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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04854720
Enrollment
182
Registered
2021-04-22
Start date
2019-03-10
Completion date
2021-01-11
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissure Sealant

Keywords

Conventional glass ionomer, fissure sealant, giomer, laser fluorescence, newly erupted teeth, resin modified glass ionomer

Brief summary

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.

Detailed 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.

Interventions

DEVICEFuji® 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.

DEVICEClinpro™ 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.

DEVICEBeautifil 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.

DEVICEFuji 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.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Randomization was performed by a computer-generated random sorting sequence (sealed in opaque envelopes that sequentially numbered randomly selected through).

Intervention model description

randomized controlled, three-arm parallel, single-blinded, split-mouth clinical trial

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.18 months after the clinical applicationsThe primary outcome of the study was the assessment of clinical retention rates at 18th months.
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.18 months after the clinical applicationsThe primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.18 months after the clinical applicationsThe primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.18 months after the clinical applicationsThe primary outcome of the study was the assessment of secondary caries rates at 18th months.

Secondary

MeasureTime frameDescription
The assessment of remineralization capacity using DIAGNOdent device18 months after the clinical applicationsThe secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026