Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Izmir, Turquie
- Izmir Katip Celebi University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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).
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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.
Autres noms:
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.
Autres noms:
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Expérimental: 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).
|
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.
Autres noms:
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.
Autres noms:
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Expérimental: 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).
|
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.
Autres noms:
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
Délai: 18 months after the clinical applications
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The primary outcome of the study was the assessment of clinical retention rates at 18th months.
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18 months after the clinical applications
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The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.
Délai: 18 months after the clinical applications
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The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
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18 months after the clinical applications
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The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.
Délai: 18 months after the clinical applications
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The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
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18 months after the clinical applications
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The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.
Délai: 18 months after the clinical applications
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The primary outcome of the study was the assessment of secondary caries rates at 18th months.
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18 months after the clinical applications
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The assessment of remineralization capacity using DIAGNOdent device
Délai: 18 months after the clinical applications
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The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.
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18 months after the clinical applications
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2018-TDU-DİŞF-0050
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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