Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries (CPP-ACP)
14. juli 2026 opdateret af: Mansoura University
Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries: Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years.
Participants will be randomly allocated into three groups. Remineralization and caries activity will be assessed using DIAGNOdent readings, International Caries Classification and Management System (ICCMS) criteria, and the decayed, missed, and filled surfaces (DMFS) index over a 12-month follow-up period.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ghada E Elhindawy
- Telefonnummer: 00201102668577
- E-mail: ghada.ezzat91@yahoo.com
Studiesteder
-
-
-
Al Mansurah, Egypten
- Rekruttering
- Faculty of Dentistry, Mansoura University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
Patients' ages should be 15-20 years. Patients should have at least three to four teeth with ICDAS II scores of 1-2. Patients should have moderate-to-high caries risk.
Exclusion Criteria:
Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: nano-eggshell varnish group 1
Nano-eggshell varnish will be professionally applied to the teeth surfaces every 3 months according to the manufacturer's instructions.
Participants will be instructed to avoid eating or drinking for at least 30 minutes after application.
|
Nano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries.
|
|
Eksperimentel: Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2
Participants will be instructed to apply CPP-ACP (GC tooth mousse) daily after tooth brushing at bedtime.
The material will be kept on the tooth surfaces for at least 3 minutes before rinsing.
|
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste was applied daily by participants after tooth brushing at bedtime and left on teeth for at least 3 minutes before rinsing.
|
|
Aktiv komparator: Sodium fluoride varnish (5%) group 3
Sodium fluoride varnish (5%) will be professionally applied every 3 months according to manufacturer instructions.
Participants will be instructed to avoid eating or drinking for at least 30 minutes after application.
|
5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in remineralization of initial enamel caries
Tidsramme: Baseline to 12 months
|
Change in remineralization of initial enamel caries measured by DIAGNOdent readings from baseline to 12 months.
When the DIAGNOdent reading decreases, it means good remineralization ability.
|
Baseline to 12 months
|
|
Change in DIAGNOdent readings
Tidsramme: Baseline, 3, 6, 9, and 12 months
|
The DIAGNOdent device will be used to quantify changes in enamel demineralization and remineralization over time.
Measurements will be recorded at different follow-up intervals
|
Baseline, 3, 6, 9, and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Caries activity assessment using ICCMS criteria
Tidsramme: Baseline, 3, 6, 9, and 12 months
|
Caries activity will be assessed using the International Caries Classification and Management System (ICCMS) criteria.
Lesions will be classified as active or inactive based on surface texture, appearance, and plaque stagnation area
|
Baseline, 3, 6, 9, and 12 months
|
|
Change in the Decayed, Missing, and Filled Surfaces (DMFS) index
Tidsramme: baseline, after 6 and 12 months
|
Dental caries experience will be evaluated using the Decayed, Missing, and Filled Surfaces (DMFS) index at baseline and after 6 and 12 months to assess overall changes in caries experience.
|
baseline, after 6 and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Sarhan M, El Baz M, Hamza O. Remineralization effect of eggshell powder on post-orthodontic white spot lesions compared to CPP-ACP: a randomized controlled clinical trial. Egyptian Dental Journal. 2021. 67(3): 2701-2710.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. december 2025
Primær færdiggørelse (Anslået)
20. december 2026
Studieafslutning (Anslået)
20. december 2026
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
17. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- M0409023PP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data available upon request
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .