跳至主要内容
临床试验/NCT07732127
NCT07732127招募中不适用

Early Detection of Initial Caries Using Fluorescent Starch Nano-particles Compared With Salivary Biomarkers

Menoufia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

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
Diagnosis of Initial Caries

研究概览

简要总结

Dental caries is one of the most prevalent chronic oral diseases worldwide and remains a major public health concern. The disease begins with microscopic demineralization of enamel, which is reversible if diagnosed at an early stage. Therefore, early detection of carious lesions is essential to implement preventive and minimally invasive treatment strategies before irreversible tooth destruction occurs.

详细描述

Conventional diagnostic methods, including visual-tactile examination, radiographic assessment, and caries detection systems such as the International Caries Detection and Assessment System (ICDAS), are routinely used to diagnose caries. However, these methods have several limitations. Visual examination depends greatly on the clinician's experience and often detects lesions only after visible changes in enamel have occurred.

Similarly, bitewing radiographs have limited sensitivity for detecting early enamel lesions because radiographic changes become evident only after considerable mineral loss. Consequently, many early carious lesions remain undetected until the disease has progressed.

In addition, saliva liquid sample had gained increasing attention as a valuable diagnostic method. Saliva contains numerous biological molecules that reflect the metabolic activity of the oral environment. Changes in salivary biomarkers associated with demineralization, inflammation, microbial activity, and host immune response may occur before obvious clinical manifestations become visible. Therefore, salivary biomarker analysis provides a non-invasive approach for detecting biological changes related to the initiation and progression of dental caries.

These limitations have encouraged the development of more sensitive, non-invasive diagnostic techniques capable of identifying carious lesions before irreversible structural damage becomes clinically apparent using fluorescent starch nano-particles. One of these emerging technologies is LumiCare mouth rinse, a fluorescence-based diagnostic aid that enhances the visualization of early enamel demineralization by highlighting areas of altered mineral content. This technique has the potential to improve the detection of initial carious lesions that may not be recognized using conventional clinical examination alone.

Recent research suggests that combining structural detection methods with biological indicators may significantly improve the diagnostic accuracy of early caries detection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •- Presence of at least one suspected initial enamel carious lesion.

排除标准

  • •Cavitated carious lesions
  • •Previous restorative treatment on the examined tooth
  • •Antibiotic therapy during the previous month,
  • •Systemic diseases affecting salivary secretion
  • •Xerostomia or salivary gland disorders

研究组 & 干预措施

Group B: Control Group

Placebo Comparator

About 30 healthy participants

干预措施: Fluorescent Starch Nano-particles (Procedure)

Group A: Caries Group

Active Comparator

About 30 participants will subject to Fluorescent Starch Nano-particles Compared with Salivary Biomarkers to detect the initial caries .

干预措施: Fluorescent Starch Nano-particles (Procedure)

结局指标

主要结局

Diagnosis of Initial Caries

时间窗: immediately after the intervention

Evaluation of the participants by Using Fluorescent Starch Nano-particles and Salivary Biomarkers in early detection of initial caries

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

walaa Mohammed

Lecturer at the conservative department, Faculty of Dentistry

Menoufia University

研究点 (1)

Loading locations...

相似试验