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Completed

NCT Number: NCT04854720

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

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.

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Key information

Conditions

Fissure Sealant

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fuji® II LC CAPSULE

Device

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.

Other names: Fuji® II LC CAPSULE, GC Corporation, Tokyo, Japan

Clinpro™ XT Varnish

Device

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.

Other names: Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA

Beautifil Flow

Device

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.

Other names: Beautifil Flow, Shofu, Kyoto, Japan

Fuji Triage® CAPSULE

Device

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.

Other names: Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan

Primary outcomes

  1. The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.

    Time frame: 18 months after the clinical applications

    The primary outcome of the study was the assessment of clinical retention rates at 18th months.

  2. The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.

    Time frame: 18 months after the clinical applications

    The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.

  3. The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.

    Time frame: 18 months after the clinical applications

    The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.

  4. The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.

    Time frame: 18 months after the clinical applications

    The primary outcome of the study was the assessment of secondary caries rates at 18th months.

Secondary outcomes

  1. The assessment of remineralization capacity using DIAGNOdent device

    Time frame: 18 months after the clinical applications

    The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 22, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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