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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Salma hany Nadeem, BDS 2022
- Telefonnummer: (+2)01033719904
- E-post: salma.hany@dentistry.cu.edu.eg
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
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:
-
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Tidsram: Time Frame: Baseline, 6 months, 12 months, 18 months.
|
Time Frame: Baseline, 6 months, 12 months, 18 months.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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