Early Detection of Initial Caries Using Fluorescent Starch Nano-particles Compared With Salivary Biomarkers
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 28, 2026
July 1, 2026
12 months
July 23, 2026
July 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnosis of Initial Caries
Evaluation of the participants by Using Fluorescent Starch Nano-particles and Salivary Biomarkers in early detection of initial caries
immediately after the intervention
Study Arms (2)
Group A: Caries Group
ACTIVE COMPARATORAbout 30 participants will subject to Fluorescent Starch Nano-particles Compared with Salivary Biomarkers to detect the initial caries .
Group B: Control Group
PLACEBO COMPARATORAbout 30 healthy participants
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- Presence of at least one suspected initial enamel carious lesion.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menoufia Dental Hospital
Shibīn al Kawm, Menoufia, Egypt
Study Officials
- STUDY CHAIR
Walaa Mohamed Hassan, Lecturer
conservative department, Faculty of Dentistry, Menofia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer at the conservative department, Faculty of Dentistry
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 28, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 25, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share