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Clinical Evaluation of SHOFU FX-LC RMGI Restoration Versus FUJI II RGMI in Management of Anterior Carious Cervical Lesions

8. november 2026 opdateret af: Salma Hany Mohamed Saeed, Cairo University

Clinical Evaluation of Acrylamide Based RMGI Restoration Versus Conventional Resin Modified Glass Ionomer in Management of Patients Having Anterior Carious Cervical Lesions: A Randomized Clinical Trial.

The development of resin-modified glass ionomers (RMGIs) represents a strategic evolution designed to augment the mechanical performance of conventional glass ionomers. By incorporating a resin matrix, these materials achieve notable physical improvements, including superior fracture toughness, increased resistance to occlusal wear, and higher resilience to moisture degradation, alongside the clinical advantage of a prolonged working time. (Hübel 2003)However, an excessive proportion of hydrophobic multifunctional monomers within the RMGI matrix suppresses the essential aqueous acid-base reaction.

To overcome conventional resin modified glass ionomer drawbacks, FX-LC tried to overcome it by incorporating a new multifunctional acrylamide monomer called New Generation Acrylamide monomer (NGA monomer) with which they claim that it exhibits high water solubility due to its four amide bonds (-CO-NH-) and demonstrates high polymerization reactivity, even in the presence of water. It has unique properties that are not found in conventional multifunctional monomers

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient inclusion:

    1. Adult Patients age >18 years.
    2. Males or Females
    3. Patients with good likelihood of recall availability.

Tooth inclusion:

  1. Permanent anterior teeth with cervical Class V, carious lesions (ICDAS 3-5)
  2. Vital and with positive reaction to cold stimulus.
  3. Well-formed and fully erupted teeth.

Exclusion Criteria:

  • Patient exclusion:

    1. Participants with general/systemic illness.
    2. Pregnant or lactating females.
    3. Concomitant participation in another research study.
    4. Inability to comply with study procedures.
    5. Heavy Bruxism Habits.
    6. Last experience with allergic reactions against any components of the used materials.
    7. Patients receiving orthodontic treatment.

Tooth exclusion:

  1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  2. Non-vital teeth, Fractured or cracked teeth.
  3. Secondary carious lesions.
  4. Hypocalcified or hypoplastic 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: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SHOFU FX-LC RMGI

After rubber dam isolation, the prepared cavities will be conditioned using Dentin conditioner (GlasIonomer FX-LC Conditioner, Japan) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (SHOFU FX- LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds.

The mixture then is extruded directly out of capsule into prepared cavities with a capsule gun ensuring that no air bubbles will be included.

FX-LC is RMGI which incorporates New Generation Acrylamide monomer, After rubber dam isolation, the prepared cavities will be conditioned using Dentin conditioner (GlasIonomer FX-LC Conditioner, Japan) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (SHOFU FX- LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds.

The mixture then is extruded directly out of capsule into prepared cavities with a capsule gun ensuring that no air bubbles will be included.

Light curing unit will be used to cure the material for 10 seconds with a visible light unit at 470 nm, holding the light as close to the surface as possible, according to manufacturer instruction.

Aktiv komparator: FUJI II RMGI

Cavities will be conditioned using using Dentin conditioner (GC Dentine ConditionerS) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (Fuji II LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds. The mixture then is extruded directly out of capsule into prepared cavity with a capsule gun ensuring that no air bubbles will be included.

light curing unit will be used to cure the material for 20 seconds with a visible light unit at 470 nm, holding the light as close to the surface as possible, according to manufacturer instruction.

FUJI II, Conventional resin modifies glass ionomer will bwe applied. Cavities will be conditioned using using Dentin conditioner (GC Dentine ConditionerS) 10-20% polyacrylic acid for 20 seconds then will be rinsed with copious amount of water for 15 seconds and dried with oil free compressed air for 5 seconds till the surface had a matte shiny appearance.

The (Fuji II LC) capsule will be inserted into a high-speed amalgamator (Mix 2000, Carlo De Giorgi, Milano, Italy) and triturated for 10 seconds. The mixture then is extruded directly out of capsule into prepared cavity with a capsule gun ensuring that no air bubbles will be included.

light curing unit will be used to cure the material for 20 seconds with a visible light unit at 470 nm, holding the light as close to the surface as possible, according to manufacturer instruction.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Tidsramme: Time Frame: Baseline, 6 months, 12 months, 18 months.
Time Frame: Baseline, 6 months, 12 months, 18 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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 (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

8. november 2026

Først indsendt, der opfyldte QC-kriterier

8. november 2026

Først opslået (Faktiske)

13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 22051999

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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