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

Izmir Katip Celebi University

Status: Completed

Conditions: Fissure Sealant

Treatments: Device: Beautifil Flow; Device: Fuji® II LC CAPSULE; Device: Fuji Triage® CAPSULE; Device: Clinpro™ XT Varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT04854720

2018-TDU-DİŞF-0050

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 182 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 3 patient groups

Group 1 (Fuji II LC-Fuji Triage)

Experimental group

Description:

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).

Treatment:

Device: Fuji Triage® CAPSULE

Device: Fuji® II LC CAPSULE

Group 2 (Clinpro XT Varnish-Fuji Triage)

Experimental group

Description:

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).

Treatment:

Device: Fuji Triage® CAPSULE

Device: Clinpro™ XT Varnish

Group 3 (Beautiful Flow- Fuji Triage)

Experimental group

Description:

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).

Treatment:

Device: Fuji Triage® CAPSULE

Device: Beautifil Flow