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Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars

1. května 2021 aktualizováno: Merve AKCAY, Izmir Katip Celebi University

Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial

The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.

The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.

Typ studie

Intervenční

Zápis (Aktuální)

182

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Krocan
      • Izmir, Krocan
        • Izmir Katip Celebi University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

5 let až 9 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
  • Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
  • Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
  • Children who haven't any systemic disease that prevents the application,
  • Cooperative children who allowed the clinical applications.

Exclusion Criteria:

  • Teeth with proximal and initial caries,
  • Teeth with applied fissure sealant,
  • Teeth with developmental defects such as hypoplasia and restorations,
  • Non-cooperative children who don't allow the clinical applications,
  • Children and parents who denied the participation in the follow-up appointments.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Group 1 (Fuji II LC-Fuji Triage)
In Group 1, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Fuji® II LC, GC Corporation, Tokyo, Japan) (test 1). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).
Přístroj: Fuji® II LC CAPSULE

Fuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth.

Test 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions.

Ostatní jména:
  • Fuji® II LC CAPSULE, GC Corporation, Tokyo, Japan
Přístroj: Fuji Triage® CAPSULE

Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth.

Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.

Ostatní jména:
  • Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan
Experimentální: Group 2 (Clinpro XT Varnish-Fuji Triage)
In Group 2, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA) (test 2). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).
Přístroj: Fuji Triage® CAPSULE

Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth.

Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.

Ostatní jména:
  • Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan
Přístroj: Clinpro™ XT Varnish

Clinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products.

Test 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions.

Ostatní jména:
  • Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA
Experimentální: Group 3 (Beautiful Flow- Fuji Triage)
In Group 3, newly erupted mandibular permanent first molars were sealed with Giomer containing fissure sealant material (Beautifil Flow, Shofu, Kyoto, Japan) (test 3). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).
Přístroj: Fuji Triage® CAPSULE

Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth.

Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.

Ostatní jména:
  • Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan
Přístroj: Beautifil Flow

Beautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant.

Test 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions.

Ostatní jména:
  • Beautifil Flow, Shofu, Kyoto, Japan

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
Časové okno: 18 months after the clinical applications
The primary outcome of the study was the assessment of clinical retention rates at 18th months.
18 months after the clinical applications
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.
Časové okno: 18 months after the clinical applications
The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
18 months after the clinical applications
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.
Časové okno: 18 months after the clinical applications
The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
18 months after the clinical applications
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.
Časové okno: 18 months after the clinical applications
The primary outcome of the study was the assessment of secondary caries rates at 18th months.
18 months after the clinical applications

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The assessment of remineralization capacity using DIAGNOdent device
Časové okno: 18 months after the clinical applications
The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.
18 months after the clinical applications

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Izmir Katip Celebi University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. března 2019

Primární dokončení (Aktuální)

16. listopadu 2020

Dokončení studie (Aktuální)

11. ledna 2021

Termíny zápisu do studia

První předloženo

18. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

18. dubna 2021

První zveřejněno (Aktuální)

22. dubna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. května 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. května 2021

Naposledy ověřeno

1. května 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 2018-TDU-DİŞF-0050

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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