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Clinical Trials/NCT07732127
NCT07732127RecruitingNot Applicable

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

Menoufia University1 site in 1 country60 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Diagnosis of Initial Caries

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Group B: Control Group

Placebo Comparator

About 30 healthy participants

Intervention: 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 .

Intervention: Fluorescent Starch Nano-particles (Procedure)

Outcomes

Primary Outcomes

Diagnosis of Initial Caries

Time Frame: immediately after the intervention

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

walaa Mohammed

Lecturer at the conservative department, Faculty of Dentistry

Menoufia University

Study Sites (1)

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