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Early Detection of Initial Caries Using Fluorescent Starch Nano-particles Compared With Salivary Biomarkers
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Walaa Mohamed Hassan, M.D
- Telefoonnummer: +201098246330
- E-mail: walaamohammed700@dent.menofia.edu.eg
Studie Locaties
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Menoufia
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Shibīn al Kawm, Menoufia, Egypte
- Werving
- Menoufia Dental Hospital
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Contact:
- Walaa Mohamed Hassan, M.D
- Telefoonnummer: +201098246330
- E-mail: walaamohammed700@dent.menofia.edu.eg
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Contact:
- Mahmoud Ahmed Abdo Saeed, M.D
- Telefoonnummer: +201226567748
- E-mail: dr.mahmoudsaeed2014@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Group A: Caries Group
About 30 participants will subject to Fluorescent Starch Nano-particles Compared with Salivary Biomarkers to detect the initial caries .
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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.
Andere namen:
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Placebo-vergelijker: Group B: Control Group
About 30 healthy participants
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Diagnosis of Initial Caries
Tijdsspanne: immediately after the intervention
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Evaluation of the participants by Using Fluorescent Starch Nano-particles and Salivary Biomarkers in early detection of initial caries
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immediately after the intervention
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Walaa Mohamed Hassan, Lecturer, conservative department, Faculty of Dentistry, Menofia University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Initial Caries Early Detection
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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