Clinical Evaluation of SHOFU FX-LC RMGI Restoration Versus FUJI II RGMI in Management of Anterior Carious Cervical Lesions
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Salma hany Nadeem, BDS 2022
- Telefoonnummer: (+2)01033719904
- E-mail: salma.hany@dentistry.cu.edu.eg
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Patient inclusion:
- Adult Patients age >18 years.
- Males or Females
- Patients with good likelihood of recall availability.
Tooth inclusion:
- Permanent anterior teeth with cervical Class V, carious lesions (ICDAS 3-5)
- Vital and with positive reaction to cold stimulus.
- Well-formed and fully erupted teeth.
Exclusion Criteria:
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Patient exclusion:
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy Bruxism Habits.
- Last experience with allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment.
Tooth exclusion:
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Secondary carious lesions.
- Hypocalcified or hypoplastic teeth
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Tijdsspanne: Time Frame: Baseline, 6 months, 12 months, 18 months.
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Time Frame: Baseline, 6 months, 12 months, 18 months.
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Medewerkers en onderzoekers
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Primaire voltooiing (Geschat)
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 22051999
Plan Individuele Deelnemersgegevens (IPD)
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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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