跳至主要内容
临床试验/NCT06152081
NCT06152081招募中不适用

A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools

Tufts University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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