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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07732127
Enrollment
60
Registered
2026-07-28
Start date
2026-07-01
Completion date
2027-07-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Initial Caries

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. 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.

Interventions

PROCEDUREFluorescent Starch Nano-particles

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.

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of Initial Cariesimmediately after the interventionEvaluation of the participants by Using Fluorescent Starch Nano-particles and Salivary Biomarkers in early detection of initial caries

Countries

Egypt

Contacts

CONTACTWalaa Mohamed Hassan, M.D
walaamohammed700@dent.menofia.edu.eg+201098246330
STUDY_CHAIRWalaa Mohamed Hassan, Lecturer

conservative department, Faculty of Dentistry, Menofia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026