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NCT Number: NCT07732127

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

While LumiCare mouth rinse identifies early mineral changes within enamel, salivary biomarkers provide information regarding the biological activity of the disease.

The integration of both diagnostic approaches may overcome many of the limitations associated with conventional diagnostic methods and enable clinicians to identify initial carious lesions at a much earlier stage.

However, limited evidence is available regarding the combined use of LumiCare mouth rinse and salivary biomarkers for the diagnosis of initial enamel caries.Therefore, further clinical investigation is required to evaluate whether this combined approach offers superior diagnostic performance compared with conventional methods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescent Starch Nano-particles

Procedure

The evaluation of the diagnostic accuracy of LumiCare mouth rinse combined with salivary biomarkers for the early detection of initial enamel caries and to compare its diagnostic performance with conventional clinical diagnostic methods.

Other names: Salivary Biomarkers

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Walaa Mohamed Hassan, M.D

CONTACT

[email protected]

+201098246330

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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