Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars
18. august 2026 opdateret af: Galal Ali Mohamed Ebaid
Evaluation of the Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars: A Randomized Clinical Trial
This study will evaluate the clinical performance, Streptococcus mutans count, and salivary pH for Cention-N, Zirconomer, and resin-modified glass ionomer in Class I restoration of primary molars.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A vital aspect of overall health is dental health. Recurrent effects of oral disease on eating, sleeping, working, and social duties are subtle and widespread, and they collectively form a hidden pandemic.
The most widely used substitute for amalgam is glass ionomer cement (GIC), which has recognized the capacity to produce fluoride and played a major role in their growing application in dentistry.
The components of resin-modified GICs (RMGIC) are the same as those of ordinary glass-ionomers: polyacid, water, and basic glass powder. A monomer component and related initiator system are also present. RMGICs were created when monomeric ingredients such as 2-hydroxyethyl methacrylate (HEMA), urethane dimethacrylate (UDMA), and bisphenol-A-glycidyl methacrylate (Bis-GMA) were added to the ionomer composition.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Galal A Elkady, B.Sc
- Telefonnummer: 00201001375178
- E-mail: dr_galal86@yahoo.com
Studiesteder
-
-
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Cairo, Egypten, 11651
- Rekruttering
- Al-Azhar University (Faculty of Dentistry)
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Underforsker:
- Adel F Hussein, MD
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Kontakt:
- Galal A Elkady, B.Sc
- Telefonnummer: 00201001375178
- E-mail: dr_galal86@yahoo.com
-
Underforsker:
- Waleed O Kadour, MD
-
-
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
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Children aged between 4-9 years.
- Children who have Class I lesions in both the maxillary and mandibular arches.
- Primary molar teeth had class I carious lesions in occlusal pits and fissures; the gap between intercuspal surfaces should not be exceeded during cavity preparation.
- Primary molars free of periapical pathosis.
- Primary molars free root resorption.
Exclusion Criteria:
- Primary molars with preapical pathosis or hypersensitivity.
- Primary molars with periodontal diseases or mobile molar tooth that indicated for extraction.
- Nonfunctioning teeth with no opposing dentition; heavy occlusion or signs of severe attrition; and endodontically treated teeth.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group A
Primary molars with Class I cavity restoration using Cention-N material according to the manufacturer's instructions.
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Class I cavity restoration using Cention-N self-curing resin-based dental restorative material according to the manufacturer's instructions.
|
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Eksperimentel: Group B
Primary molars with Class I cavity restoration using Zirconomer material according to the manufacturer's instructions
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Class I cavity restoration using Zirconomer zirconia-reinforced glass ionomer restorative material according to the
|
|
Aktiv komparator: Group C
Primary molars with Class I cavity restoration using Resin-Modified Glass Ionomer (RMGI) material according to the manufacturer's instructions
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Class I cavity restoration using Resin-Modified Glass Ionomer (RMGI) restorative material according to the manufacturer's instructions
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Performance of Restorations
Tidsramme: 6 months post-restoration
|
Evaluation of the clinical performance of restorations using modified USPHS (FDI) criteria.
It systematically grades how restorative materials (like composite resins, glass ionomers, and ceramics) perform in the mouth over time
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6 months post-restoration
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Streptococcus Mutans Count
Tidsramme: 6 months post-restoration
|
Assessment of Streptococcus mutans bacterial count in saliva/plaque samples expressed in CFU/mL will be recorded.
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6 months post-restoration
|
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Salivary pH Level
Tidsramme: 6 months post-restoration
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Salivary pH changes will be measured using a digital pH meter.
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6 months post-restoration
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. august 2025
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
18. august 2026
Først indsendt, der opfyldte QC-kriterier
18. august 2026
Først opslået (Faktiske)
20. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1021/3954
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-delingstidsramme
After the end of study for one year.
IPD-delingsadgangskriterier
The data will be available upon a reasonable request from the corresponding author.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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