结局
- Caries progression in those who do and do not use e-cigarettes/vapes(12 months)